Levofloxacin Eye Drops


Pronunciation: lee-voe-FLOX-ah-sin
Generic Name: Levofloxacin
Brand Name: Quixin
Levofloxacin Eye Drops are used for:

Treating eye infections caused by bacteria sensitive to Levofloxacin Eye Drops. It may also be used for other conditions as determined by your doctor.

Levofloxacin Eye Drops are a fluoroquinolone eye drop. It works by blocking bacteria from reproducing in the eye.

Do NOT use Levofloxacin Eye Drops if: you are allergic to any ingredient in Levofloxacin Eye Drops or any other fluoroquinolone antibiotic (eg, ciprofloxacin, gatifloxacin)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Levofloxacin Eye Drops:

Some medical conditions may interact with Levofloxacin Eye Drops. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Levofloxacin Eye Drops. Because little, if any, of Levofloxacin Eye Drops are absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Levofloxacin Eye Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Levofloxacin Eye Drops:

Use Levofloxacin Eye Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Levofloxacin Eye Drops are only for the eye. Do not get it in your nose or mouth. To use Levofloxacin Eye Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them. To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed. Do not wear contact lenses while you are using Levofloxacin Eye Drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them. Levofloxacin Eye Drops works best if it is used at the same time each day. To clear up your infection completely, use Levofloxacin Eye Drops for the full course of treatment. Keep using it even if you feel better in a few days. Do not miss any doses of Levofloxacin Eye Drops. If you miss a dose of Levofloxacin Eye Drops, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Levofloxacin Eye Drops.

Important safety information: Levofloxacin Eye Drops may cause dizziness or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Levofloxacin Eye Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Be sure to use Levofloxacin Eye Drops for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. Long-term or repeated use of Levofloxacin Eye Drops may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this. If you notice vision changes, vaginal irritation or itching, or white patches in your mouth, contact your doctor at once. Diabetes patients - Levofloxacin Eye Drops may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Levofloxacin Eye Drops should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Levofloxacin Eye Drops while you are pregnant. Levofloxacin Eye Drops are found in breast milk. Do not breast-feed while taking Levofloxacin Eye Drops. Possible side effects of Levofloxacin Eye Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Eye dryness; eye pain, burning, or discomfort; feeling of something in the eye; fever; headache; sensitivity to light; sore throat; strange taste; temporary decreased vision.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); eyelid itching; eye or eyelid swelling.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Levofloxacin Eye Drops:

Store Levofloxacin Eye Drops at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Levofloxacin Eye Drops out of the reach of children and away from pets.

General information: If you have any questions about Levofloxacin Eye Drops, please talk with your doctor, pharmacist, or other health care provider. Levofloxacin Eye Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Levofloxacin Eye Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Levofloxacin resources Levofloxacin Use in Pregnancy & Breastfeeding Levofloxacin Support Group 0 Reviews for Levofloxacin - Add your own review/rating Compare Levofloxacin with other medications Conjunctivitis, Bacterial Ophthalmic Surgery


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Levofloxacin


Pronunciation: LEE-voe-FLOX-a-sin
Generic Name: Levofloxacin
Brand Name: Levaquin

Levofloxacin is associated with an increased risk of tendon problems. These include pain, swelling, inflammation, and possible breakage of tendons. The risk of tendon problems is greater in patients who are older than 60 years, patients who take corticosteroids (eg, prednisone), and in those who have received kidney, heart, or lung transplants. The Achilles tendon in the back of the foot/ankle is most often affected. However, problems may also occur in other tendons (eg, in the shoulder, arm, or hand). Problems may occur while you take Levofloxacin or up to several months after you stop taking it.

Signs of tendon problems may include pain, soreness, redness, or swelling of a tendon or joint; bruising right after an injury in a tendon area; hearing or feeling a snap or pop in a joint or tendon area; or inability to move or bear weight on a joint or tendon area. Tell your doctor right away if you experience any of these symptoms while you take Levofloxacin or within several months after you stop taking it.

Levofloxacin may worsen muscle weakness and breathing problems in patients with myasthenia gravis. Do not take Levofloxacin if you have a history of myasthenia gravis.


Levofloxacin is used for:

Treating infections caused by certain bacteria. It may also be used to prevent or slow anthrax after exposure.

Levofloxacin is a quinolone antibiotic. It works by killing sensitive bacteria.

Do NOT use Levofloxacin if: you are allergic to any ingredient in Levofloxacin or to any other quinolone antibiotic (eg, ciprofloxacin) you have a certain type of irregular heartbeat (QT prolongation, long QT syndrome) or low blood potassium levels you have a history of myasthenia gravis you are taking cisapride or certain antiarrhythmics (eg, amiodarone, procainamide, quinidine, sotalol)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Levofloxacin:

Some medical conditions may interact with Levofloxacin. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of severe or persistent diarrhea, skin sensitivity to the sun, diabetes, low blood potassium levels, chest pain, angina, heart problems (eg, enlarged heart, heart failure), a heart attack, irregular heartbeat (eg, QT prolongation), or if you have a family member with a history of fast, slow, or irregular heartbeat (eg, QT prolongation) if you have a stomach infection, liver problems, brain or nervous system problems, muscle problems (eg, myasthenia gravis), increased pressure in the brain, Alzheimer disease, brain blood vessel problems, or a history of seizures if you have a history of bone, joint, or tendon problems; rheumatoid arthritis; liver problems; kidney problems or decreased kidney function; or a heart, kidney, or lung transplant if you take corticosteroids (eg, prednisone) or participate in strenuous physical work or exercise

Some MEDICINES MAY INTERACT with Levofloxacin. Tell your health care provider if you are taking any other medicines, especially any of the following:

Antiarrhythmics (eg, amiodarone , procainamide, quinidine, sotalol), arsenic, astemizole, cisapride, dofetilide, droperidol, haloperidol, imidazoles (eg, ketoconazole), macrolides (eg, erythromycin), methadone, paliperidone, phenothiazines (eg, chlorpromazine), pimozide, ranolazine, serotonin receptor antagonists (eg, dolasetron), telithromycin, terfenadine, or ziprasidone because the risk of serious heart problems, including irregular heartbeat, may be increased Insulin or oral diabetes medicines (eg, glyburide) because the risk of high or low blood sugar may be increased Corticosteroids (eg, prednisone) because the risk of tendon problems may be increased Anticoagulants (eg, warfarin) because the risk of bleeding may be increased Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) or theophylline because the risk of serious side effects, including seizures, may be increased Serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine) because the risk of their side effects may be increased by Levofloxacin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Levofloxacin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Levofloxacin:

Use Levofloxacin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Levofloxacin comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Levofloxacin refilled. Drinking extra fluids while you are taking Levofloxacin is recommended. Check with your doctor for instructions. Levofloxacin is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Levofloxacin at home, a health care provider will teach you how to use it. Be sure you understand how to use Levofloxacin. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Do not use Levofloxacin if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. Levofloxacin works best if it is used at the same time each day. To clear up your infection completely, use Levofloxacin for the full course of treatment. Keep using it even if you feel better in a few days. Do not miss any doses of Levofloxacin. If you miss a dose of Levofloxacin, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Levofloxacin.

Important safety information: Levofloxacin may cause dizziness or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Levofloxacin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor. Levofloxacin only works against bacteria; it does not treat viral infections (eg, the common cold). Be sure to use Levofloxacin for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. Long-term or repeated use of Levofloxacin may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this. Tell your doctor right away if you experience pain or swelling of a tendon or weakness or loss of use of a joint area. Rest the area and avoid exercise until further instruction from your doctor. Levofloxacin may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Levofloxacin. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. If you are scheduled to receive a typhoid vaccine while you are using Levofloxacin, talk with your doctor. Levofloxacin may decrease the effectiveness of the vaccine. Diabetes patients - Levofloxacin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Levofloxacin may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Levofloxacin. Lab tests, including liver and kidney function and complete blood cell counts, may be performed while you use Levofloxacin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Levofloxacin with caution in the ELDERLY; they may be more sensitive to its effects (eg, tendon problems), especially if they take corticosteroids (eg, prednisone). They may also be more sensitive to other effects (eg, irregular heartbeat, liver problems). Levofloxacin should be used with extreme caution in CHILDREN younger than 18 years; they may be more sensitive to its effects, especially joint and tendon problems. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Levofloxacin while you are pregnant. Levofloxacin is found in breast milk. Do not breast-feed while using Levofloxacin. Possible side effects of Levofloxacin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; gas; headache; light-headedness; nausea; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody or tarry stools; chest pain; decreased or painful urination; fainting; fast or irregular heartbeat; fever, chills, sore throat, or unusual cough; hallucinations; inability to move or bear weight on a joint or tendon area; moderate or severe sunburn; mood or mental changes (eg, new or worsening anxiety, nervousness, agitation, confusion, depression, restlessness, sleeplessness); muscle pain or weakness; new or worsening nightmares; pain, soreness, redness, swelling, weakness, or bruising of a tendon or joint area; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea; severe or persistent dizziness, light-headedness, tiredness, or weakness; severe or persistent stomach pain or cramps; shortness of breath or trouble breathing; suicidal thoughts or actions; symptoms of high or low blood sugar (eg, dizziness; fainting; fast breathing; flushing; increased thirst, hunger, or urination; increased sweating; vision changes); symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the skin or eyes); symptoms of nerve problems (eg, changes in perception of heat or cold; decreased sensation of touch; unusual burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet); tremors; unusual bruising or bleeding; vaginal discharge, irritation, or odor; vision changes; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Levofloxacin:

Levofloxacin is usually handled and stored by a health care provider. If you are using Levofloxacin at home, store Levofloxacin as directed by your pharmacist or health care provider. Keep Levofloxacin out of the reach of children and away from pets.

General information: If you have any questions about Levofloxacin, please talk with your doctor, pharmacist, or other health care provider. Levofloxacin is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Levofloxacin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Levofloxacin resources Levofloxacin Use in Pregnancy & Breastfeeding Drug Images Levofloxacin Drug Interactions Levofloxacin Support Group 157 Reviews for Levofloxacin - Add your own review/rating Levofloxacin Prescribing Information (FDA) Levofloxacin Professional Patient Advice (Wolters Kluwer) Levofloxacin Monograph (AHFS DI) levofloxacin Advanced Consumer (Micromedex) - Includes Dosage Information Levaquin Prescribing Information (FDA) Levaquin Consumer Overview Compare Levofloxacin with other medications Anthrax Anthrax Prophylaxis Bacterial Infection Bladder Infection Bronchitis Chlamydia Infection Epididymitis, Sexually Transmitted Gonococcal Infection, Disseminated Gonococcal Infection, Uncomplicated Kidney Infections Nongonococcal Urethritis Nosocomial Pneumonia Otitis Media Pelvic Inflammatory Disease Pneumonia Prostatitis Sinusitis Skin Infection Streptococcal Infection Tuberculosis, Active Urinary Tract Infection


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Levofloxacin Tablets



FULL PRESCRIBING INFORMATION Warning
Fluoroquinolones, including levofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants [see Warnings and Precautions (5.1)].
Fluoroquinolones, including levofloxacin,  may exacerbate muscle weakness in persons with myasthenia gravis. Avoid levofloxacin in patients with a known history of myasthenia gravis [see Warnings and Precautions (5.2)]. Indications and Usage for Levofloxacin Tablets
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Levofloxacin Tablets and other antibacterial drugs, Levofloxacin Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
 
Levofloxacin Tablets are indicated for the treatment of adults (?18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed in this section. Levofloxacin injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).
Culture and susceptibility testing
 
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Clinical Pharmacology (12.4)]. Therapy with Levofloxacin Tablets may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected.
 
As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with Levofloxacin Tablets. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance. Nosocomial Pneumonia
Levofloxacin Tablets are indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal ?-lactam is recommended [see Clinical Studies (14.1)]. Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen
Levofloxacin Tablets are indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.2)].
 
MDRSP isolates are strains resistant to two or more of the following antibacterials: penicillin (MIC ?2 mcg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole. Community-Acquired Pneumonia: 5-day Treatment Regimen

Levofloxacin Tablets are indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.3)].

Acute Bacterial Sinusitis: 5-day and 10 to 14 day Treatment Regimens

Levofloxacin Tablets are indicated for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies (14.4)].

Acute Bacterial Exacerbation of Chronic Bronchitis

Levofloxacin Tablets are indicated for the treatment of acute bacterial exacerbation of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.

Complicated Skin and Skin Structure Infections

Levofloxacin Tablets are indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis [see Clinical Studies (14.5)].

Uncomplicated Skin and Skin Structure Infections
Levofloxacin Tablets are indicated for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes. Chronic Bacterial Prostatitis
Levofloxacin Tablets are indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis [see Clinical Studies (14.6)]. Complicated Urinary Tract Infections: 5-day Treatment Regimen

Levofloxacin Tablets are indicated for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis [see Clinical Studies (14.7)].

Complicated Urinary Tract Infections: 10-day Treatment Regimen
Levofloxacin Tablets are indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa [see Clinical Studies (14.8)]. Acute Pyelonephritis: 5 or 10-day Treatment Regimen

Levofloxacin Tablets are indicated for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia [see Clinical Studies (14.7, 14.8)].

Uncomplicated Urinary Tract Infections

Levofloxacin Tablets are indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus.

Inhalational Anthrax (Post-Exposure)

Levofloxacin Tablets are indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of Levofloxacin Tablets is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin Tablets have not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of Levofloxacin Tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged Levofloxacin Tablets therapy should only be used when the benefit outweighs the risk [see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.9)].

Levofloxacin Tablets Dosage and Administration Dosage in Adult Patients with Normal Renal Function
The usual dose of Levofloxacin Tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
 
These recommendations apply to patients with creatinine clearance ? 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ? 50 mL/min) Type of Infection1 Dosed Every
24 hours Duration
(days)2 1 Due to the designated pathogens [see Indications and Usage (1)].
2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
3 Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
4 Due to Streptococcus pneumoniae (excluding multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
5 This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
6 This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
7 Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
8 The safety of Levofloxacin Tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged Levofloxacin Tablets therapy should only be used when the benefit outweighs the risk.
   Nosocomial Pneumonia
750 mg
7-14
   Community Acquired Pneumonia3
500 mg
7-14
   Community Acquired Pneumonia4
750 mg
5
   Acute Bacterial Sinusitis
750 mg
5
500 mg
10-14
     Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
   Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7-14
   Uncomplicated SSSI
500 mg
7-10
   Chronic Bacterial Prostatitis
500 mg
28
   Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)5
750 mg
5
   Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)6
250 mg
10
   Uncomplicated Urinary Tract Infection
250 mg
3
   Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg and ? 6 months of age7,8
   Pediatric patients < 50 kg and ? 6 months of age7,8
500 mg
see Table 2 below (2.2)
608
608
Dosage in Pediatric Patients
The dosage in pediatric patients ? 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ? 6 months of age 1 Due to Bacillus anthracis [see Indications and Usage (1.13)]
2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
3 Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
4 The safety of Levofloxacin Tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged Levofloxacin Tablets therapy should only be used when the benefit outweighs the risk.
Type of Infection1
Dose
Freq. Once
every
Duration2
   Inhalational Anthrax (post-exposure)3, 4
      Pediatric patients > 50 kg and ? 6 months of age
500 mg
24 hr
60 days4
      Pediatric patients < 50 kg and ? 6 months of age
8 mg/kg
(not to exceed 250 mg
per dose)
12 hr
60 days4
Dosage Adjustment in Adults with Renal Impairment
Administer Levofloxacin Tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
 
No adjustment is necessary for patients with a creatinine clearance ? 50 mL/min.
 
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
 
Table 3 shows how to adjust dose based on creatinine clearance.
Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance <50 mL/min) Dosage in
Normal Renal
Function Every
24 hours Creatinine
Clearance
20 to 49 mL/min Creatinine
Clearance
10 to 19 mL/min Hemodialysis or
Chronic Ambulatory
Peritoneal Dialysis
(CAPD)    750 mg
   750 mg every 48 hours
   750 mg initial dose, then
   500 mg every 48 hours
   750 mg initial dose, then 
   500 mg every 48 hours
   500 mg
   500 mg initial dose, then 
   250 mg every 24 hours
   500 mg initial dose, then
   250 mg every 48 hours
   500 mg initial dose, then 
   250 mg every 48 hours
   250 mg
   No dosage adjustment required
   250 mg every 48 hours. 
   If treating uncomplicated 
   UTI, then no dosage 
   adjustment is required
   No information on 
   dosing adjustment is available
Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins

Levofloxacin Tablets should be administered at least two hours before or two hours after antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine chewable/buffered tablets or the pediatric powder for oral solution [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

Administration Instructions
Food and Levofloxacin Tablets
 
Levofloxacin Tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets 
 
Adequate hydration of patients receiving oral Levofloxacin Tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)]. Dosage Forms and Strengths
Levofloxacin Tablets, 250 mg are terra pink colored capsule shaped, biconvex film-coated tablets, debossed with ‘13’ on one side and ‘T’ on the other side.
 
Levofloxacin Tablets, 500 mg are peach colored capsule shaped, biconvex film-coated tablets, debossed with ‘12’ on one side and ‘T’ on the other side.
 
Levofloxacin Tablets, 750 mg are white capsule shaped, biconvex film-coated tablets, debossed with ‘11’ on one side and ‘T’ on the other side. Contraindications
Levofloxacin Tablets are contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [see Warnings and Precautions (5.3)]. Warnings and Precautions Tendinopathy and Tendon Rupture

Fluoroquinolones, including levofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in those taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have been reported in patients taking fluoroquinolones who do not have the above risk factors. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Levofloxacin should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug [see Adverse Reactions (6.3); Patient Counseling Information (17.3)].

Exacerbation of Myasthenia Gravis
Fluoroquinolones, including levofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness  in persons with myasthenia gravis. Postmarketing serious adverse events, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in persons with myasthenia gravis. Avoid levofloxacin in patients with a known history of myasthenia gravis [see Adverse Reactions (6.3); Patient Counseling Information (17.3)]. Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with fluoroquinolones, including levofloxacin. These reactions often occur following the first dose. Some reactions have been accompanied by cardiovascular collapse, hypotension/shock, seizure, loss of consciousness, tingling, angioedema (including tongue, laryngeal, throat, or facial edema/swelling), airway obstruction (including bronchospasm, shortness of breath, and acute respiratory distress), dyspnea, urticaria, itching, and other serious skin reactions. Levofloxacin should be discontinued immediately at the first appearance of a skin rash or any other sign of hypersensitivity. Serious acute hypersensitivity reactions may require treatment with epinephrine and other resuscitative measures, including oxygen, intravenous fluids, antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated [see Adverse Reactions (6); Patient Counseling Information (17.3)].

