País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
terconazole (UNII: 0KJ2VE664U) (terconazole - UNII:0KJ2VE664U)
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
terconazole
terconazole 8 mg in 1 g
VAGINAL
PRESCRIPTION DRUG
Terconazole vaginal cream 0.8% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream 0.8% 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 0.8% (NDC 0168-0347-20) is available in 20 gram tubes with a measured dose applicator. Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. 46270465A R05/2020 #34 Remove this portion before dispensing
New Drug Application
TERCONAZOLE VAGINAL CREAM 0.8%- TERCONAZOLE CREAM E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC. ---------- TERCONAZOLE VAGINAL CREAM 0.8% DESCRIPTION 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 Following intravaginal administration of terconazole in humans, absorption ranged from 5-8% in three hysterectomized subjects and 12-16% in two non-hysterectomized subjects with tubal ligations. Following daily intravaginal administration of 0.8% terconazole 40 mg (0.8% cream x 5 g) for seven days to normal humans, plasma concentrations were low and gradually rose to a daily peak (mean of 5.9 ng/mL or 0.006 mcg/mL) at 6.6 hours. Results from similar studies in patients with vulvovaginal candidiasis indicate that the slow rate of absorption, the lack of accumulation, and the mean peak plasma concentration of terconazole was not different from that observed in healthy women. The absorption characteristics of terconazole 0.8% in pregnant or non-pregnant patients with vulvovaginal candidiasis were also similar to those found in normal volunteers. Following oral (30 mg) administration of C-labelled terconazole, the harmonic half-life of elimination from the blood for the parent terconazole was 6.9 hours (range 4.0-11.3). Terconazole is extensively metabolized; the plasma AUC for terconazole compared to the AUC for total radioact Leer el documento completo