Mycobacterium avium-intracellulare, Treatment Medications


Drugs associated with Mycobacterium avium-intracellulare, Treatment

The following drugs and medications are in some way related to, or used in the treatment of Mycobacterium avium-intracellulare, Treatment. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.


Drug List: Azithromycin-3-Day-Dose-Pack Biaxin Biaxin-Xl-Extended-Release-Tablets Cipro Cipro-I-V Cipro-Xr-Extended-Release-Tablets Floxin Myambutol Mycobutin Zithromax Zmax-Extended-Release-Oral-Suspension


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AzaSite


Generic Name: azithromycin ophthalmic (a ZITH roe MYE sin off THAL mik)
Brand Names: AzaSite

What is azithromycin ophthalmic?

Azithromycin is a macrolide antibiotic that fights bacteria.

Azithromycin ophthalmic (for the eyes) is used to treat eye infections caused by bacteria.

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

What is the most important information I should know about azithromycin ophthalmic? You should not use this medication if you are allergic to azithromycin. Do not use this medication while wearing contact lenses. Azithromycin ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using azithromycin ophthalmic before putting your contact lenses in.

You should not wear contact lenses while you still have active symptoms of the eye infection you are treating.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Serious side effects of azithromycin ophthalmic may include eye drainage or crusting, severe eye irritation, feeling like there is something in your eye, watery eyes, increased light sensitivity, eye redness or swelling, any signs of new infection.

Although the risk of serious side effects is low when azithromycin ophthalmic is used in the eyes, side effects can occur if the medicine is absorbed into your bloodstream. Stop using the medicine and get emergency medical help if you have any signs of a severe skin reaction, such as fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

What should I discuss with my health care provider before taking azithromycin ophthalmic? You should not use this medication if you are allergic to azithromycin (Zithromax). FDA pregnancy category B. Azithromycin ophthalmic is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether azithromycin ophthalmic 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 use azithromycin ophthalmic?

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

Azithromycin ophthalmic is usually applied twice daily for 2 days, and then once daily for 5 more days. Follow your doctor's instructions.

Wash your hands before using eye medication.

To apply the eye drops:

Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.

Use only the number of drops your doctor has prescribed.

Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.

If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.

Also wait at least 10 minutes before using any other eye drops that your doctor has prescribed.

Do not allow the tip of the dropper to touch any surface, including your eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Store an unopened bottle of azithromycin ophthalmic in the refrigerator. Do not freeze. After opening the bottle, you may keep the medication at room temperature for up to 14 days. Keep the bottle tightly closed when not in use. Protect from moisture and heat. What happens if I miss a dose?

Use the missed dose as soon as you remember. 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. What should I avoid while taking azithromycin ophthalmic? Do not use this medication while wearing contact lenses. Azithromycin ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using azithromycin ophthalmic before putting your contact lenses in.

You should not wear contact lenses while you still have active symptoms of the eye infection you are treating.

Azithromycin ophthalmic 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.

Although the risk of serious side effects is low when azithromycin ophthalmic is used in the eyes, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream. Stop using the medicine and get emergency medical help if you have any signs of a severe skin reaction, such as:

fever, sore throat;

swelling in your face or tongue, burning in your eyes; or

skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Stop using azithromycin ophthalmic and call your doctor at once if you have a serious side effect such as:

drainage or crusting of your eye;

severe burning, stinging, itching, or other irritation after using the eye drops;

feeling like there is something in your eye;

watery eyes, increased light sensitivity;

eye redness or swelling; or

any signs of a new infection.

Less serious side effects may include:

blurred vision;

stuffy nose; or

mild stinging, burning, or irritation of your eyes.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect azithromycin ophthalmic?

It is not likely that other drugs you take orally or inject will have an effect on azithromycin ophthalmic used in the eyes. But many drugs can interact with each other. Tell your doctor about all medicines you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More AzaSite resources AzaSite Side Effects (in more detail) AzaSite Dosage AzaSite Use in Pregnancy & Breastfeeding AzaSite Support Group 1 Review for AzaSite - Add your own review/rating AzaSite Advanced Consumer (Micromedex) - Includes Dosage Information AzaSite Consumer Overview AzaSite Prescribing Information (FDA) Azasite Drops MedFacts Consumer Leaflet (Wolters Kluwer) Compare AzaSite with other medications Conjunctivitis, Bacterial Neonatal Conjunctivitis Where can I get more information? Your doctor or pharmacist can provide more information about azithromycin ophthalmic.

See also: AzaSite side effects (in more detail)


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Azithromycin Tablets


Pronunciation: ay-ZITH-roe-MYE-sin
Generic Name: Azithromycin
Brand Name: Zithromax
Azithromycin is used for:

Treating mild to moderate infections caused by certain bacteria. It may also be used alone or with other medicines to treat or prevent certain infections in persons with advanced HIV infection. It may also be used for other conditions as determined by your doctor.

Azithromycin is a macrolide antibiotic. It slows the growth of, or sometimes kills, sensitive bacteria by reducing the production of important proteins needed by the bacteria to survive.

Do NOT use Azithromycin if: you are allergic to any ingredient in Azithromycin, to other macrolide antibiotics (eg, erythromycin), or to ketolide antibiotics (eg, telithromycin) you have a history of liver problems or yellowing of the skin or eyes caused by any doseform (eg, tablets, suspension, injection) of Azithromycin you are taking cisapride, dofetilide, dronedarone, nilotinib, pimozide, propafenone, or tetrabenazine

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

Before using Azithromycin:

Some medical conditions may interact with Azithromycin. 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 liver or kidney problems, myasthenia gravis, or abnormal heart rhythms

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

Antiarrhythmics (eg, disopyramide, dofetilide, dronedarone, propafenone), arsenic, astemizole, bepridil, chloroquine, cisapride, dolasetron, domperidone, droperidol, halofantrine, haloperidol, histone deacetylase inhibitors (eg, romidepsin), lithium, maprotiline, methadone, paliperidone, pentamidine, phenothiazines (eg, thioridazine), pimozide, quinolone antibiotics (eg, levofloxacin), terfenadine, tetrabenazine, toremifene, tricyclic antidepressants (eg, amitriptyline), vandetanib, or ziprasidone because the risk of heart problems, including irregular heartbeat, may be increased Nelfinavir because it may increase the risk of Azithromycin's side effects Rifamycins (eg, rifampin) because the risk of their side effects may be increased by Azithromycin or they may decrease Azithromycin's effectiveness Anticoagulants (eg, warfarin), carbamazepine, cyclosporine, digoxin, ergot derivatives (eg, ergotamine), nilotinib, phenytoin, theophylline, triazolam, or tyrosine kinase receptor inhibitors (eg, dasatinib) because the risk of their side effects may be increased by Azithromycin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Azithromycin 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 Azithromycin:

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

Take Azithromycin by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Do not take an antacid that has aluminum or magnesium in it within 1 hour before or 2 hours after you take Azithromycin. Azithromycin works best if it is taken at the same time each day. To clear up your infection completely, use Azithromycin for the full course of treatment. Keep using it even if you feel better in a few days. If you miss a dose of Azithromycin, 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 Azithromycin.

Important safety information: Azithromycin may cause drowsiness, dizziness, blurred vision, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Azithromycin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Azithromycin may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Azithromycin. 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 or watery stools occur. Do not treat diarrhea without first checking with your doctor. Tell your doctor or dentist that you take Azithromycin before you receive any medical or dental care, emergency care, or surgery. Severe and sometimes fatal liver problems have been reported with the use of Azithromycin. Contact your doctor immediately if you develop symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, vomiting, or loss of appetite; unusual itching). Discuss any questions or concerns with your doctor. Long-term or repeated use of Azithromycin 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. Be sure to use Azithromycin 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. Azithromycin only works against bacteria; it does not treat viral infections (eg, the common cold). Azithromycin should not be used 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 taking Azithromycin while you are pregnant. It is not known if Azithromycin is found in breast milk. If you are or will be breast-feeding while you take Azithromycin, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Azithromycin:

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 or loose stools; headache; mild stomach pain; nausea; upset stomach; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness; wheezing); bloody or watery stools; changes in hearing or hearing loss; chest pain; eye or vision problems; irregular heartbeat; muscle weakness; pounding in the chest; red, swollen, blistered, or peeling skin; ringing in the ears; seizure; severe or persistent diarrhea; stomach cramps or pain; symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, vomiting, or loss of appetite; unusual itching); trouble speaking or swallowing; unusual vaginal itching, odor, or discharge.

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 diarrhea; nausea; upset stomach; vomiting.

Proper storage of Azithromycin:

Store Azithromycin below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Azithromycin out of the reach of children and away from pets.

General information: If you have any questions about Azithromycin, please talk with your doctor, pharmacist, or other health care provider. Azithromycin is to be used only by the patient for whom it is prescribed. Do not share it with other people. Do not use Azithromycin for other health conditions. If your symptoms do not improve within a few days 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 Azithromycin. 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 Azithromycin resources Azithromycin Use in Pregnancy & Breastfeeding Drug Images Azithromycin Drug Interactions Azithromycin Support Group 105 Reviews for Azithromycin - Add your own review/rating Compare Azithromycin with other medications Babesiosis Bacterial Endocarditis Prevention Bacterial Infection Bartonellosis Bronchitis Cervicitis Chancroid COPD, Acute Cystic Fibrosis Gonococcal Infection, Uncomplicated Granuloma Inguinale Legionella Pneumonia Lyme Disease, Erythema Chronicum Migrans Mycobacterium avium-intracellulare, Prophylaxis Mycobacterium avium-intracellulare, Treatment Mycoplasma Pneumonia Nongonococcal Urethritis Otitis Media Pelvic Inflammatory Disease Pharyngitis Pneumonia Sinusitis Skin Infection Tonsillitis/Pharyngitis Toxoplasmosis Typhoid Fever Upper Respiratory Tract Infection


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Bacterial Endocarditis Prevention (Bacterial Endocarditis Prophylaxis) Medications


Drugs associated with Bacterial Endocarditis Prevention

The following drugs and medications are in some way related to, or used in the treatment of Bacterial Endocarditis Prevention. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Bacterial Endocarditis Prevention (Bacterial Endocarditis Prophylaxis)

Medical Encyclopedia:

Endocarditis Infectious endocarditis
Drug List: Amoxil Ancef Azithromycin-3-Day-Dose-Pack Biaxin Biaxin-Xl-Extended-Release-Tablets Bio-Cef Cleocin Cleocin-Hcl Cleocin-Pediatric-Suspension Cleocin-Phosphate-Iv Dispermox Duricef E-E-S-Granules-Suspension E-E-S-200 E-E-S-400 E-E-S-400-Filmtab Ery-Tab Eryc-Delayed-Release-Particles-Capsules Eryped-Drops Erythrocin Erythromycin-Lactobionate-I-V Erythrocin-Stearate-Filmtab Garamycin-Solution Ilosone Keflex Kefzol Lyphocin Panixine Pce Principen Rocephin Trimox Vancocin Vancocin-Hcl Vancocin-Hcl-Pulvules Zithromax Zmax-Extended-Release-Oral-Suspension


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Azithromycin Suspension


Pronunciation: ay-ZITH-roe-MYE-sin
Generic Name: Azithromycin
Brand Name: Zithromax
Azithromycin Suspension is used for:

Treating mild to moderate infections caused by certain bacteria. It may also be used alone or with other medicines to treat or prevent certain infections in persons with advanced HIV infection. It may also be used for other conditions as determined by your doctor.

Azithromycin Suspension is a macrolide antibiotic. It slows the growth of, or sometimes kills, sensitive bacteria by reducing the production of important proteins needed by the bacteria to survive.

Do NOT use Azithromycin Suspension if: you are allergic to any ingredient in Azithromycin Suspension, to other macrolide antibiotics (eg, erythromycin), or to ketolide antibiotics (eg, telithromycin) you have a history of liver problems or yellowing of the skin or eyes caused by any doseform (eg, tablets, suspension, injection) of Azithromycin Suspension you are taking cisapride, dofetilide, dronedarone, nilotinib, pimozide, propafenone, or tetrabenazine

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

Before using Azithromycin Suspension:

Some medical conditions may interact with Azithromycin Suspension. 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 liver or kidney problems, myasthenia gravis, or abnormal heart rhythms

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

Antiarrhythmics (eg, disopyramide, dofetilide, dronedarone, propafenone), arsenic, astemizole, bepridil, chloroquine, cisapride, dolasetron, domperidone, droperidol, halofantrine, haloperidol, histone deacetylase inhibitors (eg, romidepsin), lithium, maprotiline, methadone, paliperidone, pentamidine, phenothiazines (eg, thioridazine), pimozide, quinolone antibiotics (eg, levofloxacin), terfenadine, tetrabenazine, toremifene, tricyclic antidepressants (eg, amitriptyline), vandetanib, or ziprasidone because the risk of heart problems, including irregular heartbeat, may be increased Nelfinavir because it may increase the risk of Azithromycin Suspension's side effects Rifamycins (eg, rifampin) because the risk of their side effects may be increased by Azithromycin Suspension or they may decrease Azithromycin Suspension's effectiveness Anticoagulants (eg, warfarin), carbamazepine, cyclosporine, digoxin, ergot derivatives (eg, ergotamine), nilotinib, phenytoin, theophylline, triazolam, or tyrosine kinase receptor inhibitors (eg, dasatinib) because the risk of their side effects may be increased by Azithromycin Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Azithromycin Suspension 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 Azithromycin Suspension:

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

Take Azithromycin Suspension by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Do not take an antacid that has aluminum or magnesium in it within 1 hour before or 2 hours after you take Azithromycin Suspension. Shake well before each use. Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose. Azithromycin Suspension works best if it is taken at the same time each day. To clear up your infection completely, take Azithromycin Suspension for the full course of treatment. Keep taking it even if you feel better in a few days. If you miss a dose of Azithromycin Suspension, 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 Azithromycin Suspension.