Other Serious and Sometimes Fatal Reactions
Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with fluoroquinolones, including levofloxacin. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following: 
fever, rash, or severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson Syndrome); vasculitis; arthralgia; myalgia; serum sickness; allergic pneumonitis; interstitial nephritis; acute renal insufficiency or failure; hepatitis; jaundice; acute hepatic necrosis or failure; anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.

The drug should be discontinued immediately at the first appearance of skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted [see Adverse Reactions (6); Patient Counseling Information (17.3)].

Hepatotoxicity

Postmarketing reports of severe hepatotoxicity (including acute hepatitis and fatal events) have been received for patients treated with levofloxacin. No evidence of serious drug-associated hepatotoxicity was detected in clinical trials of over 7,000 patients. Severe hepatotoxicity generally occurred within 14 days of initiation of therapy and most cases occurred within 6 days. Most cases of severe hepatotoxicity were not associated with hypersensitivity [see Warnings and Precautions (5.4)]. The majority of fatal hepatotoxicity reports occurred in patients 65 years of age or older and most were not associated with hypersensitivity. Levofloxacin should be discontinued immediately if the patient develops signs and symptoms of hepatitis [see Adverse Reactions (6); Patient Counseling Information (17.3)].

Central Nervous System Effects
Convulsions,  and toxic psychoses, increased intracranial pressure (including pseudotumor cerebri) have been reported in patients receiving fluoroquinolones, including levofloxacin. Fluoroquinolones may also central nervous system stimulation which may lead to tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and, rarely, suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions occur in patients receiving levofloxacin, the drug should be discontinued and appropriate measures instituted. As with other fluoroquinolones, levofloxacin should be used with caution in patients with a known or suspected central nervous system (CNS) disorder that may predispose them to seizures or lower the seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose them to seizures or lower the seizure threshold (e.g., certain drug therapy, renal dysfunction.) [see Adverse Reactions (6); Drug Interactions (7.4, 7.5); Patient Counseling Information (17.3)]. Clostridium difficile-Associated Diarrhea
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including levofloxacin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
 
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated [see Adverse Reactions (6.2), Patient Counseling Information (17.3)]. Peripheral Neuropathy
Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including levofloxacin. Levofloxacin should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation in order to prevent the development of an irreversible condition [see Adverse Reactions (6), Patient Counseling Information (17.3)]. Prolongation of the QT Interval
Some fluoroquinolones, including levofloxacin, have been associated with prolongation of the QT interval on the electrocardiogram and infrequent cases of arrhythmia. Rare cases of torsade de pointes have been spontaneously reported during postmarketing surveillance in patients receiving fluoroquinolones, including levofloxacin. Levofloxacin should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval [see Adverse Reactions (6.3), Use in Specific Populations (8.5), and Patient Counseling Information (17.3)]. Musculoskeletal Disorders in Pediatric Patients and Arthropathic Effects in Animals
Levofloxacin is indicated in pediatric patients (?6 months of age) only for the prevention of inhalational anthrax (post-exposure) [see Indications and Usage (1.13)]. An increased incidence of musculoskeletal disorders (arthralgia, arthritis, tendinopathy, and gait abnormality) compared to controls has been observed in pediatric patients receiving levofloxacin [see Use in Specific Populations (8.4)].
 
In immature rats and dogs, the oral administration of levofloxacin resulted in increased osteochondrosis. Histopathological examination of the weight-bearing joints of immature dogs dosed with levofloxacin revealed persistent lesions of the cartilage. Other fluoroquinolones also produce similar erosions in the weight-bearing joints and other signs of arthropathy in immature animals of various species [see Animal Toxicology and/or Pharmacology (13.2)]. Blood Glucose Disturbances
As with other fluoroquinolones, disturbances of blood glucose, including symptomatic hyper- and hypoglycemia, have been reported with levofloxacin, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g., glyburide) or with insulin. In these patients, careful monitoring of blood glucose is recommended. If a hypoglycemic reaction occurs in a patient being treated with levofloxacin, levofloxacin should be discontinued and appropriate therapy should be initiated immediately [see Adverse Reactions (6.2); Drug Interactions (7.3); Patient Counseling Information (17.4)]. Photosensitivity/Phototoxicity
Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (e.g., burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, “V” area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of fluoroquinolones after sun or UV light exposure. Therefore, excessive exposure to these sources of light should be avoided. Drug therapy should be discontinued if photosensitivity/phototoxicity occurs [see Adverse Reactions (6.3); Patient Counseling Information (17.3)]. Development of Drug Resistant Bacteria
Prescribing levofloxacin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria [see Patient Counseling Information (17.1)]. Adverse Reactions Serious and Otherwise Important Adverse Reactions
The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:
  Tendon Effects [see Warnings and Precautions (5.1)] Exacerbation of Myasthenia Gravis [see Warnings and Precautions (5.2)] Hypersensitivity Reactions [see Warnings and Precautions (5.3)] Other Serious and Sometimes Fatal Reactions [see Warnings and Precautions (5.4)] Hepatotoxicity [see Warnings and Precautions (5.5)] Central Nervous System Effects [see Warnings and Precautions (5.6)] Clostridium difficile-Associated Diarrhea [see Warnings and Precautions (5.7)] Peripheral Neuropathy [see Warnings and Precautions (5.8)] Prolongation of the QT Interval [see Warnings and Precautions (5.9)] Musculoskeletal Disorders in Pediatric Patients [see Warnings and Precautions (5.10)] Blood Glucose Disturbances [see Warnings and Precautions (5.11)] Photosensitivity/Phototoxicity [see Warnings and Precautions (5.12)] Development of Drug Resistant Bacteria [see Warnings and Precautions (5.13)]
Crystalluria and cylindruria have been reported with quinolones, including levofloxacin. Therefore, adequate hydration of patients receiving levofloxacin should be maintained to prevent the formation of a highly concentrated urine [see Dosage and Administration (2.5)]. Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
 
The data described below reflect exposure to levofloxacin in 7537 patients in 29 pooled Phase 3 clinical trials. The population studied had a mean age of 50 years (approximately 74% of the population was < 65 years of age), 50% were male, 71% were Caucasian, 19% were Black. Patients were treated with levofloxacin for a wide variety of infectious diseases [see Indications and Usage (1)]. Patients received levofloxacin doses of 750 mg once daily, 250 mg once daily, or 500 mg once or twice daily. Treatment duration was usually 3 to 14 days, and the mean number of days on therapy was 10 days.
 
The overall incidence, type and distribution of adverse reactions was similar in patients receiving levofloxacin doses of 750 mg once daily, 250 mg once daily, and 500 mg once or twice daily. Discontinuation of levofloxacin due to adverse drug reactions occurred in 4.3% of patients overall, 3.8% of patients treated with the 250 mg and 500 mg doses and 5.4% of patients treated with the 750 mg dose. The most common adverse drug reactions leading to discontinuation with the 250 and 500 mg doses were gastrointestinal (1.4%), primarily nausea (0.6%); vomiting (0.4%); dizziness (0.3%); and headache (0.2%). The most common adverse drug reactions leading to discontinuation with the 750 mg dose were gastrointestinal (1.2%), primarily nausea (0.6%), vomiting (0.5%); dizziness (0.3%); and headache (0.3%).
 
Adverse reactions occurring in ?1% of levofloxacin-treated patients and less common adverse reactions, occurring in 0.1 to <1% of levofloxacin-treated patients, are shown in Table 4 and Table 5, respectively. The most common adverse drug reactions (?3%) are nausea, headache, diarrhea, insomnia, constipation, and dizziness. Table 4: Common (?1%) Adverse Reactions Reported in Clinical Trials with Levofloxacin System/Organ Class Adverse Reaction %
(N = 7537) a N = 7274
b N = 3758 (women)
   Infections and Infestations
   moniliasis
1
   Psychiatric Disorders
   insomniaa
   [see Warnings and Precautions (5.6)]
4
   Nervous System Disorders
   headache
   dizziness
   [see Warnings and Precautions (5.6)]
6
3
   Respiratory, Thoracic and 
   Mediastinal Disorders
   dyspnea
   [see Warnings and Precautions (5.3)]
1
   Gastrointestinal Disorders
   nausea
   diarrhea
   constipation
   abdominal pain
   vomiting
   dyspepsia
7
5
3
2
2
2
   Skin and Subcutaneous 
   Tissue Disorders
   rash [see Warnings and Precautions (5.3)] 
   pruritus
2
1
   Reproductive System and 
   Breast Disorders
   vaginitis
1b
   General Disorders and 
   Administration Site Conditions
   edema
   injection site reaction
   chest pain
1
1
1
Table 5: Less Common (0.1 to 1%) Adverse Reactions Reported in Clinical Trials with Levofloxacin (N = 7537) System/Organ Class Adverse Reaction a N = 7274
   Infections and Infestations
   genital moniliasis
   Blood and Lymphatic System Disorders
   anemia
   thrombocytopenia
   granulocytopenia
   [see Warnings and Precautions (5.4)]
   Immune System Disorders
   allergic reaction
   [see Warnings and Precautions (5.3, 5.4)]
   Metabolism and Nutrition Disorders
   hyperglycemia
   hypoglycemia
   [see Warnings and Precautions (5.11)]
   hyperkalemia
   Psychiatric Disorders
   anxiety
   agitation
   confusion
   depression
   hallucination
   nightmarea
   [see Warnings and Precautions (5.6)]
   sleep disordera
   anorexia
   abnormal dreaminga
   Nervous System Disorders
   tremor
   convulsions
   [see Warnings and Precautions (5.6)]
   paresthesia 
   [see Warnings and Precautions (5.8)]
   vertigo
   hypertonia
   hyperkinesias
   abnormal gait
   somnolencea
   syncope
   Respiratory, Thoracic and Mediastinal Disorders
   epistaxis
   Cardiac Disorders
   cardiac arrest
   palpitation
   ventricular tachycardia
   ventricular arrhythmia
   Vascular Disorders
   phlebitis
   Gastrointestinal Disorders
   gastritis
   stomatitis
   pancreatitis
   esophagitis
   gastroenteritis
   glossitis
   pseudomembranous/C. difficile colitis
   [see Warnings and Precautions (5.7)]
   Hepatobiliary Disorders
   abnormal hepatic function
   increased hepatic enzymes
   increased alkaline phosphatase
   Skin and Subcutaneous Tissue Disorders
   urticaria [see Warnings and Precautions (5.3)]
   Musculoskeletal and Connective Tissue Disorders
   arthralgia
   tendinitis
   [see Warnings and Precautions (5.1)]
   myalgia
   skeletal pain
   Renal and Urinary Disorders
   abnormal renal function
   acute renal failure [see Warnings and Precautions (5.4)]
In clinical trials using multiple-dose therapy, ophthalmologic abnormalities, including cataracts and multiple punctate lenticular opacities, have been noted in patients undergoing treatment with quinolones, including levofloxacin. The relationship of the drugs to these events is not presently established. Postmarketing Experience
Table 6 lists adverse reactions that have been identified during post-approval use of levofloxacin. Because these reactions are reported voluntarily from a population of uncertain size, reliably estimating their frequency or establishing a causal relationship to drug exposure is not always possible.
Table 6: Postmarketing Reports Of Adverse Drug Reactions System/Organ Class Adverse Reaction    Blood and Lymphatic System Disorders
   pancytopenia
   aplastic anemia
   leucopenia
   hemolytic anemia
   [see Warnings and Precautions (5.4)]
   eosinophilia
   Immune System Disorders
   hypersensitivity reactions, sometimes fatal including:
      anaphylactic/anaphylactoid reactions
      anaphylactic shock 
      angioneurotic edema
      serum sickness
   [see Warnings and Precautions (5.3, 5.4)]
   Psychiatric Disorders
   psychosis
   paranoia
   isolated reports of suicide attempt and suicidal ideation 
   [see Warnings and Precautions (5.6)]
   Nervous System Disorders
   exacerbation of myasthenia gravis [see Warnings and Precautions (5.2)]
   anosmia
   ageusia
   parosmia
   dysgeusia
   peripheral neuropathy [see Warnings and Precautions (5.8)]
   isolated reports of encephalopathy
   abnormal electroencephalogram (EEG)
   dysphonia
   pseudotumor cerebri [see Warnings and Precautions (5.6)]    Eye Disorders
   vision disturbance, including diplopia
   visual acuity reduced
   vision blurred
   scotoma
   Ear and Labyrinth Disorders
   hypoacusis
   tinnitus
   Cardiac Disorders
   isolated reports of torsade de pointes
   electrocardiogram QT prolonged
   [see Warnings and Precautions (5.9)]
   tachycardia
   Vascular Disorders
   vasodilatation
   Respiratory, Thoracic and Mediastinal Disorders
   isolated reports of allergic pneumonitis [see Warnings and Precautions (5.4)]
   Hepatobiliary Disorders
   hepatic failure (including fatal cases)
   hepatitis
   jaundice
   [see Warnings and Precautions (5.4, 5.5)]
   Skin and Subcutaneous Tissue Disorders
   bullous eruptions to include:
      Stevens-Johnson Syndrome
      toxic epidermal necrolysis
      erythema multiforme
   [see Warnings and Precautions (5.4)]
   photosensitivity/phototoxicity reaction [see Warnings and Precautions (5.12)]
   leukocytoclastic vasculitis
   Musculoskeletal and Connective Tissue Disorders
   tendon rupture [see Warnings and Precautions (5.1)]
   muscle injury, including rupture
   rhabdomyolysis
   Renal and Urinary Disorders
   interstitial nephritis [see Warnings and Precautions (5.4)]
   General Disorders and Administration Site Condi


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Levofloxacin Oral Solution


Dosage Form: oral solution
FULL PRESCRIBING INFORMATION WARNING:

Fluoroquinolones, including Levofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants [See Warnings and Precautions (5.1) ].

Fluoroquinolones, including Levofloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid Levofloxacin in patients with a known history of myasthenia gravis. [See Warnings and Precautions (5.2)]

Indications and Usage for Levofloxacin Oral Solution

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Levofloxacin and other antibacterial drugs, Levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Levofloxacin Oral Solution is indicated for the treatment of adults (?18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed in this section.


Culture and susceptibility testing

Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Clinical Pharmacology (12.4)]. Therapy with Levofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected.

As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with Levofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.

Nosocomial Pneumonia

Levofloxacin is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal ?-lactam is recommended [see Clinical Studies (14.1)].

Community-Acquired Pneumonia: 7–14 day Treatment Regimen

Levofloxacin is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Dosage and Administration (2.1)  and Clinical Studies (14.2)].

MDRSP isolates are strains resistant to two or more of the following antibacterials: penicillin (MIC ?2 mcg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.

Community-Acquired Pneumonia: 5-day Treatment Regimen

Levofloxacin is indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Dosage and Administratin (2.1) and Clinical Studies (14.3)].

Acute Bacterial Sinusitis: 5-day and 10–14 day Treatment Regimens

Levofloxacin is indicated for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies (14.4)].

Acute Bacterial Exacerbation of Chronic Bronchitis

Levofloxacin is indicated for the treatment of acute bacterial exacerbation of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.

Complicated Skin and Skin Structure Infections

Levofloxacin is indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis [see Clinical Studies (14.5)].

Uncomplicated Skin and Skin Structure Infections

Levofloxacin is indicated for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes.

Chronic Bacterial Prostatitis

Levofloxacin is indicated for the treatment of chronic bacterial prostatitis due to Escherichiacoli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis [see Clinical Studies (14.6)].

Complicated Urinary Tract Infections: 5-day Treatment Regime

Levofloxacin is indicated for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis [see Clinical Studies (14.7)].

Complicated Urinary Tract Infections: 10-day Treatment Regimen

Levofloxacin is indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa [see Clinical Studies (14.8)].

Acute Pyelonephritis: 5 or 10-day Treatment Regimen

Levofloxacin is indicated for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia [see Clinical Studies (14.7, 14.8)].

Uncomplicated Urinary Tract Infections

Levofloxacin is indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus.

Inhalational Anthrax (Post-Exposure)

Levofloxacin is indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of Levofloxacin is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of Levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged Levofloxacin therapy should only be used when the benefit outweighs the risk [see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.9)].

Levofloxacin Oral Solution Dosage and Administration Dosage in Adult Patients with Normal Renal Function

The usual dose of Levofloxacin Oral Solution is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.

These recommendations apply to patients with creatinine clearance ? 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

* Due to the designated pathogens [see Indications and Usage (1)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. ? Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see  Clinical Studies (14.9)] ? The safety of Levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10 ), Specific Populations (8.4), andClinical Studies (14.9)] Prolonged Levofloxacin therapy in adults should only be used when the benefit outweighs the risk. Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ? 50 mL/min) Type of Infection* Dose Every 24 hours

Duration

(days)† Nosocomial Pneumonia 750 mg 7-14 Community Acquired Pneumonia‡ 500 mg 7-14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10-14   Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7-14 Uncomplicated SSSI 500 mg 7-10 Chronic Bacterial Prostatitis 500 mg 28 Complicated Urinary Tract Infection(cUTI) or Acute Pyelonephritis (AP)¶ 750 mg 5 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)# 250 mg 10 Uncomplicated Urinary Tract Infection 250 mg 3

Inhalational Anthrax (Post-Exposure)

Adults and Pediatric Patients > 50 kg and ? 6 months of age??

500 mg 608 Pediatric Patients < 50 kg and ? 6 months of age7,8 8 mg/kg BID (not to exceed 250 mg/dose) 608 Dosage in Pediatric Patients

The dosage in pediatric patients ? 6 months of age is described below in Table 2.

* Due to Bacillus anthracis [see Indications and Usage (1.13)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)] § The safety of Levofloxacin in pediatric patients for durations of therapy beyond 14 has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), andClinical Studies (14.9).] Prolonged Levofloxacin therapy should only be used when the benefit outweighs the risk Table 2: Dosage in Pediatric Patients ? 6 months of age Type of infection* Dose Freq. Once every Duration† Inahalational Anthrax (post-exposure)‡,§ Pediatric patients > 50 kg and ? 6 months of age 500 mg 24 hr 60 days§ Pediatric patients < 50 kg and ? 6 months of age 8 mg/kg (not to exceed 250 mg per dose) 12 hr 60 days§ Dosage Adjustment in Adults with Renal Impairment

Administer Levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.

