国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
TERCONAZOLE (UNII: 0KJ2VE664U) (TERCONAZOLE - UNII:0KJ2VE664U)
Actavis Pharma, Inc
TERCONAZOLE
TERCONAZOLE 4 mg in 1 g
VAGINAL
PRESCRIPTION DRUG
Terconazole Vaginal Cream is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As this product is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures. Patients known to be hypersensitive to terconazole or to any of the components of the cream.
Terconazole Vaginal Cream 0.4% is available in 45 g (NDC 0591-3196-89) tubes with a measured-dose applicator. Store at Controlled Room Temperature 15°–30°C (59°–86°F). Terconazole Vaginal Cream 0.8% is available in 20 g (NDC 0591-3197-52) tubes with a measured-dose applicator. Store at Controlled Room Temperature 15°–30°C (59°–86°F).
New Drug Application Authorized Generic
TERCONAZOLE- TERCONAZOLE CREAM ACTAVIS PHARMA, INC ---------- TERCONAZOLE VAGINAL CREAM 0.4% 7-DAY REGIMEN TERCONAZOLE VAGINAL CREAM 0.8% 3-DAY REGIMEN DESCRIPTION Terconazole Vaginal Cream 0.4% is a white to off-white, water washable cream for intravaginal administration containing 0.4% of the antifungal agent terconazole, _cis_-1-[_p_-[[2-(2,4-Dichlorophenyl)-2- (1_H_-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water. Terconazole Vaginal Cream 0.8% is a white to off-white, water washable cream for intravaginal administration containing 0.8% of the antifungal agent terconazole, _cis_-1-[_p_-[[2-(2,4-Dichlorophenyl)-2- (1_H_-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water. The structural formula of terconazole is as follows: Terconazole, a triazole derivative, is a white to almost white powder with a molecular weight of 532.47. It is insoluble in water; sparingly soluble in ethanol; and soluble in butanol. CLINICAL PHARMACOLOGY ABS ORPTION Following a single intravaginal application of a suppository containing 240 mg C-terconazole to healthy women, approximately 70% (range: 64–76%) of terconazole remains in the vaginal area during the suppository retention period (16 hours); approximately 10% (range: 5–16%) of the administered radioactivity was absorbed systemically over 7 days. Maximum plasma concentrations of terconazole occur 5 to 10 hours after intravaginal application of the cream or suppository. Systemic exposure to terconazole is approximately proportional to the applied dose, whether as the cream or suppository. The rate and extent of absorption of terconazole are 阅读完整的文件