País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
TERCONAZOLE (UNII: 0KJ2VE664U) (TERCONAZOLE - UNII:0KJ2VE664U)
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
TERCONAZOLE
TERCONAZOLE 4 mg in 1 g
VAGINAL
PRESCRIPTION DRUG
Terconazole vaginal cream 0.4% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream 0.4% 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: NDC 0168-0346-46 45 gram tube, with a measured dose applicator. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I2346C R09/14 #22 --------------------------------------------------------------------------------------------------------------------------------------------
Abbreviated New Drug Application
TERCONAZOLE- TERCONAZOLE CREAM E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC. ---------- TERCONAZOLE VAGINAL CREAM 0.4% RX ONLY 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. 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 ABSORPTION 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. 14 DISTRIBUTION 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. METABOLISM Systemically absorbed terconazole is extensively metabolized (>95%). ELIMINATION Across various studies in healthy women, after single or multiple intravaginal administration of terconazole as the cream o Leia o documento completo