Country: United States
Language: English
Source: NLM (National Library of Medicine)
Terconazole (UNII: 0KJ2VE664U) (Terconazole - UNII:0KJ2VE664U)
Rebel Distributors Corp
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 45 g tubes with a measured-dose applicator. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
TERCONAZOLE- TERCONAZOLE CREAM REBEL DISTRIBUTORS CORP ---------- 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 Following intravaginal administration of terconazole in humans, absorption ranged from 5-8% in three hysterectomized subjects and 12-16% in two nonhysterectomized subjects with tubal ligations. 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 radioactivity was 0.6%. Total radioactivity was eliminated from the blood with a harmonic half-life of 52.2 hours (range 44- 60). Excretion of radioactivity was both by renal (32-56%) and fecal (47-52%) routes. _In vitro_, terconazole is highly protein bound (94.9%) and the degree of binding is independent of drug concentration. Photosensitivity reactions were observed in some normal volunteers following repeated dermal application of terconazole 2.0% and 0.8% creams under conditions of filtered artificial ultraviolet light. Photosensitivity reactions have not been observed in U.S. and foreign clinical trials in patients who were treated with terconazole vaginal cream 0.4%. MICROBIOLOGY Terconazole exhibits Read the complete document