Important safety information: Azithromycin Suspension may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Azithromycin Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Azithromycin Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Azithromycin Suspension. 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 or watery stools occur. Do not treat diarrhea without first checking with your doctor. Tell your doctor or dentist that you take Azithromycin Suspension before you receive any medical or dental care, emergency care, or surgery. Severe and sometimes fatal liver problems have been reported with the use of Azithromycin Suspension. Contact your doctor immediately if you develop symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, vomiting, or loss of appetite; unusual itching). Discuss any questions or concerns with your doctor. Long-term or repeated use of Azithromycin Suspension 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. Be sure to use Azithromycin Suspension 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. Azithromycin Suspension only works against bacteria; it does not treat viral infections (eg, the common cold). Azithromycin Suspension should be used with extreme caution in CHILDREN younger than 6 months; 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 taking Azithromycin Suspension while you are pregnant. It is not known if Azithromycin Suspension is found in breast milk. If you are or will be breast-feeding while you take Azithromycin Suspension, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Azithromycin Suspension:

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 or loose stools; headache; mild stomach pain; nausea; upset stomach; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness; wheezing); bloody or watery stools; changes in hearing or hearing loss; chest pain; eye or vision problems; irregular heartbeat; muscle weakness; pounding in the chest; red, swollen, blistered, or peeling skin; ringing in the ears; seizure; severe or persistent diarrhea; stomach cramps or pain; symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, vomiting, or loss of appetite; unusual itching); trouble speaking or swallowing; unusual vaginal itching, odor, or discharge.

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 diarrhea; nausea; upset stomach; vomiting.

Proper storage of Azithromycin Suspension:

Store mixed suspension between 41 and 86 degrees F (5 and 30 degrees C). Use within 10 days of mixing. Keep tightly closed. Throw away any unused suspension after therapy. Keep medicine in original container. Do not store in the bathroom. Keep Azithromycin Suspension out of the reach of children and away from pets.

General information: If you have any questions about Azithromycin Suspension, please talk with your doctor, pharmacist, or other health care provider. Azithromycin Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people. Do not use Azithromycin Suspension for other health conditions. If your symptoms do not improve within a few days 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 Azithromycin Suspension. 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 Azithromycin resources Azithromycin Use in Pregnancy & Breastfeeding Drug Images Azithromycin Drug Interactions Azithromycin Support Group 105 Reviews for Azithromycin - Add your own review/rating Compare Azithromycin with other medications Babesiosis Bacterial Endocarditis Prevention Bacterial Infection Bartonellosis Bronchitis Cervicitis Chancroid COPD, Acute Cystic Fibrosis Gonococcal Infection, Uncomplicated Granuloma Inguinale Legionella Pneumonia Lyme Disease, Erythema Chronicum Migrans Mycobacterium avium-intracellulare, Prophylaxis Mycobacterium avium-intracellulare, Treatment Mycoplasma Pneumonia Nongonococcal Urethritis Otitis Media Pelvic Inflammatory Disease Pharyngitis Pneumonia Sinusitis Skin Infection Tonsillitis/Pharyngitis Toxoplasmosis Typhoid Fever Upper Respiratory Tract Infection


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Azithromycin Single-Dose Packet


Pronunciation: ay-ZITH-roe-MYE-sin
Generic Name: Azithromycin
Brand Name: Zithromax
Azithromycin Single-Dose Packet is used for:

Treating mild to moderate infections caused by certain bacteria. It may also be used alone or with other medicines to treat or prevent certain infections in persons with advanced HIV infection. It may also be used for other conditions as determined by your doctor.

Azithromycin Single-Dose Packet is a macrolide antibiotic. It slows the growth of, or sometimes kills, sensitive bacteria by reducing the production of important proteins needed by the bacteria to survive.

Do NOT use Azithromycin Single-Dose Packet if: you are allergic to any ingredient in Azithromycin Single-Dose Packet, to other macrolide antibiotics (eg, erythromycin), or to ketolide antibiotics (eg, telithromycin) you have a history of liver problems or yellowing of the skin or eyes caused by any doseform (eg, tablets, suspension, injection) of Azithromycin Single-Dose Packet you are taking cisapride, dofetilide, dronedarone, nilotinib, pimozide, propafenone, or tetrabenazine

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

Before using Azithromycin Single-Dose Packet:

Some medical conditions may interact with Azithromycin Single-Dose Packet. 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 liver or kidney problems, myasthenia gravis, or abnormal heart rhythms

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

Antiarrhythmics (eg, disopyramide, dofetilide, dronedarone, propafenone), arsenic, astemizole, bepridil, chloroquine, cisapride, dolasetron, domperidone, droperidol, halofantrine, haloperidol, histone deacetylase inhibitors (eg, romidepsin), lithium, maprotiline, methadone, paliperidone, pentamidine, phenothiazines (eg, thioridazine), pimozide, quinolone antibiotics (eg, levofloxacin), terfenadine, tetrabenazine, toremifene, tricyclic antidepressants (eg, amitriptyline), vandetanib, or ziprasidone because the risk of heart problems, including irregular heartbeat, may be increased Nelfinavir because it may increase the risk of Azithromycin Single-Dose Packet's side effects Rifamycins (eg, rifampin) because the risk of their side effects may be increased by Azithromycin Single-Dose Packet or they may decrease Azithromycin Single-Dose Packet's effectiveness Anticoagulants (eg, warfarin), carbamazepine, cyclosporine, digoxin, ergot derivatives (eg, ergotamine), nilotinib, phenytoin, theophylline, triazolam, or tyrosine kinase receptor inhibitors (eg, dasatinib) because the risk of their side effects may be increased by Azithromycin Single-Dose Packet

This may not be a complete list of all interactions that may occur. Ask your health care provider if Azithromycin Single-Dose Packet 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 Azithromycin Single-Dose Packet:

Use Azithromycin Single-Dose Packet as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Azithromycin Single-Dose Packet by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Mix the entire contents of the packet thoroughly with 2 ounces (approximately 60 mL) of water. Drink the entire contents immediately; add an additional 2 ounces of water, mix, and drink to be certain you receive all the medicine. Do not take an antacid that has aluminum or magnesium in it within 1 hour before or 2 hours after you take Azithromycin Single-Dose Packet. To clear up your infection completely, take Azithromycin Single-Dose Packet for the full course of treatment. Keep taking it even if you feel better in a few days. Only one dose of Azithromycin Single-Dose Packet is required. If you forget to take Azithromycin Single-Dose Packet, take it as soon as you remember.

Ask your health care provider any questions you may have about how to use Azithromycin Single-Dose Packet.

Important safety information: Azithromycin Single-Dose Packet may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Azithromycin Single-Dose Packet with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Azithromycin Single-Dose Packet may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Azithromycin Single-Dose Packet. 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 or watery stools occur. Do not treat diarrhea without first checking with your doctor. Tell your doctor or dentist that you take Azithromycin Single-Dose Packet before you receive any medical or dental care, emergency care, or surgery. Severe and sometimes fatal liver problems have been reported with the use of Azithromycin Single-Dose Packet. Contact your doctor immediately if you develop symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, vomiting, or loss of appetite; unusual itching). Discuss any questions or concerns with your doctor. Long-term or repeated use of Azithromycin Single-Dose Packet 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. Be sure to use Azithromycin Single-Dose Packet 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. Azithromycin Single-Dose Packet only works against bacteria; it does not treat viral infections (eg, the common cold). Azithromycin Single-Dose Packet should not be used 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 taking Azithromycin Single-Dose Packet while you are pregnant. It is not known if Azithromycin Single-Dose Packet is found in breast milk. If you are or will be breast-feeding while you take Azithromycin Single-Dose Packet, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Azithromycin Single-Dose Packet:

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 or loose stools; headache; mild stomach pain; nausea; upset stomach; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness; wheezing); bloody or watery stools; changes in hearing or hearing loss; chest pain; eye or vision problems; irregular heartbeat; muscle weakness; pounding in the chest; red, swollen, blistered, or peeling skin; ringing in the ears; seizure; severe or persistent diarrhea; stomach cramps or pain; symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, vomiting, or loss of appetite; unusual itching); trouble speaking or swallowing; unusual vaginal itching, odor, or discharge.

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 diarrhea; nausea; upset stomach; vomiting.

Proper storage of Azithromycin Single-Dose Packet:

Store unopened packets between 41 and 86 degrees F (5 and 30 degrees C). Store away from heat, moisture, and light. Keep medicine in original packet until use. Do not store in the bathroom. Keep Azithromycin Single-Dose Packet out of the reach of children and away from pets.

General information: If you have any questions about Azithromycin Single-Dose Packet, please talk with your doctor, pharmacist, or other health care provider. Azithromycin Single-Dose Packet is to be used only by the patient for whom it is prescribed. Do not share it with other people. Do not use Azithromycin Single-Dose Packet for other health conditions. If your symptoms do not improve within a few days 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 Azithromycin Single-Dose Packet. 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 Azithromycin resources Azithromycin Use in Pregnancy & Breastfeeding Drug Images Azithromycin Drug Interactions Azithromycin Support Group 105 Reviews for Azithromycin - Add your own review/rating Compare Azithromycin with other medications Babesiosis Bacterial Endocarditis Prevention Bacterial Infection Bartonellosis Bronchitis Cervicitis Chancroid COPD, Acute Cystic Fibrosis Gonococcal Infection, Uncomplicated Granuloma Inguinale Legionella Pneumonia Lyme Disease, Erythema Chronicum Migrans Mycobacterium avium-intracellulare, Prophylaxis Mycobacterium avium-intracellulare, Treatment Mycoplasma Pneumonia Nongonococcal Urethritis Otitis Media Pelvic Inflammatory Disease Pharyngitis Pneumonia Sinusitis Skin Infection Tonsillitis/Pharyngitis Toxoplasmosis Typhoid Fever Upper Respiratory Tract Infection


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Bartonellosis Medications


Definition of Bartonellosis: Cat scratch disease is an infectious illness caused by the bacteria More...

Drugs associated with Bartonellosis

The following drugs and medications are in some way related to, or used in the treatment of Bartonellosis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Bartonellosis

Medical Encyclopedia:

Cat scratch disease
Drug List: Azithromycin-3-Day-Dose-Pack Doryx-Delayed-Release-Capsules Doxy-100 Doxy-200 E-E-S-Granules-Suspension E-E-S-200 E-E-S-400 E-E-S-400-Filmtab Ery-Tab Eryc-Delayed-Release-Particles-Capsules Eryped-Drops Erythrocin Erythromycin-Lactobionate-I-V Erythrocin-Stearate-Filmtab Ilosone Monodox Ocudox-Convenience-Kit Oraxyl Pce Rifadin Rifadin-Iv Rimactane Vibra-Tabs Vibramycin Zithromax Zmax-Extended-Release-Oral-Suspension


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azithromycin


Generic Name: azithromycin (a ZITH roe MYE sin)
Brand names: Azithromycin 3 Day Dose Pack, Azithromycin 5 Day Dose Pack, Zithromax, Zithromax TRI-PAK, Zithromax Z-Pak, Zmax, Zithromax IV

What is azithromycin?

Azithromycin is in a group of drugs called macrolide antibiotics. Azithromycin fights bacteria in the body.

Azithromycin is used to treat many different types of infections caused by bacteria, such as respiratory infections, skin infections, ear infections, and sexually transmitted diseases.

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

What is the most important information I should know about azithromycin? You should not use this medication if you have ever had jaundice or liver problems caused by taking azithromycin. You should not use azithromycin if you are allergic to it or to similar drugs such as erythromycin (E-Mycin, Ery-Tab, E.E.S.), clarithromycin (Biaxin), telithromycin (Ketek), or troleandomycin (Tao).

There are many other medicines that can interact with azithromycin. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Azithromycin will not treat a viral infection such as the common cold or flu.

Do not take antacids that contain aluminum or magnesium within 2 hours before or after you take azithromycin. This includes Rolaids, Maalox, Mylanta, Milk of Magnesia, Pepcid Complete, and others. These antacids can make azithromycin less effective when taken at the same time.

What should I discuss with my healthcare provider before taking azithromycin? You should not use this medication if you have ever had jaundice or liver problems caused by taking azithromycin. You should not use azithromycin if you are allergic to it or to similar drugs such as erythromycin (E-Mycin, Ery-Tab, E.E.S.), clarithromycin (Biaxin), telithromycin (Ketek), or troleandomycin (Tao).

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

liver disease;

kidney disease;

myasthenia gravis;

a heart rhythm disorder; or

a history of Long QT syndrome.

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 azithromycin passes into breast milk or if it could harm a nursing baby. Do not take this medication without telling your doctor if you are breast-feeding a baby. How should I take azithromycin?

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. The dose and length of treatment with azithromycin may not be the same for every type of infection.

To use the oral suspension single dose packet: Open the packet and pour the medicine into 2 ounces of water. Stir this mixture and drink all of it right away. Do not save for later use. Throw away any mixed oral suspension that has not been used within 12 hours.

To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Azithromycin may be taken with or without food. Take the medicine with food if it upsets your stomach. Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked 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 medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Azithromycin will not treat a viral infection such as the common cold or flu. Store at room temperature away from moisture and heat. Throw away any unused liquid medicine after 10 days. 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 symptoms may include nausea, vomiting, diarrhea, and stomach discomfort.

What should I avoid while taking azithromycin? Do not take antacids that contain aluminum or magnesium within 2 hours before or after you take azithromycin. This includes Rolaids, Maalox, Mylanta, Milk of Magnesia, Pepcid Complete, and others. These antacids can make azithromycin less effective when taken at the same time.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking azithromycin and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. Azithromycin can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Azithromycin 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 azithromycin and call your doctor at once if you have a serious side effect such as:

diarrhea that is watery or bloody;

chest pain, uneven heartbeats;

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

mild nausea, vomiting, diarrhea, constipation;

stomach pain or upset;

dizziness, tired feeling, or headache;

nervous feeling, sleep problems (insomnia);

vaginal itching or discharge;

mild itching or skin rash;

ringing in your ears, problems with hearing; or

decreased sense of taste or smell.

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.

