terconazole

FDA Drug Profile — Terconazole, Terconazole Vaginal Cream 0.8%

Drug Details

Generic Name
terconazole
Brand Names
Terconazole, Terconazole Vaginal Cream 0.8%
Application Number
ANDA076712
Sponsor
A-S Medication Solutions
NDC Codes
4
Dosage Forms
CREAM
Routes
VAGINAL
Active Ingredients
TERCONAZOLE

Indications and Usage

INDICATIONS AND USAGE Terconazole Vaginal Suppositories, 80 mg is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As this product is effective only for vulvovaginitis caused by the genus Candida , the diagnosis should be confirmed by KOH smears and/or cultures.

Warnings

WARNINGS Anaphylaxis and toxic epidermal necrolysis have been reported during terconazole therapy. Terconazole therapy should be discontinued if anaphylaxis or toxic epidermal necrolysis develops.