Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)
Actavis Pharma, Inc.
MICONAZOLE NITRATE
MICONAZOLE NITRATE 200 mg
VAGINAL
PRESCRIPTION DRUG
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. Patients known to be hypersensitive to this drug.
Miconazole Nitrate Vaginal Suppositories USP, 200 mg are available as elliptically shaped white to off-white suppositories in packages of three with a vaginal applicator NDC 0472-1738-03. Store at controlled room temperature 15° to 30°C (59° to 86°F). Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 Rev. A 7/2020
Abbreviated New Drug Application
MICONAZOLE NITRATE- MICONAZOLE NITRATE SUPPOSITORY ACTAVIS PHARMA, INC. ---------- MICONAZOLE NITRATE VAGINAL SUPPOSITORIES USP, 200 MG PHYSICIAN’S INSERT RX ONLY DESCRIPTION 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 H Cl N O•HNO ; the molecular weight is 479.14 and the structural formula may be represented as follows: 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 vaginal suppositories (100 mg) to healthy subjects resulted in 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 Miconazole Nitrate Vaginal Suppositories USP, 200 mg for 3 days was compared with treatment for 7 days with Miconazole Nitrate Vaginal Cream 2%. The clinical cure rates (free of microbiological evidence and clinical signs and symptoms of candidiasis at 8 to 10 days and 30 to 35 days post therapy) were numerically lower, although not statistically different, with the 3-Day Suppository when compared with the 7-Day Cream. INDICATIONS AND USAGE 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 18 14 4 2 3 miconazole nitrate is Belgenin tamamını okuyun