Azithromycin Dosing Information

Usual Adult Dose for Otitis Media:

Immediate release: 500 mg orally on the first day followed by 250 mg orally once a day on days 2 through 5

Usual Adult Dose for Upper Respiratory Tract Infection:

Immediate release: 500 mg orally on the first day followed by 250 mg orally once a day on days 2 through 5

Usual Adult Dose for Bronchitis:

Immediate release: 500 mg orally on the first day followed by 250 mg orally once a day on days 2 through 5

Usual Adult Dose for Pneumonia:

Community acquired:
Oral:
Immediate release: 500 mg orally on the first day followed by 250 mg orally once a day on days 2 through 5 for mild infections
Extended release suspension: 2 g orally once for mild to moderate infections
IV: 500 mg IV once a day for at least 2 days followed by 500 mg (immediate release formulation) orally once a day to complete a 7- to 10-day course of therapy
The IV dose should be reconstituted and diluted according to the manufacturer's recommendations, and administered as an infusion over not less than 60 minutes.

Usual Adult Dose for Tonsillitis/Pharyngitis:

Immediate release: 500 mg orally on the first day followed by 250 mg orally once a day on days 2 through 5
Recommended as an alternative (second line therapy) in patients who cannot use first line therapy

Usual Adult Dose for Sinusitis:

Acute bacterial sinusitis:
Immediate release: 500 mg orally once a day for 3 days
Extended release suspension: 2 g orally once for mild to moderate infections

Usual Adult Dose for Skin or Soft Tissue Infection:

Uncomplicated:
Immediate release: 500 mg orally on the first day followed by 250 mg orally once a day on days 2 through 5

Usual Adult Dose for Gonococcal Infection -- Uncomplicated:

Immediate release: 2 g orally once

Usual Adult Dose for Chancroid:

Immediate release: 1 g orally once

Usual Adult Dose for Nongonococcal Urethritis:

Immediate release: 1 g orally once

Usual Adult Dose for Cervicitis:

Immediate release: 1 g orally once

Usual Adult Dose for Pelvic Inflammatory Disease:

500 mg IV once a day for at least 2 days followed by 250 mg (immediate release formulation) orally once a day to complete a 7-day course of therapy
The IV dose should be reconstituted and diluted according to the manufacturer's recommendations, and administered as an infusion over not less than 60 minutes.

Usual Adult Dose for Granuloma Inguinale:

Immediate release: 1 g orally once a week for at least 3 weeks and until all lesions have completely healed
This regimen is recommended by the Centers for Disease Control and Prevention as an alternative to doxycyline.

Usual Adult Dose for Legionella Pneumonia:

500 mg IV once a day for at least 2 days followed by 500 mg (immediate release formulation) orally once a day to complete a 7- to 10-day course of therapy
The IV dose should be reconstituted and diluted according to the manufacturer's recommendations, and administered as an infusion over not less than 60 minutes.

Usual Adult Dose for Mycoplasma Pneumonia:

Immediate release: 500 mg orally on the first day followed by 250 mg orally once a day on days 2 through 5
Severe infection: 500 mg IV once a day can be administered for at least 2 days followed by 500 mg (immediate release formulation) orally once a day to complete a 7- to 10-day course of therapy
The IV dose should be reconstituted and diluted according to the manufacturer's recommendations, and administered as an infusion over not less than 60 minutes.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease -- Acute:

Acute bacterial exacerbations (mild to moderate):
Immediate release: 500 mg orally once daily for 3 days
or
500 mg orally on the first day followed by 250 mg orally once a day on days 2 through 5

Usual Adult Dose for Mycobacterium avium-intracellulare -- Prophylaxis:

Patients with advanced HIV infection:
Immediate release: 1200 mg orally once a week alone or with rifabutin

Usual Adult Dose for Mycobacterium avium-intracellulare -- Treatment:

Patients with advanced HIV infection:
Immediate release: 500 mg orally once a day plus ethambutol, with or without rifabutin

Usual Adult Dose for Bacterial Infection:

Pertussis:
Immediate release: 500 mg orally on the first day followed by 250 mg orally once a day on days 2 through 5

Usual Adult Dose for Lyme Disease -- Erythema Chronicum Migrans:

Immediate release: 500 mg orally once a day

Usual Adult Dose for Bacterial Endocarditis Prophylaxis:

Immediate release: 500 mg orally once 30 to 60 minutes prior to the procedure

Usual Adult Dose for Toxoplasmosis:

Immediate release: 1200 to 1500 mg orally once a day

Usual Adult Dose for Typhoid Fever:

Immediate release: 1000 mg orally on the first day followed by 500 mg orally once a day for 6 days
Alternatively, a dosage of 1000 mg orally once a day for 5 days may also be used.

Usual Pediatric Dose for Pneumonia:

Community acquired:
6 months or older:
Immediate release: 10 mg/kg (maximum: 500 mg/dose) orally as a single dose on the first day followed by 5 mg/kg (maximum: 250 mg/dose) orally once a day on days 2 thru 5
or
30 mg/kg orally once
or
10 mg/kg orally once a day for 3 days
Extended release suspension:
Less than 34 kg: 60 mg/kg orally once for mild to moderate infections
34 kg or more: 2 g orally once for mild to moderate infections

Usual Pediatric Dose for Sinusitis:

Acute bacterial sinusitis:
6 months or older:
Immediate release: 10 mg/kg orally once a day for 3 days
16 years or older:
Immediate release: 500 mg orally once a day for 3 days
Extended release suspension: 2 g orally once for mild to moderate infections

Usual Pediatric Dose for Otitis Media:

Acute:
6 months or older:
Immediate release: 30 mg/kg (maximum: 1500 mg/dose) orally once
or
10 mg/kg (maximum: 500 mg/dose) orally once a day for 3 days
or
10 mg/kg (maximum: 500 mg/dose) orally as a single dose on the first day followed by 5 mg/kg (maximum: 250 mg/dose) orally once a day on days 2 thru 5

Usual Pediatric Dose for Tonsillitis/Pharyngitis:

2 years or older:
Immediate release: 12 mg/kg (maximum: 500 mg/dose) orally once a day for 5 days
Recommended as an alternative (second line therapy) in patients who cannot use first line therapy

Usual Pediatric Dose for Skin or Soft Tissue Infection:

Uncomplicated:
16 years or older:
Immediate release: 500 mg orally on the first day followed by 250 mg orally once a day on days 2 through 5

Usual Pediatric Dose for Bacterial Infection:

Pertussis:
Immediate release:
Neonates: 10 mg/kg orally once a day for 5 days.
Less than 6 months: 10 mg/kg orally once a day for 5 days.
6 months or older: 10 mg/kg (maximum: 500 mg/dose) orally as a single dose on the first day followed by 5 mg/kg (maximum: 250 mg/dose) orally once a day on days 2 thru 5.

Usual Pediatric Dose for Upper Respiratory Tract Infection:

Immediate release:
6 months or older: 10 mg/kg (maximum: 500 mg/dose) orally as a single dose on the first day followed by 5 mg/kg (maximum: 250 mg/dose) orally once a day on days 2 thru 5

Usual Pediatric Dose for Mycobacterium avium-intracellulare -- Prophylaxis:

Unlabeled use:
Primary prevention:
Children: 20 mg/kg (maximum: 1200 mg/dose) once a week (preferred) or 5 mg/kg (maximum: 250 mg/dose) orally once a day.
Secondary prevention:
Children: 5 mg/kg (maximum: 250 mg/dose) orally once a day plus ethambutol, with or without rifabutin.

Usual Pediatric Dose for Mycobacterium avium-intracellulare -- Treatment:

Unlabeled use:
Children: 10-12 mg/kg/day (maximum dose: 500 mg/day) orally once daily.

Usual Pediatric Dose for Typhoid Fever:

6 months or older:
Immediate release: 10 mg/kg orally once a day for 7 days

Usual Pediatric Dose for Chancroid:

Immediate release: 20 mg/kg (maximum: 1 g/dose) orally once

Usual Pediatric Dose for Nongonococcal Urethritis:

Uncomplicated:
Immediate release:
Less than 8 years and less than 45 kg: 20 mg/kg (maximum: 1 g/dose) orally once.
8 years or older and 45 kg or more: 1 g orally once.

Usual Pediatric Dose for Cervicitis:

Uncomplicated:
Immediate release:
Less than 8 years and less than 45 kg: 20 mg/kg (maximum: 1 g/dose) orally once.
8 years or older and 45 kg or more: 1 g orally once.

Usual Pediatric Dose for Gonococcal Infection -- Uncomplicated:

16 years or older:
Immediate release: 2 g orally once

Usual Pediatric Dose for Chronic Obstructive Pulmonary Disease -- Acute:

Acute bacterial exacerbations (mild to moderate):
16 years or older:
Immediate release: 500 mg orally once a day for 3 days
or
500 mg orally on the first day followed by 250 mg orally once a day on days 2 through 5

Usual Pediatric Dose for Babesiosis:

Immediate release: 12 mg/kg (maximum: 600 mg/dose) orally once a day for 7 to 10 days plus oral atovaquone

Usual Pediatric Dose for Bacterial Endocarditis Prophylaxis:

Immediate release: 15 mg/kg (maximum: 500 mg) orally once 30 to 60 minutes prior to procedure

Usual Pediatric Dose for Cystic Fibrosis:

Chronic Pseudomonas aeruginosa infection:
Children 6 years or older and adolescents:
25 to less than 40 kg: 250 mg orally on Mondays, Wednesdays, Fridays
40 kg or more: 500 mg orally on Mondays, Wednesdays, Fridays
If side effects are intolerable, the dose should be decreased to twice a week, or if necessary, once a week.

What other drugs will affect azithromycin?

Many drugs can interact with azithromycin. Below is just a partial list. Tell your doctor if you are using:

digoxin (Lanoxin, Lanoxicaps);

carbamazepine (Carbatrol, Tegretol);

cyclosporine (Neoral, Sandimmune);

phenytoin (Dilantin);

pimozide (Orap);

theophylline (Theo-Dur, Theolair, Theochron);

triazolam (Halcion);

warfarin (Coumadin, Jantoven);

another antibiotic, especially clarithromycin (Biaxin) or erythromycin (E-Mycin, E.E.S, Ery-Tab);

a calcium channel blocker such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;

cholesterol-lowering medicines such as lovastatin (Mevacor), atorvastatin (Lipitor), or simvastatin (Zocor);

ergot medicine such as methysergide (Sansert), ergotamine (Ergostat, Medihaler, Cafergot, Ercaf, Wigraine), dihydroergotamine mesylate (D.H.E., Migranal Nasal Spray);

HIV medicines such as nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Invirase); or

alprazolam (Xanax), diazepam (Valium), midazolam (Versed), or triazolam (Halcion).

This list is not complete and there are many other drugs that can interact with azithromycin. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you. More azithromycin resources Azithromycin Use in Pregnancy & Breastfeeding Drug Images Azithromycin Drug Interactions Azithromycin Support Group 105 Reviews for Azithromycin - Add your own review/rating azithromycin Advanced Consumer (Micromedex) - Includes Dosage Information Azithromycin Professional Patient Advice (Wolters Kluwer) Azithromycin MedFacts Consumer Leaflet (Wolters Kluwer) Azithromycin Monograph (AHFS DI) Zithromax Prescribing Information (FDA) Zithromax Consumer Overview Zmax Prescribing Information (FDA) Zmax Extended-Release Oral Suspension MedFacts Consumer Leaflet (Wolters Kluwer) Compare azithromycin with other medications Babesiosis Bacterial Endocarditis Prevention Bacterial Infection Bartonellosis Bronchitis Cervicitis Chancroid COPD, Acute Cystic Fibrosis Gonococcal Infection, Uncomplicated Granuloma Inguinale Legionella Pneumonia Lyme Disease, Erythema Chronicum Migrans Mycobacterium avium-intracellulare, Prophylaxis Mycobacterium avium-intracellulare, Treatment Mycoplasma Pneumonia Nongonococcal Urethritis Otitis Media Pelvic Inflammatory Disease Pharyngitis Pneumonia Sinusitis Skin Infection Tonsillitis/Pharyngitis Toxoplasmosis Typhoid Fever Upper Respiratory Tract Infection Where can I get more information? Your pharmacist can provide more information about azithromycin.


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Otitis Media Medications


Definition of Otitis Media:

Infection and inflammation of the middle ear space and ear drum.

Symptoms include earache, fever and in some cases, diminished hearing.

Drugs associated with Otitis Media

The following drugs and medications are in some way related to, or used in the treatment of Otitis Media. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

See sub-topics

Topics under Otitis Media Chronic Otitis Media (2 drugs in 2 topics) Otitis Media with Perforation of Ear Drum (0 drugs) Perforated Tympanic Membrane (0 drugs)
Drug List: A-B-Otic Ak-Spore-Hc-Otic-Suspension Amoclan-Suspension Amoxil Augmentin Augmentin-Es-600-Suspension Augmentin-Xr-Extended-Release-Tablets Aurodex Auroto Azithromycin-3-Day-Dose-Pack Bactrim Bactrim-Ds Beepen-Vk Biaxin Biaxin-Xl-Extended-Release-Tablets Bicillin-C-R Bicillin-C-R-900-300 Bicillin-L-A-Suspension Bio-Cef Cedax Ceftin Cefzil Ceptaz Chlorphenylcaine-Ear-Drops Ciprodex Co-Trimoxazole Coly-Mycin-S-Drops Cort-Biotic Cortatrigen Cortatrigen-Modified Cortisporin-Solution Cortisporin-Tc-Drops Cortomycin-Solution Cotrim Dispermox Dolotic Drotic Dynabac Dynabac-D5-Pak E-E-S-Granules-Suspension E-E-S-200 E-E-S-400 E-E-S-400-Filmtab Ery-Tab Eryc-Delayed-Release-Particles-Capsules Eryped-Drops Erythrocin Erythromycin-Lactobionate-I-V Erythrocin-Stearate-Filmtab Eryzole Floxin-Otic Fortaz Gantrisin-Suspension Gantrisin-Pediatric Ilosone Permapen-Isoject Keflex Levaquin Levaquin-Leva-Pak Lorabid Lorabid-Pulvules Masporin-Otic Omnicef Omnicef-Omni-Pac Oti-Sone Otimar Otocort-Sterile-Solution Otocort-Sterile-Suspension Otogesic Panixine Pc-Pen-Vk Pce Pediazole Pediotic Pen-V Penicillin-G-Procaine-Injectable-Suspension Penicillin-Vk Pfizerpen Primsol-Solution Principen Proloprim Raniclor Rocephin Rx-Otic Septra Septra-Ds Smz-Tmp-Ds Spectrobid Sulfatrim-Suspension Sulfatrim-Pediatric Sulfimycin Suprax Tazicef Tequin Tequin-Teqpaq Trimox Trimpex Truxazole Tympagesic Uad-Otic Vantin Veetids Velosef Zinacef Zithromax Zmax-Extended-Release-Oral-Suspension


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Seldane


Generic Name: terfenadine (ter FEN a deen)
Brand Names: Seldane

What is terfenadine?

