Myasthenia Gravis Medications


Definition of Myasthenia Gravis: Myasthenia gravis is a neuromuscular disorder characterized by variable weakness of voluntary muscles, which often improves with rest and worsens with activity. The condition is caused by an abnormal immune response.

Drugs associated with Myasthenia Gravis

The following drugs and medications are in some way related to, or used in the treatment of Myasthenia Gravis. 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 Myasthenia Gravis

Micromedex Care Notes:

Myasthenia Gravis

Medical Encyclopedia:

Myasthenia gravis

Harvard Health Guide:

Symptoms and treatment for Myasthenia Gravis
Drug List: Mestinon Mestinon-Timespan Mytelase Mytelase-Chloride Prostigmin Prostigmin-Bromide Regonol Soliris
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Mestinon Controlled-Release Tablets


Pronunciation: peer-id-oh-STIG-meen
Generic Name: Pyridostigmine
Brand Name: Mestinon
Mestinon Controlled-Release Tablets are used for:

Treating myasthenia gravis. It may also be used for other conditions as determined by your doctor.

Mestinon Controlled-Release Tablets are a cholinesterase inhibitor. It works by improving nerve impulses in muscles so that the muscles are better able to work.

Do NOT use Mestinon Controlled-Release Tablets if: you are allergic to any ingredient in Mestinon Controlled-Release Tablets you are taking quinine or quinidine you have a stomach, intestinal, or urinary blockage

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

Before using Mestinon Controlled-Release Tablets:

Some medical conditions may interact with Mestinon Controlled-Release Tablets. 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 heart problems (eg, heart block, slow heartbeat), a urinary tract infection, asthma, or kidney problems

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

Quinine or quinidine because effectiveness of Mestinon Controlled-Release Tablets may be decreased Succinylcholine because actions and side effects may be increased by Mestinon Controlled-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Mestinon Controlled-Release Tablets 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 Mestinon Controlled-Release Tablets:

Use Mestinon Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Mestinon Controlled-Release Tablets may be taken with or without food. Take with food if it upsets your stomach. Swallow Mestinon Controlled-Release Tablets whole. Do not break, crush, or chew before swallowing. If you miss a dose of Mestinon Controlled-Release Tablets, 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 Mestinon Controlled-Release Tablets.

Important safety information: Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Mestinon Controlled-Release Tablets. Use Mestinon Controlled-Release Tablets with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Mestinon Controlled-Release Tablets, discuss with your doctor the benefits and risks of using Mestinon Controlled-Release Tablets during pregnancy. Mestinon Controlled-Release Tablets are excreted in breast milk. If you are or will be breast-feeding while you are using Mestinon Controlled-Release Tablets, check with your doctor or pharmacist to discuss the risks to your baby. Possible side effects of Mestinon Controlled-Release Tablets:

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); diarrhea; fainting; increased production of saliva; increased sweating; muscle weakness; nausea; small pupils; stomach cramps; trouble breathing; vision changes; vomiting; weakness.

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: Mestinon 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; fainting; increased production of saliva; increased sweating; muscle weakness; nausea; small pupils; stomach cramps; trouble breathing; vision changes; vomiting; weakness.

Proper storage of Mestinon Controlled-Release Tablets:

Store Mestinon Controlled-Release Tablets between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Mestinon Controlled-Release Tablets out of the reach of children and away from pets.

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

This information is a summary only. It does not contain all information about Mestinon Controlled-Release Tablets. 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 Mestinon resources Mestinon Side Effects (in more detail) Mestinon Use in Pregnancy & Breastfeeding Drug Images Mestinon Drug Interactions Mestinon Support Group 6 Reviews for Mestinon - Add your own review/rating Compare Mestinon with other medications Dysautonomia Myasthenia Gravis Nerve Agent Pretreatment Reversal of Nondepolarizing Muscle Relaxants
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Mestinon Timespan


Generic Name: pyridostigmine (py rid o STIG meen)
Brand Names: Mestinon, Mestinon Timespan

What is Mestinon Timespan (pyridostigmine)?

Pyridostigmine affects chemicals in the body that are involved in the communication between nerve impulses and muscle movement.

Pyridostigmine is used to treat the symptoms of myasthenia gravis. It is also used in military personnel who have been exposed to nerve gas.

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

What is the most important information I should know about Mestinon Timespan (pyridostigmine)? You should not use pyridostigmine if you are allergic to it, or if you have a bladder or bowel obstruction.

Before taking pyridostigmine, tell your doctor if you have asthma, kidney disease, an ulcer or other serious stomach disorder, high blood pressure, heart disease, overactive thyroid, or a history of seizures.

The amount and timing of this medicine is extremely important to the success of your treatment. Carefully follow your doctor's instructions about how much medicine to take and when to take it.

This medication may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Your doctor may occasionally change your dose to make sure you get the best results. You may be asked to keep a daily record of when you took each dose and how long the effects lasted. This will help your doctor determine if your dose needs to be adjusted.

If you need surgery, tell the surgeon ahead of time that you are using pyridostigmine. You may need to stop using the medicine for a short time. What should I discuss with my health care provider before taking Mestinon Timespan (pyridostigmine)? You should not use pyridostigmine if you are allergic to it, or if you have a bladder or bowel obstruction.

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

asthma;

kidney disease;

an ulcer or other serious stomach disorder;

high blood pressure, heart disease;

overactive thyroid; or

a history of seizures.

It is not known whether pyridostigmine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether pyridostigmine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I take Mestinon Timespan (pyridostigmine)?

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

Take this medicine with food or milk if it upsets your stomach. Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Measure liquid medicine with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one.

The amount and timing of this medicine is extremely important to the success of your treatment. Carefully follow your doctor's instructions about how much medicine to take and when to take it.

Your doctor may occasionally change your dose to make sure you get the best results. You may be asked to keep a daily record of when you took each dose and how long the effects lasted. This will help your doctor determine if your dose needs to be adjusted.

If you need surgery, tell the surgeon ahead of time that you are using pyridostigmine. You may need to stop using the medicine for a short time. Store at room temperature away from moisture and heat.

Keep the tablets in their original container, along with the canister of moisture-absorbing preservative that comes with this medicine.

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, stomach cramps, sweating, blurred vision, drooling, and weak or shallow breathing.

Worsening muscle weakness, or no change in your myasthenia gravis symptoms, may also be signs of overdose.

What should I avoid while taking Mestinon Timespan (pyridostigmine)? This medication may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Drinking alcohol can increase certain side effects of pyridostigmine. Mestinon Timespan (pyridostigmine) 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 pyridostigmine and call your doctor at once if you have any of these serious side effects:

extreme muscle weakness, muscle twicthing;

slurred speech, vision problems;

severe vomiting or diarrhea;

cough with mucus;

confusion, anxiety, panic attacks;

seizure (convulsions); or

worsening or no improvement in your symptoms of myasthenia gravis.

Less serious side effects may include:

cold sweat, pale skin;

urinating more than usual;

watery eyes;

mild nausea, vomiting, or upset stomach;

warmth or tingly feeling; or

mild rash or itching.

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

What other drugs will affect Mestinon Timespan (pyridostigmine)?

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

atropine (Atreza, Sal-Tropine);

belladonna (Donnatal, and others);

benztropine (Cogentin);

clidinium (Quarzan);

clozapine (Clozaril, FazaClo);

dimenhydrinate (Dramamine);

methscopolamine (Pamine), scopolamine (Transderm Scop);

glycopyrrolate (Robinul);

mepenzolate (Cantil);

bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

cold medicine, allergy medicine, or sleeping pills that contain an antihistamine such as diphenhydramine (Tylenol PM) or doxylamine (Unisom);

heart rhythm medication such as quinidine (Quin-G), procainamide (Procan, Pronestyl), disopyramide (Norpace), flecaininde (Tambocor), mexiletine (Mexitil), propafenone, (Rythmol), and others;

irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine);

medicine to treat Alzheimer's dementia, such as donepezil (Aricept), rivastigmine (Exelon), or tacrine (Cognex); or

a steroid such as betamethasone (Celestone) or dexamethasone (Cortastat, Dexasone, Solurex, DexPak).

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

More Mestinon Timespan resources Mestinon Timespan Side Effects (in more detail) Mestinon Timespan Use in Pregnancy & Breastfeeding Drug Images Mestinon Timespan Drug Interactions Mestinon Timespan Support Group 1 Review for Mestinon Timespan - Add your own review/rating Pyridostigmine Prescribing Information (FDA) Mestinon MedFacts Consumer Leaflet (Wolters Kluwer) Mestinon Prescribing Information (FDA) Pyridostigmine Bromide Monograph (AHFS DI) Regonol Prescribing Information (FDA) Compare Mestinon Timespan with other medications Dysautonomia Myasthenia Gravis Nerve Agent Pretreatment Reversal of Nondepolarizing Muscle Relaxants Where can I get more information? Your pharmacist can provide more information about pyridostigmine.

See also: Mestinon Timespan side effects (in more detail)


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Progesterone Insert


Pronunciation: proe-JES-ter-one
Generic Name: Progesterone
Brand Name: Endometrin
Progesterone Insert is used for:

Supporting embryo implants and early pregnancy in certain women. It is also used as part of an assisted reproductive technology (ART) treatment program. It may also be used for other conditions as determined by your doctor.

Progesterone Insert is a hormone. It works by changing the lining of the uterus.

Do NOT use Progesterone Insert if: you are allergic to any ingredient in Progesterone Insert you have vaginal bleeding of an unknown cause, you have had a recent miscarriage, or the embryo is implanted outside the uterus (ectopic pregnancy) you know or suspect that you have breast cancer you have bleeding in the brain or severe blood vessel problems you have a history of bleeding or blood clotting problems (eg, blood clots in the legs, lungs, or eyes), heart attack, stroke, or liver disease you are using other vaginal products (eg, vaginal antifungal creams)

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

Before using Progesterone Insert:

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

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a history of heart or blood vessel problems, depression or other mental/mood problems, or cancer

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

Carbamazepine or rifampin because they may decrease Progesterone Insert's effectiveness Other vaginal products (eg, vaginal antifungal creams) because they may alter Progesterone Insert's actions

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

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

An extra patient leaflet is available with Progesterone Insert. Talk to your pharmacist if you have questions about this information. Wash your hands before and after using Progesterone Insert. Unwrap the applicator and place one insert in the space provided at the end of the applicator. You may use Progesterone Insert while standing, sitting, or when lying on your back with your knees bent. Gently place the thin end of the applicator well into the vagina. Push the plunger to release the insert, then remove the applicator and throw it away in the trash. If you miss a dose of Progesterone Insert, 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 Progesterone Insert.

Important safety information: Progesterone Insert may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Progesterone Insert with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do not use Progesterone Insert at the same time as other vaginal therapy without checking with your doctor. Progesterone Insert may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away. Progesterone Insert should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Progesterone Insert is used to support early pregnancy. Progesterone Insert is found in breast milk. If you are or will be breast-feeding while you use Progesterone Insert, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Progesterone Insert:

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:

Bloating; breast tenderness; constipation; cramping; drowsiness; fluid retention; headache; nausea; stomach pain; tiredness; vaginal burning or irritation; vomiting.

