FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
VANDAZOLE is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in non-pregnant women.
History
There is currently no drug history available for this drug.
Other Information
VANDAZOLE (metronidazole vaginal gel, 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.
C6H9N3O3 M.W. 171.16
VANDAZOLE is a colorless to yellow gel, containing metronidazole 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.
Sources
Vandazole Manufacturers
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Upsher-smith Laboratories, Inc.
Vandazole | Upsher-smith Laboratories, Inc.
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 [see Patient Counseling Information (17.4)].
Not for ophthalmic, dermal, or oral use.
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