Terfenadine was withdrawn from the U.S. market in 1998.

Terfenadine is an antihistamine. Antihistamines prevent sneezing, runny nose, itching and watering of the eyes, and other allergic symptoms.

Terfenadine is used to treat allergies, hives (urticaria), and other allergic inflammatory conditions.

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

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

Terfenadine was withdrawn from the U.S. market in 1998.

Do not take terfenadine with any of the following medicines: the antifungal drugs ketoconazole (Nizoral) or itraconazole (Sporanox); the antibiotics erythromycin (E.E.S., E-Mycin, Ery-Tab), clarithromycin (Biaxin), or azithromycin (Zithromax); or the ulcer drug cimetidine (Tagamet, Tagamet HB). A dangerous drug interaction could occur. Who should not take terfenadine? You cannot take terfenadine if you are taking any of the following medicines:

the antifungal drugs ketoconazole (Nizoral) or itraconazole (Sporanox);

the antibiotics erythromycin (E.E.S., E-Mycin, Ery-Tab), clarithromycin (Biaxin), or azithromycin (Zithromax); or

the ulcer drug cimetidine (Tagamet, Tagamet HB).

A dangerous side effect involving irregular heartbeats could occur if you take terfenadine with any of the medicines listed above.

Before taking this medication, tell your doctor if you have

asthma or another lung disease;

low potassium levels in your blood;

urinary retention or an enlarged prostate;

kidney or liver disease; or

heart disease, especially an irregular heartbeat.

You may not be able to take terfenadine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

Terfenadine is in the FDA pregnancy category C. This means that it is not known whether terfenadine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. It is not known whether terfenadine passes into breast milk. Do not take terfenadine without first talking to your doctor if you are breast-feeding a baby. How should I take terfenadine?

Take terfenadine as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass (8 ounces) of water. Do not crush, break, or chew the tablets. Swallow them whole.

Terfenadine is usually taken twice a day, in the morning and the evening. Never take more of this medication than is directed by your doctor. If your symptoms are not being adequately treated, talk to your doctor.

Store terfenadine 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 your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose? Seek emergency medical attention.

Symptoms of a terfenadine overdose include headache, drowsiness, irregular heartbeat, nausea, and vomiting.

What should I avoid while taking terfenadine? Use caution when driving, operating machinery, or performing other hazardous activities. Terfenadine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking terfenadine. Terfenadine side effects If you experience any of the following serious side effects, stop taking terfenadine and call your doctor immediately or seek emergency medical attention.

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

an irregular heartbeat; or

seizures.

If you experience any of the following less serious side effects, continue taking terfenadine and talk to your doctor:

drowsiness or dizziness;

headache;

nervousness;

nausea, diarrhea, or abdominal discomfort;

dry mouth; or

dry skin or itchiness.

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.

What other drugs will affect terfenadine? Never take terfenadine with any of the following medications:

antifungal drugs such as ketoconazole (Nizoral) and itraconazole (Sporanox);

antibiotics such as erythromycin (E.E.S., E-Mycin, Ery-Tab, others), clarithromycin (Biaxin), and azithromycin (Zithromax); or

ulcer drugs such as cimetidine (Tagamet, Tagamet HB).

A dangerous side effect involving irregular heartbeats could occur if you take terfenadine with any of the medicines listed above.

Before taking this medication, tell your doctor if you are taking any of the following medicines:

a beta-blocker (heart medication) such as propranolol (Inderal) or metoprolol (Lopressor);

a monoamine oxidase inhibitor (MAOI) antidepressant such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate);

a tricyclic antidepressant such as amitriptyline (Elavil), doxepin (Sinequan), or nortriptyline (Pamelor); or

caffeine, amphetamines, decongestants, or diet pills.

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

More Seldane resources Seldane Side Effects (in more detail) Seldane Use in Pregnancy & Breastfeeding Drug Images Seldane Drug Interactions Seldane Support Group 1 Review for Seldane - Add your own review/rating Seldane Consumer Overview Compare Seldane with other medications Allergies Conjunctivitis, Allergic Eye Redness/Itching Hay Fever Urticaria Where can I get more information? Your pharmacist has additional information about terfenadine written for health professionals that you may read. What does my medication look like?

Terfenadine was withdrawn from the U.S. market in 1998.

See also: Seldane side effects (in more detail)


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Bronchitis Medications


Definition of Bronchitis: Bronchitis is an inflammation of the bronchi -- the main air passages to the lungs.

Drugs associated with Bronchitis

The following drugs and medications are in some way related to, or used in the treatment of Bronchitis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Bronchitis

Medical Encyclopedia:

Bronchitis
Drug List: Ala-Tet Altarussin Amibid-La Amoclan-Suspension Amoxil Augmentin Augmentin-Es-600-Suspension Augmentin-Xr-Extended-Release-Tablets Avelox Avelox-I-V Azithromycin-3-Day-Dose-Pack Bactrim Bactrim-Ds Benylin-E-Extra-Strength-Chest-Congestion Biaxin Biaxin-Xl-Extended-Release-Tablets Bidex-400 Broncodur-Liquid Bronkometer Bronkosol Cedax Ceftin Cefzil Cipro Cipro-I-V Cipro-Xr-Extended-Release-Tablets Co-Trimoxazole Copd Cotrim Difil-G Difil-G-Forte Dilex-G-Liquid Dilex-G-200 Dilex-G-400-Tablets Dilor Dilor-400 Dispermox Doryx-Delayed-Release-Capsules Doxy-100 Doxy-200 Drituss-G Duratuss-G Dy-G Dycill Dyfilin-Gg Dyflex-G Dylix-Elixir Dynabac Dynabac-D5-Pak Dynapen Dyphyllin-Gg Dyphylline-Gg Dyphylline-Gg-Es E-E-S-Granules-Suspension E-E-S-200 E-E-S-400 E-E-S-400-Filmtab Ed-Bron-G-Liquid Elixophyllin-Gg-Liquid Ery-Tab Eryc-Delayed-Release-Particles-Capsules Eryped-Drops Erythrocin Erythromycin-Lactobionate-I-V Erythrocin-Stearate-Filmtab Factive Floxin Ganidin-Nr Gg-200-Nr Guaifenesin-La Guaifenex-G Guaifenex-La Guaituss-Liquid Hytuss-Immediate-Release-Capsules Ilosone Jay-Phyl Ketek Ketek-Pak Levaquin Levaquin-Leva-Pak Liquibid Lorabid Lorabid-Pulvules Lufyllin Lufyllin-400 Lufyllin-Gg Maxaquin Monodox Mucinex Mucinex-Children-S-Granules Muco-Fen-1200 Neothylline Ocudox-Convenience-Kit Omnicef Omnicef-Omni-Pac Oraxyl Organidin-Nr-Immediate-Release-Capsules Panfil-G Pce Primaxin-Im Primaxin-Iv Principen Q-Bid-La Quibron Quibron-300 Qvar-Aerosol-Solution Raniclor Robitussin Scot-Tussin Septra Septra-Ds Smz-Tmp-Ds Spectracef Sulfatrim-Suspension Sulfatrim-Pediatric Sumycin Suprax Tequin Tequin-Teqpaq Theomar-Gg-Liquid Trimox Diabetic-Tussin-Ex Vantin Vibra-Tabs Vibramycin Zagam Zagam-Respipac Zinacef Zithromax Zmax-Extended-Release-Oral-Suspension


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Azyter


1. Name Of The Medicinal Product

Azyter

2. Qualitative And Quantitative Composition

Each gram of solution contains 15 mg of azithromycin dihydrate equivalent to 14.3 mg of azithromycin.

One single-dose container of 250 mg solution contains 3.75 milligrams of azithromycine dihydrate.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Eye drops, solution in single-dose container.

Clear, colourless to slightly yellow, oily liquid.

4. Clinical Particulars 4.1 Therapeutic Indications

Local antibacterial treatment of conjunctivitis caused by susceptible strains:

- Purulent bacterial conjunctivitis,

- Trachomatous conjunctivitis caused by Chlamydia trachomatis.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology And Method Of Administration

Posology

Adults, Adolescents (12 to 17 years), children (2 to 11 years):

Instil one drop in the conjunctival fornix twice a day, morning and evening, during three days.

It is unnecessary to prolong treatment beyond three days.

Adherence to the dosing regimen is important for the success of treatment.

Children (1 to 2 years)

For trachomatous conjunctivitis, no dose adjustment is necessary.

For purulent bacterial conjunctivitis, there is no sufficient experience with Azyter in children younger than 2 years of age (see section 5.1).

Children (less than1 year)

There is no sufficient experience with Azyter in children younger than 1 year of age for trachomatous conjunctivitis as well as for purulent bacterial conjunctivitis (see section 5.1).

Elderly patients:

No dose adjustment is necessary.

Method of administration

Ocular use.

The patient should be advised to:

- thoroughly wash hands before and after the instillation,

- avoid touching the eye or eyelids with the dropper tip of the single-dose container,

- discard the single-dose container after use, and not keep it for subsequent use.

4.3 Contraindications

Hypersensitivity to azithromycin, to any other macrolide or to the excipient.

4.4 Special Warnings And Precautions For Use

The eye drops solution should not be injected nor be swallowed.

The eye drops solution should not be used for peri- or intra-ocular injection.

In the event of an allergic reaction, the treatment should be discontinued.

Based on the international consensus on diseases involving the eye and genital tractus and susceptible to be transmitted to new-borns, non-trachomatous conjunctivitis caused by Chlamydia trachomatis and conjunctivitis caused by Neisseria gonorrhoeae require a systemic treatment.

Except for the treatment of trachomatous conjunctivitis, Azyter is not recommended in infants under 2 years of age due to the lack of sufficient clinical data in this class of age.

This treatment is not intended to be used as prophylaxic treatment of bacterial conjunctivitis in newborn infants.

The patient should be informed that it is not necessary to continue to instil the eye drops solution after the end of treatment on the third day, even if residual signs of bacterial conjunctivitis remain.

Symptomatic relief occurs generally within 3 days. If there are no signs of improvement after 3 days, diagnosis should be reconsidered.

Contact lenses should not be worn by patients with bacterial conjunctivitis.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No specific interaction study has been performed with Azyter.

In view of the absence of detectable concentrations of azithromycin in the plasma during the administration of Azyter by ocular instillation (see section 5.2), none of the interactions with other medicinal products described for orally administered azithromycin is expected with use of the eye drops solution.

In the event of concomitant treatment with another eye drops solution, an interval of 15 minutes should be respected between instillation of the two solutions. Azyter should be instilled last.

4.6 Pregnancy And Lactation

Pregnancy

There are no adequate and well controlled studies in pregnant women. Animal reproduction studies show passage across the placenta. No teratogenic effects were observed in rat reproduction studies (see further section 5.3). Since animal studies are not always predictive of human response, Azyter should be used with caution during pregnancy.

Lactation

Limited data indicate that azithromycin is excreted in breast milk, but, considering the low dose and the low systemic availability, the doses taken by the new-born are negligible. Consequently, breast feeding is possible during the treatment.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects on the ability to drive and use machines have been performed.

Vision may be transiently blurred after instillation. In this case, the patient should be advised to avoid driving or using machines until normal vision has been re-established.

4.8 Undesirable Effects

During clinical trials and according to post-marketing safety data on Azyter eye drops solution, the following treatment-related signs and symptoms were reported:

Eye disorders

   

Very common (

 

Ocular discomfort (pruritus, burning, stinging) upon instillation.

 

Common (

 

Blurred vision, sticky eye sensation, foreign body sensation upon instillation.

 

Uncommon (

 

Lachrymation increased upon instillation.

Immune system disorders

   

Very rare (< 10,000)

 

Hypersensitivity.

4.9 Overdose

The total amount of azithromycin in a single-dose container, containing a sufficient quantity for treating both eyes, is too small to induce adverse effects after inadvertent intravenous or oral administration.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: antibiotics, ATC code: S01AA26

Mode of action

Azithromycin is a second-generation macrolide antibiotic belonging to the azalide group.

It inhibits the synthesis of bacterial proteins by binding to the 50S ribosomal subunit and preventing peptide translocation.

Mechanism of resistance

Generally, the resistance of different bacterial species to macrolides has been reported to occur by three mechanisms associated with target site alteration, antibiotic modification, or altered antibiotic transport (efflux). Various efflux pump systems have been described in bacteria. An important efflux system in streptococci is conferred by the mef genes and results in a macrolide-restricted resistance (M phenotype). Target modification is controlled by erm encoded methylases (MLSB phenotype) and results in cross-resistance to several classes of antibiotics (see below).

A complete cross-resistance exists among erythromycin, azithromycin, other macrolides and lincosamides and streptogramin B for Streptococcus pneumoniae, beta-haemolytic streptococci of group A, Enterococcus spp. and Staphylococcus aureus, including methicillin-resistant S. aureus (MRSA).

Constitutive mutants in inducibly resistant strains with erm(A) or erm(C) can be selected in vitro at low frequencies ~10-7 cfu in the presence of azithromycin.

Breakpoints

The list of micro-organisms presented hereafter has been targeted to the indications (see section 4.1.).

Note that the breakpoints and in-vitro activity spectrum presented hereafter are those applicable to systemic use. These breakpoints may not be applicable to topical ocular application of the drug product due to the local concentrations that are reached and the local physicochemical conditions that may influence the overall activity of the agent at the site of application.