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

Severe allergic reactions (eg, rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; calf or leg pain, swelling, or tenderness; change in emotions, mood, or behavior; chest pain; coughing up blood; fainting; one-sided weakness; pain in the groin; partial or complete loss of vision; stomach pain, swelling, or tenderness; sudden, severe headache, vomiting, dizziness, or fainting; sudden shortness of breath; swelling of hands, ankles, or feet; unusual vaginal itching, discharge, or odor; visual or speech disturbances; weakness or numbness in an arm or leg; yellowing of the skin or eyes.

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

See also: Progesterone side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Progesterone Insert:

Store Progesterone Insert at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat and light. Do not remove from the sealed foiled pouch until just before use. Keep Progesterone Insert out of the reach of children and away from pets.

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

This information is a summary only. It does not contain all information about Progesterone Insert. 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 Progesterone resources Progesterone Side Effects (in more detail) Progesterone Use in Pregnancy & Breastfeeding Progesterone Drug Interactions Progesterone Support Group 15 Reviews for Progesterone - Add your own review/rating Compare Progesterone with other medications Amenorrhea Endometrial Hyperplasia, Prophylaxis Perimenopausal Symptoms Premature Labor Progesterone Insufficiency Seizures Uterine Bleeding
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H. pylori eradication agents


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Agents used in treatment of Helicobacter Pylori are medicines used for stomach acid inhibition, combined with antibacterial agents. Treatment is for one week with a proton pump inhibitor or an antacid (or antisecretory agents), and two appropriate antibacterial agents. This one week triple therapy does give a good eradication rate.

See also

Medical conditions associated with H. pylori eradication agents:

Helicobacter Pylori Infection Drug List: Prevpac-Therapy-Pack Pylera Helidac-Therapy-Pack
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Monistat 1 Combo Pack Cream


Pronunciation: mi-KON-a-zole
Generic Name: Miconazole
Brand Name: Monistat 1 Combo Pack
Monistat 1 Combo Pack Cream is used for:

Treating vaginal yeast infections and relieving external vulvar itching and irritation associated with yeast infection.

Monistat 1 Combo Pack Cream is an antifungal agent. It works by weakening the cell membrane of the fungus, resulting in the death of the fungus.

Do NOT use Monistat 1 Combo Pack Cream if: you are allergic to any ingredient in Monistat 1 Combo Pack Cream you have never had a vaginal yeast infection diagnosed by a doctor

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

Before using Monistat 1 Combo Pack Cream:

Some medical conditions may interact with Monistat 1 Combo Pack Cream. 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 the blood disease porphyria or a history of liver disease, or you have been exposed to HIV if you have stomach, shoulder, or lower back pain; fever; chills; nausea; foul-smelling vaginal discharge; or vomiting if this is the first time you have had vaginal itching and discomfort if you have vaginal yeast infections often (eg, once a month or 3 in 6 months) if you are taking antibiotics

Some MEDICINES MAY INTERACT with Monistat 1 Combo Pack Cream. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants (eg, warfarin) because the risk of side effects such as bruising or bleeding may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Monistat 1 Combo Pack Cream 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 Monistat 1 Combo Pack Cream:

Use Monistat 1 Combo Pack Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Monistat 1 Combo Pack Cream comes with an additional patient leaflet. Read it carefully and reread it each time you get Monistat 1 Combo Pack Cream refilled. Monistat 1 Combo Pack Cream is for vaginal use only. Do not use in the eyes or take by mouth. Suppositories - Using the applicator provided, insert the suppository high into the vagina at bedtime. External cream - Squeeze a small amount of cream onto your finger and gently spread the cream onto the itchy, irritated skin outside the vagina as directed by your doctor or on the packaging. Wash your hands immediately after using Monistat 1 Combo Pack Cream. To clear up your infection completely, continue using Monistat 1 Combo Pack Cream for the full course of treatment. If you miss a dose of Monistat 1 Combo Pack Cream, 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 Monistat 1 Combo Pack Cream.

Important safety information: Monistat 1 Combo Pack Cream is for vaginal use only. Avoid contact with the eyes, nose, or mouth. If you get Monistat 1 Combo Pack Cream in your eyes, flush with a generous amount of cool water. It is important to use Monistat 1 Combo Pack Cream for the full course of treatment. Failure to do so may decrease the effectiveness of Monistat 1 Combo Pack Cream and increase the risk that the fungus will no longer be sensitive to Monistat 1 Combo Pack Cream and will not be able to be treated by this or certain other antibiotics in the future. If your symptoms do not improve within 3 days, if they last more than 7 days, or if they become worse, stop using Monistat 1 Combo Pack Cream and contact your health care provider at once. You may have a more serious illness. Do not use Monistat 1 Combo Pack Cream for itching caused by other conditions. Dry the outside vaginal area completely after showering, bathing, or swimming. Do not go swimming for at least 9 to 12 hours after applying Monistat 1 Combo Pack Cream. Change out of wet bathing suits or damp workout clothes as soon as possible. Continue using Monistat 1 Combo Pack Cream even during your menstrual period. Do not use tampons while you are using Monistat 1 Combo Pack Cream or until all of your symptoms go away. Use unscented pads or pantiliners. Do not have vaginal sexual intercourse while you are using Monistat 1 Combo Pack Cream. Monistat 1 Combo Pack Cream may decrease the effectiveness of condoms and diaphragms, increasing the chance of pregnancy or risk of sexually transmitted disease. Do not use these products for at least 1 day after treatment with Monistat 1 Combo Pack Cream. Do not use tampons, douches, spermicides, or other vaginal products while using Monistat 1 Combo Pack Cream. Overuse of topical products may worsen your condition. Do not use Monistat 1 Combo Pack Cream in CHILDREN younger than 12 years of age unless advised to do so by your health care provider. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Monistat 1 Combo Pack Cream, discuss with your doctor the benefits and risks of using Monistat 1 Combo Pack Cream during pregnancy. It is unknown if Monistat 1 Combo Pack Cream is excreted in breast milk. If you are or will be breast-feeding while you are using Monistat 1 Combo Pack Cream, check with your doctor or pharmacist. Possible side effects of Monistat 1 Combo Pack Cream:

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:

Headache; mild vaginal burning, irritation, or itching; stomach cramps.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever or chills; foul-smelling vaginal discharge; nausea; severe or prolonged vaginal burning, irritation, or itching; stomach pain; swelling; vomiting.

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

See also: Monistat Combo Pack side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Monistat 1 Combo Pack Cream:

Store Monistat 1 Combo Pack Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Do not use if the wrapper on the applicator or suppository is torn or damaged. Keep Monistat 1 Combo Pack Cream out of the reach of children and away from pets.

General information: If you have any questions about Monistat 1 Combo Pack Cream, please talk with your doctor, pharmacist, or other health care provider. Monistat 1 Combo Pack Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Monistat 1 Combo Pack Cream. 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 Monistat 1 Combo Pack resources Monistat 1 Combo Pack Side Effects (in more detail) Monistat 1 Combo Pack Use in Pregnancy & Breastfeeding Monistat 1 Combo Pack Drug Interactions 0 Reviews for Monistat Combo Pack - Add your own review/rating Compare Monistat 1 Combo Pack with other medications Vaginal Yeast Infection
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Radian B Muscle Lotion


1. Name Of The Medicinal Product

Radian B Liniment/Radian B Muscle Lotion/Radian B Sport Muscle Lotion/ Radian B Winter Sport Muscle Lotion/ Cura Heat Pain Relief Lotion

2. Qualitative And Quantitative Composition

Menthol

1.4

%w/v

Camphor

0.6

%w/v

Aspirin

1.2

%w/v

Equivalent to ammonium salicylate

1.0

%w/v

Methyl Salicylate

0.6

%w/v

Equivalent to salicylic acid

(as Methyl and Ethyl Esters)

0.54

%w/v

3. Pharmaceutical Form

Liniment for topical application to human beings.

4. Clinical Particulars 4.1 Therapeutic Indications

For symptomatic relief of muscular aches and pains, including fibrositis, sciatica, lumbago, sprained ligaments, bruises, muscle stiffness, strains, tennis elbow, golf shoulder.

4.2 Posology And Method Of Administration

Posology: For external application.

For Adults and Children Over 12 Years:

Apply the lotion on the affected part once or twice, leaving 10-15 minutes between applications. Smooth in or massage if preferred. If necessary, repeat application up to three times daily, reducing to morning and evening when acute symptoms subside.

When convenient, use after a warm bath.

Children Under 12: Not recommended for children under 12.

Elderly: The adult dose is appropriate.

4.3 Contraindications

Not to be used on children under 12 years old. Do not apply to skin abrasions. Do not apply to irritated skin. Not to be used by persons who are sensitive to any of the ingredients. If irritation develops, use of the product should be discontinued. Pregnancy and lactation.

4.4 Special Warnings And Precautions For Use

Keep away from eyes and other sensitive areas. If symptoms persist, consult a doctor. Flammable: Do not use near naked flame. Should not be placed on or used near polished or painted surfaces.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There have been reports that topical salicylates may potentiate the anticoagulant effects of warfarin.

4.6 Pregnancy And Lactation

Use of the product during pregnancy and lactation is not recommended.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

If used on tender skin do not cover immediately after application. If an adverse reaction occurs, discontinue use immediately. Known side effects of menthol - contact dermatitis or eczema, hypersensitivity reactions characterised by urticaria, flushing and headache.

4.9 Overdose

When used externally as directed, overdose is unlikely.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Radian B is manufactured using the following active ingredients; Menthol, camphor, aspirin and methyl salicylate. The finished product contains menthol, camphor, ammonium salicylate and a mixture of methyl and ethyl esters of salicylic acid. The product provides salicylate ions which have analgesic properties. Methyl and ethyl salicylate are readily absorbed through the skin and have counter-irritant properties. Menthol relieves itching, dilates the vessels causing a sensation of coldness followed by an analgesic effect. Camphor acts as a rubefacient and mild analgesic and is employed as a counter-irritant.

5.2 Pharmacokinetic Properties

The active ingredients are well-documented pharmacopoeial ingredients. The extent of percutaneous absorption in human volunteers of (14C) acetyl salicylic acid from Radian B was studied and estimated by measurement of blood and urinary concentrations of radioactivity. Significant absorption through the skin was indicated by the excretion of almost 10% of the applied radioactivity in the urine within 5 days with approximately 5.5% in the first 24 hours.

5.3 Preclinical Safety Data

None

6. Pharmaceutical Particulars 6.1 List Of Excipients

Industrial Methylated Spirit 95

Glycerol

Citronella oil

Ammonia '880'

Water (purified)

6.2 Incompatibilities

None known

6.3 Shelf Life

60 months

6.4 Special Precautions For Storage

Store below 25°C

6.5 Nature And Contents Of Container

Ribbed oval glass bottle with polypropylene insert and plastic cap. Polythene bottle and plastic cap. Pack sizes 50 and 100ml.

