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Vagistat-1

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Vagistat-1

Vagistat-1

INDICATIONS

VAGISTAT-1 (tioconazole) is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As VAGISTAT-1 (tioconazole) has been shown to be effective only for candidal vulvovaginitis, the diagnosis should be confirmed by KOH smears and/or cultures. Other pathogens commonly associated with vulvovaginitis should be ruled out by appropriate methods.

Studies have shown that women taking oral contraceptives have a cure rate similar to those not taking such agents when treated with VAGISTAT-1 (tioconazole) .

Safety and effectiveness in pregnant and diabetic patients have not been established (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION

VAGISTAT-1 (tioconazole) has been found to be effective as a single- dose treatment for vulvovaginal candidiasis. Using the prefilled applicator, insert one applicator- full intravaginally. Administration of VAGISTAT-1 (tioconazole) just prior to bedtime may be preferred.

HOW SUPPLIED

VAGISTAT-1 (tioconazole) is supplied in a ready-to-use, prefilled, single-dose vaginal applicator (NDC 0087-0657-40). Each applicator-full will deliver approximately 4.6 grams of VAGISTAT-1 containing 65 mg of tioconazole per gram of ointment.

Storage: Store at controlled room temperature 15°-30° C (59°-86° F).

WARNING: Manufactured with 1,1,1-trichloroethane, a substance which harms public health and environment by destroying ozone in the upper atmosphere.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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