According to the EUCAST (European Committee on Antimicrobial Susceptibility Testing) the following breakpoints have been defined for azithromycin:

- Haemophilus influenzae : S

- Moraxella catarrhalis: S

- Neisseria gonorrhoeae: S

- Staphylococcus aureus: S

- Streptococcus pneumoniae: S

- Streptococcus A, B, C, G: S

For other species, EUCAST allows that erythromycin can be used to determine the susceptibility of the listed bacteria to azithromycin.

The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence is such that the utility of the agent in at least some types of infections is questionable.

Table: Antibacterial spectrum of azithromycin for bacterial species relevant to the indications

Commonly susceptible species

Aerobic Gram-negative

Moraxella (Branhamella) catarrhalis

Neisseria gonorrhoeae1

Haemophilus influenzae$

Haemophilus parainfluenzae$

Other micro-organisms

Chlamydia trachomatis*

Species for which acquired resistance may be a problem

Aerobic Gram-positive

Staphylococcus aureus Methi-S

Staphylococcus aureus Methi-R

Staphylococcus capitis

Staphylococcus coagulase negative Methi-S

Staphylococcus coagulase negative Methi-R

Staphylococcus epidermidis

Staphylococcus haemolyticus

Staphylococcus hominis

Staphylococcus hyicus

Staphylococcus intermedius

Staphylococcus warnerii

Streptococcus pneumoniae

Streptococcus pyogenes

Streptococci viridans

Streptococcus agalactiae

Streptococcus group G

Inherently resistant organisms

Aerobic Gram positive

Corynebacterium spp.

Enterococcus faecium

Aerobic Gram-negative

Pseudomonas aeruginosa

Acinetobacter

* Clinical effectiveness is demonstrated by sensitive isolated organisms for approved indications.

$ The correlation between H. influenzae macrolide MICs and clinical outcome is weak. Therefore, breakpoints for macrolides and related antibiotics were set to categorise wild type H. influenzae as intermediate.

Natural intermediate susceptibility

1 Conjunctivitis caused by Neisseria gonorrhoeae require a systemic treatment (see section 4.4).

Information from clinical trials

- Trachomatous conjunctivitis caused by Chlamydia trachomatis.

Azyter was evaluated in a two-month, randomised, double-masked study comparing Azyter with a single oral dose of azithromycin for the treatment of trachoma in 670 children (1-10 years). The primary efficacy variable was the clinical cure at Day 60, i.e. a grade TF0 (simplified WHO grading scale). At Day 60, clinical cure rate of Azyter instilled twice daily for 3 days (96.3%) was non-inferior to that of oral azithromycin (96.6%).

- Purulent bacterial conjunctivitis.

Azyter was evaluated in a randomised, investigator-masked study comparing Azyter, instilled twice daily for 3 days, with tobramycin 0.3% eye drops, instilled every two hours for 2 days then four times daily for 5 days, for the treatment of purulent bacterial conjunctivitis in 1043 patients (ITT set), including 109 children up to the age of 11 years from whom 5 were newborn infants (0 to 27 days) and 38 infants and toddlers (28 days to 23 months of age). In the Per Protocol set (n=471), there were no newborns and only 16 infants and toddlers. The clinical study was performed in different areas in Europe, North Africa, and India. The primary efficacy variable was the clinical cure at Day 9 in the PP set, defined as a score of 0 for both the bulbar conjunctival injection and the purulent discharge. At Day 9, clinical cure rate of Azyter (87.8%) was non-inferior to that of tobramycin (89.4%). Microbiological resolution rate of Azyter was comparable to that of tobramycin.

5.2 Pharmacokinetic Properties

Azithromycin was not detected in the blood of patients with bacterial conjunctivitis after instillation of Azyter at the recommended dose (detection limit: 0.0002 µg/mL of plasma).

5.3 Preclinical Safety Data

In animals, azithromycin caused reversible phospholipidosis. This effect was seen after oral exposures which were about 300 times in excess of the maximum human exposure after ocular administration indicating little relevance to clinical use.

Electrophysiological investigations have shown that azithromycin prolongs the QT interval.

Carcinogenic potential

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Mutagenic potential

There was no evidence of a potential for genetic and chromosome mutations in in vivo and in vitro test models.

Reproductive toxicity

No teratogenic effects were observed in embryotoxicity studies in rats after oral administration of azithromycin. In rats, azithromycin dosages of 100 and 200 mg/kg body weight/day led to mild retardations in fetal ossification and in maternal weight gain. In peri- and postnatal studies in rats, mild retardations following treatment with 50 mg/kg/day azithromycin and above were observed. These effects were seen after oral administration at exposures which were about 1000 times in excess of the maximum human exposures after ocular administration. Because of the high safety margin, these findings do not point to a relevant risk for human reproduction.

Ocular toxicity

Ocular administration of Azyter eye drops to animals twice or three times a day during 28 days did not demonstrate any local or systemic toxic effect.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Triglycerides, medium-chain.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Shelf-life of product in its commercial packaging: 18 months

After opening of the single-dose container, the eye drops, solution should be used immediately.

Discard the opened single-dose container immediately after first use.

6.4 Special Precautions For Storage

Do not store above 25°C.

Keep the single-dose containers in the sachet in order to protect them from light.

6.5 Nature And Contents Of Container

Single-dose low-density polyethylene container, each containing 0.25 g, enclosed in a sachet.

Pack-size: box of six single-dose containers.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

LABORATOIRES THEA

12, rue Louis Bl?riot

63017 CLERMONT-FERRAND CEDEX 2

FRANCE

8. Marketing Authorisation Number(S)

PL 20162/0012

9. Date Of First Authorisation/Renewal Of The Authorisation

25/03/2011

10. Date Of Revision Of The Text

25/03/2011


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Metronidazole Hydrochloride


Class: Antiprotozoals, Miscellaneous
VA Class: AM900
CAS Number: 443-48-1
Brands: Flagyl, Helidac Therapy

Carcinogenic in mice and rats.152 156 197 430 495

Avoid unnecessary use; reserve for use in approved indications..152 156 197 430 495 (See Uses.)

Introduction

Antibacterial and antiprotozoal;.152 197 430 494 495 nitroimidazole derivative.494

Uses for Metronidazole Hydrochloride Bone and Joint Infections

Adjunct for treatment of bone and joint infections caused by Bacteroides, including the B. fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus).152 197 495

Endocarditis

Treatment of endocarditis caused by Bacteroides (including the B. fragilis group).152 197 495

Gynecologic Infections

Treatment of gynecologic infections (including endometritis, endomyometritis, tubo-ovarian abscess, postsurgical vaginal cuff infection) caused by Bacteroides (including the B. fragilis group), Clostridium, Peptococcus niger, or Peptostreptococcus.152 197 495

Treatment of acute pelvic inflammatory disease (PID); used in conjunction with other anti-infectives.199 341 496 Metronidazole is included in PID regimens to provide coverage against anaerobes.341

When a parenteral regimen is indicated for PID, an initial regimen of IV cefoxitin and IV or oral doxycycline is recommended followed by oral doxycycline; if tubo-ovarian abscess is present, some experts recommend that the oral follow-up regimen include metronidazole (or clindamycin) in addition to doxycycline.341

When an oral regimen is indicated for PID, an single IM dose of ceftriaxone, cefoxitin (with oral probenecid), or cefotaxime is recommended in conjunction with oral doxycycline (with or without oral metronidazole).199 341 496 Alternatively, if a parenteral cephalosporin is not feasible and the community prevalence and individual risk for gonorrhea is low, a regimen of oral levofloxacin or oral ofloxacin (with or without oral metronidazole) may be considered.496

Intra-abdominal Infections

Treatment of intra-abdominal infections (including peritonitis, intra-abdominal abscess, liver abscess) caused by susceptible Bacteroides (including the B. fragilis group), Clostrium, Eubacterium, P. niger, or Peptostreptococcus.152 197 495

Meningitis and Other CNS Infections

Treatment of CNS infections (including meningitis, brain abscess) caused by Bacteroides (including the B. fragilis group).152 197 495

Respiratory Tract Infections

Treatment of respiratory tract infections (including pneumonia) caused by Bacteroides (including the B. fragilis group).152 197 495

Septicemia

Treatment of septicemia caused by Bacteroides (including the B. fragilis group) or Clostridium.152 197 495

Skin and Skin Structure Infections

Treatment of skin and skin structure infections caused by Bacteroides (including the B. fragilis group), Clostridium, Fusobacterium, P. niger, or Peptostreptococcus.152 197 495

Amebiasis

Treatment of acute intestinal amebiasis and amebic liver abscess caused by Entamoeba histolytica.100 152 153 197 364 368 370 Oral metronidazole or oral tinidazole followed by a luminal amebicide (iodoquinol, paromomycin) is the regimen of choice for mild to moderate or severe intestinal disease and for amebic hepatic abscess.100 153 364 368 370

Bacterial Vaginosis

Treatment of bacterial vaginosis (formerly called Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in pregnant or nonpregnant women.199 292 297 298 302 341 365 366 430

CDC recommends treatment of bacterial vaginosis in all symptomatic women (including pregnant women).341 In addition, asymptomatic pregnant women at high risk for complications of pregnancy should be screened (preferably at the first prenatal visit) and treatment initiated if needed.341

Treatment recommendations for bacterial vaginosis in HIV-infected women are the same as those for women without HIV infection.341

Regimens of choice in nonpregnant women are a 7-day regimen of oral metronidazole, a 5-day regimen of intravaginal metronidazole gel, or a 7-day regimen of intravaginal clindamycin cream;341 alternative regimens are a 7-day regimen of oral clindamycin or 3-day regimen of intravaginal clindamycin suppositories.341 The preferred regimens for pregnant women are a 7-day regimen of oral metronidazole or a 7-day regimen of oral clindamycin.341

Regardless of regimen used, relapse or recurrence is common;287 295 297 298 300 302 307 341 365 an alternative regimen (e.g., topical therapy when oral therapy was used initially) may be used in such situations.297 341

Routine treatment of asymptomatic male sexual contacts of women who have relapsing or recurrent bacterial vaginosis not recommended.341

Balantidiasis

Alternative to tetracycline for treatment of balantidiasis† caused by Balantidium coli.100 153

Blastocystis hominis Infections

Treatment of infections caused by Blastocystis hominis†.100 153 368 371 372 May be effective, but metronidazole resistance may be common.153

Clinical importance of B. hominis as a cause of GI pathology is controversial;100 153 368 371 372 unclear when treatment is indicated.100 368 371 Some clinicians suggest treatment be reserved for certain individuals (e.g., immunocompromised patients) when symptoms persist and no other pathogen or process is found to explain their GI symptoms.100 368

Clostridium difficile-associated Diarrhea and Colitis

Treatment of Clostridium difficile-associated diarrhea and colitis† (CDAD; also known as antibiotic-associated diarrhea and colitis, C. difficile diarrhea, C. difficile colitis, and pseudomembranous colitis).100 125 126 127 128 129 131 132 312 313 314 315 316 344 345 443 444 445 446 447

Drugs of choice are metronidazole and vancomycin; 100 312 313 314 315 316 metronidazole generally preferred and vancomycin reserved for those with severe or potentially life-threatening colitis, patients in whom metronidazole-resistant C. difficile is suspected, patients in whom metronidazole is contraindicated or not tolerated, or those who do not respond to metronidazole.100 126 127 312 313 314 315 316 322 323 406 443 444 445 446 447 448

Crohn’s Disease

Mangement of Crohn’s disease† as an adjunct to conventional therapies.101 102 103 104

Has been used with467 468 471 475 476 477 485 or without ciprofloxacin;101 102 103 104 105 469 470 471 472 473 474 478 479 484 485 486 for induction of remission of mildly to moderately active Crohn’s disease†.101 102 103 104 105 467 468 469 471 472 473 474 475 476 477 478 479 484

Has been used for refractory perianal Crohn’s disease†.102 104 105 470 471 474 478 479 485 486

Dientamoeba fragilis Infections

Treatment of infections caused by Dientamoeba fragilis†.153 Drugs of choice are iodoquinol, paromomycin, tetracycline, or metronidazole.153

Dracunculiasis

Treatment of dracunculiasis† caused by Dracunculus medinensis (guinea worm disease).153

Treatment of choice is slow extraction of worm combined with wound care.153 Metronidazole is not curative, but decreases inflammation and facilitates worm removal.153

Giardiasis

Treatment of giardiasis†.100 153 367 452 Drugs of choice are metronidazole, tinidazole, or nitazoxanide;100 153 367 452 alternatives are paromomycin, furazolidone (no longer commercially available in the US), or quinacrine (not commercially available in the US).100 153 367

Treatment of asymptomatic carriers of giardiasis†.100 367 Treatment of such carriers not generally recommended, except possibly in patients with hypogammaglobulinemia or cystic fibrosis or in an attempt to prevent household transmission of the disease from toddlers to pregnant women.100

Helicobacter pylori Infection and Duodenal Ulcer Disease

Treatment of Helicobacter pylori infection and duodenal ulcer disease (active or a history of duodenal ulcer); eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Used in a multiple-drug regimen that includes metronidazole, tetracycline, and bismuth subsalicylate and a histamine H2-receptor antagonist.455 If initial 14-day regimen does not eradicate H. pylori, a retreatment regimen that does not include metronidazole should be used.455

Nongonococcal Urethritis

Treatment of recurrent and persistent urethritis† in patients with nongonococcal urethritis who have already been treated with a recommended regimen (i.e., azithromycin, doxycycline, erythromycin, ofloxacin or levofloxacin).341

Oral metronidazole or oral tinidazole used in conjunction with oral azithromycin (if azithromycin was not used in the initial regimen) is the regimen recommended by CDC for recurrent and persistent urethritis in patients who were compliant with their initial regimen and have not been re-exposed.341

Rosacea

Treatment of inflammatory lesions (papules and pustules) and erythema associated with rosacea† (acne rosacea).137 139 145 146 148 168 180 181 Topical metronidazole may be preferred to oral metronidazole.137 181

Tetanus

Adjunct in treatment of tetanus caused by C. tetani.100 489

Trichomoniasis

Treatment of symptomatic and asymptomatic trichomoniasis when Trichomonas vaginalis has been demonstrated by an appropriate diagnostic procedure (e.g., wet smear and/or culture, OSOM Trichomonas Rapid Test, Affirm VP III).100 152 153 197 199 297 298 302 337 338 339 341

Drug of choice is metronidazole or tinidazole.100 153 199 297 302 337 338 339 341 Goal of treatment is to provide symptomatic relief, achieve microbiologic cure, and reduce transmission; to achieve this goal, both the index patient and sexual (particularly steady) partner(s) should be treated.153 199 297 302 339 341

If treatment failure occurs with initial metronidazole treatment and reinfection is excluded, alternative regimens using metronidazole or tinidazole can be used.153 199 341 If retreatment is ineffective, consultation with an expert (available through CDC) is recommended.341

Perioperative Prophylaxis

Perioperative prophylaxis to reduce the incidence of postoperative anaerobic bacterial infections in patients undergoing colorectal surgery.109 110 111 112 156 495 Preferred regimens are IV cefoxitin alone; IV cefazolin and IV metronidazole; oral erythromycin and oral neomycin; or oral metronidazole and oral neomycin.110 112 490

Perioperative prophylaxis in patients undergoing appendectomy†;109 111 110 112 113 used in conjunction with cefazolin.110 Preferred regimens for appendectomy (nonperforated) are IV cefoxitin alone or IV cefazolin and IV metronidazole.110

Prophylaxis in Sexual Assault Victims

Empiric anti-infective prophylaxis in sexual assault victims†; used in conjunction with IM ceftriaxone and oral azithromycin or doxycycline.199 341

Metronidazole Hydrochloride Dosage and Administration Administration

Administer orally152 197 430 or by continuous or intermittent IV infusion.156 495 Do not administer by rapid IV injection because of the low pH of the reconstituted product.156 495

In the treatment of serious anaerobic infections, parenteral route usually is used initially and oral metronidazole substituted when warranted by patient’s condition.152 197

Oral Administration

Administer extended-release tablets at least 1 hour before or 2 hours after meals.430

IV Infusion

For solution and drug compatibility information, see Compatibility under Stability.