White HDPE bottle with red urea cap and wad. Pack sizes: 30, 125 and 250ml oval bottles and 500 and 2000ml round bottles.

Boston round silver HDPE bottle and silver polypropylene cap without wad. Pack size 500ml.

Silver HDPE bottle with silver coloured, black urea cap and wad and LDPE insert. Pack sizes: 125 and 250ml oval bottle.

Silver HDPE bottle with LDPE plug insert and warm red coloured, spigot seal polypropylene cap. Pack sizes: 125, 250ml and 500ml oval bottle.

White polypropylene bottle with an angled neck containing an applicator, consisting of polypropylene plug, ring and spring, encasing a red polyurethane foam, with a red polypropylene cap. Pack size 80ml.

6.6 Special Precautions For Disposal And Other Handling

No special precautions necessary

7. Marketing Authorisation Holder

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0359

9. Date Of First Authorisation/Renewal Of The Authorisation

30 April 2002

10. Date Of Revision Of The Text

04/03/2008


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Mycelex-7 Combo Pack Cream


Pronunciation: kloe-TRIM-a-zole
Generic Name: Clotrimazole
Brand Name: Mycelex-7 Combo Pack
Mycelex-7 Combo Pack Cream is used for:

Treating vaginal yeast infections and relieving external vulvar itching and irritation associated with yeast infection.

Mycelex-7 Combo Pack Cream is an antifungal agent. It works by weakening the cell membrane of the fungus, resulting in the death of the fungus.

Do NOT use Mycelex-7 Combo Pack Cream if: you are allergic to any ingredient in Mycelex-7 Combo Pack Cream you have never had a vaginal yeast infection diagnosed by a doctor you have itching caused by a condition other than a yeast infection you have stomach, shoulder, or lower back pain; fever; chills; nausea; foul-smelling vaginal discharge; or vomiting

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

Before using Mycelex-7 Combo Pack Cream:

Some medical conditions may interact with Mycelex-7 Combo Pack Cream. 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 the blood disease porphyria or a history of liver disease or diabetes, or you have been exposed to HIV if this is the first time you have had vaginal itching and discomfort if you have vaginal yeast infections often (eg, your symptoms return within 2 months) or your symptoms do not clear up with treatment if you are taking antibiotics

Some MEDICINES MAY INTERACT with Mycelex-7 Combo Pack Cream. However, no specific interactions with Mycelex-7 Combo Pack Cream are known at this time.

Ask your health care provider if Mycelex-7 Combo Pack Cream 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 Mycelex-7 Combo Pack Cream:

Use Mycelex-7 Combo Pack Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Mycelex-7 Combo Pack Cream. Talk to your pharmacist if you have questions about this information. Mycelex-7 Combo Pack Cream is for vaginal use only. Do not use it rectally or take by mouth. Suppositories - Using the applicator provided, insert 1 suppository high into the vagina at bedtime for 7 days. Mycelex-7 Combo Pack Cream comes with one applicator to be used for all 7 days of treatment. Do not throw away applicator after use. Separate the pieces of the applicator and wash with warm, soapy water immediately after use. Rinse thoroughly. Make sure the applicator is completely dry before the next use. External cream - Squeeze a small amount of cream onto your finger and gently spread the cream onto the itchy, irritated skin outside the vagina as directed by your doctor or on the packaging. Wash your hands immediately after using Mycelex-7 Combo Pack Cream. To clear up your infection completely, use Mycelex-7 Combo Pack Cream for the full course of treatment. Keep using it even if you feel better in a few days. If you miss a dose of Mycelex-7 Combo Pack Cream, 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 Mycelex-7 Combo Pack Cream.

Important safety information: Mycelex-7 Combo Pack Cream is for vaginal use only. Avoid contact with the eyes, nose, or mouth. If you get Mycelex-7 Combo Pack Cream in your eyes, flush with a generous amount of cool water. Be sure to use Mycelex-7 Combo Pack Cream 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. If your symptoms do not improve within 3 days, if they last more than 7 days, or if they get worse, check with your doctor. Do not use Mycelex-7 Combo Pack Cream for itching caused by other conditions. Dry the outside vaginal area completely after showering, bathing, or swimming. Do not go swimming for at least 9 to 12 hours after applying Mycelex-7 Combo Pack Cream. Change out of wet bathing suits or damp workout clothes as soon as possible. Continue using Mycelex-7 Combo Pack Cream even during your menstrual period. Do not use tampons while you are using Mycelex-7 Combo Pack Cream or until all of your symptoms go away. Use unscented pads or pantiliners. Do not have vaginal sexual intercourse while you are using Mycelex-7 Combo Pack Cream. Mycelex-7 Combo Pack Cream may decrease the effectiveness of condoms and diaphragms, increasing the chance of pregnancy or risk of sexually transmitted disease. Do not use tampons, douches, spermicides, or other vaginal products while using Mycelex-7 Combo Pack Cream. If you use topical products too often, your condition may become worse. Mycelex-7 Combo Pack Cream should not be used in CHILDREN younger than 12 years old; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Mycelex-7 Combo Pack Cream while you are pregnant. It is not known if Mycelex-7 Combo Pack Cream is found in breast milk. If you are or will be breast-feeding while you use Mycelex-7 Combo Pack Cream, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Mycelex-7 Combo Pack Cream:

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:

Headache; mild vaginal burning, irritation, or itching; stomach cramps.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever or chills; foul-smelling vaginal discharge; nausea; severe or prolonged vaginal burning, irritation, or itching; stomach pain; swelling; vomiting.

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

See also: Mycelex-7 Combo Pack side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Mycelex-7 Combo Pack Cream:

Store Mycelex-7 Combo Pack Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Avoid temperatures above 86 degrees F (30 degrees C). Avoid freezing. Store away from heat, moisture, and light. Do not store in the bathroom. Do not use if the wrapper on the applicator or suppository is torn or damaged. Keep Mycelex-7 Combo Pack Cream out of the reach of children and away from pets.

General information: If you have any questions about Mycelex-7 Combo Pack Cream, please talk with your doctor, pharmacist, or other health care provider. Mycelex-7 Combo Pack Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Mycelex-7 Combo Pack Cream. 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 Mycelex-7 Combo Pack resources Mycelex-7 Combo Pack Side Effects (in more detail) Mycelex-7 Combo Pack Use in Pregnancy & Breastfeeding Mycelex-7 Combo Pack Support Group 0 Reviews for Mycelex-7 Combo Pack - Add your own review/rating Compare Mycelex-7 Combo Pack with other medications Cutaneous Candidiasis Tinea Corporis Tinea Cruris Tinea Pedis Tinea Versicolor Vaginal Yeast Infection
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Boots Clotrimazole 500mg Vaginal Tablet


Boots Clotrimazole 500 mg Vaginal Tablet

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat thrush. However, you still need to use it carefully to get the best results from it.

Keep this leaflet, you may need to read it again Ask your pharmacist if you need more information or advice You must contact a pharmacist or doctor if your symptoms worsen or do not go away after 3 days What this medicine is for

This medicine contains Clotrimazole which belongs to a group of medicines called antifungals, which act to treat infections caused by fungi. It can be used to treat thrush (vaginal candidiasis). Thrush is a common infection caused by a yeast (or fungus), which may live harmlessly in the vagina without you even noticing it. However, in certain circumstances, it may develop into an infection in the vagina and symptoms may spread to the surrounding area. These symptoms may include one or more of the following:

Itching of the vagina and surrounding area (the vulva) Redness and swelling of the tissues of the vagina and vulva Soreness of the vagina and vulva A white non-smelling discharge from the vagina

Thrush may be aggravated by sexual intercourse, but it is not a sexually transmitted disease. Sometimes however, thrush can be passed to your partner through sexual intercourse.

If your partner has penile thrush he may have one or more of the following symptoms:

Soreness and redness of the penis Tightness of the foreskin An abnormal penile discharge Before you use this medicine

This medicine can be used by women between the ages of 16 and 60 years. However, some people should not use this medicine or should seek the advice of their pharmacist or doctor first.

Do not use: If you are allergic to any of the ingredients If you are pregnant, unless your doctor tells you to – if your doctor tells you to use the pessary do not use the applicator to insert it Talk to your pharmacist or doctor: If this is the first time you have had these symptoms If you are under 16 years, or 61 years or older If you have had thrush more than twice in the last 6 months If you or your partner have been exposed to a sexually transmitted disease If you have lower stomach pain, or pain or a burning sensation on passing urine If you have abnormal or irregular vaginal bleeding, or a blood-stained discharge If you have sores, ulcers or blisters on your vulva or vagina Other important information

The ingredients in the pessary may affect the latex used in contraceptives such as condoms and diaphragms. This may reduce the effectiveness of the contraceptives. You should therefore use other methods of contraception for at least 5 days after using the pessary.

You can help the treatment to work if you follow these simple self-help tips:

Although the infected area will itch, do not scratch as this will damage the surface of the skin and cause the infection to spread further Keep the affected areas of skin clean Pay particular attention to drying the skin but avoid excessive rubbing

To help prevent thrush from coming back once you have treated it, follow these simple steps:

Wash daily Wear cotton underwear and loose fitting clothing Try to avoid wearing tights, nylon underwear and tight fitting clothing After going to the toilet, wipe yourself from the front to the back, as a thrush infection may be transferred from the bowel Try to avoid washing with perfumed soaps or using vaginal deodorants Do not rub hard with sponges or flannels and avoid hot baths with strong perfumed oils Change your sanitary protection regularly If you take other medicines

Before you use this medicine, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time. If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

How to use this medicine

The carton contains a single pessary held inside a foil blister pack and an applicator for insertion of the pessary into the vagina. Check the foil is not broken before use. If it is, do not use the pessary.

Women aged 16 to 60 years: Insert the pessary into the vagina at night using the applicator provided.

If you are pregnant do not use the applicator. Wash and dry your hands, and insert the pessary with your fingers.

Directions for inserting the pessary Remove the applicator from the packaging Pull out the plunger until it stops Remove the pessary from the blister pack and place the pessary firmly into the applicator To fit the pessary into the applicator, squeeze the applicator lightly on either side. The pessary fits tightly into the applicator and needs to be pushed into the holder about 1 cm Carefully put the applicator as deep as is comfortable into the vagina (this is easiest when laying on your back with your knees bent up) Holding the applicator in place, slowly press the plunger until it stops so that the pessary is deposited into the vagina. Remove the applicator Dispose of the applicator in a safe place, out of the reach of children The applicator cannot be flushed down the toilet Wash your hands thoroughly after use

For use in the vagina only.

Do not use the pessary at the same time as you are having a period. Wait until your period has finished.

Do not use for children under 16 years, or if you are an adult of 61 years or older, unless your doctor tells you to.

Do not use more than one pessary.

After you use the pessary the symptoms of thrush (itching, burning, discharge) should go away within 3 days.

If symptoms worsen or do not go away after 3 days talk to your doctor.