No adjustment is necessary for patients with a creatinine clearance ? 50 mL/min.

In patients with impaired renal function (creatinine clearance<50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6).]

Table 3 shows how to adjust dose based on creatinine clearance.

Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance < 50 mL/min) Dosage in Normal Renal Function Every 24 hours Creatinine Clearance 20 to 49 mL/min Creatinine Clearance 10 to 19 mL/min Hemodialysis or Chronic Ambulatory Peritoneal Dialysis (CAPD) 750 mg 750 mg every 48 hours 750 mg initial dose, then 500 mg every 48 hours 750 mg initial dose, then 500 mg every 48 hours 500 mg 500 mg initial dose, then 250 mg every 24 hours 500 mg initial dose, then 250 mg every 48 hours 500 mg initial dose, then 250 mg every 48 hours 250 mg No dosage adjustment required 250 mg every 48 hours. If treating uncomplicated UTI, then no dosage adjustment is required No information on dosing adjustment is available Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins


Levofloxacin Oral Solution

Levofloxacin Oral Solution should be administered at least two hours before or two hours after antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine chewable/buffered tablets or the pediatric powder for oral solution [see Drug Interactions (7.1)  and Patient Counseling Information (17.2)].

Administration Instructions


Food and Levofloxacin Oral Solution

It is recommended that Levofloxacin Oral Solution be taken 1 hour before or 2 hours after eating.


Hydration for Patients Receiving Levofloxacin Oral Solution

Adequate hydration of patients receiving oral or intravenous Levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

Dosage Forms and Strengths

ORAL SOLUTION

25 mg/mL, clear yellow to clear greenish-yellow color Contraindications

Levofloxacin is contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [see Warnings and Precautions (5.3)].

Warnings and Precautions Tendinopathy and Tendon Rupture

Fluoroquinolones, including Levofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in those taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have been reported in patients taking fluoroquinolones who do not have the above risk factors. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Levofloxacin should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug. [see Adverse Reactions (6.3); Patient Counseling Information (17.3)].

Exacerbation of Myasthenia Gravis

Fluoroquinolones, including Levofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Postmarketing serious adverse events, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in persons with myasthenia gravis. Avoid Levofloxacin in patients with a known history of myasthenia gravis. [see Adverse Reactions (6.3); Patient Counseling Information (17.3)]

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with fluoroquinolones, including Levofloxacin. These reactions often occur following the first dose. Some reactions have been accompanied by cardiovascular collapse, hypotension/shock, seizure, loss of consciousness, tingling, angioedema (including tongue, laryngeal, throat, or facial edema/swelling), airway obstruction (including bronchospasm, shortness of breath, and acute respiratory distress), dyspnea, urticaria, itching, and other serious skin reactions. Levofloxacin should be discontinued immediately at the first appearance of a skin rash or any other sign of hypersensitivity. Serious acute hypersensitivity reactions may require treatment with epinephrine and other resuscitative measures, including oxygen, intravenous fluids, antihistamines,corticosteroids, pressor amines, and airway management, as clinically indicated [see Adverse Reactions (6); Patient Counseling Information (17.3)].

Other Serious and Sometimes Fatal Reactions

Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with fluoroquinolones, including Levofloxacin. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:

fever, rash, or severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson Syndrome); vasculitis; arthralgia; myalgia; serum sickness; allergic pneumonitis; interstitial nephritis; acute renal insufficiency or failure; hepatitis; jaundice; acute hepatic necrosis or failure; anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.

The drug should be discontinued immediately at the first appearance of skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted [see Adverse Reactions (6); Patient Counseling Information (17.3)].

Hepatotoxicity

Post-marketing reports of severe hepatotoxicity (including acute hepatitis and fatal events) have been received for patients treated with Levofloxacin. No evidence of serious drug-associated hepatotoxicity was detected in clinical trials of over 7,000 patients. Severe hepatotoxicity generally occurred within 14 days of initiation of therapy and most cases occurred within 6 days. Most cases of severe hepatotoxicity were not associated with hypersensitivity [see Warnings and Precautions (5.4)]. The majority of fatal hepatotoxicity reports occurred in patients 65 years of age or older and most were not associated with hypersensitivity. Levofloxacin should be discontinued immediately if the patient develops signs and symptoms of hepatitis [see Adverse Reactions (6); Patient Counseling Information (17.3)].

Central Nervous System Effects

Convulsions, toxic psychoses, and increased intracranial pressure (including pseudotumor cerebri) have been reported in patients receiving fluoroquinolones, including Levofloxacin. Fluoroquinolones may also cause central nervous system stimulation which may lead to tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and, rarely, suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions occur in patients receiving Levofloxacin, the drug should be discontinued and appropriate measures instituted. As with other fluoroquinolones, Levofloxacin should be used with caution in patients with a known or suspected central nervous system (CNS) disorder that may predispose them to seizures or lower the seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose them to seizures or lower the seizure threshold (e.g., certain drug therapy, renal dysfunction.) [see Adverse Reactions (6); Drug Interactions (7.4, 7.5); Patient Counseling (17.3)].

Clostridium difficile-Associated Diarrhea

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Levofloxacin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated [see Adverse Reactions (6.2), Patient Counseling Information (17.3)].

Peripheral Neuropathy

Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including Levofloxacin. Levofloxacin should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation in order to prevent the development of an irreversible condition [see Adverse Reactions (6), Patient Counseling Information (17.3)].

Prolongation of the QT Interval

Some fluoroquinolones, including Levofloxacin, have been associated with prolongation of the QT interval on the electrocardiogram and infrequent cases of arrhythmia. Rare cases of torsade de pointes have been spontaneously reported during postmarketing surveillance in patients receiving fluoroquinolones, including Levofloxacin. Levofloxacin should be avoided in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval [see Adverse Reactions (6.3), Use in Specific Populations (8.5), and Patient Counseling Information (17.3)].

Musculoskeletal Disorders in Pediatric Patients and Arthropathic Effects in Animals

Levofloxacin is indicated in pediatric patients (? 6 months of age) only for the prevention of inhalational anthrax (post-exposure) [see Indications and Usage (1.13)]. An increased incidence of musculoskeletal disorders (arthralgia, arthritis, tendinopathy, and gait abnormality) compared to controls has been observed in pediatric patients receiving Levofloxacin [see Use in Specific Populations (8.4)].

In immature rats and dogs, the oral and intravenous administration of levofloxacin resulted in increased osteochondrosis. Histopathological examination of the weight-bearing joints of immature dogs dosed with levofloxacin revealed persistent lesions of the cartilage. Other fluoroquinolones also produce similar erosions in the weight-bearing joints and other signs of arthropathy in immature animals of various species [see Animal Toxicology And/Or Pharmacology (13.2)].

Blood Glucose Disturbances

As with other fluoroquinolones, disturbances of blood glucose, including symptomatic hyper- and hypoglycemia, have been reported with Levofloxacin, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g., glyburide) or with insulin. In these patients, careful monitoring of blood glucose is recommended. If a hypoglycemic reaction occurs in a patient being treated with Levofloxacin, Levofloxacin should be discontinued and appropriate therapy should be initiated immediately [see Adverse Reactions (6.2); Drug Interactions (7.3); Patient Counseling Information (17.4)].

Photosensitivity/Phototoxicity

Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (e.g., burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, “V” area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of fluoroquinolones after sun or UV light exposure. Therefore, excessive exposure to these sources of light should be avoided. Drug therapy should be discontinued if photosensitivity/phototoxicity occurs [see Adverse Reactions (6.3); Patient Counseling Information (17.3)].

Development of Drug Resistant Bacteria

Prescribing Levofloxacin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria [see Patient Counseling Information (5.12)].

Adverse Reactions

To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Serious and Otherwise Important Adverse Reactions

The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:

Tendon Effects [see Warnings and Precaution (5.1)] Exacerbation of Myasthenia Gravis [see Warnings and Precautions (5.2)] Hypersensitivity Reactions [see Warnings and Precautions (5.3)] Other Serious and Sometimes Fatal Reactions [see Warnings and Precautions (5.4)] Hepatotoxicity [see Warnings and Precautions (5.5)] Central Nervous System Effects [see Warnings and Precautions (5.6)] Clostridium difficile-Associated Diarrhea [see Warnings and Precautions (5.7)] Peripheral Neuropathy [see Warnings and Precautions (5.8)] Prolongation of the QT Interval [see Warnings and Precautions (5.9)] Musculoskeletal Disorders in Pediatric Patients [see Warnings and Precautions (5.10)] Blood Glucose Disturbances [see Warnings and Precautions (5.11)] Photosensitivity/Phototoxicity [see Warnings and Precautions (5.12)] Development of Drug Resistant Bacteria [see Warnings and Precautions (5.13)]

Crystalluria and cylindruria have been reported with quinolones, including Levofloxacin. Therefore, adequate hydration of patients receiving Levofloxacin should be maintained to prevent the formation of a highly concentrated urine [see Dosage and Administration (2.5)].

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to Levofloxacin in 7537 patients in 29 pooled Phase 3 clinical trials. The population studied had a mean age of 50 years (approximately 74% of the population was < 65 years of age), 50% were male, 71% were Caucasian, 19% were Black. Patients were treated with Levofloxacin for a wide variety of infectious diseases [see Indications and Usage (1)] . Patients received Levofloxacin doses of 750 mg once daily, 250 mg once daily, or 500 mg once or twice daily. Treatment duration was usually 3–14 days, and the mean number of days on therapy was 10 days.

The overall incidence, type and distribution of adverse reactions was similar in patients receiving Levofloxacin doses of 750 mg once daily, 250 mg once daily, and 500 mg once or twice daily. Discontinuation of Levofloxacin due to adverse drug reactions occurred in 4.3% of patients overall, 3.8% of patients treated with the 250 mg and 500 mg doses and 5.4% of patients treated with the 750 mg dose. The most common adverse drug reactions leading to discontinuation with the 250 and 500 mg doses were gastrointestinal (1.4%), primarily nausea (0.6%); vomiting (0.4%); dizziness (0.3%); and headache (0.2%). The most common adverse drug reactions leading to discontinuation with the 750 mg dose were gastrointestinal (1.2%), primarily nausea (0.6%), vomiting (0.5%); dizziness (0.3%); and headache (0.3%).

Adverse reactions occurring in ?1% of Levofloxacin-treated patients and less common adverse reactions, occurring in 0.1 to <1% of Levofloxacin-treated patients, are shown in Table 4 and Table 5, respectively. The most common adverse drug reactions (?3%) are nausea, headache, diarrhea, insomnia, constipation, and dizziness.

* N = 7274 † N = 3758 (women) Table 4: Common (?1%) Adverse Reactions Reported in Clinical Trials with Levofloxacin System/Organ Class Adverse Reaction

%

 

(N=7537) Infections and Infestations moniliasis 1 Psychiatric Disorders insomnia* [see Warnings and Precautions (5.6)]. 4 Nervous System Disorders headache 6 dizziness [see Warnings and Precautions (5.6)]. 3   Respiratory, Thoracic and Mediastinal Disorders dyspnea [see Warnings and Precautions (5.3)] 1 Gastrointestinal Disorders nausea 7 diarrhea 5   constipation 3   abdominal pain 2   vomiting 2   dyspepsia 2   Skin and Subcutaneous Tissue Disorders rash [see Warnings and Precautions (5.3)] 2 pruritis 1   Reproductive System and Breast Disorders vaginitis 1† General Disorders and Administration Site Conditions edema 1 injection site reaction 1   chest pain 1   * N = 7274 Table 5: Less Common (0.1 to 1%) Adverse Reactions Reported in Clinical Trials with Levofloxacin (N=7537) System/Organ Class Adverse Reaction Infections and Infestations genital moniliasis Blood and Lymphatic System Disorders anemia thrombocytopenia   granulocytopenia   [see Warnings and Precautions (5.4)]   Immune System Disorders allergic reaction [see Warnings and Precautions (5.3, 5.4)] Metabolism and Nutrition Disorders hyperglycemia hypoglycemia   [see Warnings and Precautions (5.11)]     hyperkalemia   Psychiatric Disorders anxiety agitation  


More




Ciprofloxacin Hydrochloride


Class: Quinolones
VA Class: AM900
Chemical Name: 1-Cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7(1-piperazinyl)-3-quinolinecarboxylic acid
CAS Number: 85721-33-1
Brands: Cipro, ProQuin

Fluoroquinolones, including ciprofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all age groups.1 579 715 851 852 This risk is further increased in older adults (usually those >60 years of age), individuals receiving concomitant corticosteroids, and kidney, heart, or lung transplant recipients.1 579 715 851 852 (See Tendinopathy and Tendon Rupture under Cautions.)

REMS:

FDA approved a REMS for ciprofloxacin to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of ciprofloxacin and consists of the following: medication guide. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Antibacterial; fluoroquinolone.1 181 205 206 479 481 579 715

Uses for Ciprofloxacin Hydrochloride Bone and Joint Infections

Treatment of bone and joint infections (including osteomyelitis)205 296 326 362 365 367 368 369 370 371 375 474 479 535 706 caused by susceptible Pseudomonas aeruginosa,1 205 296 300 326 359 362 368 369 370 371 380 433 474 479 535 579 Enterobacter cloacae,1 362 369 370 375 380 474 579 706 or Serratia marcescens;1 296 362 368 369 370 380 474 579 also has been used in bone and joint infections caused by E. aerogenes†,369 370 706 Escherichia coli†,362 368 369 370 474 535 Klebsiella pneumoniae†,326 368 371 Morganella morganii†,369 370 or Proteus mirabilis†.368 369 371 380 474 706

Has been used for treatment of bone and joint infections caused by susceptible gram-positive bacteria, including Staphylococcus aureus†,296 326 370 474 535 S. epidermidis†,326 474 535 other coagulase-negative staphylococci†,326 370 or Enterococcus faecalis†.370 Other anti-infectives generally preferred for these gram-positive infections,522 538 but ciprofloxacin may be a useful alternative for treatment of infections caused by susceptible oxacillin-resistant (methicillin-resistant) staphylococci.522 538

Endocarditis

Alternative for treatment of native or prosthetic valve endocarditis† caused by fastidious gram-negative bacilli known as the HACEK group (Actinobacillus actinomycetemcomitans, Cardiobacterium hominis, Eikenella corrodens, Haemophilus aphrophilus, H. influenzae, H. parainfluenzae, H. paraphrophilus, Kingella denitrificans, K. kingae).768 AHA and IDSA recommend ceftriaxone or ampicillin-sulbactam as drugs of choice,768 but a fluoroquinolone (ciprofloxacin, levofloxacin, moxifloxacin) may be considered when ?-lactam anti-infectives cannot be used.768 Consultation with an infectious disease specialist is recommended.768

Alternative for treatment of uncomplicated right-sided S. aureus native valve endocarditis†.768 For native valve staphylococcal endocarditis, AHA and IDSA recommend IV nafcillin or oxacillin (with or without gentamicin) as regimen of choice and IV cefazolin (with or without gentamicin) as an alternative; IV vancomycin is recommended when staphylococci are oxacillin-resistant.768 An oral regimen of ciprofloxacin and rifampin can be considered in IV drug abusers who will not comply with a parenteral regimen.768 769

Alternative to gentamicin in regimens used for treatment of coagulase-negative staphylococcal endocarditis in the presence of prosthetic valves or materials†.768 For prosthetic valve staphylococcal endocarditis, AHA and IDSA recommend IV nafcillin or oxacillin with oral or IV rifampin and parenteral gentamicin; IV vancomycin with oral or IV rifampin and parenteral gentamicin is recommended when staphylococci are oxacillin-resistant.768 If causative organism is resistant to aminoglycosides, AHA and IDSA suggest a fluoroquinolone replace gentamicin in these regimens, provided in vitro susceptibility tests indicate the organism is susceptible to the fluoroquinolone.768

Empiric treatment of culture-negative endocarditis†.768 For empiric treatment of native valve culture-negative endocarditis, AHA and IDSA recommend a regimen of ampicillin-sulbactam with gentamicin or a regimen of vancomycin, gentamicin, and ciprofloxacin.768 Selection of the most appropriate anti-infective regimen is difficult and should be guided by epidemiologic features and clinical course of the infection.768 Consultation with an infectious diseases specialist is recommended.768

GI Infections

Treatment of infectious diarrhea caused by susceptible enterotoxigenic E. coli,1 293 297 474 477 Campylobacter fetus subsp. jejuni,1 293 297 350 474 538 Salmonella (see Typhoid Fever and other Salmonella Infections under Uses), Shigella297 477 538 612 flexneri,1 612 S. boydii, S. sonnei,1 474 or S. dysenteriae.1 612 Active in vitro against most pathogens associated with infectious diarrhea; may be a drug of choice for empiric treatment.296 350 378 420 493 522 610 611 Consider increasing emergence of fluoroquinolone-resistant Campylobacter secondary to widespread use of the drugs; use judiciously for treatment and prevention of enteropathogenic diarrhea.588 589

Alternative to co-trimoxazole for treatment of GI infections caused by Cyclospora† or Isospora†.477 533 667

Treatment of GI infections caused by Yersinia enterocolitica† or Y. pseudotuberculosis†.681 These infections usually self-limited, but IDSA, AAP, and others recommend anti-infectives for severe infections or when septicemia or other invasive disease occurs.477 667 681 Some suggest that the role of anti-infectives in management of enterocolitis, pseudoappendicitis syndrome, or mesenteric adenitis caused by Yersinia needs further evaluation.677

Treatment of travelers’ diarrhea†.378 399 420 525 650 651 661 677 679 Generally self-limited and may resolve within 3–4 days without anti-infective treatment;420 525 648 if diarrhea is moderate or severe, persists for >3 days, or is associated with fever or bloody stools, short-term (1–3 days) anti-infective treatment may be indicated.420 525 648 Fluoroquinolones (ciprofloxacin, levofloxacin, norfloxacin, ofloxacin) usually drugs of choice when treatment, including self-treatment, is indicated.420 525 594 611 612 650 648 661 677 679 Azithromycin is a treatment alternative for those who should not receive fluoroquinolones (e.g., children, pregnant women) and may be a drug of choice for travelers in areas with a high prevalence of fluoroquinolone-resistant Campylobacter (e.g., Thailand, India) or those who have not responded after 48 hours of fluoroquinolone treatment.420 525 Rifaximin is another alternative for treatment of travelers’ diarrhea caused by noninvasive E. coli.420 525

