MICONAZOLE NITRATE

Miconazole Nitrate Vaginal Suppositories USP, 200 mg are white to off-white suppositories, each containing the antifungal agent, miconazole nitrate, USP 1-[2,4-Dichloro-β-[(2,4- dichlorobenzyl)oxy] phenethyl]-imidazole mononitrate, 200 mg, in a hydrogenated vegetable oil base. The molecular formula is C 18 H 14 Cl 4 N 2 O•HNO 3 ; the molecular weight is 479.14 and the structural formula may be represented as follows: 009711be-figure-01

Miconazole Nitrate Vaginal Suppositories USP, 200 mg are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). Effectiveness in pregnancy has not been established. As miconazole nitrate 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.

Miconazole Nitrate Vaginal Suppositories USP, 200 mg: 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.

Patients known to be hypersensitive to this drug.

During clinical studies with Miconazole Nitrate Vaginal Suppositories USP, 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%. To report SUSPECTED ADVERSE EVENTS, contact Teva Pharmaceuticals USA, Inc., at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.