NUVESSA

Following a single, intravaginal 5 g dose of NUVESSA (equivalent to 65 mg of metronidazole) to 20 healthy female subjects, a mean maximum serum metronidazole concentration (C max ) of 239 ng/mL was observed (range: 114 to 428 ng/mL). The average time to achieve this C max was 7.3 hours (range: 4 to 18 hours). This C max is approximately 2% of the mean maximum serum concentration reported in healthy subjects administered a single, oral 500 mg dose of metronidazole tablets (mean C max = 12,785 ng/...

A single, randomized, double-blind, vehicle-controlled clinical trial was conducted to evaluate the efficacy of NUVESSA. Subjects had a clinical diagnosis of bacterial vaginosis defined by the presence of a homogenous vaginal discharge that (a) had a pH ≥ 4.7, (b) emitted a "fishy" amine odor when mixed with a 10% KOH solution ("whiff" test), and (c) contained clue cells ≥ 20% of the total vaginal epithelial cells. In addition, to be eligible for analysis subjects must have had a Gram stain Nugent score ≥ 4 and have been negative for N. gonorrhoeae and C. trachomatis . Non-pregnant females at ...

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...

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 NUVESSA is contraindicated in persons who have shown hypersensitivity to metronidazole, parabens, other ingredients of the f...

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, th...

7 DRUG INTERACTIONS The intravaginal administration of a single dose of NUVESSA results in lower systemic exposure to metronidazole that is approximately 2% to 4% of that achieved following oral administration of 500 mg metronidazole tablets [see Clinical Pharmacology ( 12.3 )] . The following drug interactions were reported for oral metronidazole. Warfarin and other coumarin anticoagulants: Prolo...