Prevention of travelers’ diarrhea† in individuals traveling for relatively short periods to areas where enterotoxigenic E. coli and other causative bacterial pathogens (e.g., Shigella) are known to be susceptible to the drug.420 525 610 611 661 677 679 CDC and others do not recommend anti-infective prophylaxis in most individuals traveling to areas of risk;420 525 661 677 679 the principal preventive measures are prudent dietary practices.525 650 651 661 If anti-infective prophylaxis is used (e.g., in immunocompromised individuals such as those with HIV infection), a fluoroquinolone (ciprofloxacin, levofloxacin, ofloxacin, norfloxacin) is recommended for nonpregnant adults,420 525 661 although the increasing incidence of quinolone resistance in pathogens that cause travelers’ diarrhea (e.g., Campylobacter) should be considered.420 525

Intra-abdominal Infections

Parenteral treatment of complicated intra-abdominal infections caused by E. coli, Ps. aeruginosa, P. mirabilis, K. pneumoniae, or Bacteroides fragilis; used in conjunction with oral metronidazole.1 579

For immunosuppressed patients or those with severe intra-abdominal infections, IDSA recommends an initial empiric regimen with broad spectrum of activity such as meropenem or imipenem; a third or fourth generation cephalosporin (cefepime, cefotaxime, ceftazidime, ceftizoxime, ceftriaxone) in conjunction with metronidazole; ciprofloxacin in conjunction with metronidazole; piperacillin-tazobactam; or aztreonam in conjunction with metronidazole.773 For mild to moderate community-acquired intra-abdominal infections, IDSA recommends an initial empiric regimen with narrower spectrum of activity such as ampicillin-sulbactam; cefazolin or cefuroxime in conjunction with metronidazole; ticarcillin-clavulanate; ertapenem; or a fluoroquinolone (ciprofloxacin, levofloxacin, moxifloxacin) in conjunction with metronidazole.773

Meningitis and CNS Infections

Has been used for treatment of meningitis and other CNS infections† caused by susceptible gram-negative bacteria (e.g., Ps. aeruginosa, Salmonella) either alone or in conjunction with other drugs (e.g., aminoglycoside, ceftriaxone or cefotaxime).360 707 762 763 764 765 818

Safety and efficacy not established for CNS infections;293 481 only low ciprofloxacin concentrations attained in CSF.1 436 707 (See Distribution under Pharmacokinetics.) Fluoroquinolones (including ciprofloxacin) generally considered for treatment of meningitis only when the infection is caused by multidrug-resistant gram-negative bacilli or when the usually recommended anti-infectives cannot be used or have been ineffective.774

Otic Infections

Treatment of malignant otitis externa† caused by Ps. aeruginosa.781 782 783 784 785 816 Treatment of choice usually is ciprofloxacin or an antipseudomonal ?-lactam (e.g., ceftazidime, imipenem).781 782 783 784 Consider the possibility of ciprofloxacin-resistant strains if there is an inadequate response to treatment.783 784 785

Respiratory Tract Infections

Treatment of respiratory tract infections (including bronchiectasis,333 374 474 479 596 bronchitis,205 297 301 333 335 345 346 347 356 374 435 466 474 479 lung abscess,474 596 pneumonia)205 326 333 346 347 356 357 435 466 474 479 491 596 caused by susceptible E. cloacae,1 333 474 579 E. coli,1 333 345 355 474 491 579 Haemophilus influenzae,1 297 301 324 333 346 351 380 427 474 491 596 579 H. parainfluenzae,1 297 474 579 K. pneumoniae,1 297 301 333 345 351 380 474 579 P. mirabilis,1 380 474 579 Ps. aeruginosa,1 300 301 324 333 346 359 374 380 427 433 474 579 or S. pneumoniae;1 324 326 333 345 346 355 356 357 425 427 474 491 also has been used for respiratory tract infections caused by susceptible E. aerogenes†,474 K. oxytoca†,474 or S. aureus†.333 345 380 491

Treatment of acute sinusitis caused by susceptible H. influenzae, M. catarrhalis, or S. pneumoniae.1

Treatment of acute exacerbations of chronic bronchitis caused by susceptible Moraxella catarrhalis.1 324 333 346 356 395 427 474 491 579

Parenteral treatment of nosocomial pneumonia caused by susceptible H. influenzae or K. pneumoniae.579

Most effective in treatment of respiratory tract infections caused by H. influenzae or M. catarrhalis;178 296 298 479 596 treatment failures have occurred when used in infections caused by S. pneumoniae178 324 358 425 427 479 or Ps. aeruginosa.178 324 346 358 427 479 596

Not a drug of first choice for pneumonia caused by S. pneumoniae;1 generally should not be used for empiric treatment of community-acquired pneumonia (CAP) when S. pneumoniae is likely or suspected.5 178 296 356 427 479 522 621 IDSA and ATS state that other fluoroquinolones with enhanced activity against S. pneumoniae (gemifloxacin, levofloxacin, moxifloxacin) are drugs of choice for empiric treatment of CAP in outpatients at risk for infections caused by drug-resistant S. pneumoniae (DRSP) and also are drugs of choice for empiric treatment of CAP in inpatients.605

Treatment of acute exacerbations of bronchopulmonary Ps. aeruginosa infections in cystic fibrosis patients.178 205 296 299 301 302 304 305 307 308 309 310 311 359 424 474 479 As with other anti-infectives, Ps. aeruginosa may be cleared temporarily from the sputum, but a bacteriologic cure rarely is obtained and should not be expected in these patients.205 306 307 309 310 312 424 425 466 474 479

Probably should not be used for treatment of aspiration pneumonia since these infections generally involve anaerobic bacteria.293 296 621

Skin and Skin Structure Infections

Treatment of skin and skin structure infections (e.g., cellulitis, abscesses, folliculitis, furunculosis, pyoderma, postoperative wound infections, infected ulcers, burns, or wounds) caused by susceptible C. freundii,1 372 474 579 E. cloacae,1 362 474 579 E. coli,1 326 372 374 375 376 377 380 474 579 K. oxytoca,474 K. pneumoniae,1 362 372 376 377 380 474 579 M. morganii,1 474 579 P. mirabilis,1 362 364 372 376 377 380 474 579 P. vulgaris,1 372 474 579 P. stuartii,1 374 377 474 579 Ps. aeruginosa,1 280 300 326 359 362 372 374 375 376 377 382 433 474 579 S. marcescens†,362 380 S. aureus (oxacillin-susceptible strains),1 326 362 364 372 373 374 375 376 377 382 466 474 579 S. epidermidis,1 364 372 375 376 377 382 474 579 or S. pyogenes (group A ?-hemolytic streptococci).1 362 373 374 579

Urinary Tract Infections (UTIs) and Prostatitis

Treatment of complicated UTIs and pyelonephritis caused by susceptible E. coli in pediatric patients 1–17 years of age.1 579 Not a drug of first choice in pediatric patients because of increased risk of adverse events (e.g., events related to joints and/or surrounding tissues) in this age group.1 579 (See Musculoskeletal Effects under Cautions.)

Treatment of acute uncomplicated cystitis in adults caused by susceptible E. coli, P. mirabilis, S. saprophyticus, or E. faecalis.715

Treatment of complicated or uncomplicated UTIs in adults caused by susceptible gram-negative bacteria, including Citrobacter diversus,1 474 579 C. freundii,1 339 340 341 375 380 474 579 E. cloacae,1 327 332 380 474 579 E. coli,1 297 326 327 329 332 336 338 339 340 351 352 353 375 380 474 504 579 715 K. pneumoniae,1 297 327 329 336 338 340 341 353 375 474 504 579 715 M. morganii,1 340 341 474 579 P. mirabilis,1 327 332 336 340 352 353 474 504 579 715 Providencia rettgeri,1 474 579 Ps. aeruginosa,1 297 300 326 327 336 338 339 340 341 351 353 359 375 379 380 474 538 579 715 or S. marcescens;1 340 341 353 380 474 504 579 also has been used for UTIs caused by E. aerogenes†,474 Klebsiella oxytoca†,474 or P. stuartii†.326 474

Treatment of UTIs in adults caused by susceptible gram-positive bacteria, including S. aureus†,327 353 380 S. epidermidis,1 327 336 340 474 579 S. saprophyticus,1 332 579 or E. faecalis.1 327 336 339 340 341 353 474 538 579 715

Treatment of acute uncomplicated pyelonephritis in adults caused by E. coli.715

Treatment of recurrent UTIs and chronic prostatitis in adults caused by E. coli or P. mirabilis in men.1 180 294 296 339 343 379 466 579 May be a drug of choice because high concentrations are attained in prostatic tissue.180 293 338 339 343 466 479

Usually reserved for treatment of complicated UTIs, especially those caused by multidrug-resistant bacteria;299 336 379 425 481 551 generally not recommended for uncomplicated UTIs (e.g., acute cystitis) unless more commonly employed urinary anti-infectives are likely to be ineffective or other equally effective, less expensive anti-infectives are contraindicated or not tolerated.293 299 522 551 585

Anthrax

Postexposure prophylaxis to reduce the incidence or progression of disease following suspected or confirmed exposure to aerosolized Bacillus anthracis spores (inhalational anthrax).1 579 663 667 668 670 678 681 682 683 686 Initial drug of choice for such prophylaxis is ciprofloxacin or doxycycline.668 683 696 697 Based on in vitro data, other fluoroquinolones (e.g., moxifloxacin, ofloxacin, levofloxacin) are considered alternatives to ciprofloxacin when needed.668

Treatment of inhalational anthrax.667 668 670 678 683 686 Monotherapy may be effective for anthrax that occurs as the result of natural or endemic exposures, but a multiple-drug parenteral regimen (ciprofloxacin or doxycycline and 1 or 2 other anti-infectives predicted to be effective) is recommended for inhalational anthrax that occurs as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism.668 686 703 Other drugs suggested as possibilities to augment ciprofloxacin or doxycycline in such multiple-drug regimens include chloramphenicol, clindamycin, rifampin, vancomycin, macrolides (azithromycin, clarithromycin, erythromycin), imipenem, meropenem, penicillin, ampicillin, daptomycin, quinupristin and dalfopristin, linezolid, and aminoglycosides (gentamicin).668 683 686 If meningitis is established or suspected, some clinicians suggest a multiple-drug regimen that includes a fluoroquinolone (e.g., ciprofloxacin) and 1 or 2 additional agents with good CSF penetration (e.g., ampicillin or penicillin, meropenem, rifampin, vancomycin, chloramphenicol).668 683 770

Treatment of cutaneous anthrax†, including that occurring following exposure to B. anthracis spores in the context of biologic warfare or bioterrorism.686 Parenteral multiple-drug regimen recommended for initial treatment when there are signs of systemic involvement, extensive edema, or lesions on the head and neck668 670 686 or when cutaneous anthrax occurs in children <2 years of age.703

Treatment of GI and oropharyngeal anthrax.681 If occurring in the context of biologic warfare or bioterrorism, use parenteral regimens recommended for inhalational anthrax.668 681 686 703

Prophylaxis following ingestion of B. anthracis spores† in contaminated meat.662

Although ciprofloxacin not usually used in children <18 years of age or in pregnant women, CDC and others state ciprofloxacin can be used when necessary in these patients for postexposure prophylaxis or treatment of anthrax since the benefits of ciprofloxacin outweigh the risks.703

Bartonella Infections

Treatment of infections caused by Bartonella henselae† (e.g., cat scratch disease, bacillary angiomatosis, peliosis hepatitis).733

Cat scratch disease generally self-limited in immunocompetent individuals and may resolve spontaneously in 2–4 months; some clinicians suggest that anti-infectives be considered for acutely or severely ill patients with systemic symptoms, particularly those with hepatosplenomegaly or painful lymphadenopathy, and probably is indicated in immunocompromised patients.667 729 730 731 732 Anti-infectives also indicated in patients with B. henselae infections who develop bacillary angiomatosis, neuroretinitis, or Parinaud’s oculoglandular syndrome.730 731 732 Optimum regimens have not been identified; some clinicians recommend azithromycin, ciprofloxacin, erythromycin, doxycycline, rifampin, co-trimoxazole, gentamicin, or third generation cephalosporins.538 667 729 730 731 732 733

Brucellosis

Treatment of brucellosis† caused by Brucella melitensis.538 624 683 771 772 Ciprofloxacin used in conjunction with rifampin is an alternative to a regimen of a tetracycline and rifampin.538 683 771 772

Capnocytophaga Infections

Alternative to penicillin G for treatment of infections caused by Capnocytophaga canimorsus†.538

Chancroid

Treatment of chancroid† (genital ulcers caused by Haemophilus ducreyi).321 462 538 606 631

CDC and others recommend azithromycin, ceftriaxone, ciprofloxacin, or erythromycin as drugs of choice for treatment of chancroid.606 631 HIV-infected patients and uncircumcised patients may not respond to treatment as well as those who are HIV-negative or circumcised.606 631

Crohn’s Disease

Management of Crohn’s disease† as an adjunct to conventional therapies.737 742 743 744 745 746 747 748

Has been used (with737 742 744 745 746 748 or without metronidazole743 747 ) for induction of remission of mildly to moderately active Crohn’s disease.737 742 743 744 745 746 747 748 May be more effective in patients with ileitis than in those with colitis.739 742

Has been used in the management of refractory perianal Crohn’s disease†.737 739 750 751 Relapse usually occurs when the drug is discontinued.739


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Mag-200


Generic Name: magnesium oxide (mag NEE see um OCK side)
Brand Names: Mag-200, Mag-Ox 400, MagGel, Uro-Mag

What is Mag-200 (magnesium oxide)?

Magnesium is a naturally occurring mineral. Magnesium is important for many systems in the body especially the muscles and nerves.

Magnesium oxide is used as a supplement to maintain adequate magnesium in the body.

Magnesium oxide may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Mag-200 (magnesium oxide)?

Before taking magnesium oxide, tell your doctor if you have any other medical conditions, allergies, or if you take other medicines or other herbal/health supplements. Magnesium oxide may not be recommended in some situations.

Who should not take Mag-200 (magnesium oxide)? Do not take magnesium oxide without first talking to your doctor if you have kidney disease.

Before taking magnesium oxide, tell your doctor if you have any other medical conditions, allergies, or if you take other medicines or other herbal/health supplements. Magnesium oxide may not be recommended in some situations.

It is not known whether magnesium oxide will harm an unborn baby. Do not take magnesium oxide without first talking to your doctor if you are pregnant or planning a pregnancy. It is not known whether magnesium oxide will harm an nursing baby. Do not take magnesium oxide without first talking to your doctor if you are breast-feeding a baby. How should I take Mag-200 (magnesium oxide)?

Take magnesium oxide exactly as directed by your doctor or as directed on the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take the tablets and capsules with a full glass of water.

To ensure that you get the correct dose, measure the liquid form of magnesium with a dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Do not take more magnesium oxide than is directed. Store magnesium oxide at room temperature away from moisture and heat. What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose? Seek emergency medical attention.

Symptoms of an magnesium oxide overdose include nausea, vomiting, flushing, low blood pressure, a slow heartbeat, drowsiness, coma, and death.

What should I avoid while taking Mag-200 (magnesium oxide)?

There are no restrictions on food, beverages, or activity while taking magnesium oxide unless otherwise directed by your doctor.

Mag-200 (magnesium oxide) side effects Stop taking magnesium oxide and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take magnesium oxide and talk to your doctor if you experience diarrhea or an upset stomach.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Mag-200 (magnesium oxide)?

Before taking magnesium oxide, talk to your doctor if you are taking

a tetracycline antibiotic such as tetracycline (Sumycin, Achromycin V, and others), demeclocycline (Declomycin), doxycycline (Vibramycin, Monodox, Doxy, and others), minocycline (Minocin, Dynacin, and others), or oxytetracycline (Terramycin, and others);

a fluoroquinolone antibiotic such as ciprofloxacin (Cipro), ofloxacin (Floxin), enoxacin (Penetrex), norfloxacin (Noroxin), sparfloxacin (Zagam), levofloxacin (Levaquin), lomefloxacin (Maxaquin), grepafloxacin (Raxar), and others;

penicillamine (Cuprimine);

digoxin (Lanoxin, Lanoxicaps); or

nitrofurantoin (Macrodantin, Furadantin, others).

You not be able to take magnesium oxide, or you may require a dosage adjustment or special monitoring during your treatment if you are taking any of the medicines listed above.

Drugs other than those listed here can also interact with magnesium oxide. Talk to your doctor and pharmacist before taking any over-the-counter or prescription medicines.

More Mag-200 resources Mag-200 Side Effects (in more detail) Mag-200 Use in Pregnancy & Breastfeeding Mag-200 Drug Interactions Mag-200 Support Group 0 Reviews for Mag-200 - Add your own review/rating Magnesium Oxide Professional Patient Advice (Wolters Kluwer) Magnesium Oxide MedFacts Consumer Leaflet (Wolters Kluwer) Compare Mag-200 with other medications Constipation Duodenal Ulcer GERD Hypomagnesemia Indigestion Pathological Hypersecretory Disorder Stomach Ulcer Urinary Tract Stones Where can I get more information? Your pharmacist has additional information about magnesium oxide written for health professionals that you may read.

See also: Mag-200 side effects (in more detail)


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zinc gluconate


Generic Name: zinc gluconate (ZINK GLUE koe nate)
Brand names: Orazinc, Orazinc 110(obsolete)

What is zinc gluconate?

Zinc is a naturally occurring mineral. Zinc is important for growth and for the development and health of body tissues.

Zinc gluconate is used to treat and to prevent zinc deficiency.

Zinc gluconate may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about zinc gluconate?

Before using zinc gluconate, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use zinc gluconate if you have certain medical conditions.

Avoid taking this medication with foods that are high in calcium or phosphorus, which can make it harder for your body to absorb zinc gluconate. Foods high in calcium or phosphorus include milk, cheese, yogurt, ice cream, dried beans or peas, lentils, nuts, peanut butter, beer, cola soft drinks, and hot cocoa.

Zinc gluconate can make certain antibiotics less effective. Tell your doctor about all other medications you are using before you start taking zinc gluconate.

