Metronidazole Vaginal Gel, 1.3 %

1 INDICATIONS AND USAGE Metronidazole vaginal gel is indicated for the treatment of bacterial vaginosis in females 12 years of age and older. Metronidazole vaginal gel is a nitroimidazole antimicrobial indicated for the treatment of bacterial vaginosis in females 12 years of age and older. ( 1 )

6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The most common adverse reactions observed in adult clinical studies (incidence ≥1%) were vulvovaginal candidiasis, headache, vulvovaginal pruritus, nausea, diarrhea, and dysmenorrhea. The most common adverse reactions observed in pediatric clinical studies (incidence ≥1%) was vulvovaginal discomfort. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact. Encube Ethicals Private Limited, at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

8.1 Pregnancy Risk Summary There are no data available on the use of metronidazole vaginal gel in pregnant women. Metronidazole usage in pregnancy has been associated with certain congenital anomalies (see Data ) . In animal reproduction studies, no fetotoxicity or teratogenicity was observed when metronidazole was administered orally to pregnant rats and rabbits, during organogenesis at up to 30 times and 60 times the recommended human dose based on body surface area comparison, respectively (see Data ) .

5 WARNINGS AND PRECAUTIONS • Central and peripheral nervous system effects: Convulsive seizures and peripheral neuropathy have been reported in patients treated with oral or intravenous metronidazole. Discontinue promptly if abnormal neurologic signs develop. ( 5.1 ) • Interference with laboratory tests: Metronidazole may interfere with certain serum chemistry laboratory values. ( 5.3 ) 5.1 Central and Peripheral Nervous System Effects Convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with oral or intravenous metronidazole. Metronidazole vaginal gel should be administered with caution to patients with central nervous system diseases. 4 CONTRAINDICATIONS • History of hypersensitivity to metronidazole, parabens, other ingredients of the formulation, or other nitroimidazole derivatives (4.1) • Concomitant use of disulfiram or within 2 weeks of disulfiram ( 4.2 , 7.1 ) • Concomitant use of alcohol ( 4.3 , 7.2 ) 4.1 Hypersensitivity Metronidazole vaginal gel is contraindicated in persons who have shown hypersensitivity to metronida...