Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
Terconazole (UNII: 0KJ2VE664U) (Terconazole - UNII:0KJ2VE664U)
Taro Pharmaceuticals U.S.A., Inc.
VAGINAL
PRESCRIPTION DRUG
Terconazole Vaginal Suppositories, 80 mg 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 suppositories.
Terconazole Vaginal Suppositories 80 mg are available as 2.5 g, elliptically-shaped white to off-white suppositories in packages of three with a vaginal applicator. NDC 51672-1330-3 Store at 20°- 25°C (68°- 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
TERCONAZOLE- TERCONAZOLE SUPPOSITORY TARO PHARMACEUTICALS U.S.A., INC. ---------- TERCONAZOLE VAGINAL SUPPOSITORIES 80 MG RX ONLY DESCRIPTION Terconazole Vaginal Suppositories are white to off-white suppositories for intravaginal administration containing 80 mg 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, in triglycerides derived from coconut and/or palm kernel oil (a base of hydrogenated vegetable oils) and butylated hydroxyanisole. The structural formula of terconazole is as follows: TERCONAZOLE C H Cl N O 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 to 76%) of terconazole remains in the vaginal area during the suppository retention period (16 hours); approximately 10% (range: 5 to 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 similar in patients with vulvovaginal candidiasis (pregnant or non-pregnant) and healthy subjects. DIS TRIBUTION Terconazole is highly protein bound (94.9%) in human plasma and the degree of binding is independent of drug concentration over the range of 0.01 to 5 mcg/mL. METABOLIS M Systemically absorbed terconazole is extensively metabolized (>95%). 26 31 2 5 3 14 ELIMINATION Across various studies in healthy women, after single or multiple intravaginal administration of terconazole as the cream or suppository/ovule, the mean eliminati Baca dokumen lengkapnya