Commercially available metronidazole injection for IV infusion does not need to be diluted or neutralized prior to IV administration.156 495

Metronidazole hydrochloride powder for injection must by reconstituted, diluted, and then neutralized prior to IV administration.156

Reconstitution and Dilution

Reconstitute metronidazole hydrochloride powder for injection by adding 4.4 mL of sterile or bacteriostatic water for injection, 0.9% sodium chloride injection, or bacteriostatic sodium chloride injection to the vial containing 500 mg of metronidazole.156 The reconstituted solution contains approximately 100 mg of metronidazole/mL and has a pH of 0.5–2.156

The reconstituted metronidazole hydrochloride solution must be further diluted with 0.9% sodium chloride injection, 5% dextrose injection, or lactated Ringer’s injection to a concentration of ?8 mg/mL.156

The reconstituted and diluted metronidazole hydrochloride solution must then be neutralized by adding approximately 5 mEq of sodium bicarbonate injection for each 500 mg of metronidazole.156 The addition of sodium bicarbonate to the metronidazole hydrochloride solution may generate carbon dioxide gas and it may be necessary to relieve gas pressure in the container.156

Rate of Administration

IV infusions usually are infused over 1 hour.156 495

Dosage

Available as metronidazole152 156 197 430 495 and metronidazole hydrochloride;156 dosage expressed in terms of metronidazole.156

Pediatric Patients General Dosage in Neonates† Oral or IV

Neonates <1 week of age: AAP recommends 7.5 mg/kg every 24–48 hours in those weighing <1.2 g, 7.5 mg/kg every 24 hours in those weighing 1.2–2 kg, or 7.5 mg/kg every 12 hours in those weighing >2 kg.100

Neonates 1–4 weeks of age: AAP recommends 7.5 mg/kg every 24–48 hours in those weighing <1.2 kg, 7.5 mg/kg every 12 hours in those weighing 1.2–2 kg, and 15 mg/kg every 12 hours in those weighing >2 kg.100

General Dosage in Children ?1 Month of Age† Oral

15–35 mg/kg daily in 3 divided doses.100 AAP states oral route inappropriate for severe infections.100

Amebiasis Entamoeba histolytica Infections Oral

35–50 mg/kg daily in 3 divided doses given for 7–10 (usually 10) days;152 153 197 370 follow-up with a luminal amebicide (e.g., iodoquinol, paromomycin).153

Bacterial Vaginosis† Oral

Children weighing <45 kg: 15 mg/kg daily (up to 1 g) in 2 divided doses given for 7 days.100

Adolescents: 500 mg twice daily for 7 days.100

Balantidiasis† Oral

35–50 mg/kg daily in 3 divided doses given for 5 days.153

Blastocystis hominis Infections† Oral

20–35 mg/kg daily in 3 divided doses given for 10 days may improve symptoms in some patients.100

Crohn’s Disease† Oral

10–20 mg/kg daily (up to 1 g daily) has been recommended for children with mild perianal Crohn’s disease† or those intolerant to sulfasalazine or mesalamine.487

Clostridium difficile-associated Diarrhea and Colitis† Oral

30–50 mg/kg daily in 3 or 4 equally divided doses given for 7–10 days (not to exceed adult dosage).100 445 446

Dientamoeba fragilis Infections† Oral

20–40 mg/kg daily in 3 divided doses given for 10 days.153

Dracunculiasis† Oral

25 mg/kg daily (up to 750 mg) in 3 divided doses given for 10 days.153 Is not curative, but may decrease inflammation and facilitate worm removal.153

Giardiasis† Oral

15 mg/kg daily in 3 divided doses given for 5–7 days.153 367 452

Nongonococcal Urethritis† Oral

Recurrent or persistent urethritis in adolescents: A single 2-g dose given in conjunction with a single 1-g dose of oral azithromycin (if azithromycin not used in the initial regimen).341

Tetanus† Oral

30 mg/kg daily (up to 4 g daily) in 4 doses given for 10–14 days.100

IV

30 mg/kg daily (up to 4 g daily) in 4 doses given for 10–14 days.100

Trichomoniasis† Oral

Prepubertal children weighing <45 kg: 15 mg/kg daily in 3 divided doses (up to 2 g daily) given for 7 days.100 153

Adolescents: A single 2-g dose or 500 mg twice daily for 7 days.100

Prophylaxis in Sexual Assault Victims† Oral

Preadolescent children weighing <45 kg: 15 mg/kg daily given in 3 divided doses for 7 days given in conjunction with IM ceftriaxone and either oral azithromycin or oral erythromycin.100 341

Adolescents and preadolescent children weighing ?45 kg: A single 2-g dose given in conjunction with IM ceftriaxone and either oral azithromycin or oral doxycycline.100 341

Adults Anaerobic Bacterial Infections Serious Infections Oral

7.5 mg/kg every 6 hours (up to 4 g daily).152 156 197

IV, then Oral

An initial IV loading dose of 15 mg/kg followed by IV maintenance doses of 7.5 mg/kg every 6 hours.156 495 After clinical improvement occurs, switch to oral metronidazole (7.5 mg/kg every 6 hours).156 495

Total duration of treatment usually is 7–10 days, but infections of bone and joints, lower respiratory tract, or endocardium may require longer treatment.156 495

Gynecologic Infections Pelvic Inflammatory Disease Oral

500 mg twice daily given for 14 days; used in conjunction with a single IM dose of ceftriaxone (250 mg), cefoxitin (2 g with oral probenecid 1 g), or another parenteral cephalosporin (e.g., cefotaxime) and 14-day regimen of oral doxycycline (100 mg twice daily).341 496

Alternatively, 500 mg twice daily given for 14 days; used in conjunction with a 14-day regimen of oral ofloxacin (400 mg twice daily) or levofloxacin (500 mg once daily).199 341 496 Regimens containing a fluoroquinolone should only be considered when a parenteral cephalosporin is not feasible and the community prevalence and individual risk of gonorrhea is low.496

Amebiasis Entamoeba histolytic Infections Oral

750 mg 3 times daily given for 5–10 (usually 10) days for intestinal amebiasis152 153 197 364 368 370 or 500–750 mg 3 times daily given for 5–10 (usually 10) days for amebic liver abscess.152 197 364 368 370 Alternatively, amebic liver abscess has been treated with 2.4 g once daily given for 1 or 2 days.364

Follow-up with a luminal amebicide (e.g., iodoquinol, paromomycin) after metronidazole.153 364 368 370

IV

500 mg every 6 hours for 10 days.364

Bacterial Vaginosis Nonpregnant Women Oral

Conventional tablets: 500 mg twice daily given for 7 days.100 199 286 297 298 300 301 302 341 366 A single 2-g dose has been used (e.g., for patients who may be noncompliant with the multiple-dose regimen),120 122 199 292 297 but appears to be less effective than other regimens and is no longer recommended by CDC.341

Extended-release tablets: 750 mg once daily given for 7 days.199 341 416 417 430

Pregnant Women Oral

Conventional tablets: 500 mg twice daily or 250 mg 3 times daily given for 7 days.341 416 417

Contraindicated during first trimester of pregnancy.152 197 430 In addition, single-dose regimens not recommended in pregnant women because of the slightly higher serum concentrations attained, which may reach fetal circulation.152

Balantidiasis† Oral

750 mg 3 times daily given for 5 days.153

Blastocystis hominis Infections† Oral

750 mg 3 times daily given for 10 days may improve symptoms in some patients.100 153

Crohn’s Disease† Oral

400 mg twice daily101 103 105 or 1 g daily has been effective for treatment of active Crohn’s disease†.467 472 473 475 476 482 For treatment of refractory perineal disease, 20 mg/kg (1–1.5 g) given in 3–5 divided doses daily has been employed.102 103 104 105 478 486

Clostridium difficile-associated Diarrhea and Colitis† Oral

750 mg to 2 g daily in 3 or 4 divided doses given for 7–14 days.125 126 129 131 132 133 313 314

Dose-ranging studies to determine comparative efficacy have not been performed; most commonly employed regimens are 250 mg 4 times daily or 500 mg 3 times daily given for 10 days.443 444 445 446

IV

500–750 mg every 6–8 hours; use when oral therapy is not feasible.134 161 162 313 342 343 445

Dientamoeba fragilis Infections† Oral

500–750 mg 3 times daily given for 10 days.153

Dracunculiasis† Oral

250 mg 3 times daily given for 10 days.153 Is not curative, but may decrease inflammation and facilitate worm removal.153

Giardiasis† Oral

250 mg 3 times daily given for 5–7 days.153 367 452

Helicobacter pylori Infection and Duodenal Ulcer Disease Oral

250 mg in conjunction with tetracycline (500 mg) and bismuth subsalicylate (525 mg) 4 times daily (at meals and at bedtime) for 14 days; these drugs should be given concomitantly with an H2-receptor antagonist in recommended dosage.455

Nongonococcal Urethritis† Oral

Recurrent or persistent urethritis: A single 2-g dose given in conjunction with a single 1-g dose of oral azithromycin (if azithromycin not used in the initial regimen).341

Tetanus† IV

500 mg every 6 hours given for 7–10 days.489

Trichomoniasis Initial Treatment Oral

2 g as a single dose152 153 199 341 or in 2 divided doses.152 Alternatively, 500 mg twice daily given for 7 days153 199 341 or 375 mg twice daily given for 7 days.199 197 Manufacturer also recommends 250 mg 3 times daily given for 7 days.152

Retreatment Oral

500 mg twice daily given for 7 days.297 341 If repeated failure occurs, CDC recommends 2 g once daily given for 5 days.297 341 Others recommend retreatment with 2–4 g daily for 7–14 days if metronidazole-resistant strains are involved.153 199

Do not administer repeat courses of treatment unless presence of T. vaginalis is confirmed by wet smear and/or culture and an interval of 4–6 weeks has passed since the initial course.152 197

If treatment of resistant infection is guided by in vitro susceptibility testing under aerobic conditions, some clinicians recommend that T. vaginalis strains exhibiting low-level resistance (minimum lethal concentration [MLC] <100 mcg/mL) be treated with 2 g daily for 3–5 days, those with moderate (intermediate) resistance (MLC 100–200 mcg/mL) be treated with 2–2.5 g daily for 7–10 days, and those with high-level resistance (MLC >200 mcg/mL) be treated with 3–3.5 g daily for 14–21 days.124 302 338 340 Because strains with high-level resistance are difficult to treat,124 297 302 338 340 CDC recommends that patients with culture-documented infection who do not respond to repeat regimens at dosages up to 2 g daily for 3–5 days and in whom the possibility of reinfection has been excluded should be managed in consultation with an expert (available through CDC).297 341

Perioperative Prophylaxis Colorectal Surgery IV

0.5 g given at induction of anesthesia (within 0.5–1 hour prior to incision); used in conjunction with IV cefazolin (1–2 g).110

Manufacturer recommends 15 mg/kg by IV infusion over 30–60 minutes 1 hour prior to the procedure and, if necessary, 7.5 mg/kg by IV infusion over 30–60 minutes at 6 and 12 hours after the initial dose.156 495 The initial preoperative dose must be completely infused approximately 1 hour prior to surgery to ensure adequate serum and tissue concentrations of metronidazole at the time of incision.156 495 Prophylactic use of metronidazole should be limited to the day of surgery and should not be continued for more than 12 hours after surgery.156 495

Oral

2 g with oral neomycin sulfate (2 g) given at 7 p.m. and 11 p.m. on day before surgery; used in conjunction with appropriate diet and catharsis.110

Prophylaxis in Sexual Assault Victims† Oral

A single 2-g dose given in conjunction with IM ceftriaxone and either oral azithromycin or oral doxycycline.100 341

Special Populations Hepatic Impairment

Decrease dosage in patients with severe hepatic impairment and monitor plasma concentrations of the drug.152 156 160 197 430 495

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic function.152 197 430

Cautions for Metronidazole Hydrochloride Contraindications

Hypersensitivity to metronidazole or other nitroimidazole derivatives.152 156 197 430 495 Cautious desensitization has been used in some situations when use of metronidazole was considered necessary.341 436 (See Hypersensitivity Reactions and Desensitization under Cautions.)

