MetroGel Vaginal Gel

MetroGel Vaginal Gel is used for:

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

MetroGel 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 MetroGel Vaginal Gel if:

• you are allergic to any ingredient in MetroGel 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 MetroGel Vaginal Gel:

Some medical conditions may interact with MetroGel 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, 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 nerve, brain, or blood problems; Crohn disease; or a history of liver problems

Some MEDICINES MAY INTERACT with MetroGel 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 they may decrease MetroGel Vaginal Gel's effectiveness
• 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 risk of their side effects may be increased by MetroGel Vaginal Gel
• 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 MetroGel Vaginal Gel

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

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

• An extra patient leaflet is available with MetroGel Vaginal Gel. Talk to your pharmacist if you have questions about this information.
• If you are using MetroGel 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 MetroGel 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 MetroGel Vaginal Gel.
• To clear up your infection completely, use MetroGel Vaginal Gel for the full course of treatment. Keep using it even if you feel better in a few days.
• If you miss a dose of MetroGel 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 MetroGel Vaginal Gel.

Important safety information:

• MetroGel Vaginal Gel may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use MetroGel Vaginal Gel with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol while you are using MetroGel Vaginal Gel without first checking with your doctor.
• MetroGel Vaginal Gel is for vaginal use only. Do not get MetroGel Vaginal Gel in your eyes, nose, or mouth. If you get MetroGel Vaginal Gel in your eyes, rinse immediately with a generous amount of cool water.
• Do not have vaginal sexual intercourse while you are using MetroGel Vaginal Gel.
• Be sure to use MetroGel Vaginal Gel for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Long-term or repeated use of MetroGel Vaginal Gel may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• MetroGel Vaginal Gel may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using MetroGel Vaginal Gel.
• Use MetroGel Vaginal Gel with caution in the ELDERLY; they may be more sensitive to its effects.
• MetroGel Vaginal Gel should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using MetroGel Vaginal Gel while you are pregnant. It is not known if MetroGel Vaginal Gel is found in breast milk after vaginal use. Do not breast-feed while using MetroGel Vaginal Gel.

Possible side effects of MetroGel 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.

Severe allergic reactions (rash; hives; itching; 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.

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

General information:

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