Vandazole
(Metronidazole)Vandazole Prescribing Information
VANDAZOLE
®is indicated in the treatment of bacterial vaginosis (formerly referred to as
The recommended dose is one applicator full of VANDAZOLE, (approximately 5 grams of gel containing approximately 37.5 mg of metronidazole) administered intravaginally once a day for 5 days. For once a day dosing, VANDAZOLE should be administered at bedtime
Not for ophthalmic, dermal, or oral use.
Gel, 0.75%. VANDAZOLE is a clear, colorless to yellow gel in a 70 g tube, supplied with 5 vaginal applicators. Each applicator delivers approximately 5 g of gel containing 37.5 mg of metronidazole, USP.
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
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 Cmaxwas 9.5 hours (range: 4 to 17 hours) after dosing with metronidazole vaginal gel. This Cmaxis approximately 2% of the mean maximum serum concentration reported in healthy subjects administered a single, oral 500 mg dose of metronidazole (mean Cmax= 12,785 ng/mL).
The extent of exposure [area under the curve (AUC)] of metronidazole, when administered as a single intravaginal 5 gram dose of metronidazole vaginal gel (equivalent to 37.5 mg of metronidazole), was 5,989 ng•hr/mL (range: 2,797 to 10,515 ng•hr/mL). This AUC0-∞is approximately 5% of the reported AUC of metronidazole following a single oral 500 mg dose of metronidazole approximately 125,000 ng•hr/mL.
Following single and multiple 5 gram doses of a similar metronidazole vaginal gel product to 4 patients with bacterial vaginosis, a mean maximum serum metronidazole concentration of 214 ng/mL on Day 1 and 294 ng/mL (range: 228 to 349 ng/mL) on Day 5 were reported. Steady state metronidazole serum concentrations following oral dosages of 400 to 500 mg twice a day have been reported to range from 6,000 to 20,000 ng/mL.
VANDAZOLE (metronidazole gel, USP), 0.75% is the vaginal dosage form of the nitroimidazole antimicrobial metronidazole at a concentration of 0.75%. Chemically, metronidazole is a 2-methyl-5-nitroimidazole-1-ethanol.
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3M.W. 171.16
VANDAZOLE is a colorless to yellow gel, containing metronidazole, USP at a concentration of 7.5 mg/g (0.75%). The gel also contains edetate disodium, hypromellose, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide (to adjust pH).
Each applicator full of 5 grams of vaginal gel contains approximately 37.5 mg of metronidazole, USP.
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
Outcome | Vandazole | Active Control | Treatment Difference (%) |
% Cure | % Cure | ||
Therapeutic Cure | 42.8 | 30.9 | 11.9 [2.8, 21.0] |
Clinical Cure | 52.4 | 45.3 | 7.1 [-2.3, 16.5] |
Nugent Score Cure | 52.0 | 41.1 | 10.9 [1.5, 20.3] |
1 Modified intent-to-treat population | |||