First trimester of pregnancy.152 197 430

Helidac Therapy (kit containing tetracycline, metronidazole, bismuth subsalicylate) contraindicated in pregnant or nursing women, pediatric patients, patients with hepatic or renal impairment, patients with known allergy to aspirin or salicylates, and those with known hypersensitivity to any component of the kit.455

Warnings/Precautions Warnings Seizures and Peripheral Neuropathy

Seizures and peripheral neuropathy (characterized by numbness or paresthesia of an extremity) reported with metronidazole.152 156 197 430 495

Persistent peripheral neuropathy reported in some patients receiving prolonged therapy.430 If abnormal neurologic signs develop, promptly discontinue drug..152 156 197 430

Use with caution in those with CNS diseases.152 197 430

Sensitivity Reactions Hypersensitivity Reactions and Desensitization

Hypersensitivity reactions, including urticaria, pruritus, erythematous rash, flushing, nasal congestion, fever, and fleeting joint pains sometimes resembling serum sickness, have been reported with metronidazole.152 156 197 430 495

Because there are no effective alternatives to metronidazole in the US for treatment of trichomoniasis, CDC states that desensitization can be attempted in patients with metronidazole hypersensitivity.341 The possibility that desensitization may be hazardous should be considered435 and adequate procedures (e.g., established IV access, BP monitoring) and therapies (e.g., epinephrine, corticosteroids, antihistamines, oxygen) for management of an acute hypersensitivity reaction should be readily available.435 Pretreatment (e.g., with an antihistamine and/or corticosteroid) also should be considered.435

Desensitization has been performed by administering increasing doses of IV metronidazole incrementally until a therapeutic dose was achieved, at which time oral dosing was initiated.435 In this regimen, an initial 5-mcg dose of IV metronidazole was given and the dose increased at 15- to 20-minute intervals to 15, 50, 150, and 500 mcg and then to 1.5, 5, 15, 30, 60, and 125 mg.435 After the 125-mg IV dose, dosing was switched to oral metronidazole and doses of 250, 500, and 2 g were given at 1-hour intervals.435 For trichomoniasis, desensitization dosing can be stopped after the 2-g dose.435 Patient should be monitored for ?4 hours after the last dose (24 hours if there was any evidence of a reaction).435

General Precautions Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of metronidazole and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.152 197 430 495

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.152 197 430 495 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.152 197 430 495

Surgical procedures should be performed in conjunction with metronidazole therapy when indicated.152 156 197 430 495

In mixed aerobic and anaerobic infections, anti-infectives appropriate for treatment of aerobic bacteria should be used in conjunction with metronidazole.152 156 197 430 495

History of Blood Dyscrasia

Use with caution in patients with evidence or history of blood dyscrasias.152 156


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Isosorbide


In the US, Isosorbide (isosorbide mononitrate systemic) is a member of the drug class miscellaneous uncategorized agents.

US matches:

Isosorbide Isosorbide Dinitrate Isosorbide Dinitrate Extended-Release Isosorbide Dinitrate/Hydralazine Isosorbide Mononitrate Isosorbide Mononitrate Sustained-Release Tablets Isosorbide dinitrate Oral, Sublingual Isosorbide Mononitrate Extended Release Isosorbide Dinitrate/Hydralazine Hydrochloride

UK matches:

Isosorbide Dinitrate Tablets 10mg, 20mg Isosorbide Mononitrate Tablets 10mg, 20mg, 40mg (Actavis UK Ltd) Isosorbide Dinitrate Injection Concentrate BP 1mg/ml (SPC) Isosorbide Dinitrate Tablets BP 10mg (SPC) Isosorbide Dinitrate Tablets BP 20mg (SPC) Isosorbide mononitrate 20mg tablets (SPC) Isosorbide Mononitrate 40mg (SPC) Isosorbide Mononitrate Tablets 40mg (SPC) Ingredient matches for Isosorbide Isosorbide

Isosorbide (BAN, JAN, USAN) is known as Isosorbide in the US.

Isosorbide Mononitrate

Isosorbide Mononitrate is reported as an ingredient of Isosorbide in the following countries:

Bosnia & Herzegowina Cyprus

International Drug Name Search

Glossary

BAN British Approved Name JAN Japanese Accepted Name SPC Summary of Product Characteristics (UK) USAN United States Adopted Name
Click for further information on drug naming conventions and International Nonproprietary Names.


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Zithromax


Pronunciation: ay-ZITH-roe-MYE-sin
Generic Name: Azithromycin
Brand Name: Zithromax
Zithromax is used for:

Treating infections caused by certain bacteria. It may also be used for other conditions as determined by your doctor.

Zithromax is a macrolide antibiotic. It slows the growth of, or sometimes kills, sensitive bacteria by reducing the production of important proteins needed by the bacteria to survive.

Do NOT use Zithromax if: you are allergic to any ingredient in Zithromax, to other macrolide antibiotics (eg, erythromycin), or to ketolide antibiotics (eg, telithromycin) you have a history of liver problems or yellowing of the skin or eyes caused by any doseform (eg, tablets, suspension, injection) of Zithromax you are taking cisapride, dofetilide, dronedarone, nilotinib, pimozide, propafenone, or tetrabenazine

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

Before using Zithromax:

Some medical conditions may interact with Zithromax. 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 liver or kidney problems, myasthenia gravis, or abnormal heart rhythms

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

Antiarrhythmics (eg, disopyramide, dofetilide, dronedarone, propafenone), arsenic, astemizole, bepridil, chloroquine, cisapride, dolasetron, domperidone, droperidol, halofantrine, haloperidol, histone deacetylase inhibitors (eg, romidepsin), lithium, maprotiline, methadone, paliperidone, pentamidine, phenothiazines (eg, thioridazine), pimozide, quinolone antibiotics (eg, levofloxacin), terfenadine, tetrabenazine, toremifene, tricyclic antidepressants (eg, amitriptyline), vandetanib, or ziprasidone because the risk of heart problems, including irregular heartbeat, may be increased Nelfinavir because it may increase the risk of Zithromax's side effects Rifamycins (eg, rifampin) because the risk of their side effects may be increased by Zithromax or they may decrease Zithromax's effectiveness Anticoagulants (eg, warfarin), carbamazepine, cyclosporine, digoxin, ergot derivatives (eg, ergotamine), nilotinib, phenytoin, theophylline, triazolam, or tyrosine kinase receptor inhibitors (eg, dasatinib) because the risk of their side effects may be increased by Zithromax

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zithromax 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 Zithromax:

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

Zithromax is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Zithromax at home, a health care provider will teach you how to use it. Be sure you understand how to use Zithromax. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. Do not use Zithromax 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. To clear up your infection completely, use Zithromax for the full course of treatment. Keep using it even if you feel better in a few days. If you miss a dose of Zithromax, 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 Zithromax.

Important safety information: Zithromax may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Zithromax with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Zithromax may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Zithromax. 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 or watery stools occur. Do not treat diarrhea without first checking with your doctor. Tell your doctor or dentist that you take Zithromax before you receive any medical or dental care, emergency care, or surgery. Severe and sometimes fatal liver problems have been reported with the use of Zithromax. Contact your doctor immediately if you develop symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, vomiting, or loss of appetite; unusual itching). Discuss any questions or concerns with your doctor. Long-term or repeated use of Zithromax 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. Be sure to use Zithromax 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. Zithromax only works against bacteria; it does not treat viral infections (eg, the common cold). Zithromax should be used with extreme caution in CHILDREN younger than 16 years; 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 Zithromax while you are pregnant. It is not known if Zithromax is found in breast milk. If you are or will be breast-feeding while you use Zithromax, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Zithromax:

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 or loose stools; headache; mild stomach pain; nausea; upset stomach; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness; wheezing); bloody or watery stools; changes in hearing or hearing loss; chest pain; eye or vision problems; irregular heartbeat; muscle weakness; pain or inflammation at the injection site; pounding in the chest; red, swollen, blistered, or peeling skin; ringing in the ears; seizure; severe or persistent diarrhea; stomach cramps or pain; symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, vomiting, or loss of appetite; unusual itching); trouble speaking or swallowing; unusual vaginal itching, odor, or discharge.

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: Zithromax 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. Symptoms may include diarrhea; nausea; upset stomach; vomiting.

Proper storage of Zithromax:

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

General information: If you have any questions about Zithromax, please talk with your doctor, pharmacist, or other health care provider. Zithromax is to be used only by the patient for whom it is prescribed. Do not share it with other people. Do not use Zithromax for other health conditions. If your symptoms do not improve within a few days 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 Zithromax. 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 Zithromax resources Zithromax Side Effects (in more detail) Zithromax Use in Pregnancy & Breastfeeding Drug Images Zithromax Drug Interactions Zithromax Support Group 48 Reviews for Zithromax - Add your own review/rating Zithromax Consumer Overview Zithromax Advanced Consumer (Micromedex) - Includes Dosage Information Zithromax Prescribing Information (FDA) Azithromycin Monograph (AHFS DI) Azithromycin Professional Patient Advice (Wolters Kluwer) Zmax Prescribing Information (FDA) Compare Zithromax with other medications Babesiosis Bacterial Endocarditis Prevention Bacterial Infection Bartonellosis Bronchitis Cervicitis Chancroid COPD, Acute Cystic Fibrosis Gonococcal Infection, Uncomplicated Granuloma Inguinale Legionella Pneumonia Lyme Disease, Erythema Chronicum Migrans Mycobacterium avium-intracellulare, Prophylaxis Mycobacterium avium-intracellulare, Treatment Mycoplasma Pneumonia Nongonococcal Urethritis Otitis Media Pelvic Inflammatory Disease Pharyngitis Pneumonia Sinusitis Skin Infection Tonsillitis/Pharyngitis Toxoplasmosis Typhoid Fever Upper Respiratory Tract Infection


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ceftizoxime


Generic Name: ceftizoxime (sef ti ZOX eem)
Brand Names: Cefizox

What is ceftizoxime injection?

Ceftizoxime is in a group of drugs called cephalosporin (SEF a low spor in) antibiotics. It works by fighting bacteria in your body.

Ceftizoxime injection is used to treat many kinds of bacterial infections, including severe or life-threatening forms.

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

What is the most important information I should know about ceftizoxime injection? Do not use this medication if you are allergic to ceftizoxime, or to similar antibiotics, such as Ceclor, Ceftin, Cefzil, Duricef, Keflex, Omnicef, Spectracef, Suprax, and others.

Before using this medication, tell your doctor if you are allergic to any drugs (especially penicillin). Also tell your doctor if you have liver or kidney disease, a stomach or intestinal disorder, or if you are malnourished.

Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Ceftizoxime will not treat a viral infection such as the common cold or flu.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

This medication can cause you to have unusual results with certain lab tests to check for glucose (sugar) in the urine. Tell any doctor who treats you that you are using ceftizoxime.

What should I discuss with my health care provider before using ceftizoxime injection? Do not use this medication if you are allergic to ceftizoxime, or to other cephalosporin antibiotics, such as:

cefaclor (Ceclor);

cefadroxil (Duricef);

cefdinir (Omnicef);

cefditoren (Spectracef);

cefixime (Suprax);

cefprozil (Cefzil);

ceftazidime (Fortaz);

cefotaxime (Claforan);

cefuroxime (Ceftin);

cephalexin (Keflex); and others.

Before using this medication, tell your doctor if you are allergic to any drugs (especially penicillins), or if you have:

kidney disease;

liver disease;

a stomach or intestinal disorder such as colitis; or

if you are malnourished.

If you have any of these conditions, you may not be able to use ceftizoxime, or you may need a dosage adjustment or special tests during treatment.

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. Ceftizoxime can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use ceftizoxime injection?

Ceftizoxime is given as an injection into a muscle or a vein. Injection into a vein must be given slowly through an IV infusion, and can take up to 30 minutes to complete.

Your doctor, nurse, or other healthcare provider will give you this injection. You may be given instructions on how to use your injections at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles, syringes, and other items used in giving the medicine.

Use the medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Ceftizoxime will not treat a viral infection such as the common cold or flu.

To use the medicine, thaw it in a refrigerator or at room temperature. Do not warm in a microwave or boiling water. Keep thawed medicine in the refrigerator and use it within 28 days after thawing it. Do not refreeze thawed medicine.

What happens if I miss a dose?

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

If you are receiving this medication at a clinic, call your doctor if you miss an appointment for your injection.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a ceftizoxime overdose may include seizure (convulsions). What should I avoid while using ceftizoxime injection?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Ceftizoxime injection 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. Call your doctor at once if you have any of these serious side effects:

diarrhea that is watery or bloody;

severe pain, burning, irritation, or skin changes where the needle was placed;

skin rash, bruising, severe tingling, numbness, pain, muscle weakness;

uneven heartbeats;

fever, chills, body aches, flu symptoms;

easy bruising or bleeding, unusual weakness;

fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

seizure (black-out or convulsions); or

jaundice (yellowing of the eyes or skin).

Less serious side effects are more likely to occur, such as:

pain, irritation, or hardening where the injection was given;

stomach pain, nausea, vomiting;

numbness or tingling;

headache; or

vaginal itching or discharge.

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.

Ceftizoxime Dosing Information

Usual Adult Dose for Bacteremia:

1 to 4 g IV or IM every 8 to 12 hours for 14 days, depending on the nature and severity of the infection
Doses up to 12 g/day may be used for severe, life-threatening infections.

Usual Adult Dose for Cystitis:

500 mg IV or IM every 12 hours for 3 to 7 days

Usual Adult Dose for Epiglottitis:

1 to 4 g IV every 8 to 12 hours for 7 to 10 days, depending on the nature and severity of the infection
Doses up to 12 g/day may be used for severe, life-threatening infections.

Usual Adult Dose for Gonococcal Infection -- Disseminated:

1 g IV or IM every 8 hours
Parenteral therapy should continue for 24 hours after clinical improvement has been observed. Oral therapy with cefixime or cefpodoxime should then be continued to complete a total course of at least 1 week.
Doxycycline therapy for 7 days (if not pregnant) or single dose azithromycin is also recommended to treat possible concurrent chlamydial infection.
The patient's sexual partner(s) should also be evaluated/treated.

Usual Adult Dose for Gonococcal Infection -- Uncomplicated:

Uncomplicated infections of the cervix, urethra, or rectum: 500 mg IM once
Doxycycline therapy for 7 days (if not pregnant) or single dose azithromycin is also recommended to treat possible concurrent chlamydial infection.
The patient's sexual partner(s) should also be evaluated/treated.
This regimen is recommended as an alternative regimen by the Centers for Disease Control and Prevention.

