Metronidazole Vaginal Gel

Generic Name: Metronidazole Vaginal Gel (me-troe-NIH-duh-zole)
Brand Name: MetroGel Vaginal

Metronidazole Vaginal Gel is used for:

Treating certain bacterial infections of the vagina (bacterial vaginosis). It may also be used for other conditions as determined by your doctor.

Metronidazole Vaginal Gel is an antiprotozoal and antibacterial. It is thought to work by entering the bacterial cell, acting on some components of the cell and destroying the bacteria.

Do NOT use Metronidazole Vaginal Gel if:

• you are allergic to any ingredient in Metronidazole Vaginal Gel (including parabens) or to other nitroimidazoles (eg, tinidazole)
• you have taken disulfiram within the past 2 weeks

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

Before using Metronidazole Vaginal Gel:

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

• if you are pregnant, plan 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 nerve, brain, or blood problems; Crohn disease; or a history of liver problems

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

• Barbiturates (eg, phenobarbital) or phenytoin because the effectiveness of Metronidazole Vaginal Gel may be decreased
• Anticoagulants (eg, warfarin), busulfan, ergot alkaloids (eg, ergotamine), HIV protease inhibitors containing alcohol (eg, amprenavir solution), imatinib, lithium, or macrolide immunosuppressants (eg, tacrolimus) because the actions and side effects of these medicines may be increased
• Disulfiram because side effects, such as mental or mood changes, may occur
• Oral contraceptives (eg, birth control pills) because their effectiveness may be decreased by Metronidazole Vaginal Gel

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

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

• Metronidazole Vaginal Gel comes with an additional patient leaflet. Read it carefully and reread it each time you get Metronidazole Vaginal Gel refilled.
• If you are using Metronidazole Vaginal Gel once daily, use it at bedtime.
• Screw the end of the applicator onto the tube. Slowly squeeze gel out of the tube and into the applicator. The plunger will stop when the applicator is full.
• You may insert Metronidazole Vaginal Gel lying on your back with your knees bent or in any comfortable position. Hold the filled applicator by the barrel, and gently insert into vagina as far as it will comfortably go. Slowly press the plunger until it stops, and then withdraw the applicator.
• After use, pull the plunger out of the barrel. Wash both the plunger and barrel in warm, soapy water and rinse thoroughly. To put the applicator back together, gently push the plunger back into the barrel.
• Wash your hands after using Metronidazole Vaginal Gel.
• To clear up your infection completely, continue using Metronidazole Vaginal Gel for the full course of treatment even if you feel better in a few days.
• If you miss a dose of Metronidazole Vaginal Gel, 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 Metronidazole Vaginal Gel.

Important safety information:

• Metronidazole Vaginal Gel may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Metronidazole Vaginal Gel. Using Metronidazole Vaginal Gel alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Do not drink alcohol while you are using Metronidazole Vaginal Gel without first checking with your doctor.
• Metronidazole Vaginal Gel is for vaginal use only. Do not get Metronidazole Vaginal Gel in your eyes, nose, or mouth. If you get Metronidazole Vaginal Gel in your eyes, rinse immediately with a generous amount of cool water.
• Do not have vaginal sexual intercourse while you are using this medicine.
• It is important to use Metronidazole Vaginal Gel for the full course of treatment. Failure to do so may decrease the effectiveness of Metronidazole Vaginal Gel and may increase the risk that the bacteria will no longer be sensitive to Metronidazole Vaginal Gel and will not be able to be treated by this or certain other antibiotics in the future.
• Long-term or repeated use of Metronidazole Vaginal Gel may cause a second infection. Your doctor may want to change your medicine to treat the second infection. Contact your doctor if signs of a second infection occur.
• Metronidazole Vaginal Gel may interfere with certain lab test results. Make sure your doctor and laboratory personnel know you are taking Metronidazole Vaginal Gel.
• Use Metronidazole Vaginal Gel with caution in the ELDERLY because they may be more sensitive to its effects.
• Use Metronidazole Vaginal Gel with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Metronidazole Vaginal Gel during pregnancy. It is unknown if Metronidazole Vaginal Gel is excreted in breast milk after vaginal use. Do not breast-feed while using Metronidazole Vaginal Gel.

Possible side effects of Metronidazole Vaginal Gel:

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:

Dizziness; headache; nausea; pelvic discomfort; stomach upset; unusual taste; vaginal irritation; vomiting.

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); depression; fever, chills, or sore throat; numbness, tingling, or burning of your arms, hands, legs, or feet; seizures; severe or persistent vaginal irritation; stomach pain; unusual bruising or bleeding; vaginal odor, itching, or discharge .

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include nausea; seizures; vomiting.

Proper storage of Metronidazole Vaginal Gel:

Store Metronidazole Vaginal Gel at room temperature, between 59 to 86 degrees F (15 to 30 degrees C). Avoid extreme heat and cold. Protect from freezing. Store away from heat, moisture, and light. Keep Metronidazole Vaginal Gel out of the reach of children and away from pets.

General information:

• If you have any questions about Metronidazole Vaginal Gel, please talk with your doctor, pharmacist, or other health care provider.
• Metronidazole Vaginal Gel 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.

This information is a summary only. It does not contain all information about Metronidazole Vaginal Gel. 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.

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