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.

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.

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.

Patients known to be hypersensitive to this drug.

During clinical studies with MONISTAT 3 Vaginal Suppository (miconazole nitrate, 200 mg) 301 patients were treated. The incidence of vulvovaginal burning, itching or irritation was 2%. Complaints of cramping (2%) and headaches (1.3%) were also reported. Other complaints (hives, skin rash) occurred with less than a 0.5% incidence. The therapy-related dropout rate was 0.3%.

Overdosage of miconazole nitrate in humans has not been reported to date. In mice, rats, guinea pigs and dogs, the oral LD 50 values were found to be 578.1, > 640, 275.9 and > 160 mg/kg, respectively.

MONISTAT 3 Vaginal Suppositories: One suppository (miconazole nitrate, 200 mg) is inserted intravaginally once daily at bedtime for three consecutive days. Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures to rule out other pathogens.

MONISTAT 3 Suppositories (miconazole nitrate, 200 mg) are available as 2.5 gm elliptically shaped white to off-white suppositories in packages of three (NDC 0062-5437-01) with a vaginal applicator. Store at 59–86°F (15–30°C).

ORTHO PHARMACEUTICAL CORPORATION
Raritan, New Jersey 08869

© OPC 1984
PRINTED IN USA
REV OCT. 1996
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