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Monistat 3 (Miconazole Nitrate Vaginal) - Summary

 


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MONISTAT 3 SUMMARY

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

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.

MONISTAT 3 Vaginal Suppositories are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). Effectiveness in pregnancy and in diabetic patients has not been established. As MONISTAT is effective only for candidal vulvovaginitis, the diagnosis should be confirmed by KOH smear and/or cultures. Other pathogens commonly associated with vulvovaginitis (Trichomonas and Haemophilus vaginalis [Gardnerella]) should be ruled out by appropriate laboratory methods.


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MONISTAT 3 NEWS HIGHLIGHTS

Published Studies Related to Monistat 3 (Miconazole Vaginal)

Safety and efficacy of bedtime versus daytime administration of the miconazole nitrate 1200 mg vaginal ovule insert to treat vulvovaginal candidiasis. [2005.01]

Comparison of dermatopharmacokinetic vs. clinicial efficacy methods for bioequivalence assessment of miconazole nitrate vaginal cream, 2% in humans. [2002.03]

[Efficacy and tolerance of 200 mg of fenticonazole versus 400 mg of miconazole in the intravaginal treatment of mycotic vulvovaginitis] [2002.02]

Single-dose miconazole nitrate vaginal ovule in the treatment of vulvovaginal candidiasis: two single-blind, controlled studies versus miconazole nitrate 100 mg cream for 7 days. [2000.05]

A comparative clinical evaluation of econazole nitrate, miconazole, and nystatin in the treatment of vaginal candidiasis. [2000.01]

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Clinical Trials Related to Monistat 3 (Miconazole Vaginal)

Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients [Completed]

Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081) [Completed]

Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans [Recruiting]

Comparative Efficacy of Ovule vs Tablet [Recruiting]

Antifungal Use in Oncohematological Neutropenic Patients [Recruiting]

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Page last updated: 2007-05-02

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