If anyone accidentally swallows the pessary: Talk to a doctor straight away or go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some.

If you get these side effects see a doctor:

Allergic reaction (e.g. skin rash, red or itchy skin)

These other effects are less serious.

If they bother you talk to a pharmacist:

Mild burning or irritation straight after inserting the pessary

The side effects of this medicine can be very similar to the symptoms that you are treating.

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 25°C.

Protect from moisture.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

This vaginal tablet contains Clotrimazole 500 mg, which is the active ingredient.

As well as the active ingredient, the vaginal tablet also contains lactose, adipic acid, pregelatinised maize starch, sodium hydrogen carbonate, microcrystalline cellulose, magnesium stearate, maize starch, stearic acid, colloidal silicon dioxide, polysorbate 80.

The pack contains 1 vaginal tablet with an applicator.

Who makes this medicine

Manufactured for

The Boots Company PLC Nottingham NG2 3AA

Marketing Authorisation Holder and Manufacturer:

Tillomed Laboratories Ltd 3 Howard Road Eaton Socon St Neots Cambridgeshire PE19 3ET

Leaflet prepared February 2008

If you would like any further information about this medicine, please contact

The Boots Company PLC Nottingham NG2 3AA

3379eMC


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Monistat 7 Combination Pack


miconazole nitrate
Dosage Form: cream
Monistat 7 Combination Pack Triple Action

Drug Facts

Active ingredients Purpose Miconazole nitrate 2% (100 mg in each applicatorful) Vaginal antifungal Miconazole nitrate 2% (external cream) Vaginal antifungal Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection Warnings

For vaginal use only

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have

vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS

Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

When using this product

do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur if you do not get complete relief ask a doctor before using another product

Stop use and ask a doctor if

symptoms do not get better in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions before using this product, read the enclosed consumer information leaflet for complete directions and information adults and children 12 years of age and over: applicators: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw away applicator after use. external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina (vulva). Use 2 times daily for up to 7 days, as needed. children under 12 years of age: ask a doctor Other information

do not use if seal over tube opening has been punctured or embossed design

do not purchase if carton is open store at 20°-25°C (68°-77°F) Inactive ingredients benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol Questions?

If you have any questions or comments, please call 1-877-666-4782

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC-30014-003-07

MONISTAT®7
COMBINATION PACK
Miconazole Nitrate Cream (2%) and Miconazole Nitrate Cream (2%)

(Miconazole Nitrate 100 mg per applicator)

ORTHO
CLINICALLY PROVEN
Multi-Symptom Relief

VAGINAL ANTIFUNGAL

CURES MOST VAGINAL YEAST INFECTIONS AND
RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION

7-Day Vaginal Cream with Disposable Applicators
PLUS External Cream

Net Wt. 1.59 oz. (45g)
+ 0.32 oz. (9g) Tube


Monistat 7 Combination Pack  TRIPLE ACTION
miconazole nitrate  kit Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 30014-003 Packaging # NDC Package Description Multilevel Packaging 1 30014-003-07 1 KIT In 1 PACKAGE, COMBINATION None QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 TUBE, WITH APPLICATOR   0.1 g Part 2 1 TUBE   0.009 g Part 1 of 2 MICONAZOLE NITRATE 
miconazole nitrate  cream Product Information       Route of Administration VAGINAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Miconazole Nitrate (Miconazole) Miconazole Nitrate 20 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0.1 g In 1 TUBE, WITH APPLICATOR None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017450 04/10/2010
Part 2 of 2 MICONASOLE NITRATE 
miconazole nitrate  cream Product Information       Route of Administration VAGINAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Miconazole Nitrate (Miconazole) Miconazole Nitrate 20 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0.009 g In 1 TUBE None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017450 04/10/2010
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017450 04/10/2010
Labeler - McNeil, PPC, Inc. (801375143) Revised: 04/2010McNeil, PPC, Inc.
More Monistat 7 Combination Pack resources Monistat 7 Combination Pack Side Effects (in more detail) Monistat 7 Combination Pack Use in Pregnancy & Breastfeeding Monistat 7 Combination Pack Drug Interactions Monistat 7 Combination Pack Support Group 0 Reviews for Monistat 7 Combination Pack - Add your own review/rating Compare Monistat 7 Combination Pack with other medications Vaginal Yeast Infection
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Sentry HC Worm X



Dosage Form: FOR ANIMAL USE ONLY
Broad Spectrum De-Wormer Chewable Tablets for Large Dogs INDICATIONS & USAGE

For Removal of Hookworms in Puppies and Dogs

Ancylostoma caninum Uncinaria stenocephala For Removal of Large Roundworms (Ascarids) in Puppies and Dogs
Toxocara canis Toxascaris leonina To Prevent Reinfection of Large Roundworms in Puppies, Adult Dogs and Lactating Bitches After Whelping
Toxocara canis ACTIVE INGREDIENT (in each chewable) Pyrantel Pamoate (113.5 mg) How is Sentry HC Worm X Supplied Net Contents:    2 Tablet Count
Net Contents:    4 Tablet Count
Net Contents:  12 Tablet Count STORAGE Store at controlled room temperature of 59-86 degrees F (15-30 degrees C). PACKAGE LABEL PRINCIPAL DISPLAY PANEL Sentry HC Worm X
Distributed by:
Sergeant's Pet Care Products, Inc., Omaha NE 68130
www.sentrypetcare.com
ANADA #200-281, Approved by FDA
Sentry HC Worm X 
pyrantel pamoate  tablet, chewable Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 21091-402 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRANTEL PAMOATE (PYRANTEL) PYRANTEL PAMOATE 113.5 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color brown Score no score Shape ROUND Size 10mm Flavor LIVER (Pork Liver Powder) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 21091-402-02 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 2 TABLET In 1 BLISTER PACK This package is contained within the CARTON (21091-402-02) 2 21091-402-04 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 4 TABLET In 1 BLISTER PACK This package is contained within the CARTON (21091-402-04) 3 21091-402-12 6 BLISTER PACK In 1 CARTON contains a BLISTER PACK 3 12 TABLET In 1 BLISTER PACK This package is contained within the CARTON (21091-402-12)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200281 01/16/2008
Labeler - Sergeant's Pet Care Products, Inc. (876995171) Establishment Name Address ID/FEI Operations Virbac Bridgeton 808558100 manufacture Revised: 11/2010Sergeant's Pet Care Products, Inc.

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Monistat 3


miconazole nitrate
Dosage Form: vaginal cream, vaginal suppositories
MONISTAT® 3
COMBINATION PACK

Miconazole Nitrate Vaginal Suppositories (200 mg) and Miconazole Nitrate Vaginal Cream
(2%)
Vaginal Antifungal

DRUG FACTS

Active ingredients Purpose Miconazole nitrate (200 mg in each suppository) Vaginal antifungal Miconazole nitrate 2% (external cream) Vaginal antifungal Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection Warnings

For vaginal use only

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have

vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS

Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

When using this product

do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur if you do not get complete relief ask a doctor before using another product.

Stop use and ask a doctor if

symptoms do not get better in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions before using this product read the enclosed consumer information leaflet for complete directions and information adults and children 12 years of age and over: suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Throw away applicator after use. external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed. children under 12 years of age: ask a doctor Other information do not use if printed suppository blister is torn, open or incompletely sealed

do not use if seal over tube opening has been punctured or embossed design

do not purchase if carton is open store at 20°-25°C (68°-77°F) Inactive ingredients

suppository: hydrogenated vegetable oil base

external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol

Questions? If you have any questions or comments, please call 1-877-666-4782
Visit our website @ www.monistat.com

PRINCIPAL DISPLAY PANEL

30014-018-03

MONISTAT® 3
COMBINATION PACK

Miconazole Nitrate Vaginal uppositories (200mg) and Miconazole Nitrate Vaginal Cream (2%)
Vaginal Antifungal

(Miconazole Nitrate 200 mg per suppository plus 2% external vulvar cream)

CURES MOST VAGINAL YEAST INFECTIONS

AND RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION

ORTHO

3 Vaginal Suppositories with Reusable
Applicator plus External Cream

Net Wt. 3 Suppositories
0.32 oz (9g) tube


Monistat 3 COMBINATION PACK 
miconazole nitrate  kit Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 30014-018 Packaging # NDC Package Description Multilevel Packaging 1 30014-018-03 1 KIT In 1 PACKAGE, COMBINATION None QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK   3  Part 2 1 TUBE   9 g Part 1 of 2 Monistat 3 
miconazole nitrate  suppository Product Information       Route of Administration VAGINAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Miconazole Nitrate (Miconazole) Miconazole Nitrate 200 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 3 SUPPOSITORY In 1 BLISTER PACK None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020670 12/10/2009
Part 2 of 2 Monistat 3 
miconazole nitrate  cream Product Information       Route of Administration VAGINAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Miconazole Nitrate (Miconazole) Miconazole Nitrate 10 mg  in 0.5 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 9 g In 1 TUBE None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020670 12/10/2009
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020670 12/10/2009
Labeler - McNeil-PPC, Inc. (801375143) Establishment Name Address ID/FEI Operations Draxis Specialty Pharmaceuticals Inc., Canada 243604761 Analysis, Manufacture Revised: 12/2009McNeil-PPC, Inc.
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Lacrisert


hydroxypropyl cellulose
Dosage Form: ophthalmic insert

STERILE OPHTHALMIC INSERT

Lacrisert Description

Lacrisert1 (hydroxypropyl cellulose ophthalmic insert) is a sterile, translucent, rod-shaped, water soluble, ophthalmic insert made of hydroxypropyl cellulose, for administration into the inferior cul-de-sac of the eye.

The chemical name for hydroxypropyl cellulose is cellulose, 2-hydroxypropyl ether. It is an ether of cellulose in which hydroxypropyl groups (-CH2CHOHCH3) are attached to the hydroxyls present in the anhydroglucose rings of cellulose by ether linkages. A representative structure of the monomer is:

The molecular weight is typically 1 ? 106.

Hydroxypropyl cellulose is an off-white, odorless, tasteless powder. It is soluble in water below 38°C, and in many polar organic solvents such as ethanol, propylene glycol, dioxane, methanol, isopropyl alcohol (95%), dimethyl sulfoxide, and dimethyl formamide.

Each Lacrisert is 5 mg of hydroxypropyl cellulose. Lacrisert contains no preservatives or other ingredients. It is about 1.27 mm in diameter by about 3.5 mm long.

Lacrisert is supplied in packages of 60 units, together with illustrated instructions and a special applicator for removing Lacrisert from the unit dose blister and inserting it into the eye. A spare applicator is included in each package.

1 Registered trademark of ATON PHARMA, INC.
COPYRIGHT © ATON PHARMA, INC., 2007
All rights reserved Lacrisert - Clinical Pharmacology Pharmacodynamics

Lacrisert acts to stabilize and thicken the precorneal tear film and prolong the tear film breakup time which is usually accelerated in patients with dry eye states. Lacrisert also acts to lubricate and protect the eye.