What should I discuss with my healthcare provider before taking zinc gluconate?

Before using zinc gluconate, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use zinc gluconate if you have certain medical conditions.

It is not known whether zinc gluconate will harm an unborn baby. Do not take zinc gluconate without telling your doctor if you are pregnant or could become pregnant during treatment. It is not known whether zinc gluconate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take zinc gluconate?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Take zinc gluconate with a full glass of water. Take zinc gluconate with food if it upsets your stomach.

Your healthcare provider may occasionally change your dose to make sure you get the best results from zinc gluconate. The recommended dietary allowance of zinc gluconate increases with age. Follow your healthcare provider's instructions. You may also consult the National Academy of Sciences "Dietary Reference Intake" or the U.S. Department of Agriculture's "Dietary Reference Intake" (formerly "Recommended Daily Allowances" or RDA) listings for more information.

Store at room temperature away from moisture and heat. What happens if I miss a dose?

Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, severe vomiting, dehydration, and restlessness.

What should I avoid while taking zinc gluconate? Avoid taking this medication with foods that are high in calcium or phosphorus, which can make it harder for your body to absorb zinc gluconate. Foods high in calcium or phosphorus include milk, cheese, yogurt, ice cream, dried beans or peas, lentils, nuts, peanut butter, beer, cola soft drinks, and hot cocoa. Zinc gluconate side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

nausea; or

upset stomach.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Zinc gluconate Dosing Information

Usual Adult Dose for Dietary Supplement:

Dosage: 105 mg to 350 mg daily.

What other drugs will affect zinc gluconate?

The following drugs can interact with or be made less effective by zinc gluconate. Tell your doctor if you are using any of these:

a blood thinner such as warfarin (Coumadin);

methyltestosterone (Android, Methitest, Oreton);

penicillamine (Cuprimine, Depen);

risedronate (Actonel);

a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap); or

an antibiotic such as ciprofloxacin (Cipro), ofloxacin (Floxin), norfloxacin (Noroxin), levofloxacin (Levaquin), and others.

This list is not complete and other drugs may interact with zinc gluconate. Tell your healthcare provider about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More zinc gluconate resources Zinc gluconate Side Effects (in more detail) Zinc gluconate Use in Pregnancy & Breastfeeding Zinc gluconate Drug Interactions Zinc gluconate Support Group 0 Reviews for Zinc gluconate - Add your own review/rating Orazinc MedFacts Consumer Leaflet (Wolters Kluwer) Compare zinc gluconate with other medications Dietary Supplementation Where can I get more information? Your pharmacist can provide more information about zinc gluconate.

See also: zinc gluconate side effects (in more detail)


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zinc sulfate


Generic Name: zinc sulfate (ZINK SUL fate)
Brand names: Orazinc 110, Orazinc 220, Verazinc, Zinc-220, Zincate, Zinca-pak, Mar-Zinc, Zinc CR, Micro-Zn, Zinc 50 mg Pink

What is zinc sulfate?

Zinc is a naturally occurring mineral. Zinc is important for growth and for the development and health of body tissues.

Zinc sulfate is used to treat and to prevent zinc deficiency.

Zinc sulfate may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about zinc sulfate?

Before using zinc sulfate, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use zinc sulfate if you have certain medical conditions.

Avoid taking this medication with foods that are high in calcium or phosphorus, which can make it harder for your body to absorb zinc sulfate. Foods high in calcium or phosphorus include milk, cheese, yogurt, ice cream, dried beans or peas, lentils, nuts, peanut butter, beer, cola soft drinks, and hot cocoa.

Zinc sulfate can make certain antibiotics less effective. Tell your doctor about all other medications you are using before you start taking zinc sulfate.

What should I discuss with my healthcare provider before taking zinc sulfate?

Before using zinc sulfate, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use zinc sulfate if you have certain medical conditions.

It is not known whether zinc sulfate will harm an unborn baby. Do not take zinc sulfate without telling your doctor if you are pregnant or could become pregnant during treatment. It is not known whether zinc sulfate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take zinc sulfate?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Take zinc sulfate with a full glass of water. Take zinc sulfate with food if it upsets your stomach.

Your healthcare provider may occasionally change your dose to make sure you get the best results from zinc sulfate. The recommended dietary allowance of zinc sulfate increases with age. Follow your healthcare provider's instructions. You may also consult the National Academy of Sciences "Dietary Reference Intake" or the U.S. Department of Agriculture's "Dietary Reference Intake" (formerly "Recommended Daily Allowances" or RDA) listings for more information.

Store at room temperature away from moisture and heat. What happens if I miss a dose?

Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, severe vomiting, dehydration, and restlessness.

What should I avoid while taking zinc sulfate? Avoid taking this medication with foods that are high in calcium or phosphorus, which can make it harder for your body to absorb zinc sulfate. Foods high in calcium or phosphorus include milk, cheese, yogurt, ice cream, dried beans or peas, lentils, nuts, peanut butter, beer, cola soft drinks, and hot cocoa. Zinc sulfate side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

nausea; or

upset stomach.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect zinc sulfate?

The following drugs can interact with or be made less effective by zinc sulfate. Tell your doctor if you are using any of these:

a blood thinner such as warfarin (Coumadin);

methyltestosterone (Android, Methitest, Oreton);

penicillamine (Cuprimine, Depen);

risedronate (Actonel);

a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap); or

an antibiotic such as ciprofloxacin (Cipro), ofloxacin (Floxin), norfloxacin (Noroxin), levofloxacin (Levaquin), and others.

This list is not complete and other drugs may interact with zinc sulfate. Tell your healthcare provider about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More zinc sulfate resources Zinc sulfate Use in Pregnancy & Breastfeeding Drug Images Zinc sulfate Drug Interactions Zinc sulfate Support Group 1 Review for Zinc sulfate - Add your own review/rating Zinc Sulfate MedFacts Consumer Leaflet (Wolters Kluwer) Zinc Sulfate Professional Patient Advice (Wolters Kluwer) Orazinc 110 Advanced Consumer (Micromedex) - Includes Dosage Information Compare zinc sulfate with other medications Vitamin/Mineral Supplementation and Deficiency Where can I get more information? Your pharmacist can provide more information about zinc sulfate.


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All Day Calcium ER Extended-Release Caplets


Pronunciation: KAL-see-um KAR-bo-nate with VYE-ta-min D
Generic Name: Calcium Carbonate with Vitamin D
Brand Name: All Day Calcium ER
All Day Calcium ER Extended-Release Caplets are used for:

Treating or preventing calcium and vitamin D deficiency. It may also be used for other conditions as determined by your doctor.

All Day Calcium ER Extended-Release Caplets are a dietary supplement. It works by providing extra calcium and vitamin D to the body.

Do NOT use All Day Calcium ER Extended-Release Caplets if: you are allergic to any ingredient in All Day Calcium ER Extended-Release Caplets you have high blood calcium levels or high blood vitamin D levels

Contact your doctor or health care provider right away if any of these apply to you.

Before using All Day Calcium ER Extended-Release Caplets:

Some medical conditions may interact with All Day Calcium ER Extended-Release Caplets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances (including shellfish) if you have high blood phosphate levels or high levels of calcium in the urine if you have dehydration, heart problems, hardening of the arteries, kidney problems, kidney stones, or sarcoidosis

Some MEDICINES MAY INTERACT with All Day Calcium ER Extended-Release Caplets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Mycophenolate because its effectiveness may be decreased by All Day Calcium ER Extended-Release Caplets Dabigatran because its effectiveness may be decreased by All Day Calcium ER Extended-Release Caplets

This may not be a complete list of all interactions that may occur. Ask your health care provider if All Day Calcium ER Extended-Release Caplets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use All Day Calcium ER Extended-Release Caplets:

Use All Day Calcium ER Extended-Release Caplets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take All Day Calcium ER Extended-Release Caplets by mouth with or without food. Take All Day Calcium ER Extended-Release Caplets with a full glass of water (8 oz/240 mL). Swallow All Day Calcium ER Extended-Release Caplets whole. Do not break, crush, or chew before swallowing. If you also take azole antifungals (eg, ketoconazole), bisphosphonates (eg, etidronate), cation exchange resins (eg, sodium polystyrene sulfonate), cephalosporins (eg, cefdinir), doxycycline, iron, quinolones (eg, ciprofloxacin, levofloxacin), tetracyclines (eg, doxycycline), or thyroid hormones (eg, levothyroxine), ask your doctor or pharmacist how to take them with All Day Calcium ER Extended-Release Caplets. If you miss a dose of All Day Calcium ER Extended-Release Caplets, take it as soon as you remember. Continue to take it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use All Day Calcium ER Extended-Release Caplets.

Important safety information: Do not take large doses of vitamins while you use All Day Calcium ER Extended-Release Caplets unless your doctor tells you to. Tell your doctor or dentist that you take All Day Calcium ER Extended-Release Caplets before you receive any medical or dental care, emergency care, or surgery. Lab tests, including blood calcium and vitamin D levels, may be performed while you use All Day Calcium ER Extended-Release Caplets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. All Day Calcium ER Extended-Release Caplets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using All Day Calcium ER Extended-Release Caplets while you are pregnant. It is not known if All Day Calcium ER Extended-Release Caplets are found in breast milk. If you are or will be breast-feeding while you use All Day Calcium ER Extended-Release Caplets, check with your doctor. Discuss any possible risks to your baby. Possible side effects of All Day Calcium ER Extended-Release Caplets:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with All Day Calcium ER Extended-Release Caplets. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); loss of appetite; nausea; severe or persistent constipation; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; delirium; loss of consciousness; mood or mental changes; sluggishness.

Proper storage of All Day Calcium ER Extended-Release Caplets:

Store All Day Calcium ER Extended-Release Caplets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep All Day Calcium ER Extended-Release Caplets out of the reach of children and away from pets.

General information: If you have any questions about All Day Calcium ER Extended-Release Caplets, please talk with your doctor, pharmacist, or other health care provider. All Day Calcium ER Extended-Release Caplets are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about All Day Calcium ER Extended-Release Caplets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More All Day Calcium ER resources All Day Calcium ER Use in Pregnancy & Breastfeeding All Day Calcium ER Drug Interactions All Day Calcium ER Support Group 0 Reviews for All Day Calcium ER - Add your own review/rating Compare All Day Calcium ER with other medications Dietary Supplementation Osteoporosis


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Citrate of Magnesia


Generic Name: magnesium citrate (mag NEE see um SIH trate)
Brand Names: Citrate of Magnesia, Citroma

What is Citrate of Magnesia (magnesium citrate)?

Magnesium is a naturally occurring mineral. Magnesium is important for many systems in the body especially the muscles and nerves. Magnesium citrate also increases water in the intestines, which may induce defecation.

Magnesium hydroxide is used as a laxative to relieve occasional constipation (irregularity).

Magnesium citrate may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Citrate of Magnesia (magnesium citrate)?

Before taking magnesium citrate, tell your doctor if you have any other medical conditions, allergies, or if you take other medicines or other herbal/health supplements. Magnesium citrate may not be recommended in some situations.

Do not use magnesium citrate as a laxative if you have stomach (abdominal) pain, nausea, or vomiting, unless directed by a doctor. If you notice a sudden change in bowel habits that persists over a period of 2 weeks, consult your healthcare provider before using a laxative. Magnesium citrate should not be used for longer than one week, unless otherwise directed by your healthcare provider. Rectal bleeding or failure to have a bowel movement after use of a laxative may indicate a more serious condition; stop using magnesium citrate and contact your healthcare provider. What should I discuss with my healthcare provider before taking Citrate of Magnesia (magnesium citrate)? Do not take magnesium citrate without first talking to your doctor if you have kidney disease. Do not use magnesium citrate as a laxative if you have stomach (abdominal) pain, nausea, or vomiting, unless directed by a doctor. If you notice a sudden change in bowel habits that persists over a period of 2 weeks, consult your healthcare provider before using a laxative. Magnesium citrate should not be used for longer than one week, unless otherwise directed by your healthcare provider. Rectal bleeding or failure to have a bowel movement after use of a laxative may indicate a more serious condition; stop using magnesium citrate and contact your healthcare provider.

Before taking magnesium citrate, tell your doctor if you have any other medical conditions, allergies, or if you take other medicines or other herbal/health supplements. Magnesium citrate may not be recommended in some situations.

It is not known whether magnesium citrate will be harmful to an unborn baby. Do not take magnesium citrate without first talking to your doctor if you are pregnant or planning a pregnancy. It is not known whether magnesium citrate will be harmful to an nursing baby. Do not take magnesium citrate without first talking to your doctor if you are breast-feeding a baby. How should I take Citrate of Magnesia (magnesium citrate)?

Take magnesium citrate exactly as directed by your doctor or as directed on the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

For best results, take magnesium citrate on an empty stomach followed by a full glass of water. Chilling the medication in the refrigerator or giving it with ice may improve the taste.

To ensure that you get the correct dose, measure the liquid form of magnesium with a dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Do not use magnesium citrate as a laxative if you have stomach (abdominal) pain, nausea, or vomiting, unless directed by a doctor. If you notice a sudden change in bowel habits that persists over a period of 2 weeks, consult your healthcare provider before using a laxative. Magnesium citrate should not be used for longer than one week, unless otherwise directed by your healthcare provider. Rectal bleeding or failure to have a bowel movement after use of a laxative may indicate a more serious condition; stop using magnesium citrate and contact your healthcare provider. Do not take more magnesium citrate than is directed. Store magnesium citrate at room temperature away from moisture and heat. What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose? Seek emergency medical attention.

Symptoms of an magnesium citrate overdose include nausea, vomiting, flushing, low blood pressure, a slow heartbeat, drowsiness, coma, and death.

What should I avoid while taking Citrate of Magnesia (magnesium citrate)?

There are no restrictions on food, beverages, or activity while taking magnesium citrate unless otherwise directed by your doctor.

Citrate of Magnesia (magnesium citrate) side effects Stop taking magnesium citrate and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take magnesium citrate and talk to your doctor if you experience diarrhea, upset stomach, dizziness, or sweating.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Citrate of Magnesia (magnesium citrate)?

Before taking magnesium citrate, talk to your doctor if you are taking

a tetracycline antibiotic such as tetracycline (Sumycin, Achromycin V, and others), demeclocycline (Declomycin), doxycycline (Vibramycin, Monodox, Doxy, and others), minocycline (Minocin, Dynacin, and others), or oxytetracycline (Terramycin, and others);

a fluoroquinolone antibiotic such as ciprofloxacin (Cipro), ofloxacin (Floxin), enoxacin (Penetrex), norfloxacin (Noroxin), sparfloxacin (Zagam), levofloxacin (Levaquin), lomefloxacin (Maxaquin), grepafloxacin (Raxar), and others;

penicillamine (Cuprimine);

digoxin (Lanoxin, Lanoxicaps); or

nitrofurantoin (Macrodantin, Furadantin, others).

You not be able to take magnesium citrate, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here can also interact with magnesium citrate. Talk to your doctor and pharmacist before taking any over-the-counter or prescription medicines, including herbal products.

More Citrate of Magnesia resources Citrate of Magnesia Side Effects (in more detail) Citrate of Magnesia Use in Pregnancy & Breastfeeding Citrate of Magnesia Drug Interactions Citrate of Magnesia Support Group 1 Review for Citrate of Magnesia - Add your own review/rating Citrate of Magnesia Solution MedFacts Consumer Leaflet (Wolters Kluwer) Magnesium Citrate Professional Patient Advice (Wolters Kluwer) Citrate Of Magnesia Advanced Consumer (Micromedex) - Includes Dosage Information Compare Citrate of Magnesia with other medications Constipation Where can I get more information? Your pharmacist has additional information about magnesium citrate written for health professionals that you may read.

See also: Citrate of Magnesia side effects (in more detail)


More




ciprofloxacin and hydrocortisone Otic


sip-roe-FLOX-a-sin hye-droe-KLOR-ide, hye-droe-KOR-ti-sone

Commonly used brand name(s)

In the U.S.

Cipro HC

In Canada

Cipro Hc

Available Dosage Forms:

Suspension

Therapeutic Class: Anti-Infective/Anti-Inflammatory Combination

Pharmacologic Class: Adrenal Glucocorticoid

Chemical Class: Ciprofloxacin

Uses For ciprofloxacin and hydrocortisone

Ciprofloxacin and hydrocortisone is a combination medicine used to treat otitis externa. Otitis externa, also known as Swimmer's ear, is an infection of the outer ear canal caused by bacteria. The ear canal and outer part of the ear may be swollen, red, and painful.

Ciprofloxacin belongs to the class of medicines known as fluoroquinolone antibiotics. It works by killing the bacteria or preventing their growth. Hydrocortisone is a corticosteroid (cortisone-like medicine) that is used to relieve the redness, itching, and swelling caused by ear infections.

ciprofloxacin and hydrocortisone is available only with your doctor's prescription.

Before Using ciprofloxacin and hydrocortisone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ciprofloxacin and hydrocortisone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ciprofloxacin and hydrocortisone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ciprofloxacin and hydrocortisone combination in children.

