MetroGel Vaginal Vaginal Gel

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

MetroGel Vaginal 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.

MetroGel Vaginal 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 Vaginal Gel if:

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

Some medical conditions may interact with MetroGel Vaginal 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 MetroGel Vaginal 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 MetroGel Vaginal 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 MetroGel Vaginal Vaginal Gel

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

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

MetroGel Vaginal Vaginal Gel comes with an additional patient leaflet. Read it carefully and reread it each time you get MetroGel Vaginal Vaginal Gel refilled.
If you are using MetroGel Vaginal 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 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 Vaginal Gel.
To clear up your infection completely, continue using MetroGel Vaginal Vaginal Gel for the full course of treatment even if you feel better in a few days.
If you miss a dose of MetroGel Vaginal 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 Vaginal Gel.

Important safety information:

MetroGel Vaginal 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 MetroGel Vaginal Vaginal Gel. Using MetroGel Vaginal 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 MetroGel Vaginal Vaginal Gel without first checking with your doctor.
MetroGel Vaginal Vaginal Gel is for vaginal use only. Do not get MetroGel Vaginal Vaginal Gel in your eyes, nose, or mouth. If you get MetroGel Vaginal 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 MetroGel Vaginal Vaginal Gel for the full course of treatment. Failure to do so may decrease the effectiveness of MetroGel Vaginal Vaginal Gel and may increase the risk that the bacteria will no longer be sensitive to MetroGel Vaginal 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 MetroGel Vaginal 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.
MetroGel Vaginal Vaginal Gel may interfere with certain lab test results. Make sure your doctor and laboratory personnel know you are taking MetroGel Vaginal Vaginal Gel.
Use MetroGel Vaginal Vaginal Gel with caution in the ELDERLY because they may be more sensitive to its effects.
Use MetroGel Vaginal 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 MetroGel Vaginal Vaginal Gel during pregnancy. It is unknown if MetroGel Vaginal Vaginal Gel is excreted in breast milk after vaginal use. Do not breast-feed while using MetroGel Vaginal Vaginal Gel.

Possible side effects of MetroGel Vaginal 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 MetroGel Vaginal Vaginal Gel:

Store MetroGel Vaginal 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 MetroGel Vaginal Vaginal Gel out of the reach of children and away from pets.

General information:

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

Issue Date: September 5, 2007

Database Edition 07.3.1.003