Lacrisert usually reduces the signs and symptoms resulting from moderate to severe dry eye syndromes, such as conjunctival hyperemia, corneal and conjunctival staining with rose bengal, exudation, itching, burning, foreign body sensation, smarting, photophobia, dryness and blurred or cloudy vision. Progressive visual deterioration which occurs in some patients may be retarded, halted, or sometimes reversed.

In a multicenter crossover study the 5 mg Lacrisert administered once a day during the waking hours was compared to artificial tears used four or more times daily. There was a prolongation of tear film breakup time and a decrease in foreign body sensation associated with dry eye syndrome in patients during treatment with inserts as compared to artificial tears; these findings were statistically significantly different between the treatment groups. Improvement, as measured by amelioration of symptoms, by slit lamp examination and by rose bengal staining of the cornea and conjunctiva, was greater in most patients with moderate to severe symptoms during treatment with Lacrisert. Patient comfort was usually better with Lacrisert than with artificial tears solution, and most patients preferred Lacrisert.

In most patients treated with Lacrisert for over one year, improvement was observed as evidenced by amelioration of symptoms generally associated with keratoconjunctivitis sicca such as burning, tearing, foreign body sensation, itching, photophobia and blurred or cloudy vision.

During studies in healthy volunteers, a thickened precorneal tear film was usually observed through the slit-lamp while Lacrisert was present in the conjunctival sac.

Pharmacokinetics and Metabolism

Hydroxypropyl cellulose is a physiologically inert substance. In a study of rats fed hydroxypropyl cellulose or unmodified cellulose at levels up to 5% of their diet, it was found that the two were biologically equivalent in that neither was metabolized.

Studies conducted in rats fed 14C-labeled hydroxypropyl cellulose demonstrated that when orally administered, hydroxypropyl cellulose is not absorbed from the gastrointestinal tract and is quantitatively excreted in the feces.

Dissolution studies in rabbits showed that hydroxypropyl cellulose inserts became softer within 1 hour after they were placed in the conjunctival sac. Most of the inserts dissolved completely in 14 to 18 hours; with a single exception, all had disappeared by 24 hours after insertion. Similar dissolution of the inserts was observed during prolonged administration (up to 54 weeks).

Indications and Usage for Lacrisert

Lacrisert is indicated in patients with moderate to severe dry eye syndromes, including keratoconjunctivitis sicca. Lacrisert is indicated especially in patients who remain symptomatic after an adequate trial of therapy with artificial tear solutions.

Lacrisert is also indicated for patients with:
Exposure keratitis
Decreased corneal sensitivity
Recurrent corneal erosions

Contraindications

Lacrisert is contraindicated in patients who are hypersensitive to hydroxypropyl cellulose.

Warnings

Instructions for inserting and removing Lacrisert should be carefully followed.

Precautions General

If improperly placed, Lacrisert may result in corneal abrasion (see DOSAGE AND ADMINISTRATION). Information for Patients

Patients should be advised to follow the instructions for using Lacrisert which accompany the package.

Because this product may produce transient blurring of vision, patients should be instructed to exercise caution when operating hazardous machinery or driving a motor vehicle.

Drug Interactions

Application of hydroxypropyl cellulose ophthalmic inserts to the eyes of unanesthetized rabbits immediately prior to or two hours before instilling pilocarpine, proparacaine HCl (0.5%), or phenylephrine (5%) did not markedly alter the magnitude and/or duration of the miotic, local corneal anesthetic, or mydriatic activity, respectively, of these agents. Under various treatment schedules, the anti-inflammatory effect of ocularly instilled dexamethasone (0.1%) in unanesthetized rabbits with primary uveitis was not affected by the presence of hydroxypropyl cellulose inserts.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Feeding of hydroxypropyl cellulose to rats at levels up to 5% of their diet produced no gross or histopathologic changes or other deleterious effects.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Adverse Reactions

The following adverse reactions have been reported in patients treated with Lacrisert, but were in most instances mild and transient:
Transient blurring of vision (See PRECAUTIONS)
Ocular discomfort or irritation
Matting or stickiness of eyelashes
Photophobia
Hypersensitivity
Edema of the eyelids
Hyperemia

Lacrisert Dosage and Administration

One Lacrisert ophthalmic insert in each eye once daily is usually sufficient to relieve the symptoms associated with moderate to severe dry eye syndromes. Individual patients may require more flexibility in the use of Lacrisert; some patients may require twice daily use for optimal results.

Clinical experience with Lacrisert indicates that in some patients several weeks may be required before satisfactory improvement of symptoms is achieved.

Lacrisert is inserted into the inferior cul-de-sac of the eye beneath the base of the tarsus, not in apposition to the cornea, nor beneath the eyelid at the level of the tarsal plate. If not properly positioned, it will be expelled into the interpalpebral fissure, and may cause symptoms of a foreign body. Illustrated instructions are included in each package. While in the licensed practitioner's office, the patient should read the instructions, then practice insertion and removal of Lacrisert until proficiency is achieved.

NOTE: Occasionally Lacrisert is inadvertently expelled from the eye, especially in patients with shallow conjunctival fornices. The patient should be cautioned against rubbing the eye(s) containing Lacrisert, especially upon awakening, so as not to dislodge or expel the insert. If required, another Lacrisert ophthalmic insert may be inserted. If experience indicates that transient blurred vision develops in an individual patient, the patient may want to remove Lacrisert a few hours after insertion to avoid this. Another Lacrisert ophthalmic insert maybe inserted if needed.

If Lacrisert causes worsening of symptoms, the patient should be instructed to inspect the conjunctival sac to make certain Lacrisert is in the proper location, deep in the inferior cul-de-sac of the eye beneath the base of the tarsus. If these symptoms persist, Lacrisert should be removed and the patient should contact the practitioner.

How is Lacrisert Supplied

Lacrisert, a sterile, translucent, rod-shaped, water-soluble, ophthalmic insert made of hydroxypropyl cellulose, 5 mg, is supplied as follows:

NDC 25010-805-68 in packages containing 60 unit doses (each wrapped in an aluminum blister), two reusable applicators, and a plastic storage container to store the applicators after use.

Storage

Store below 30°C (86°F).

Distributed by:
ATON PHARMA, INC.
Lawrenceville, NJ 08648, USA

Manufactured by:
Merck and Co., Inc.
West Point, PA 19486 USA

Issued June 2007

Printed in USA

INSTRUCTIONS FOR USING Lacrisert® (HYDROXYPROPYL CELLULOSE OPHTHALMIC INSERT)

Note: Your licensed practitioner or a trained associate can demonstrate the proper use of Lacrisert2. Please read and follow these instructionscarefully for your subsequent use.

Clinical experience with Lacrisert indicates that in some patients several weeks may be required before satisfactory improvement of symptoms is achieved.

Two applicators (one spare) are supplied with each package.

Before opening the package of Lacrisert, wash your hands thoroughly with soap and water.

STEP 1: On a flat surface, open blister pocket slowly and smoothly by peeling back label area. Each blister pocket contains one Lacrisert ophthalmic insert.

STEP 2: Open applicator package with label side up. Avoid touching grooved tip of the applicator. Pick up applicator by the wide end and rinse the tip thoroughly under hot running tap water. Gently shake off excess water.

STEP 3: Hold applicator with tip facing down and with forefinger on top to guide and apply gentle pressure. Lightly press the grooved tip of the applicator onto the Lacrisert ophthalmic insert and it will adhere to the applicator.

It is important to follow STEPS 4 and 5 carefully or you might experience difficulty in keeping Lacrisert (hydroxypropyl cellulose ophthalmic insert) in your eye.

STEP 4: Look into a mirror. Starting with the right eye, turn your head to the right so that the colored part of the eye is close to your nose. Use your free hand to grasp the lower lid between the thumb and index finger. Pull the lid away from the eyeball and create a pocket between the white part of the eyeball and the lid.

STEP 5: Place the tip of the applicator containing Lacrisert into the pocket. Avoid touching the colored part of the eye.

Remove the applicator. It is important, after removing the applicator, to look down, then release the lower eyelid. Lacrisert (hydroxypropyl cellulose ophthalmic insert) should remain deep in the lower pocket recess of the eye and not near the edge of the lower eyelid.

Repeat procedure with left eye, turning head to the left so that the colored part of the eye is close to your nose.

Rinse the applicator thoroughly under hot running tap water after use. Gently shake off visible water droplets and promptly return it to the storage container. Note that the storage container provides space for a strip of two Lacrisert ophthalmic inserts next to the applicator storage compartment.

IMPORTANT

If Lacrisert causes worsening of symptoms, or if new symptoms develop, it should be removed and your prescriber contacted.

Should the removal of the Lacrisert ophthalmic insert be necessary, follow these instructions.

Locate Lacrisert by pulling the lid away from the eyeball while looking for Lacrisert in a mirror. Then close the eyelids. When located, move Lacrisert upward with your fingers through the closed eyelids. Keep the lids against the eyeball and Lacrisert should slip over the lid margin so that you can remove it with a clean facial tissue without touching the colored part of the eye.

CAUTION: Because this product may produce transient blurring of vision, you should exercise caution when operating hazardous machinery or driving a motor vehicle.

Store below 30°C (86°F).

Issued May 2007

ATON PHARMA, INC.
LAWRENCEVILLE, NJ 08648, USA

2 Registered trademark of ATON PHARMA, INC.
Lacrisert 
hydroxypropyl cellulose  pellet Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 25010-805 Route of Administration OPHTHALMIC DEA Schedule      INGREDIENTS Name (Active Moiety) Type Strength hydroxypropyl cellulose (hydroxypropyl cellulose) Active 5 MILLIGRAM  In 1 PELLET Product Characteristics Color white (translucent) Score no score Shape OVAL (rod-shaped) Size 4mm Flavor Imprint Code Contains          Coating false Symbol false Packaging # NDC Package Description Multilevel Packaging 1 25010-805-68 12 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 5 PELLET In 1 BLISTER PACK This package is contained within the CARTON (25010-805-68)
Revised: 03/2008Aton Pharma, Inc. More Lacrisert resources Lacrisert Side Effects (in more detail) Lacrisert Use in Pregnancy & Breastfeeding Lacrisert Support Group 0 Reviews for Lacrisert - Add your own review/rating Lacrisert Concise Consumer Information (Cerner Multum) Lacrisert Advanced Consumer (Micromedex) - Includes Dosage Information Lacrisert Insert MedFacts Consumer Leaflet (Wolters Kluwer) FreshKote Drops MedFacts Consumer Leaflet (Wolters Kluwer) Genteal Advanced Consumer (Micromedex) - Includes Dosage Information Lacri-Lube S.O.P. Ointment MedFacts Consumer Leaflet (Wolters Kluwer) Murine Tears Drops MedFacts Consumer Leaflet (Wolters Kluwer) Murocel Eye Drops MedFacts Consumer Leaflet (Wolters Kluwer) Refresh Redness Relief Drops MedFacts Consumer Leaflet (Wolters Kluwer) Refresh liquigel Compare Lacrisert with other medications Eye Dryness/Redness
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antimyasthenic Oral, Parenteral


Class Name: antimyasthenic (Oral route, Parenteral route)

Commonly used brand name(s)

In the U.S.

