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Monistat 3 (Miconazole Nitrate Vaginal) - Description and Clinical Pharmacology

 
 



MONISTAT 3™ (miconazole nitrate, 200 mg)
Vaginal Suppositories

DESCRIPTION

MONISTAT 3 Vaginal Suppositories are white to off-white suppositories, each containing the antifungal agent, miconazole nitrate, 1-[2,4-Dichloro-β-[(2,4-dichlorobenzyl)oxy]phenethyl]-imidazole mononitrate, 200 mg, in a hydrogenated vegetable oil base. Miconazole nitrate for vaginal use is also available as MONISTAT 7 Vaginal Cream and MONISTAT 7 Vaginal Suppositories.

CLINICAL PHARMACOLOGY

Miconazole nitrate exhibits fungicidal activity in vitro against species of the genus Candida. The pharmacologic mode of action is unknown. Following intravaginal administration of miconazole nitrate, small amounts are absorbed. Administration of a single dose of miconazole nitrate suppositories (100 mg) to healthy subjects resulted in a total recovery from the urine and feces of 0.85% (± 0.43%) of the administered dose.

Animal studies indicate that the drug crossed the placenta and doses above those used in humans result in embryo- and fetotoxicity (80 mg/kg, orally), although this has not been reported in human subjects (See PRECAUTIONS).

In multi-center clinical trials in 440 women with vulvovaginal candidiasis, the efficacy of treatment with the MONISTAT 3 Vaginal Suppository for 3 days was compared with treatment for 7 days with MONISTAT 7 Vaginal Cream. The clinical cure rates (free of microbiological evidence and clinical signs and symptoms of candidiasis at 8–10 days and 30–35 days post-therapy) were numerically lower, although statistically different, with the 3-Day Suppository when compared with the 7-Day Cream.

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