Rx Item-Miconazole 3 200Mg Suppository 3 By Actavis Pharma(Teva)

MONISTAT 3- miconazole nitrate suppository
ORTHO PHARMACEUTICAL CORPORATION

DESCRIPTION

MONISTAT 3 Vaginal Suppositories are white to off-white suppositories, each containing the antifungal agent, miconazole nitrate, 1-[2,4-Dichloro-?-[(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 Indications and Usage

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.

RX ITEM-Miconazole 3 200Mg Suppository 3
NDC 00472-1738-03 UPC/GTIN No.3-04721-73803-8 Mfg.Part No.173803

Miconazole 3 200Mg Suppository 3 By Acta
BRAND: MICONAZOLE NDC: 00472-1738-03,472173803 UPC: 3-04721-73803-8,304721738038 Actavis Pharma

MICONAZOLE NITRATE VAGINA
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Buy More Save More!
Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.