Aricept Cognex Exelon Mestinon Mestinon Timespan Mytelase Chloride Prostigmin Bromide Razadyne Razadyne ER Razadyne IR

In Canada

Reminyl

Available Dosage Forms:

Tablet Syrup Tablet, Extended Release Capsule, Extended Release Solution Tablet, Disintegrating Capsule Uses For This Medicine

Antimyasthenics are given by mouth or by injection to treat myasthenia gravis. Neostigmine may also be given by injection as a test for myasthenia gravis. Sometimes neostigmine is given by injection to prevent or treat certain urinary tract or intestinal disorders. In addition, neostigmine or pyridostigmine may be given by injection as an antidote to certain types of muscle relaxants used in surgery.

These medicines are available only with your doctor's prescription.

Before Using This Medicine Allergies

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

Pediatric

Although there is no specific information comparing use of antimyasthenics in children with use in other age groups, these medicines are not expected to cause different side effects or problems in children than they do in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is not much information comparing use of antimyasthenics in the elderly with use in other age groups, these medicines are not expected to cause different side effects or problems in older people than they do in younger adults.

Pregnancy

Antimyasthenics have not been reported to cause birth defects; however, muscle weakness has occurred temporarily in some newborn babies whose mothers took antimyasthenics during pregnancy.

Breast Feeding

Antimyasthenics have not been reported to cause problems in nursing babies.

Interactions with Medicines

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

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

Atropine Metoclopramide

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

Succinylcholine Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

Intestinal blockage or Urinary tract blockage or Urinary tract infection—These medicines may make the condition worse. Proper Use of This Medicine

Your doctor may want you to take this medicine with food or milk to help lessen the chance of side effects. If you have any questions about how you should be taking this medicine, check with your doctor.

Take this medicine only as directed. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

If you are taking this medicine for myasthenia gravis:

When you first begin taking this medicine, your doctor may want you to keep a daily record of: the time you take each dose. how long you feel better after taking each dose. how long you feel worse. any side effects that occur.

This is to help your doctor decide whether the dose of this medicine should be increased or decreased and how often the medicine should be taken in order for it to be most effective in your condition.

Dosing

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

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

For ambenonium For oral dosage form (tablets): For myasthenia gravis: Adults and teenagers—At first, the dose is 5 milligrams (mg) three or four times per day. Then, if needed, the dose will be adjusted by your doctor. Children—The dose is based on body weight or size and must be determined by your doctor. The total daily dose is usually 300 micrograms (mcg) per kilogram (kg) (136 mcg per pound) of body weight or 10 mg per square meter of body surface area. This dose may be divided into three or four smaller doses. If needed, the total daily dose will be increased to 1.5 mg per kg (0.68 mg per pound) of body weight or 50 mg per square meter of body surface area. This dose may be divided into three or four smaller doses. For neostigmine For oral dosage form (tablets): For myasthenia gravis: Adults and teenagers—At first, the dose is 15 milligrams (mg) every three or four hours. Then, the dose is 150 mg taken over a twenty-four-hour period. Children—The dose is based on body weight or size and must be determined by your doctor. The total daily dose is usually 2 mg per kilogram (kg) (0.91 mg per pound) of body weight or 60 mg per square meter of body surface area. This dose may be divided into six to eight smaller doses. For injection dosage form: For myasthenia gravis: Adults and teenagers—The usual dose is 500 micrograms (mcg) injected into a muscle or under the skin. Children—The dose is based on body weight and must be determined by your doctor. It is usually 10 to 40 mcg per kg (4.5 to 18.2 mcg per pound) of body weight, injected into a muscle or under the skin, every two or three hours. For urinary tract or intestinal disorders: Adults and teenagers—The usual dose is 250 to 500 mcg, injected into a muscle or under the skin, as needed. Children—Use and dose must be determined by your doctor. For pyridostigmine For oral dosage forms (syrup and tablets): For myasthenia gravis: Adults and teenagers—At first, the dose is 30 to 60 milligrams (mg) every three or four hours. Then, the dose is 60 mg to 1.5 grams (usually 600 mg) per day. Children—The dose is based on body weight or size and must be determined by your doctor. The total daily dose is usually 7 mg per kilogram (kg) (3.2 mg per pound) of body weight or 200 mg per square meter of body surface area. This dose may be divided into five or six smaller doses. For long-acting oral dosage form (extended-release tablets): For myasthenia gravis: Adults and teenagers—The usual dose is 180 to 540 mg one or two times per day. Children—Dose must be determined by your doctor. For injection dosage form: For myasthenia gravis: Adults and teenagers—The usual dose is 2 mg, injected into a muscle or vein, every two or three hours. Children—The dose is based on body weight and must be determined by your doctor. It is usually 50 to 150 micrograms (mcg) per kg (22.7 to 68.1 mcg per pound) of body weight, injected into a muscle every four to six hours. Missed Dose

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

Storage

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Keep the syrup form of pyridostigmine from freezing.

Side Effects of This Medicine

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

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

Symptoms of overdose Blurred vision clumsiness or unsteadiness confusion convulsions (seizures) diarrhea (severe) increase in bronchial secretions or watering of mouth (excessive) increasing muscle weakness (especially in the arms, neck, shoulders, and tongue) muscle cramps or twitching nausea or vomiting (severe) shortness of breath, troubled breathing, wheezing, or tightness in chest slow heartbeat slurred speech stomach cramps or pain (severe) unusual irritability, nervousness, restlessness, or fear unusual tiredness or weakness

Check with your doctor as soon as possible if any of the following side effects occur:

Rare Redness, swelling, or pain at place of injection (for pyridostigmine injection only) skin rash (does not apply to ambenonium)

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

More common Diarrhea increased sweating increased watering of mouth nausea or vomiting stomach cramps or pain Less common Frequent urge to urinate increase in bronchial secretions unusually small pupils unusual watering of eyes

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

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

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

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


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Twinject Auto-Injector Two Pack


Generic Name: epinephrine injection (EP i NEF rin)
Brand Names: Adrenaclick, Adrenaclick Two-Pack, Adrenalin, EpiPen 2-Pak, EpiPen Auto-Injector, EpiPen JR 2-Pak, EpiPen JR Auto-Injector, Twinject Auto-Injector, Twinject Auto-Injector Two Pack

What is Twinject Auto-Injector Two Pack (epinephrine injection)?

Epinephrine is a chemical that narrows blood vessels and opens airways in the lungs. These effects can reverse severe low blood pressure, wheezing, severe skin itching, hives, and other symptoms of an allergic reaction.

Epinephrine injection is used to treat severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, and other allergens. Epinephrine is also used to treat exercise-induced anaphylaxis.

Epinephrine auto-injectors such as EpiPen and EpiPen Jr. may be kept on hand for self-injection by a person with a history of an severe allergic reaction.

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

What is the most important information I should know about Twinject Auto-Injector Two Pack (epinephrine injection)? Before using this medication, tell your doctor if you have heart disease or high blood pressure, a heart rhythm disorder, coronary artery disease, Parkinson's disease, diabetes, or a thyroid disorder.

Before using epinephrine, tell your doctor about all other medications you use, especially digoxin (digitalis, Lanoxin), heart or blood pressure medicine, heart rhythm medication, an antidepressant, a diuretic (water pill), thyroid medication, migraine headache medicine, cold or sleep medicine that contains an antihistamine, or an MAO inhibitor such as Marplan, Nardil, Azilect, Eldepryl, Emsam, or Parnate.

Seek emergency medical attention even after you use epinephrine to treat a severe allergic reaction. The effects of epinephrine may wear off after 10 or 20 minutes. You will need to receive further treatment and observation. Before using epinephrine a second time, tell your doctor if your first injection caused a serious side effect such as increased breathing difficulty, or dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure). What should I discuss with my healthcare provider before using Twinject Auto-Injector Two Pack (epinephrine injection)?

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

heart disease or high blood pressure;

a heart rhythm disorder;

coronary artery disease;

Parkinson's disease;

diabetes; or

a thyroid disorder.

FDA pregnancy category C. It is not known whether epinephrine will harm an unborn baby. If possible before using this medicine, tell your doctor if you are pregnant. Do not use epinephrine without your doctor's advice if you are breast-feeding a baby. In an emergency situation, it may not be possible before you use epinephrine to tell your caregivers if you are pregnant or breast-feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication. How should I use Twinject Auto-Injector Two Pack (epinephrine injection)?

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.

Seek emergency medical attention even after you use this medication to treat a severe allergic reaction. The effects of epinephrine may wear off after 10 or 20 minutes. You will need to receive further treatment and observation.

The auto-injector device this medicine comes in is a disposable single-use system that contains a spring-loaded needle. Epinephrine injection comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Do not remove the safety cap until you are ready to use the auto-injector. Never put your fingers over the tip when removing the safety cap or after the safety cap has been removed.

To use an epinephrine auto-injector:

Form a fist around the auto-injector with the black tip pointing down. Pull off the safety cap.

Place the black tip against the fleshy portion of your outer thigh. You may give the injection directly through your clothing. Do not put your thumb over the end of the unit.

With a quick motion, push the auto-injector firmly against your thigh. This will release the spring-loaded needle that injects the dose of epinephrine. Hold the auto-injector in place for a few seconds after activation.

Remove the auto-injector from your thigh. Carefully re-insert the used device needle-first into the carrying tube. Re-cap the tube and take it with you to the emergency room so that anyone who treats you will know how much epinephrine you have received.

Use each auto-injector only one time. Throw away after one use, even if there is still some medicine left in it.

Do not use the medication if it has changed colors or has any particles in it, or if the expiration date on the label has passed. Call your doctor for a new prescription. Store at room temperature away from moisture, heat, and light. Do not refrigerate this medication, and do not store it in a car. What happens if I miss a dose?

Since epinephrine is normally used only as needed in an emergency, you are not likely to be on a dosing schedule. Do not use repeat doses of epinephrine without a doctor's advice.

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

Overdose symptoms may include fast or pounding heartbeats, sudden and severe headache, sudden numbness or weakness, feeling like you might pass out, wheezing, trouble breathing, chest pain, or sudden problems with vision, speech, or balance.

What should I avoid while using Twinject Auto-Injector Two Pack (epinephrine injection)? Do not inject epinephrine into a vein or into the muscles of your buttocks, or it may not work as well. Inject it only into the fleshy outer portion of the thigh. Accidentally injecting epinephrine into your hands or feet may result in a loss of blood flow to those areas, and resulting numbness. If this occurs, seek emergency medical attention. Twinject Auto-Injector Two Pack (epinephrine injection) side effects Before using epinephrine a second time, call your doctor if your first injection caused a serious side effect such as increased breathing difficulty, or dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

sweating;

nausea and vomiting;

pale skin;

feeling short of breath;

dizziness;

weakness or tremors;

headache; or

feeling nervous or anxious.