Usual Adult Dose for Intraabdominal Infection:

1 to 4 g IV or IM every 8 to 12 hours for 7 to 14 days, depending on the nature and severity of the infection
Doses up to 12 g/day may be used for severe, life-threatening infections.

Usual Adult Dose for Joint Infection:

1 to 4 g IV or IM every 8 to 12 hours for 3 to 4 weeks, depending on the nature and severity of the infection
Longer therapy, up to 6 weeks, may be required in cases involving infected prosthetic joints. Doses up to 12 g/day may be used for severe, life-threatening infections.

Usual Adult Dose for Meningitis:

1 to 3 g IV every 6 to 12 hours for 10 to 14 days, depending on the nature and severity of the infection
Doses up to 12 g/day may be used for severe, life-threatening infections.

Usual Adult Dose for Osteomyelitis:

1 to 2 g IV or IM every 8 to 12 hours for 4 to 6 weeks, depending on the nature and severity of the infection
Doses up to 12 g/day may be used for severe, life-threatening infections.

Usual Adult Dose for Pelvic Inflammatory Disease:

2 g IV every 8 hours to continue until 24 hours after clinical improvement is observed
At that point, appropriate oral antimicrobial therapy may be initiated and continued for a total of 14 days of therapy.
Alternatively, 1 g ceftizoxime IM administered on an outpatient basis, followed by oral doxycycline therapy with or without metronidazole, may be substituted.
Doxycycline therapy for 14 days (if not pregnant) is also recommended to treat possible concurrent chlamydial infection. Azithromycin is active against chlamydia and may be considered for pregnant patients.
The patient's sexual partner(s) should also be evaluated/treated.

Usual Adult Dose for Peritonitis:

1 to 4 g IV or IM every 8 to 12 hours for 10 to 14 days, depending on the nature and severity of the infection
Doses up to 12 g/day may be used for severe, life-threatening infections.

Usual Adult Dose for Pneumonia:

1 to 4 g IV or IM every 8 to 12 hours for 7 to 21 days, depending on the nature and severity of the infection
Doses up to 12 g/day may be used for severe, life-threatening infections.

Usual Adult Dose for Pyelonephritis:

1 to 2 g IV or IM every 8 to 12 hours for 14 days

Usual Adult Dose for Skin or Soft Tissue Infection:

1 to 2 g IV or IM every 8 to 12 hours for 7 to 10 days, or until 3 days after acute inflammation subsides, depending on the nature and severity of the infection
For more serious infections, such as diabetic soft tissue infections, 14 to 21 days of therapy may be required.

Usual Adult Dose for Urinary Tract Infection:

1 to 2 g IV or IM every 8 to 12 hours

What other drugs will affect ceftizoxime injection?

Before using ceftizoxime, tell your doctor if you are using any of the following drugs:

an antibiotic such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), neomycin (Mycifradin, Neo-Fradin, Neo-Tab), netilmicin (Netromycin), streptomycin, or tobramycin (Nebcin, Tobi).

If you are using any of these drugs, you may not be able to use ceftizoxime, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect ceftizoxime. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More ceftizoxime resources Ceftizoxime Side Effects (in more detail) Ceftizoxime Use in Pregnancy & Breastfeeding Ceftizoxime Drug Interactions Ceftizoxime Support Group 0 Reviews for Ceftizoxime - Add your own review/rating Ceftizoxime MedFacts Consumer Leaflet (Wolters Kluwer) Compare ceftizoxime with other medications Bacteremia Bladder Infection Bone infection Epiglottitis Gonococcal Infection, Disseminated Gonococcal Infection, Uncomplicated Intraabdominal Infection Joint Infection Kidney Infections Meningitis Pelvic Inflammatory Disease Peritonitis Pneumonia Skin Infection Urinary Tract Infection Where can I get more information? Your doctor or pharmacist has information about ceftizoxime written for health professionals that you may read.

See also: ceftizoxime side effects (in more detail)


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Borderline Personality Disorder Medications


Definition of Borderline Personality Disorder: Borderline personality disorder (BPD) is a serious mental illness characterized by pervasive instability in moods, interpersonal relationships, self-image, and behavior.

Drugs associated with Borderline Personality Disorder

The following drugs and medications are in some way related to, or used in the treatment of Borderline Personality Disorder. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Borderline Personality Disorder

Medical Encyclopedia:

Borderline personality disorder

Harvard Health Guide:

Symptoms and treatment for Borderline Personality Disorder
Drug List: Abilify Abilify-Discmelt-Orally-Disintegrating-Tablets Clozaril Deplin Duleek-Dp Fazaclo Latuda Seroquel Seroquel-Xr-Sustained-Release-Tablets Zervalx Zyprexa Zyprexa-Zydis-Orally-Disintegrating-Tablets


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Seizure Prevention (Seizure Prophylaxis) Medications


Drugs associated with Seizure Prevention

The following drugs and medications are in some way related to, or used in the treatment of Seizure Prevention. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.


Drug List: Depacon Depakene Diamox Diamox-Sequels-Sustained-Release-Capsules Diastat-Gel Diastat-Acudial-Gel Diastat-Pediatric Diazepam-Intensol-Concentrate Epsom-Salt Klonopin Klonopin-Wafer-Orally-Disintegrating-Tablets Lamictal Lamictal-Cd Lamictal-Odt-Orally-Disintegrating-Tablets Lamictal-Xr-Extended-Release-Tablets Mesantoin Paradione Peganone Sabril Stavzor Sulfamag Topamax Topamax-Sprinkle Topiragen Tranxene Tranxene-Sd-Sustained-Release-Tablets Tranxene-T-Tab Tridione Valium Valrelease


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Cafergot Suppositories


Cafergot Suppositories 2 mg

ergotamine tartrate and caffeine

Read all of this leaflet carefully before you start using this medicine Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist. The information in this leaflet has been divided into the following sections: 1. What Cafergot Suppositories are and what they are used for 2. Check before you use Cafergot Suppositories 3. How to use Cafergot Suppositories 4. Possible side effects 5. How to store Cafergot Suppositories 6. Further information What Cafergot Suppositories are and what they are used for

Cafergot Suppositories belong to a group of medicines called antimigraine drugs.

Cafergot Suppositories are for insertion into the back passage (rectum).

Cafergot Suppositories are used to treat migraines which have not responded to simple painkillers. They are used at the first sign of a migraine attack to relieve the symptoms and to stop the attack getting worse.

Do not use Cafergot Suppositories to prevent migraine attacks.

Check before you use Cafergot Suppositories Do not use Cafergot Suppositories if you: are allergic (hypersensitive) to ergotamine tartrate, caffeine or any of the ingredients of Cafergot Suppositories (see section 6 Further information) have poor blood circulation to your arms and legs suffer from heart problems have high blood pressure which has not been controlled by treatment are suffering from a severe infection (septic shock) suffer from kidney problems suffer from liver disease suffer from a condition known as giant cell arteritis or temporal arteritis (the symptoms of which can include severe headache, a tender scalp and problems with your vision) suffer from a specific type of migraine called a basilar migraine (symptoms of which include giddiness, double vision, unsteadiness, fainting or loss of consciousness) or a hemiplegic migraine (symptoms of which include temporary paralysis down one side of the body, hearing impairment, numbness around the mouth leading to trouble speaking or swallowing) are pregnant or breast-feeding are taking a certain type of antibiotics (called macrolides) for example, erythromycin, clarithromycin, azithromycin are taking medicines to treat HIV or AIDS (called HIV-protease or reverse-transcriptase inhibitors) for example, amprenavir, indinavir are taking certain types of antifungals (called azole antifungals) for example, ketoconazole, miconazole are taking other anti-migraine drugs (including ergot alkaloids or drugs that end in ‘triptan’ such as sumatriptan, almotriptan, rizatriptan).

Do not give Cafergot Suppositories to children under 12 years old.

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you use Cafergot Suppositories.

Take special care with Cafergot Suppositories

Before you use Cafergot Suppositories tell your doctor if:

you have taken a triptan (such as almotriptan, rizatriptan, sumatriptan or zolmitriptan) in the last 6 hours you are a smoker.

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you use Cafergot Suppositories.

If you attend hospital, or are about to have an operation or medical procedure tell the medical staff that you use Cafergot Suppositories.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines as they may interfere with Cafergot Suppositories:

antibiotics
- used to treat bacterial infections such as macrolides (for example, erythromycin, azithromycin, clarithromycin, spiramycin, telithromycin), quinupristin, dalfopristin, tetracycline antifungals
- used to treat fungal infections such as, ketoconazole, miconazole, itraconazole, posaconazole, voriconazole antivirals
- used to treat HIV infection such as amprenavir, indinavir, nelfinavir, ritonavir, saquinavir, atazanavir, efavirenz 5HT1 agonists (triptans)
- used to treat migraines such as almotriptan, rizatriptan, sumatriptan, zolmitriptan, eletriptan, frovatriptan cimetidine
- used to treat stomach ulcers and heartburn treatments for low blood pressure for example ephedrine hydrochloride, metaraminol beta-blockers
- used to treat heart disease, angina and other heart disorders such as propranolol, oxprenolol, atenolol nicotine
- for example from smoking or nicotine replacement therapy (nicotine patches or gum) certain general anaesthetics
- for example halothane certain antidepressants
- for example reboxetine.

Please tell your doctor or pharmacist if you are taking or have recently taken/used any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Do not use Cafergot Suppositories if you are pregnant or breast-feeding.

Cafergot Suppositories can be passed into breast milk and may cause vomiting, diarrhoea, changes in blood pressure and a weak heartbeat in your baby. If you become pregnant whilst using Cafergot Suppositories tell your doctor immediately.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Cafergot Suppositories may make you dizzy or anxious. If you are affected do not drive or operate machinery until these effects have worn off.

How to use Cafergot Suppositories

Always use Cafergot Suppositories exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.

Adults and the Elderly

Cafergot Suppositories should be inserted into the back passage (rectum). The usual dosage is one suppository used at the first sign of a migraine attack. Your doctor may increase your dose to two suppositories in 24 hours, however it is important to use the lowest dose which is effective.

Keep a record of how many suppositories you use.

It is important that you:

do not use more than 2 Cafergot Suppositories in 24 hours do not use Cafergot Suppositories every day to prevent migraines do not use Cafergot Suppositories if you have already used a course of treatment within the last 4 days do not use more than 4 Cafergot Suppositories in a week

If you are not getting relief from your migraine do not use more suppositories, tell your doctor.

Children

Do not give Cafergot Suppositories to children under 12 years old.

What to do if you use more Cafergot Suppositories than you should

If you accidentally use too many Cafergot Suppositories or someone else uses any of your medicine, you should tell your doctor at once or contact your nearest accident and emergency department. Show any left-over medicines or the empty packet to the doctor.

Symptoms of an overdose include feeling or being sick, drowsiness, dizziness or confusion, having a slow or fast heartbeat, difficulty breathing, convulsions, tingling or numbness in your fingers or toes, your fingers turning blue, difficulty in passing urine or severe headache.

If you forget to use Cafergot Suppositories

Do not worry. If you forget to use a dose, use it as soon as possible, unless it is almost time to use the next dose. Do not use a double dose. Then go on as before.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Cafergot Suppositories Side Effects

Do not worry. Like all medicines, Cafergot Suppositories can cause side effects, although not everyone gets them.

If you experience severe numbness or tingling in your hands or feet, nausea, vomiting, pains in your chest or are passing less urine than normal, stop taking Cafergot Suppositories and contact a doctor or go to the nearest hospital straight away as you may need urgent medical attention.

Common side effects (that affect less than 1 person in 10): feeling or actually being sick stomach pain dizziness. Uncommon side effects (that affect less than 1 person in 100): poor circulation in your hands or feet which can make them feel cold or painful and look pale or blue pain or weakness in your arms, hands, legs or feet tingling or numbness in your hands or feet diarrhoea. Rare side effects (that affect less than 1 person in 1000): allergic reactions that may include itchy rash, swelling of the face, difficulty breathing, nettle rash slow or fast heartbeat high blood pressure muscle pain headache stroke (causing sudden weakness or numbness, dizziness or severe headache) changes in blood tests which show how the kidneys are working. Very rare side effects (that affect less than 1 person in 10 000): angina or heart attack (causing pain in the chest) gangrene (when the blood supply to extremities such as toes or fingers is cut off). The caffeine in Cafergot Suppositories may cause the following unwanted side effects: feeling of anxiety trembling sweating fast heartbeat. Cafergot Suppositories sometimes cause the following side effects in some people: rectal and anal ulcers.

If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Cafergot Suppositories

Keep out of the reach and sight of children.

Do not use Cafergot Suppositories after the expiry date which is stated on the carton (EXPIRY). The expiry date refers to the last day of that month.

Do not store above 25°C

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist on how to dispose of medicines no longer required. These measures will help protect the environment.

Further information What is in Cafergot Suppositories?

The active ingredients in this medicine are ergotamine tartrate and caffeine.

The other ingredients are: tartaric acid, lactose and suppocire AM.

What Cafergot Suppositories look like and contents of the pack

Cafergot Suppositories are off-white suppositories.

Cafergot Suppositories come in packs of 30.

Marketing Authorisation Holder and Manufacturer

The product licence holder is:

Alliance Pharmaceuticals Ltd Avonbridge House Chippenham Wiltshire SN15 2BB UK

Cafergot Suppositories are manufactured by:

Novartis Pharmaceuticals Ltd Wimblehurst Road Horsham West Sussex RH12 5AB UK

The information in this leaflet applies only to Cafergot Suppositories. If you have any questions or you are not sure about anything, ask your doctor or a pharmacist.

This leaflet was last approved: 30th March 2009

Alliance and associated devices are registered Trademarks of Alliance Pharmaceuticals Limited.

Cafergot Suppositories is a registered trademark of Novartis Pharmaceuticals Ltd and is used under licence by Alliance Pharmaceuticals Limited.

© Alliance Pharmaceuticals Ltd 2009.

UK 006


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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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