July 30, 2016
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Vandazole

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Vandazole




Overdosage
Contraindications

OVERDOSE

There is no human experience with overdosage of metronidazole vaginal gel. Vaginally applied metronidazole gel, 0.75% could be absorbed in sufficient amounts to produce systemic effects [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].

CONTRAINDICATIONS

Hypersensitivity

The use of VANDAZOLE (metronidazole vaginal gel) is contraindicated in patients with a history of hypersensitivity to metronidazole, other nitroimidazole derivatives, or parabens. Reported reactions include urticaria; erythematous rash; Stevens-Johnson Syndrome, toxic epidermal necrolysis, flushing; nasal congestion; dryness of the mouth, vagina, or vulva; fever; pruritus; fleeting joint pains [see ADVERSE REACTIONS].

Psychotic Reaction with Disulfiram

Use of oral metronidazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently. Do not administer VANDAZOLE (metronidazole vaginal gel) to patients who have taken disulfiram within the last two weeks [see ADVERSE REACTIONS].

Interaction with Alcohol

Use of oral metronidazole is associated with a disulfiram-like reaction to alcohol, including abdominal cramps, nausea, vomiting, headaches, and flushing [see ADVERSE REACTIONS]. Discontinue alcohol consumption during and for at least three days after therapy with VANDAZOLE (metronidazole vaginal gel) .

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/4/2011

Overdosage
Contraindications

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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