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

What other drugs will affect Twinject Auto-Injector Two Pack (epinephrine injection)?

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

digoxin (digitalis, Lanoxin, Lanoxicaps);

a diuretic (water pill);

levothyroxine (Levothroid, Levoxyl, Synthroid, Unithroid);

chlorpheniramine or diphenhydramine (antihistamines that a commonly contained in cold, allergy, or over-the-counter sleep medications);

an antidepressant such as amitriptyline (Elavil, Etrafon), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others;

a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;

ergot medicine such as ergotamine (Ergomar), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), or methylergonovine (Methergine);

heart rhythm medication such as quinidine (Quin-G); or

an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate).

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

More Twinject Auto-Injector Two Pack resources Twinject Auto-Injector Two Pack Side Effects (in more detail) Twinject Auto-Injector Two Pack Use in Pregnancy & Breastfeeding Twinject Auto-Injector Two Pack Drug Interactions 0 Reviews for Twinject Two Pack - Add your own review/rating Adrenaclick Auto-Injector MedFacts Consumer Leaflet (Wolters Kluwer) Adrenaclick Prescribing Information (FDA) Adrenaclick Advanced Consumer (Micromedex) - Includes Dosage Information Asthmahaler Aerosol MedFacts Consumer Leaflet (Wolters Kluwer) Epinephrine Professional Patient Advice (Wolters Kluwer) Epinephrine Monograph (AHFS DI) Epinephrine (Mydriatic) eent Monograph (AHFS DI) Medihaler-Epi Prescribing Information (FDA) Twinject Auto-Injector Prescribing Information (FDA) Compare Twinject Auto-Injector Two Pack with other medications Adams-Stokes Syndrome Allergic Reactions Asthma, acute Asystole AV Heart Block COPD, Acute Electromechanical Dissociation Shock Where can I get more information? Your doctor or pharmacist can provide more information about epinephrine injection.

See also: Twinject Two Pack side effects (in more detail)


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Adrenogenital Syndrome Medications


Definition of Adrenogenital Syndrome: Congenital adrenal hyperplasia refers to a group of inherited disorders relating to the adrenal glands, characterized by a deficiency in the hormones cortisol and aldosterone and an overproduction of androgen. More...

Drugs associated with Adrenogenital Syndrome

The following drugs and medications are in some way related to, or used in the treatment of Adrenogenital Syndrome. 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 Adrenogenital Syndrome

Medical Encyclopedia:

Congenital adrenal hyperplasia
Drug List: A-Methapred-Solution Baycadron De-Sone-La-Injection Decadron Deltasone Depo-Medrol-Suspension Dexacen-4-Injection Dexacort-Phosphate-In-Turbinaire Dexamethasone-Intensol Dexasone-Injection Dexasone-La-Injection Dexpak-Tablets-Dose-Pack Florinef Florinef-Acetate Medrol Medrol-Dosepak Methylprednisolone-Dose-Pack Meticorten Solu-Medrol-Solution Solurex-Injection Solurex-La-Injection Sterapred Sterapred-Ds Zema-Pak-10-Day
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Gyno-Pevaryl 1 Vaginal Pessary


Gyno-Pevaryl 1 vaginal pessary

Econazole nitrate

Gyno-Pevaryl is a registered trademark

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 you get side effects and they become serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist In this leaflet 1. What Gyno-Pevaryl 1 is and what it is used for 2. Before you use Gyno-Pevaryl 1 3. How to use Gyno-Pevaryl 1 4. Possible side effects 5. How to store Gyno-Pevaryl 1 6. Further information What Gyno-Pevaryl 1 is and what it is used for

The name of your medicine is Gyno-Pevaryl 1 vaginal pessary. It is called ‘Gyno-Pevaryl 1’ in this leaflet.

Gyno-Pevaryl 1 is a solid, bullet-shaped pessary (vaginal suppository). When inserted into the vagina it releases a medicine called econazole. This belongs to a group of medicines called ‘antifungals’.

Gyno-Pevaryl 1 is used for infections of the vagina and the skin around the vagina. The infections are caused by fungi and yeasts such as thrush (Candida).

Before you use Gyno-Pevaryl 1 Do not use Gyno-Pevaryl 1 if: You are allergic to anything in Gyno-Pevaryl 1 (listed in section 6 below) You are allergic to any other medicine used to treat thrush or other fungal infections You are under 16 years old

Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Gyno-Pevaryl 1.

Take special care with Gyno-Pevaryl 1

Check with your doctor or pharmacist before using this medicine if:

You are using a ‘barrier’ method of contraception. This includes condoms or diaphragms. This is because Gyno-Pevaryl 1 can damage the rubber and stop them working properly. Talk to your doctor about using another type of contraception while you are using this medicine Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.

In particular tell your doctor if you are taking:

Medicines to thin the blood (anticoagulants) such as warfarin or acenocoumarol Pregnancy and breast-feeding

Please tell your doctor before using Gyno-Pevaryl 1 if you are pregnant, think you may be pregnant or might become pregnant.

You may still be able to use Gyno-Pevaryl 1 if your doctor thinks you need to.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

This medicine is not likely to affect you being able to drive or use any tools or machines.

How to use Gyno-Pevaryl 1

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

Using the pessary Use the pessary just before going to bed. This helps it to stay in place Do not swallow the pessary Inserting the pessary with the applicator Remove the pessary from the plastic packet using the easy open tab Pull the plunger of the applicator out until it sticks Gently push the pessary into the cup. Do not force it because it might stick Lie down with your knees bent and spread apart. Insert the applicator high into your vagina, pessary first Push the plunger to release the pessary Remove the applicator and dispose of it safely in your household waste If you swallow Gyno-Pevaryl 1

If the pessary is eaten or swallowed talk to a doctor or go to the nearest hospital casualty department straight away.

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

Possible side effects

Like all medicines, Gyno-Pevaryl 1 can cause side effects, although not everybody gets them.

Stop using Gyno-Pevaryl 1 and tell your doctor straight away if you notice the following. You may need urgent medical treatment. Sudden swelling of the face or throat. Hives (also known as nettle rash or urticaria), severe irritation, reddening or blistering of your skin. These may be signs of a severe allergic reaction (affects less than 1 in 10,000 people) Other side effects: Itchy and red skin around or inside the vagina. This is much milder than an allergic reaction. Tell your doctor or pharmacist if this feeling lasts for more than a few minutes or gets worse (rash, burning or swelling)

If you get side effects and they become serious or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Gyno-Pevaryl 1

Keep out of the reach and sight of children. Store in the original container. Do not store above 30°C. Keep away from heat and sunlight.

Do not use Gyno-Pevaryl 1: After the expiry date which is stated on the label. The expiry date refers to the last day of that month If the plastic packet is broken or missing If the pessary is not light beige in colour

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

Further information

The active substance in Gyno-Pevaryl 1 is econazole nitrate. The pessary contains 150mg econazole nitrate.

The other ingredients are polygel, colloidal silicon dioxide, Witepsol H 19, Wecobee FS, stearyl heptanoate.

What Gyno-Pevaryl 1 looks like and contents of the pack

Gyno-Pevaryl 1 comes in a plastic strip containing one pessary. It is bullet-shaped and light beige in colour.

The product licence is held by: JANSSEN-CILAG LTD 50-100 Holmers Farm Way High Wycombe Bucks HP12 4EG UK Gyno-Pevaryl 1 is made by: Janssen Pharmaceutica NV Turnhoutseweg 30 B-2340 Beerse Belgium

OR

McGregor Cory Ltd Middleton Close Banbury Oxfordshire OX16 8RS UK

For information in large print, tape, CD or Braille, telephone 0800 7318450.

This leaflet was last approved in August 2008.


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Mucinex DM


guaifenesin and dextromethorphan hydrobromide
Dosage Form: tablet, extended release
Mucinex®DM

600 mg guaifenesin & 30 mg dextromethorphan HBr extended-release bi-layer tablets

EXPECTORANT & COUGH SUPPRESSANT

Drug Facts

Active ingredients (in each extended-release bi-layer tablet) Purpose Dextromethorphan HBr 30 mg Cough suppressant Guaifenesin 600 mg Expectorant Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep Warnings

Do not use

for children under 12 years of age if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus)

When using this product

do not use more than directed

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for timing of meals adults and children 12 years and older: 1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours children under 12 years of age: do not use Other information tamper evident: do not use if carton is open or if printed seal on blister is broken or missing store at 20-25°C (68-77°F) Inactive ingredients

carbomer 934P, NF; D&C yellow #10 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Distributed by:
Reckitt Benckiser Inc.
Parsippany, NJ 07054-0224
©RBI 2009

PRINCIPAL DISPLAY PANEL - 600 mg Carton

NDC 63824-056-32

Mucinex®DM

600 mg guaifenesin & 30 mg dextromethorphan HBr
extended-release bi-layer tablets

EXPECTORANT & COUGH SUPPRESSANT

12 HOUR

NEW LOOK-
SAME RELIEF

Thins And Loosens Mucus

Controls Cough

20 EXTENDED-RELEASE BI-LAYER TABLETS


Mucinex DM 
guaifenesin and dextromethorphan hydrobromide  tablet, extended release Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 63824-056 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guaifenesin (Guaifenesin) Guaifenesin 600 mg Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 30 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color WHITE (yellow and white) Score no score Shape OVAL Size 16mm Flavor Imprint Code Mucinex;600 Contains          Packaging # NDC Package Description Multilevel Packaging 1 63824-056-32 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (63824-056-32) 2 63824-056-34 4 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (63824-056-34) 3 63824-056-58 1 BOTTLE In 1 CARTON contains a BOTTLE 3 58 TABLET In 1 BOTTLE This package is contained within the CARTON (63824-056-58) 4 63824-056-72 25 POUCH In 1 CARTON contains a POUCH 4 2 TABLET In 1 POUCH This package is contained within the CARTON (63824-056-72) 5 63824-056-76 3 POUCH In 1 CARTON contains a POUCH 5 2 TABLET In 1 POUCH This package is contained within the CARTON (63824-056-76)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021620 03/31/2009
Labeler - Reckitt Benckiser, Inc. (094405024) Revised: 12/2009Reckitt Benckiser, Inc.
More Mucinex DM resources Mucinex DM Side Effects (in more detail) Mucinex DM Dosage Mucinex DM Use in Pregnancy & Breastfeeding Mucinex DM Drug Interactions Mucinex DM Support Group 0 Reviews for Mucinex DM - Add your own review/rating Mucinex DM Concise Consumer Information (Cerner Multum) Anti-Tuss DM Concise Consumer Information (Cerner Multum) Atuss-12 DX Extended-Release Liquid MedFacts Consumer Leaflet (Wolters Kluwer) Bidex-A Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Duratuss DM 12 Suspension MedFacts Consumer Leaflet (Wolters Kluwer) Guaifenesin DM Elixir MedFacts Consumer Leaflet (Wolters Kluwer) Humibid CS MedFacts Consumer Leaflet (Wolters Kluwer) Robitussin DM infant drops Scot-Tussin DM Liquid MedFacts Consumer Leaflet (Wolters Kluwer) Compare Mucinex DM with other medications Cough Expectoration
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Proctofoam HC


Proctofoam HC 1% w/w & 1% w/w Rectal Foam

(Hydrocortisone acetate & pramocaine hydrochloride)

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 Throughout this leaflet Proctofoam HC 1 % w/w & 1 % w/w Rectal Foam is called Proctofoam. Important: Proctofoam is a steroid medicine, prescribed for many different conditions, including serious illnesses You need to use it regularly to get the maximum benefit Don't stop using this medicine without talking to your doctor - you may need to reduce the dose gradually Proctofoam can cause side effects in some people (read section 4 below). Some problems such as mood changes (feeling depressed, or 'high'), or stomach problems can happen straight away. If you feel unwell in any way, keep using your medicine, but see your doctor straight away Some side effects only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read section 4 for more information) Keep away from people who have chicken-pox or shingles, if you have never had them. They could affect you severely. If you do come into contact with chicken pox or shingles, see your doctor straight away. Now read the rest of this leaflet.

