VANDAZOLE

Healthy Subjects Following a single, intravaginal 5 gram dose of metronidazole vaginal gel (equivalent to 37.5 mg of metronidazole) to 38 healthy female subjects, a mean maximum serum metronidazole concentration of 281 ng/mL was reported (range: 134 to 464 ng/mL). The average time to achieve this C max was 9.5 hours (range: 4 to 17 hours) after dosing with metronidazole vaginal gel. This C max is approximately 2% of the mean maximum serum concentration reported in healthy subjects administered a...

A single, randomized, double-blind, active-controlled clinical trial was conducted to evaluate the efficacy of VANDAZOLE for the treatment of bacterial vaginosis. A clinical diagnosis of bacterial vaginosis was defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a "fishy" amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram's stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella...

Adverse reactions occurring in ≥ 1% of patients are: fungal infection, headache, pruritus, abdominal pain, nausea, dysmenorrhea, pharyngitis, rash, infection, diarrhea, breast pain, and metrorrhagia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clini...

History of hypersensitivity to metronidazole, other nitroimidazole derivatives or parabens ( 4 ) Disulfiram: Psychotic reactions have been reported with disulfiram and oral metronidazole; do not administer concurrently with or within the last 2 weeks of disulfiram ( 4.2 , 7.1 ). Alcohol: Disulfiram-like reactions to alcohol have been reported with oral metronidazole; do not consume alcohol during ...

Central and Peripheral Nervous System Effects: Convulsive seizures and peripheral neuropathy have been reported in patients treated with oral or intravenous metronidazole; discontinue if abnormal neurologic signs develop. ( 5.1 ) Carcinogenicity in Animals: Metronidazole has been shown to be carcinogenic in mice and rats. ( 5.2 , 13.1 ) Interference with laboratory tests: Metronidazole may interfere with certain serum chemistry laboratory values ( 5.3 ) 5.1 Central and Peripheral Nervous System ...

7 DRUG INTERACTIONS The intravaginal administration of a single 5 gram dose of VANDAZOLE results in relatively lower mean systemic exposure to metronidazole that is approximately 2% to 5% of that achieved following a 500 mg oral dose of metronidazole [see Clinical Pharmacology ( 12.3 )] . The following drug interactions were reported for oral metronidazole. Warfarin and other coumarin anticoagulan...