Geriatric

No information is available on the relationship of age to the effects of ciprofloxacin and hydrocortisone combination in geriatric patients.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking ciprofloxacin and hydrocortisone, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ciprofloxacin and hydrocortisone with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Cisapride Dronedarone Mesoridazine Pimozide Rotavirus Vaccine, Live Sparfloxacin Thioridazine Tizanidine

Using ciprofloxacin and hydrocortisone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acarbose Acecainide Acetohexamide Aldesleukin Alfuzosin Alosetron Amiodarone Amitriptyline Amoxapine Apomorphine Arsenic Trioxide Asenapine Astemizole Azimilide Azithromycin Bendamustine Benfluorex Bretylium Bupropion Chlorpromazine Chlorpropamide Citalopram Clarithromycin Clomipramine Crizotinib Dasatinib Desipramine Disopyramide Dofetilide Dolasetron Droperidol Eltrombopag Erythromycin Flecainide Fluconazole Gatifloxacin Gemifloxacin Gliclazide Glimepiride Glipizide Gliquidone Glyburide Granisetron Guar Gum Halofantrine Haloperidol Ibutilide Iloperidone Imipramine Insulin Insulin Aspart, Recombinant Insulin Glulisine Insulin Lispro, Recombinant Lapatinib Levofloxacin Lopinavir Lumefantrine Mefloquine Metformin Methadone Miglitol Moricizine Moxifloxacin Nilotinib Norfloxacin Nortriptyline Octreotide Ofloxacin Ondansetron Paliperidone Pazopanib Perflutren Lipid Microsphere Posaconazole Procainamide Prochlorperazine Promethazine Propafenone Protriptyline Quetiapine Quinidine Quinine Ranolazine Salmeterol Saquinavir Sematilide Simvastatin Sodium Phosphate Sodium Phosphate, Dibasic Sodium Phosphate, Monobasic Solifenacin Sorafenib Sotalol Sunitinib Tedisamil Telavancin Telithromycin Terfenadine Tetrabenazine Theophylline Tolazamide Tolbutamide Toremifene Trazodone Trifluoperazine Trimipramine Troglitazone Vandetanib Vardenafil Vemurafenib Voriconazole Ziprasidone

Using ciprofloxacin and hydrocortisone with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alatrofloxacin Alcuronium Atracurium Balofloxacin Betamethasone Chloroquine Cinoxacin Ciprofloxacin Clinafloxacin Clozapine Colestipol Corticotropin Cortisone Cosyntropin Cyclosporine Deflazacort Dexamethasone Diclofenac Dutasteride Enoxacin Erlotinib Fleroxacin Fludrocortisone Flumequine Fluocortolone Fosphenytoin Gallamine Gemifloxacin Grepafloxacin Hexafluorenium Hydrocortisone Itraconazole Levofloxacin Licorice Lomefloxacin Methylprednisolone Metocurine Moxifloxacin Mycophenolate Mofetil Norfloxacin Ofloxacin Olanzapine Paramethasone Pefloxacin Phenytoin Prednisolone Prednisone Primidone Probenecid Prulifloxacin Rasagiline Rifapentine Ropinirole Ropivacaine Rosoxacin Rufloxacin Saiboku-To Sildenafil Sparfloxacin Temafloxacin Tosufloxacin Triamcinolone Trovafloxacin Mesylate Warfarin Zolpidem Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ciprofloxacin and hydrocortisone with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use ciprofloxacin and hydrocortisone, or give you special instructions about the use of food, alcohol, or tobacco.

Caffeine Other Medical Problems

The presence of other medical problems may affect the use of ciprofloxacin and hydrocortisone. Make sure you tell your doctor if you have any other medical problems, especially:

Viral ear infections (e.g., varicella or herpes simplex)—Should not be used in patients with these conditions. Proper Use of ciprofloxacin and hydrocortisone

ciprofloxacin and hydrocortisone is to be used only in the ear. Do not use it in the eyes and do not take it by mouth. If ciprofloxacin and hydrocortisone is accidently swallowed, call your doctor right away.

It is important that the infected ear remains clean and dry. When bathing, avoid getting the infected ear wet. Avoid swimming unless your doctor has instructed you otherwise.

To use the ear drops:

Wash your hands thoroughly with soap and water. Hold the bottle in your hands for 1 or 2 minutes to warm up the solution before putting it in your ear. Putting a cold solution in your ear could cause you to become dizzy. Shake the bottle well. Lie down on your side with your infected ear facing up. Put the drops in the infected ear. You should remain on your side for at least one minute. Repeat the above steps if both ears are infected.

To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the ear). Also, keep the container tightly closed.

Keep using ciprofloxacin and hydrocortisone for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon. Do not miss any doses.

Dosing

The dose of ciprofloxacin and hydrocortisone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of ciprofloxacin and hydrocortisone. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For ear drops dosage form: For ear infections: Adults and children above 1 year of age—Place 3 drops in the affected ear two times a day. Children younger than 1 year of age—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of ciprofloxacin and hydrocortisone, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using ciprofloxacin and hydrocortisone

If your symptoms do not improve, or if they become worse, check with your doctor.

ciprofloxacin and hydrocortisone may cause serious allergic reactions including anaphylaxis, which can be life-threatening and require immediate medical attention. Stop using ciprofloxacin and hydrocortisone and call your doctor right away if you have itching; hives; hoarseness; rash; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth.

ciprofloxacin and hydrocortisone Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known Blistering, crusting, irritation, itching, or reddening of the skin burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings cracked, dry, or scaly skin hives or welts itching redness of the skin skin rash swelling

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Headache Incidence not known Cough hair loss or thinning of hair headache, severe and throbbing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: ciprofloxacin and hydrocortisone Otic side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More ciprofloxacin and hydrocortisone Otic resources Ciprofloxacin and hydrocortisone Otic Side Effects (in more detail) Ciprofloxacin and hydrocortisone Otic Use in Pregnancy & Breastfeeding Ciprofloxacin and hydrocortisone Otic Support Group 0 Reviews for Ciprofloxacin and hydrocortisone Otic - Add your own review/rating Compare ciprofloxacin and hydrocortisone Otic with other medications Acute Otitis Externa


More




Cipro HC


Generic Name: ciprofloxacin and hydrocortisone (Otic route)

sip-roe-FLOX-a-sin hye-droe-KLOR-ide, hye-droe-KOR-ti-sone

Commonly used brand name(s)

In the U.S.

Cipro HC

In Canada

Cipro Hc

Available Dosage Forms:

Suspension

Therapeutic Class: Anti-Infective/Anti-Inflammatory Combination

Pharmacologic Class: Adrenal Glucocorticoid

Chemical Class: Ciprofloxacin

Uses For Cipro HC

Ciprofloxacin and hydrocortisone is a combination medicine used to treat otitis externa. Otitis externa, also known as Swimmer's ear, is an infection of the outer ear canal caused by bacteria. The ear canal and outer part of the ear may be swollen, red, and painful.

Ciprofloxacin belongs to the class of medicines known as fluoroquinolone antibiotics. It works by killing the bacteria or preventing their growth. Hydrocortisone is a corticosteroid (cortisone-like medicine) that is used to relieve the redness, itching, and swelling caused by ear infections.

This medicine is available only with your doctor's prescription.

Before Using Cipro HC

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ciprofloxacin and hydrocortisone combination in children.

Geriatric

No information is available on the relationship of age to the effects of ciprofloxacin and hydrocortisone combination in geriatric patients.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Cisapride Dronedarone Mesoridazine Pimozide Rotavirus Vaccine, Live Sparfloxacin Thioridazine Tizanidine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acarbose Acecainide Acetohexamide Aldesleukin Alfuzosin Alosetron Amiodarone Amitriptyline Amoxapine Apomorphine Arsenic Trioxide Asenapine Astemizole Azimilide Azithromycin Bendamustine Benfluorex Bretylium Bupropion Chlorpromazine Chlorpropamide Citalopram Clarithromycin Clomipramine Crizotinib Dasatinib Desipramine Disopyramide Dofetilide Dolasetron Droperidol Eltrombopag Erythromycin Flecainide Fluconazole Gatifloxacin Gemifloxacin Gliclazide Glimepiride Glipizide Gliquidone Glyburide Granisetron Guar Gum Halofantrine Haloperidol Ibutilide Iloperidone Imipramine Insulin Insulin Aspart, Recombinant Insulin Glulisine Insulin Lispro, Recombinant Lapatinib Levofloxacin Lopinavir Lumefantrine Mefloquine Metformin Methadone Miglitol Moricizine Moxifloxacin Nilotinib Norfloxacin Nortriptyline Octreotide Ofloxacin Ondansetron Paliperidone Pazopanib Perflutren Lipid Microsphere Posaconazole Procainamide Prochlorperazine Promethazine Propafenone Protriptyline Quetiapine Quinidine Quinine Ranolazine Salmeterol Saquinavir Sematilide Simvastatin Sodium Phosphate Sodium Phosphate, Dibasic Sodium Phosphate, Monobasic Solifenacin Sorafenib Sotalol Sunitinib Tedisamil Telavancin Telithromycin Terfenadine Tetrabenazine Theophylline Tolazamide Tolbutamide Toremifene Trazodone Trifluoperazine Trimipramine Troglitazone Vandetanib Vardenafil Vemurafenib Voriconazole Ziprasidone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alatrofloxacin Alcuronium Atracurium Balofloxacin Betamethasone Chloroquine Cinoxacin Ciprofloxacin Clinafloxacin Clozapine Colestipol Corticotropin Cortisone Cosyntropin Cyclosporine Deflazacort Dexamethasone Diclofenac Dutasteride Enoxacin Erlotinib Fleroxacin Fludrocortisone Flumequine Fluocortolone Fosphenytoin Gallamine Gemifloxacin Grepafloxacin Hexafluorenium Hydrocortisone Itraconazole Levofloxacin Licorice Lomefloxacin Methylprednisolone Metocurine Moxifloxacin Mycophenolate Mofetil Norfloxacin Ofloxacin Olanzapine Paramethasone Pefloxacin Phenytoin Prednisolone Prednisone Primidone Probenecid Prulifloxacin Rasagiline Rifapentine Ropinirole Ropivacaine Rosoxacin Rufloxacin Saiboku-To Sildenafil Sparfloxacin Temafloxacin Tosufloxacin Triamcinolone Trovafloxacin Mesylate Warfarin Zolpidem Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Caffeine Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Viral ear infections (e.g., varicella or herpes simplex)—Should not be used in patients with these conditions. Proper Use of Cipro HC

This medicine is to be used only in the ear. Do not use it in the eyes and do not take it by mouth. If this medicine is accidently swallowed, call your doctor right away.

It is important that the infected ear remains clean and dry. When bathing, avoid getting the infected ear wet. Avoid swimming unless your doctor has instructed you otherwise.

To use the ear drops:

Wash your hands thoroughly with soap and water. Hold the bottle in your hands for 1 or 2 minutes to warm up the solution before putting it in your ear. Putting a cold solution in your ear could cause you to become dizzy. Shake the bottle well. Lie down on your side with your infected ear facing up. Put the drops in the infected ear. You should remain on your side for at least one minute. Repeat the above steps if both ears are infected.

To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the ear). Also, keep the container tightly closed.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For ear drops dosage form: For ear infections: Adults and children above 1 year of age—Place 3 drops in the affected ear two times a day. Children younger than 1 year of age—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Cipro HC

If your symptoms do not improve, or if they become worse, check with your doctor.

This medicine may cause serious allergic reactions including anaphylaxis, which can be life-threatening and require immediate medical attention. Stop using this medicine and call your doctor right away if you have itching; hives; hoarseness; rash; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth.

Cipro HC Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known Blistering, crusting, irritation, itching, or reddening of the skin burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings cracked, dry, or scaly skin hives or welts itching redness of the skin skin rash swelling

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Headache Incidence not known Cough hair loss or thinning of hair headache, severe and throbbing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Cipro HC side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Cipro HC resources Cipro HC Side Effects (in more detail) Cipro HC Use in Pregnancy & Breastfeeding Cipro HC Support Group 0 Reviews for Cipro HC - Add your own review/rating Cipro HC Concise Consumer Information (Cerner Multum) Compare Cipro HC with other medications Acute Otitis Externa


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Ciprofloxacin/Hydrocortisone


Pronunciation: sip-row-FLOX-ah-sin/hye-droe-KOR-ti-sone
Generic Name: Ciprofloxacin/Hydrocortisone
Brand Name: Cipro HC Otic
Ciprofloxacin/Hydrocortisone is used for:

Treating outer ear infections caused by certain bacteria.

Ciprofloxacin/Hydrocortisone is a quinolone antibiotic and corticosteroid combination. It works by killing bacteria by stopping the production of essential proteins needed by the bacteria to survive. It also reduces inflammation (redness, swelling, itching).

Do NOT use Ciprofloxacin/Hydrocortisone if: you are allergic to any ingredient in Ciprofloxacin/Hydrocortisone or any other fluoroquinolone (eg, levofloxacin) or corticosteroid (eg, prednisone) you have a viral infection of the outer ear (eg, chickenpox, herpes) or a perforated ear drum

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ciprofloxacin/Hydrocortisone:

Some medical conditions may interact with Ciprofloxacin/Hydrocortisone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Ciprofloxacin/Hydrocortisone. Because little, if any, of Ciprofloxacin/Hydrocortisone is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Ciprofloxacin/Hydrocortisone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ciprofloxacin/Hydrocortisone:

Use Ciprofloxacin/Hydrocortisone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Shake well before each use. Ciprofloxacin/Hydrocortisone is only for the ear. Do not get it in your eyes, nose, or mouth. Wash hands before and after using Ciprofloxacin/Hydrocortisone. Before using, hold the ear drop container in your hand for a few minutes to avoid dizziness that may result from putting cold drops into the ear. If possible, it may be easier to have another person place the drops in your ear. Lie down or tilt your head so that the affected ear faces up. Gently pull the earlobe up and back to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for several minutes so the medicine can run to the bottom of the ear canal. A clean cotton plug may be gently inserted into the ear canal to prevent medicine from leaking out. To prevent germs from getting into your medicine, do not touch the applicator to any surface, including the ear. Keep the container tightly closed. To clear up your infection completely, take/use Ciprofloxacin/Hydrocortisone for the full course of treatment. Keep taking/using it even if you feel better in a few days. If you miss a dose of Ciprofloxacin/Hydrocortisone, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Ciprofloxacin/Hydrocortisone.

Important safety information: Be sure to use Ciprofloxacin/Hydrocortisone for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. Long-term or repeated use of Ciprofloxacin/Hydrocortisone may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Do not get Ciprofloxacin/Hydrocortisone in your eyes. If Ciprofloxacin/Hydrocortisone gets in your eyes, immediately flush them with cool tap water. Talk to your doctor about how to space your doses if you are using other ear drops. Do not use Ciprofloxacin/Hydrocortisone for other ear infections or conditions without checking with your doctor. If your symptoms do not get better within 7 days or if they get worse, check with your doctor. Ciprofloxacin/Hydrocortisone should be used with extreme caution in CHILDREN younger than 1 year old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ciprofloxacin/Hydrocortisone while you are pregnant. It is not known if Ciprofloxacin/Hydrocortisone is found in breast milk after topical use. Do not breast-feed while taking Ciprofloxacin/Hydrocortisone. Possible side effects of Ciprofloxacin/Hydrocortisone:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); ear redness or swelling.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Ciprofloxacin/Hydrocortisone side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Ciprofloxacin/Hydrocortisone:

Store Ciprofloxacin/Hydrocortisone below 77 degrees F ( 25 degrees C). Store away from heat, moisture, and light. Avoid freezing. Do not store in the bathroom. Throw away any unused medicine after your treatment has finished. Keep Ciprofloxacin/Hydrocortisone out of the reach of children and away from pets.

General information: If you have any questions about Ciprofloxacin/Hydrocortisone, please talk with your doctor, pharmacist, or other health care provider. Ciprofloxacin/Hydrocortisone is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Ciprofloxacin/Hydrocortisone. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Ciprofloxacin/Hydrocortisone resources Ciprofloxacin/Hydrocortisone Side Effects (in more detail) Ciprofloxacin/Hydrocortisone Use in Pregnancy & Breastfeeding Ciprofloxacin/Hydrocortisone Support Group 0 Reviews for Ciprofloxacin/Hydrocortisone - Add your own review/rating Compare Ciprofloxacin/Hydrocortisone with other medications Acute Otitis Externa


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Ciloxan Drops


Pronunciation: sip-row-FLOX-ah-sin
Generic Name: Ciprofloxacin
Brand Name: Ciloxan
Ciloxan Drops are used for:

Treating eye infections caused by certain bacteria.

Ciloxan Drops are a quinolone antibiotic. It works by killing sensitive bacteria by stopping the production of essential proteins needed by the bacteria to survive.

Do NOT use Ciloxan Drops if: you are allergic to any ingredient in Ciloxan Drops or any other fluoroquinolone antibiotic (eg, levofloxacin)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ciloxan Drops:

Some medical conditions may interact with Ciloxan Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you wear contact lenses

Some MEDICINES MAY INTERACT with Ciloxan Drops. Because little, if any, of Ciloxan Drops are absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Ciloxan Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ciloxan Drops:

Use Ciloxan Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

To use Ciloxan Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them. To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed. If you are using more than one drop of Ciloxan Drops per dose, separate the first drop from the second drop by a few minutes. Remove contact lenses before you use Ciloxan Drops. Ask your doctor how to use your contact lenses while using Ciloxan Drops. To clear up your infection completely, take/use Ciloxan Drops for the full course of treatment. Keep taking/using it even if you feel better in a few days. If you miss a dose of Ciloxan Drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Ciloxan Drops.

Important safety information: Ciloxan Drops may cause sensitivity to light. Use Ciloxan Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Sometimes Ciloxan Drops causes white crystals to form in the eye. If this occurs, contact your doctor. The crystals do not affect vision or prevent the infection from clearing. Do not use leftover medicine for treating other infections or conditions without checking with your doctor. Be sure to use Ciloxan Drops for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. Long-term or repeated use of Ciloxan Drops may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this. Ciloxan Drops should be used with extreme caution in CHILDREN younger than 1 year old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ciloxan Drops while you are pregnant. It is not known if Ciloxan Drops are found in breast milk after topical use. If you are or will be breast-feeding while you use Ciloxan Drops, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Ciloxan Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bad taste in the mouth; bloodshot eyes; crusting of eyelids; eye burning or discomfort; feeling of something in the eye; itching; sensitivity to light.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); eyelid swelling; irritation; vision changes; white crystals in the eye.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Ciloxan side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Ciloxan Drops:

Store Ciloxan Drops at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ciloxan Drops out of the reach of children and away from pets.

General information: If you have any questions about Ciloxan Drops, please talk with your doctor, pharmacist, or other health care provider. Ciloxan Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Ciloxan Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Ciloxan resources Ciloxan Side Effects (in more detail) Ciloxan Use in Pregnancy & Breastfeeding Ciloxan Support Group 0 Reviews for Ciloxan - Add your own review/rating Compare Ciloxan with other medications Conjunctivitis, Bacterial Corneal Ulcer Ophthalmic Surgery


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Ferrex 150 Plus


Generic Name: ascorbic acid and iron polysaccharide (as KORE bik AS id and EYE urn SAK a ride)
Brand Names: Fe-Tinic 150, Ferrex 150 Plus, Niferex-150

What is Ferrex 150 Plus (ascorbic acid and iron polysaccharide)?

Ascorbic acid is found in citrus fruit, tomatoes, potatoes, and leafy vegetables. Ascorbic acid is important for the skin and connective tissues, for normal chemical and hormonal production, and for the immune system.