It includes other important information on the safe and effective use of this medicine that might be especially important for you.

In this leaflet: 1. What Proctofoam is for 2. Before you use Proctofoam 3. How to use Proctofoam 4. Possible side effects 5. How to store Proctofoam 6. Further information What Proctofoam is for Proctofoam - benefit information

Proctofoam belongs to a group of medicines called steroids. Their full name is corticosteroids. These corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as Proctofoam) is an effective way to treat various illnesses involving inflammation in the body.

Proctofoam reduces this inflammation, which could otherwise go on making your condition worse You must use this medicine regularly to get maximum benefit from it. Proctofoam is used for the relief of inflammation, itching, pain, swelling and irritation associated with haemorrhoids (piles) and certain other conditions of the anus (bottom) and anal region.

Before you use Proctofoam Do not use Proctofoam: If you are allergic to pramocaine hydrochloride or to any other ingredient in Proctofoam (see section 6) If you are suffering from a bacterial infection, viral infection or fungal infection

Proctofoam is not for use in children

If any of the above applies to you talk to your doctor or pharmacist.

Check with your doctor first: If you have ever had severe depression or manic-depression (bipolar disorder). This includes having had depression before while using steroid medicines like Proctofoam. If any of your close family has had these illnesses If you have diseases of the bowel (rectum).

If any of these applies to you, talk to your doctor before using Proctofoam.

Taking other medicines

Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

If you are pregnant, trying to become pregnant or breast-feeding ask your doctor or pharmacist for advice before using Proctofoam.

How to use Proctofoam

Always use Proctofoam exactly as your doctor has told you.

Important:

Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it is not, or you are not sure, ask your doctor or pharmacist.

Remember: Do not use Proctofoam for more than 7 days Talk to your doctor if symptoms worsen, or do not improve within 7 days or if bleeding occurs You need to use your medicine regularly to get the maximum benefit. Adult dose

Proctofoam can be applied in the rectum (internal use) or to the skin around the anus (external use).

The usual dose into the rectum is one applicator of foam two or three times per day and after each bowel evacuation up to a maximum of 4 times daily For the anal area expel a small amount of foam onto two fingers and apply to the affected area. For internal use 1. Shake the canister vigorously for 30 seconds before each use. 2. Withdraw the plunger until it stops at the catch line. 3. Hold the applicator upright and insert the canister top into the applicator tip. Make sure you hold the plunger and applicator body FIRMLY with your fingers. 4. Press down gently on the canister top with your fingers, so that the foam fills about ? of the applicator body. Only a short press is needed to do this. 5. Wait for a few seconds until the foam stops expanding.
DO NOT fill the applicator in one go. Always release the canister top after a short press. 6. Repeat steps 4 & 5 above until the foam expands to just reach the 'Fill' line. This normally takes 2 to 4 short press/wait. 7. Stand with one leg raised on a chair, or lie down on your side. Hold the applicator as shown. Insert gently into the back passage and push the plunger fully into the applicator. For topical use

Shake the canister vigorously for 30 seconds before each use. Expel a small quantity of foam onto a tissue, pad or two fingers and apply the foam to the affected area.

After using the applicator Always take the applicator apart and wash it thoroughly after use The canister top should also be removed and washed Replace the canister top with care. Make sure it is placed vertically on top of the canister, and not at an angle. If you use more Proctofoam than you should

If you use too much go to your doctor as soon as possible.

If you repeatedly use too much Proctofoam you may experience fattening of the face, neck and body, hair growing on your body (women), a dusky complexion with purple patches and skin thinning.

If you forget to use Proctofoam

Do not use double the dose to make up for a missed dose. Simply take your next dose as planned.

If you stop using Proctofoam

Do not stop using Proctofoam without talking to your doctor. Your doctor may reduce your dose gradually.

Mental problems while using Proctofoam

Mental health problems can happen while using steroids like Proctofoam (see also section 4 Possible Side Effects).

These illnesses can be serious Usually they start within a few days or weeks of starting the medicine. They are more likely to happen at high doses. Most of these problems go away if the dose is lowered or the medicine is stopped. However, if problems do happen they might need treatment.

Talk to a doctor if you (or someone using this medicine), show any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.

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

Proctofoam HC Side Effects

Like all medicines, Proctofoam can cause side effects, although not everybody gets them.

Serious effects: tell your doctor straight away

Steroids can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines that contain steroids.

Feeling depressed, including thinking about suicide Feeling high (mania) or moods that go up and down Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.

If you notice any of these problems talk to a doctor straight away.

Other side effects

If you get any of the following, keep using the medicine but tell your doctor:

Unexpected fattening of the face, neck and body Irregular periods Hair starts to grow on your body (women) Dusky complexion with purple patches Skin thinning Allergic skin reaction Infection Burning sensation Itching.

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

How to store Proctofoam

Keep out of the reach and sight of children.

Do not use Proctofoam after the expiry date which is stated on the canister and carton. The expiry date refers to the last day of that month.

Do not expose to temperatures above 50°C. Keep in the original packaging to protect from sunlight Do not refrigerate Keep away from sources of ignition Do not spray on a naked flame or anything hot Do not pierce or burn the container even after use.

Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.

Further information What Proctofoam contains:

The active substances in Proctofoam are hydrocortisone acetate (1 % w/w) and pramocaine hydrochloride (1% w/w).

The other ingredients are cetyl alcohol, emulsifying wax (cetyl alcohol, sorbitan solution), methyl parahydroxybenzoate (E218), polyoxyethylene (10); stearyl ether, propylene glycol, propyl parahydroxybenzoate (E216), trolamine, purified water and propellant HP-70 consisting of isobutane and propane.

What Proctofoam looks like

Proctofoam is a white rectal foam contained in a pressurised canister.

Contents of the pack

Each pack contains canister and a plastic applicator.

Each canister contains approximately 40 doses.

Marketing Authorisation Holder in the UK: Meda Pharmaceuticals Ltd Skyway House Parsonage Road Takeley Bishop's Stortford CM22 6PU UK Manufacturer Pharmasol Limited North Way Walworth Industrial Estate Andover SP10 5AZ UK

This leaflet was last approved in January 2010.

If this leaflet is difficult to see or read or you would like it in a different format, please contact:

In the UK -

Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishop's Stortford
CM22 6PU
UK

Proctofoam is a registered trademark of Meda AB.

MP00697


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Mucinex DM Maximum Strength


guaifenesin and dextromethorphan hydrobromide
Dosage Form: tablet, extended release
Mucinex®DM

Drug Facts

Active ingredients (in each extended-release bi-layer tablet) Purpose Dextromethorphan HBr 60 mg Cough suppressant Guaifenesin 1200 mg Expectorant Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep Warnings

Do not use

for children under 12 years of age if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus)

When using this product

do not use more than directed

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for timing of meals adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age: do not use Other information tamper evident: do not use if carton is open or if printed seal on blister is broken or missing store at 20-25°C (68-77°F) Inactive ingredients

carbomer 934P, NF; D&C yellow #10 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Distributed by:
Reckitt Benckiser Inc.
Parsippany, NJ 07054-0224
©RBI 2009

PRINCIPAL DISPLAY PANEL - 1200 mg Carton

MAXIMUM STRENGTH

NDC 63824-072-35

Mucinex®DM

1200 mg guaifenesin & 60 mg dextromethorphan HBr
extended-release bi-layer tablets

EXPECTORANT & COUGH SUPPRESSANT

12 HOUR

NEW LOOK-
SAME RELIEF

Thins And Loosens Mucus

Controls Cough

14 EXTENDED-RELEASE BI-LAYER TABLETS


MUCINEX DM  MAXIMUM STRENGTH
guaifenesin and dextromethorphan hydrobromide  tablet, extended release Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 63824-072 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guaifenesin (Guaifenesin) Guaifenesin 1200 mg Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 60 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color WHITE (yellow and white) Score no score Shape OVAL Size 22mm Flavor Imprint Code Mucinex;1200 Contains          Packaging # NDC Package Description Multilevel Packaging 1 63824-072-35 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 7 TABLET In 1 BLISTER PACK This package is contained within the CARTON (63824-072-35) 2 63824-072-36 4 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 7 TABLET In 1 BLISTER PACK This package is contained within the CARTON (63824-072-36) 3 63824-072-39 1 BOTTLE In 1 CARTON contains a BOTTLE 3 38 TABLET In 1 BOTTLE This package is contained within the CARTON (63824-072-39) 4 63824-072-45 1 BOTTLE In 1 CARTON contains a BOTTLE 4 44 TABLET In 1 BOTTLE This package is contained within the CARTON (63824-072-45)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021620 03/31/2009
Labeler - Reckitt Benckiser, Inc. (094405024) Revised: 12/2009Reckitt Benckiser, Inc.
More Mucinex DM Maximum Strength resources Mucinex DM Maximum Strength Side Effects (in more detail) Mucinex DM Maximum Strength Dosage Mucinex DM Maximum Strength Use in Pregnancy & Breastfeeding Mucinex DM Maximum Strength Drug Interactions Mucinex DM Maximum Strength Support Group 0 Reviews for Mucinex DM Maximum Strength - Add your own review/rating Allfen DM Concise Consumer Information (Cerner Multum) Anti-Tuss DM Concise Consumer Information (Cerner Multum) Atuss-12 DX Extended-Release Liquid MedFacts Consumer Leaflet (Wolters Kluwer) Bidex-A Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Duratuss DM 12 Suspension MedFacts Consumer Leaflet (Wolters Kluwer) Guaifenesin DM Elixir MedFacts Consumer Leaflet (Wolters Kluwer) Humibid CS MedFacts Consumer Leaflet (Wolters Kluwer) Robitussin DM infant drops Scot-Tussin DM Liquid MedFacts Consumer Leaflet (Wolters Kluwer) Compare Mucinex DM Maximum Strength with other medications Cough Expectoration
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