METROGEL-VAGINAL (metronidazole) is the intravaginal dosage form of the synthetic antibacterial agent, metronidazole, USP at a concentration of 0.75%. Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is a 2-methyl-5-nitroimidazole-1-ethanol. It has a chemical formula of C₆H₉N₃O₃, a molecular weight of 171.16, and has the following structure:

METROGEL-VAGINAL (metronidazole) is a gelled, purified water solution, containing metronidazole at a concentration of 7.5 mg/g (0.75%). The gel is formulated at pH 4.0. The gel also contains carbomer 934P, edetate disodium, methyl paraben, propyl paraben, propylene glycol, and sodium hydroxide.

Each applicator full of 5 grams of vaginal gel contains approximately 37.5 mg of metronidazole.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, painful urination.

Tell your doctor immediately if any of these rare but very serious side effects occur: tingling or numbness of the hands and feet, seizures, signs of another infection (e.g., fever, persistent sore throat), mental/mood changes (e.g., depression).

Use of this medication for prolonged or repeated periods may result in a new vaginal yeast infection (vaginal fungal infection). Contact your doctor if you notice a change in vaginal discharge or other new symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using metronidazole, tell your doctor or pharmacist if you are allergic to it; or to other nitroimidazole antibiotics (e.g., tinidazole); or if you have any other allergies. This product may contain inactive ingredients (such as paraben preservatives), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: seizures, liver disease, certain blood disorders (blood dyscrasias), nervous system disease.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

This medication should be used only if clearly needed during pregnancy. Oral antibiotics have been used to treat vaginal infections during pregnancy, especially high-risk pregnancies (e.g., risk of early childbirth). Consult your doctor for more details and to discuss the risks and benefits.

This drug passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.