Iron polysaccharide is a form of the mineral iron. Iron is important for many functions in the body, especially for the transport of oxygen in the blood.

Ascorbic acid is used to treat and prevent vitamin C deficiency.

Iron polysaccharide is used as a dietary supplement, and to prevent and to treat iron deficiencies and iron deficiency anemia.

Ascorbic acid and iron polysaccharide may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Ferrex 150 Plus (ascorbic acid and iron polysaccharide)? Do not take more ascorbic acid and iron polysaccharide than is prescribed for you or than is directed on the package. Keep this product out of reach of children. Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. In case of accidental overdose, call a doctor or poison control center immediately.

Ascorbic acid and iron polysaccharide may decrease the absorption of other medicines. Talk to your doctor and pharmacist before taking ascorbic acid and iron polysaccharide if you take any other prescription or over-the-counter medicines.

What should I discuss with my healthcare provider before taking Ferrex 150 Plus (ascorbic acid and iron polysaccharide)?

If you do not have an iron deficiency, talk to your doctor about the use of ascorbic acid and iron polysaccharide. Generally, ascorbic acid and iron polysaccharide should not be taken chronically by individuals with a normal iron balance.

To make sure you can safely take ascorbic acid and iron polysaccharide, tell your doctor if you have any of these other conditions:

diabetes;

hemosiderosis;

hemolytic anemia;

hemochromatosis;

kidney disease or an increased risk of kidney stones;

if you are on a sodium restricted diet; or

if you are allergic to sulfites or tartrazine.

FDA pregnancy category C. It is not known whether ascorbic acid and iron polysaccharide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether ascorbic acid and iron polysaccharide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take Ferrex 150 Plus (ascorbic acid and iron polysaccharide)? Keep this product out of reach of children. Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. In case of accidental overdose, call a doctor or poison control center immediately.

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medicine with a full glass of water.

Ascorbic acid and iron polysaccharide may decrease the absorption of other medicines. Talk to your doctor and pharmacist before taking ascorbic acid and iron polysaccharide if you take any other prescription or over-the-counter medicines.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using ascorbic acid and iron polysaccharide.

Store at room temperature, away from moisture and heat. What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause decreased energy, nausea, vomiting, abdominal pain, tarry stools, weak or rapid pulse, fever, or seizure (convulsions).

What should I avoid while taking Ferrex 150 Plus (ascorbic acid and iron polysaccharide)? Do not take ascorbic acid and iron polysaccharide within 2 hours before or after you take any of the following medicines

levodopa (Larodopa, Dopar, Sinemet);

levothyroxine (Synthroid, Levoxyl, others);

methyldopa (Aldomet);

penicillamine (Cuprimine);

antacids (Amphojel, Maalox, Mylanta, Rolaids, Rulox, Tums, and others);

a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap); or

an antibiotic such as ciprofloxacin (Cipro), ofloxacin (Floxin), norfloxacin (Noroxin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), and others.

Ascorbic acid and iron polysaccharide may decrease the absorption of the drugs listed above.

Ferrex 150 Plus (ascorbic acid and iron polysaccharide) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

fever;

severe lower back pain;

painful or difficult urination;

blood in your urine; or

black or dark stools.

Less serious side effects may include:

stomach upset;

nausea or vomiting;

diarrhea;

constipation; or

temporary staining of the teeth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ferrex 150 Plus (ascorbic acid and iron polysaccharide)?

Tell your doctor about all other medicines you use, especially:

a blood thinner such as warfarin (Coumadin).

an estrogen such as Premarin, Ogen, Estratest, Vivelle, Climara, Estring, Estrace, and others; or

an oral birth control pill such as Alesse, Levlen, Ovral, Triphasil, Tri-Levlen, Lo-Ovral, and others.

This list is not complete and other drugs may interact with ascorbic acid and iron polysaccharide. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Ferrex 150 Plus resources Ferrex 150 Plus Side Effects (in more detail) Ferrex 150 Plus Use in Pregnancy & Breastfeeding Ferrex 150 Plus Drug Interactions 0 Reviews for Ferrex50 Plus - Add your own review/rating Compare Ferrex 150 Plus with other medications Dietary Supplementation Where can I get more information? Your pharmacist can provide more information about ascorbic acid and iron polysaccharide.

See also: Ferrex50 Plus side effects (in more detail)


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Niferex-150


Generic Name: ascorbic acid and iron polysaccharide (as KORE bik AS id and EYE urn SAK a ride)
Brand Names: Fe-Tinic 150, Ferrex 150 Plus, Niferex-150

What is Niferex-150 (ascorbic acid and iron polysaccharide)?

Ascorbic acid is found in citrus fruit, tomatoes, potatoes, and leafy vegetables. Ascorbic acid is important for the skin and connective tissues, for normal chemical and hormonal production, and for the immune system.

Iron polysaccharide is a form of the mineral iron. Iron is important for many functions in the body, especially for the transport of oxygen in the blood.

Ascorbic acid is used to treat and prevent vitamin C deficiency.

Iron polysaccharide is used as a dietary supplement, and to prevent and to treat iron deficiencies and iron deficiency anemia.

Ascorbic acid and iron polysaccharide may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Niferex-150 (ascorbic acid and iron polysaccharide)? Do not take more ascorbic acid and iron polysaccharide than is prescribed for you or than is directed on the package. Keep this product out of reach of children. Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. In case of accidental overdose, call a doctor or poison control center immediately.

Ascorbic acid and iron polysaccharide may decrease the absorption of other medicines. Talk to your doctor and pharmacist before taking ascorbic acid and iron polysaccharide if you take any other prescription or over-the-counter medicines.

What should I discuss with my healthcare provider before taking Niferex-150 (ascorbic acid and iron polysaccharide)?

If you do not have an iron deficiency, talk to your doctor about the use of ascorbic acid and iron polysaccharide. Generally, ascorbic acid and iron polysaccharide should not be taken chronically by individuals with a normal iron balance.

To make sure you can safely take ascorbic acid and iron polysaccharide, tell your doctor if you have any of these other conditions:

diabetes;

hemosiderosis;

hemolytic anemia;

hemochromatosis;

kidney disease or an increased risk of kidney stones;

if you are on a sodium restricted diet; or

if you are allergic to sulfites or tartrazine.

FDA pregnancy category C. It is not known whether ascorbic acid and iron polysaccharide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether ascorbic acid and iron polysaccharide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take Niferex-150 (ascorbic acid and iron polysaccharide)? Keep this product out of reach of children. Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. In case of accidental overdose, call a doctor or poison control center immediately.

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medicine with a full glass of water.

Ascorbic acid and iron polysaccharide may decrease the absorption of other medicines. Talk to your doctor and pharmacist before taking ascorbic acid and iron polysaccharide if you take any other prescription or over-the-counter medicines.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using ascorbic acid and iron polysaccharide.

Store at room temperature, away from moisture and heat. What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause decreased energy, nausea, vomiting, abdominal pain, tarry stools, weak or rapid pulse, fever, or seizure (convulsions).

What should I avoid while taking Niferex-150 (ascorbic acid and iron polysaccharide)? Do not take ascorbic acid and iron polysaccharide within 2 hours before or after you take any of the following medicines

levodopa (Larodopa, Dopar, Sinemet);

levothyroxine (Synthroid, Levoxyl, others);

methyldopa (Aldomet);

penicillamine (Cuprimine);

antacids (Amphojel, Maalox, Mylanta, Rolaids, Rulox, Tums, and others);

a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap); or

an antibiotic such as ciprofloxacin (Cipro), ofloxacin (Floxin), norfloxacin (Noroxin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), and others.

Ascorbic acid and iron polysaccharide may decrease the absorption of the drugs listed above.

Niferex-150 (ascorbic acid and iron polysaccharide) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

fever;

severe lower back pain;

painful or difficult urination;

blood in your urine; or

black or dark stools.

Less serious side effects may include:

stomach upset;

nausea or vomiting;

diarrhea;

constipation; or

temporary staining of the teeth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Niferex-150 (ascorbic acid and iron polysaccharide)?

Tell your doctor about all other medicines you use, especially:

a blood thinner such as warfarin (Coumadin).

an estrogen such as Premarin, Ogen, Estratest, Vivelle, Climara, Estring, Estrace, and others; or

an oral birth control pill such as Alesse, Levlen, Ovral, Triphasil, Tri-Levlen, Lo-Ovral, and others.

This list is not complete and other drugs may interact with ascorbic acid and iron polysaccharide. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Niferex-150 resources Niferex-150 Side Effects (in more detail) Niferex-150 Use in Pregnancy & Breastfeeding Drug Images Niferex-150 Drug Interactions Niferex-150 Support Group 0 Reviews for Niferex-150 - Add your own review/rating Compare Niferex-150 with other medications Dietary Supplementation Where can I get more information? Your pharmacist can provide more information about ascorbic acid and iron polysaccharide.

See also: Niferex-150 side effects (in more detail)


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Norfloxacin


Pronunciation: nor-FLOX-a-sin
Generic Name: Norfloxacin
Brand Name: Noroxin

Norfloxacin is associated with an increased risk of tendon problems. These include pain, swelling, inflammation, and possible breakage of tendons. The risk of tendon problems is greater in patients who are older than 60 years, patients who take corticosteroids (eg, prednisone), or in those who have received kidney, heart, or lung transplants. The Achilles tendon in the back of the foot/ankle is most often affected. However, problems may also occur in other tendons (eg, in the arm, hand, shoulder). Problems may occur while you take Norfloxacin or up to several months after you stop taking it.

Signs of tendon problems may include pain, soreness, redness, or swelling of a tendon or joint; bruising right after an injury in a tendon area; hearing or feeling a snap or pop in a joint or tendon area; or inability to move or bear weight on a joint or tendon area. Tell your doctor right away if you experience any of these symptoms while you take Norfloxacin or within several months after you stop it.

Norfloxacin may worsen muscle weakness and breathing problems in patients with myasthenia gravis. Do not take Norfloxacin if you have a history of myasthenia gravis.


Norfloxacin is used for:

Treating bacterial infections.

Norfloxacin is a fluoroquinolone antibiotic. It works by killing sensitive bacteria.

Do NOT use Norfloxacin if: you are allergic to any ingredient in Norfloxacin or to any other fluoroquinolone antibiotic (eg, levofloxacin) you have inflammation of a tendon (tendonitis) or a history of ruptured tendon caused by Norfloxacin or another fluoroquinolone (eg, levofloxacin) you have a history of myasthenia gravis you are taking certain antiarrhythmic medicines (eg, amiodarone, procainamide, quinidine, sotalol) or nitrofurantoin

Contact your doctor or health care provider right away if any of these apply to you.

Before using Norfloxacin:

Some medical conditions may interact with Norfloxacin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a stomach infection, liver problems, brain or nervous system problems, muscle problems (eg, myasthenia gravis), increased pressure in the brain, Alzheimer disease, brain blood vessel problems, or a history of seizures if you have a history of severe or persistent diarrhea, skin sensitivity to the sun, a recent heart attack, blood problems (eg, anemia, hemolysis), or glucose-6-phosphate dehydrogenase (G6PD) problems if you have a personal or family history of irregular heartbeat (eg, QT prolongation), heart problems (eg, slow heartbeat), or low blood potassium levels if you have a history of joint or tendon problems; rheumatoid arthritis; kidney problems or decreased kidney function; or a heart, kidney, or lung transplant if you take a corticosteroid (eg, prednisone) or participate in strenuous physical work or exercise

Some MEDICINES MAY INTERACT with Norfloxacin. Tell your health care provider if you are taking any other medicines, especially any of the following:

Antiarrhythmics (eg, amiodarone, disopyramide, dofetilide, quinidine , sotalol), cisapride, diuretics (eg, furosemide, hydrochlorothiazide), macrolide or ketolide antibiotics (eg, erythromycin, telithromycin), medicines for mental or mood disorders, medicines that may affect your heartbeat, phenothiazines (eg, chlorpromazine), or tricyclic antidepressants (eg, amitriptyline) because the risk of serious side effects, including irregular heartbeat and other heart problems, may be increased. Check with your doctor or pharmacist if you are unsure if any of your medicines may affect your heartbeat Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of side effects, such as seizures, may be increased Corticosteroids (eg, prednisone) because the risk of tendon damage may be increased Probenecid because it may increase the risk of Norfloxacin's side effects Nitrofurantoin because it may decrease Norfloxacin's effectiveness Anticoagulants (eg, warfarin), caffeine, clozapine, cyclosporine, methotrexate, ropinirole, serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, venlafaxine), sulfonylureas (eg, glyburide), tacrine, theophyllines, or tizanidine because the risk of their side effects may be increased by Norfloxacin Live vaccines or mycophenolate because their effectiveness may be decreased by Norfloxacin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Norfloxacin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Norfloxacin:

Use Norfloxacin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Norfloxacin comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Norfloxacin refilled. Take Norfloxacin by mouth on an empty stomach at least 1 hour before or 2 hours after a meal or eating or drinking milk or other dairy products. Take Norfloxacin with a full glass of water (8 oz/240 mL). Drinking extra fluids while you are taking Norfloxacin is recommended. Check with your doctor for instructions. Do not take any products containing magnesium, aluminum, calcium, iron, or zinc (eg, antacids, quinapril, vitamins/minerals); didanosine; sucralfate; or bismuth subsalicylate within 2 hours before or 2 hours after taking Norfloxacin. To clear up your infection completely, take Norfloxacin for the full course of treatment. Keep taking it even if you feel better in a few days. Do not miss any doses. If you miss a dose of Norfloxacin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Norfloxacin.

Important safety information: Norfloxacin may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Norfloxacin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Tell your doctor or dentist that you take Norfloxacin before you receive any medical or dental care, emergency care, or surgery. Be sure to use Norfloxacin for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. Long-term or repeated use of Norfloxacin may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this. Norfloxacin only works against bacteria; it does not treat viral infections (eg, the common cold). Avoid large amounts of food or drink that have caffeine (eg, chocolate, cocoa, coffee, cola, tea). If you experience pain or swelling of a tendon or weakness or loss of use of a joint area, notify your doctor right away. Rest the area and avoid exercise until your doctor gives you instructions. Diabetes patients - Norfloxacin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Norfloxacin may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Norfloxacin. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor. Norfloxacin may cause changes in certain heart tests (eg, electrocardiogram [ECG]). Be sure to your doctor and lab personnel know you are using Norfloxacin. Lab tests, including complete blood cell counts and liver and kidney function, may be performed while you use Norfloxacin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. Use Norfloxacin with caution in the ELDERLY; they may be more sensitive to its effects (eg, tendon problems), especially if they take corticosteroids (eg, prednisone). They may also be more sensitive to other effects (eg, irregular heartbeat). Norfloxacin should be used with extreme caution in CHILDREN younger than 18 years; safety and effectiveness in these children have not been confirmed. The risk of joint and tendon problems may be increased in CHILDREN. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Norfloxacin while you are pregnant. It is not known if Norfloxacin is found in breast milk. Do not breast-feed while taking Norfloxacin. Possible side effects of Norfloxacin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; headache; loss of appetite; nausea; stomach upset or cramps; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or tarry stools; burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet; change in sense of touch or temperature; chest pain; dark urine or change in the amount of urine; decreased amount of urine; fainting; fever, chills, or unusual cough; hallucinations; hearing changes (eg, ringing in the ears, hearing loss); inability to move or bear weight on a joint or tendon area; irregular heartbeat; joint pain or swelling; moderate to severe sunburn; mood or mental changes (eg, new or worsening anxiety, agitation, confusion, depression, restlessness, sleeplessness); muscle pain or weakness; pain, soreness, redness, swelling, weakness, or bruising of a tendon or joint area; pale stools; persistent sore throat; red, swollen, blistered, or peeling skin; seizures; severe or persistent dizziness; severe or persistent diarrhea; severe stomach pain or cramps; shortness of breath or trouble breathing; suicidal thoughts or actions; tremors; unusual bruising or bleeding; unusual fatigue; vaginal yeast infection; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Norfloxacin:

Store Norfloxacin at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Do not freeze. Keep Norfloxacin out of the reach of children and away from pets.

General information: If you have any questions about Norfloxacin, please talk with your doctor, pharmacist, or other health care provider. Norfloxacin is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Norfloxacin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Norfloxacin resources Norfloxacin Dosage Norfloxacin Use in Pregnancy & Breastfeeding Norfloxacin Drug Interactions Norfloxacin Support Group 0 Reviews for Norfloxacin - Add your own review/rating Norfloxacin Monograph (AHFS DI) Norfloxacin Professional Patient Advice (Wolters Kluwer) norfloxacin Concise Consumer Information (Cerner Multum) norfloxacin Advanced Consumer (Micromedex) - Includes Dosage Information Noroxin Prescribing Information (FDA) Compare Norfloxacin with other medications Bladder Infection Campylobacter Gastroenteritis Epididymitis, Non-Specific Gonococcal Infection, Uncomplicated Kidney Infections Prostatitis Salmonella Enteric Fever Salmonella Gastroenteritis Shigellosis Small Bowel Bacterial Overgrowth Traveler's Diarrhea Urinary Tract Infection


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sucralfate


Generic Name: sucralfate (oral) (soo KRAL fate)
Brand Names: Carafate

What is sucralfate?

Sucralfate is an anti-ulcer medication.

Sucralfate is not greatly absorbed into the body through the digestive tract. It works mainly in the lining of the stomach by adhering to ulcer sites and protecting them from acids, enzymes, and bile salts.

Sucralfate is used to treat an active duodenal ulcer. Sucralfate can heal an active ulcer, but it will not prevent future ulcers from occurring.

Sucralfate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about sucralfate?

Before taking sucralfate, tell your doctor if you have diabetes, kidney disease, or if you are on dialysis.

Take sucralfate on an empty stomach, at least 1 hour before or 2 hours after a meal. Take this medicine for the full prescribed length of time. Your symptoms may improve before the ulcer is completely healed. Avoid taking any other medications within 2 hours before or after you take sucralfate. Sucralfate can make it harder for your body to absorb other medications you take by mouth. Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for sucralfate to work in your stomach. If your doctor does recommend using an antacid, avoid taking it within 30 minutes before or after taking sucralfate. What should I discuss with my healthcare provider before taking sucralfate?

To make sure you can safely take sucralfate, tell your doctor if you have any of these other conditions:

diabetes;

kidney disease; or

if you are on dialysis.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether sucralfate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take sucralfate?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take sucralfate on an empty stomach, at least 1 hour before or 2 hours after a meal. Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Take this medicine for the full prescribed length of time. Your symptoms may improve before the ulcer is completely healed. Store at room temperature away from moisture and heat.

See also: Sucralfate dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember, but avoid taking any other medications within 2 hours after you take sucralfate. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while taking sucralfate? Avoid taking any other medications within 2 hours before or after you take sucralfate. Sucralfate can make it harder for your body to absorb other medications you take by mouth. Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for sucralfate to work in your stomach. If your doctor does recommend using an antacid, avoid taking it within 30 minutes before or after taking sucralfate. Sucralfate side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

nausea, vomiting, upset stomach;

stomach pain;

constipation, diarrhea;

mild itching or skin rash;

sleep problems (insomnia);

dizziness, drowsiness, spinning sensation;

headache; or

back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sucralfate Dosing Information

Usual Adult Dose for Duodenal Ulcer:

1 g orally on an empty stomach 4 times a day or alternatively,
2 g orally on an empty stomach 2 times a day.

Usual Adult Dose for Duodenal Ulcer Prophylaxis:

1 g orally on an empty stomach twice a day.

Usual Adult Dose for Gastric Ulcer:

1 g orally on an empty stomach 4 times a day.

Usual Adult Dose for Gastroesophageal Reflux Disease:

1 g orally on an empty stomach 4 times a day.

Usual Adult Dose for Stress Ulcer Prophylaxis:

1 g orally on an empty stomach every 4 to 6 hours.

Usual Adult Dose for Stomatitis:

1 g (10 mL) topically as a suspension 4 times a day.

Usual Adult Dose for Hyperphosphatemia of Renal Failure:

1 g orally on an empty stomach twice a day.
This dose may be titrated based on serum phosphate levels.

Usual Pediatric Dose for Stomatitis:

Safety and effectiveness of sucralfate in pediatric patients have not been established. However, the use of sucralfate may be appropriate in some situations.
Greater than 1 year: 250 to 500 mg (2.5 to 5 mL) topically as a suspension 4 times a day for treatment of stomatitis.

What other drugs will affect sucralfate?

Sucralfate can make it harder for your body to absorb other medications you take by mouth. Tell your doctor if you are taking:

cimetidine (Tagamet);

digoxin (digitalis, Lanoxin);

levothyroxine (Synthroid);

phenytoin (Dilantin);

quinidine (Quin-G);

ranitidine (Zantac);

tetracycline (Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap);

theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl, and others);

a blood thinner such as warfarin (Coumadin, Jantoven); or

certain antibiotics such as ciprofloxacin (Cipro), levofloxacin (Levaquin), lomefloxacin (Maxaquin), ketoconazole (Nizoral), and others.

This list is not complete and other drugs may interact with sucralfate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More sucralfate resources Sucralfate Side Effects (in more detail) Sucralfate Dosage Sucralfate Use in Pregnancy & Breastfeeding Drug Images Sucralfate Drug Interactions Sucralfate Support Group 16 Reviews for Sucralfate - Add your own review/rating sucralfate Advanced Consumer (Micromedex) - Includes Dosage Information Sucralfate Prescribing Information (FDA) Sucralfate Professional Patient Advice (Wolters Kluwer) Sucralfate Monograph (AHFS DI) Sucralfate MedFacts Consumer Leaflet (Wolters Kluwer) Carafate Prescribing Information (FDA) Carafate Consumer Overview Compare sucralfate with other medications Duodenal Ulcer Duodenal Ulcer Prophylaxis GERD Hyperphosphatemia of Renal Failure Stomach Ulcer Stomatitis Stress Ulcer Prophylaxis Where can I get more information? Your pharmacist can provide more information about sucralfate.

See also: sucralfate side effects (in more detail)


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ciprofloxacin and dexamethasone Otic


sip-roe-FLOX-a-sin hye-droe-KLOR-ide, dex-a-METH-a-sone

Commonly used brand name(s)

In the U.S.

Ciprodex

Available Dosage Forms:

Suspension

Therapeutic Class: Anti-Infective/Anti-Inflammatory Combination

Pharmacologic Class: Adrenal Glucocorticoid

Chemical Class: Ciprofloxacin

Uses For ciprofloxacin and dexamethasone

Ciprofloxacin and dexamethasone is a combination of two medicines used to treat ear infections. One of the medicines is an antibiotic (medicine used to fight infection) and the other is a corticosteroid (cortisone-like medicine). The antibiotic (ciprofloxacin) is used to fight ear infections. The corticosteroid (dexamethasone) is used to relieve the redness, itching, and swelling caused by ear infections.

ciprofloxacin and dexamethasone is used to treat middle ear infection with drainage through a tube in children 6 months of age and older. A middle ear infection is an infection caused by bacteria behind the eardrum. People who have a tube in the eardrum may notice drainage from the ear canal.

ciprofloxacin and dexamethasone is also used to treat outer ear canal infections in patients 6 months of age or older. An outer ear canal infection, also known as “Swimmer's Ear,” is a bacterial infection of the outer ear canal. The ear canal and outer part of the ear may swell, turn red, and be painful. Also, a fluid discharge may appear in the ear canal.

ciprofloxacin and dexamethasone is available only with your doctor's prescription.

Before Using ciprofloxacin and dexamethasone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ciprofloxacin and dexamethasone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ciprofloxacin and dexamethasone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no specific information comparing use of ciprofloxacin and dexamethasone combination in children younger than 6 months of age with use in other age groups. ciprofloxacin and dexamethasone should not be used in children under 6 months of age.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work the same way they do in younger people of if they cause different side effects or problems in older people. It is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking ciprofloxacin and dexamethasone, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ciprofloxacin and dexamethasone with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Cisapride Dronedarone Mesoridazine Pimozide Praziquantel Rilpivirine Rotavirus Vaccine, Live Sparfloxacin Thioridazine Tizanidine

Using ciprofloxacin and dexamethasone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acarbose Acecainide Acetohexamide Aldesleukin Alfuzosin Alosetron Amiodarone Amitriptyline Amoxapine Apomorphine Arsenic Trioxide Asenapine Astemizole Azimilide Azithromycin Bendamustine Benfluorex Boceprevir Bretylium Bupropion Chlorpromazine Chlorpropamide Citalopram Clarithromycin Clomipramine Crizotinib Darunavir Dasatinib Desipramine Disopyramide Dofetilide Dolasetron Droperidol Efavirenz Eltrombopag Erythromycin Etravirine Flecainide Fluconazole Fosamprenavir Gatifloxacin Gemifloxacin Gliclazide Glimepiride Glipizide Gliquidone Glyburide Granisetron Guar Gum Halofantrine Haloperidol Ibutilide Iloperidone Imatinib Imipramine Insulin Insulin Aspart, Recombinant Insulin Glulisine Insulin Lispro, Recombinant Ixabepilone Lapatinib Levofloxacin Lopinavir Lumefantrine Mefloquine Metformin Methadone Miglitol Moricizine Moxifloxacin Nevirapine Nilotinib Norfloxacin Nortriptyline Octreotide Ofloxacin Ondansetron Paliperidone Pazopanib Perflutren Lipid Microsphere Posaconazole Procainamide Prochlorperazine Promethazine Propafenone Protriptyline Quetiapine Quinidine Quinine Ranolazine Rivaroxaban Romidepsin Salmeterol Saquinavir Sematilide Simvastatin Sodium Phosphate Sodium Phosphate, Dibasic Sodium Phosphate, Monobasic Solifenacin Sorafenib Sotalol Sunitinib Tedisamil Telaprevir Telavancin Telithromycin Temsirolimus Terfenadine Tetrabenazine Thalidomide Theophylline Ticagrelor Tolazamide Tolbutamide Toremifene Trazodone Trifluoperazine Trimipramine Troglitazone Vandetanib Vardenafil Vemurafenib Voriconazole Ziprasidone

Using ciprofloxacin and dexamethasone with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alatrofloxacin Alcuronium Aminoglutethimide Aprepitant Aspirin Atracurium Balofloxacin Betamethasone Caspofungin Chloroquine Cinoxacin Ciprofloxacin Clinafloxacin Clozapine Corticotropin Cortisone Cosyntropin Cyclosporine Deflazacort Dexamethasone Diclofenac Dutasteride Enoxacin Erlotinib Fleroxacin Fludrocortisone Fluindione Flumequine Fluocortolone Fosaprepitant Fosphenytoin Gallamine Gemifloxacin Grepafloxacin Hexafluorenium Hydrocortisone Itraconazole Levofloxacin Licorice Lomefloxacin Methylprednisolone Metocurine Moxifloxacin Mycophenolate Mofetil Norfloxacin Ofloxacin Olanzapine Pancuronium Paramethasone Pefloxacin Phenobarbital Phenytoin Prednisolone Prednisone Primidone Probenecid Prulifloxacin Rasagiline Rifampin Rifapentine Ritonavir Ropinirole Ropivacaine Rosoxacin Rufloxacin Saiboku-To Sildenafil Sparfloxacin Temafloxacin Tosufloxacin Triamcinolone Trovafloxacin Mesylate Vecuronium Warfarin Zolpidem Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ciprofloxacin and dexamethasone with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use ciprofloxacin and dexamethasone, or give you special instructions about the use of food, alcohol, or tobacco.

Caffeine Other Medical Problems

The presence of other medical problems may affect the use of ciprofloxacin and dexamethasone. Make sure you tell your doctor if you have any other medical problems, especially:

Viral ear infections (infections caused by a virus)—ciprofloxacin and dexamethasone should not be used in patients with viral ear infections of the outer ear canal. Proper Use of ciprofloxacin and dexamethasone

ciprofloxacin and dexamethasone is to be used in the ear only. It is not approved for use in the eye. Do not take by mouth. If ciprofloxacin and dexamethasone is accidently swallowed call your doctor right away.

It is important that the infected ear(s) remain clean and dry. When bathing, avoid getting the infected ear(s) wet. Avoid swimming unless your doctor has instructed you otherwise.

To use:

Wash hands thoroughly with soap and water Hold the bottle of ear drops in the hand for one or two minutes to warm the medicine, then shake well. Lie down on your side with your infected ear facing up. Put drops in infected ear. To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the ear). Also, keep the container tightly closed. For Patients with Middle Ear Infection with Tubes: While the person getting the ear drops lies on their side the person giving the drops should gently press the small projection in front of the outside opening of the ear 5 times in a pumping motion. This will allow the drops to pass through the tube and into the middle ear. For patients with Outer Ear Infection (“Swimmer's Ear”): While the person getting the ear drops lies on their side, the person giving the drops should gently pull the outer ear lobe upward and backward. This will allow the ear drops to flow down into the ear canal. The person who just had the ear drops should stay on their side for at least one minute. Repeat the above steps if both ears are infected. When you have completed your course of therapy (usually 7 days), throw away the medicine that you did not use.

To help clear up your infection completely, keep using ciprofloxacin and dexamethasone for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses. If the ear drops are not used for as long as the doctor recommended your infection can return.

Dosing

The dose of ciprofloxacin and dexamethasone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of ciprofloxacin and dexamethasone. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For ear drops dosage form: For ear infections: Adults and children 6 months of age and older—Place four drops in the ear canal of infected ear two times a day for seven days. Children younger than 6 months of age—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of ciprofloxacin and dexamethasone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using ciprofloxacin and dexamethasone

If your symptoms do not improve within a week, or if they become worse, check with your doctor.

If you experience a rash or an allergic reaction to ciprofloxacin and dexamethasone, stop using it and call your doctor immediately.

ciprofloxacin and dexamethasone Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common Ear discomfort ear pain itching skin on the ear Rare Bitter, sour or unusual taste in mouth ear congestion ear debris ear residue redness of skin superimposed ear infection (second ear infection)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: ciprofloxacin and dexamethasone Otic side effects (in more detail)

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More ciprofloxacin and dexamethasone Otic resources Ciprofloxacin and dexamethasone Otic Side Effects (in more detail) Ciprofloxacin and dexamethasone Otic Use in Pregnancy & Breastfeeding Ciprofloxacin and dexamethasone Otic Support Group 11 Reviews for Ciprofloxacin and dexamethasone Otic - Add your own review/rating Compare ciprofloxacin and dexamethasone Otic with other medications Otitis Externa Otitis Media


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Ciprodex


Generic Name: ciprofloxacin and dexamethasone otic (sih pro FLOCK sah sin and dex ah MEH thah sone)
Brand Names: Ciprodex

What is ciprofloxacin and dexamethasone otic?

Ciprofloxacin is a fluoroquinolone antibiotic. Ciprofloxacin fights bacteria in the body.

Dexamethasone is a steroid. It is used with ciprofloxacin to reduce inflammation caused by an infection.

Together, ciprofloxacin and dexamethasone are used to treat ear infections.

Ciprofloxacin and dexamethasone otic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about ciprofloxacin and dexamethasone otic? Do not use this medication in the eyes or take it by mouth. Ciprofloxacin and dexamethasone otic is intended for use in the ears only. Do not touch the dropper opening to any surface, including the ears or hands. The dropper opening is sterile. If it becomes contaminated, it could cause another infection in the ear.

Notify your doctor if the condition does not improve or appears to worsen.

What should I discuss with my healthcare provider before using ciprofloxacin and dexamethasone otic? Do not use ciprofloxacin and dexamethasone otic without first talking to your doctor if you have had a previous allergic reaction to it or to another similar oral or topical medication such as:

a fluoroquinolone antibiotic such as ciprofloxacin (Cipro), gatifloxacin (Tequin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), sparfloxacin (Zagam), or trovafloxacin (Trovan);

an oral or injectable steroid such as cortisone (Cortef, Cortone), dexamethasone (Decadron), dexamethasone (Hydrocortone), methylprednisolone (Medrol), prednisolone (Prelone, Pediapred), prednisone (Orasone, Deltasone), and others; or

a topical steroid such as betamethasone (Diprosone, Diprolene), clobetasol (Temovate, Olux), fluocinolone (Synalar, Synemol, Fluonid), fluocinonide (Lidex), fluticasone (Cutivate), halobetasol (Ultravate), mometasone (Elocon), triamcinolone (Aristocort), and others.

You may not be able to use ciprofloxacin and dexamethasone otic, or you may require a dosage adjustment or special monitoring during treatment.

Ciprofloxacin and dexamethasone otic is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not use ciprofloxacin and dexamethasone otic without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether ciprofloxacin and dexamethasone otic passes into breast milk. Do not use ciprofloxacin and dexamethasone otic without first talking to your doctor if you are breast-feeding a baby. How should I use ciprofloxacin and dexamethasone otic? Use ciprofloxacin and dexamethasone otic exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you. Do not use this medication in the eyes or take it by mouth. Ciprofloxacin and dexamethasone otic is intended for use in the ears only.

In general, ciprofloxacin and dexamethasone otic should be used as follows:

Warm the drops slightly by holding them in the hands for 1 or 2 minutes. Administration of cold drops into the ear may cause dizziness.

Have another person administer the drops whenever possible. Have the affected person lie on their side or tilt the ear up to make administering a drop easier.

Gently shake the drops just before administration.

For adults, gently hold the earlobe up and back. For children, gently hold the earlobe down and back. This will allow the drops to run into the ear canal. Carefully instill the prescribed number of drops in the first ear.

Keep the ear tilted for at least 60 seconds to allow the medication to penetrate the ear.

If the patient being treated has ear tubes, the doctor may recommend gently pressing the tragus (part of the ear in front of the opening of the ear canal) five times in a pumping motion after administration of the drops. This may allow the drops to pass through the tubes into the middle ear. Follow the doctor's instructions.

Repeat the process in the other ear if prescribed.

Ciprofloxacin and dexamethasone ear drops are usually used twice a day, about 12 hours apart. Follow your doctor's instructions.

Use all of the medication that has been prescribed. Symptoms may begin to improve before the condition is completely treated. If you do not use all of the medication prescribed, the condition could return or worsen.

It is important to use ciprofloxacin and dexamethasone otic regularly to get the most benefit.

Notify your doctor if the condition does not improve or appears to worsen.

Avoid getting water inside of the affected ear(s) during treatment with ciprofloxacin and dexamethasone. Care should be used while bathing and swimming may not be recommended. Talk to your healthcare provider.

Store ciprofloxacin and dexamethasone otic at room temperature, away from moisture, heat, and direct light. Keep the bottle properly capped.

What happens if I miss a dose?

Use the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and use only the next regularly scheduled dose. Do not use a double dose of ciprofloxacin and dexamethasone otic unless otherwise directed by your doctor.

What happens if I overdose? Seek emergency medical attention if an overdose is suspected or if the medication has been ingested.

Symptoms of a ciprofloxacin and dexamethasone otic overdose are not known.

What should I avoid while using ciprofloxacin and dexamethasone? Ear infections may sometimes cause dizziness or a loss of balance. Use caution when driving, operating machinery, or performing other hazardous activities if you experience dizziness or a loss of balance. Avoid getting water inside of the affected ear(s) during treatment with ciprofloxacin and dexamethasone. Care should be used while bathing and swimming may not be recommended. Talk to your healthcare provider. Ciprofloxacin and dexamethasone otic side effects Stop using ciprofloxacin and dexamethasone otic and seek emergency medical attention or notify your doctor if you experience:

an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

skin rash; or

ear drainage, discharge, or worsening pain.

Other less serious side effects may also occur such as ear discomfort or itching or an unusual taste in the mouth. Continue to use the medication and talk to your doctor if these side effects seem excessive or unusual.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect my ciprofloxacin and dexamethasone otic? Do not use other ear drops during treatment with ciprofloxacin and dexamethasone otic without first talking to your doctor.

Drugs other than those listed here may also interact with ciprofloxacin and dexamethasone otic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More Ciprodex resources Ciprodex Side Effects (in more detail) Ciprodex Dosage Ciprodex Use in Pregnancy & Breastfeeding Ciprodex Support Group 11 Reviews for Ciprodex - Add your own review/rating Ciprodex Prescribing Information (FDA) Ciprodex Advanced Consumer (Micromedex) - Includes Dosage Information Ciprodex MedFacts Consumer Leaflet (Wolters Kluwer) Ciprodex Consumer Overview Compare Ciprodex with other medications Otitis Externa Otitis Media Where can I get more information? Your pharmacist has more information about ciprofloxacin and dexamethasone otic written for health professionals that you may read.

See also: Ciprodex side effects (in more detail)


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