TERCONAZOLE cream

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

Terconazole (UNII: 0KJ2VE664U) (Terconazole - UNII:0KJ2VE664U)

可用日期:

Taro Pharmaceuticals U.S.A., Inc.

给药途径:

VAGINAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Terconazole vaginal cream is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As terconazole vaginal cream 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.

產品總結:

Terconazole Vaginal Cream 0.8% is available in 20 gram (NDC 51672-1302-0) tubes with 3 measured-dose applicators. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

授权状态:

Abbreviated New Drug Application

产品特点

TERCONAZOLE- TERCONAZOLE CREAM
TARO PHARMACEUTICALS U.S.A., INC.
----------
TERCONAZOLE
VAGINAL CREAM 0.8%
RX ONLY
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, purified water, and stearyl
alcohol.
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
26
31
2
5
3
14
Systemically absorbed terconazole is extensively metabolized (>95%).
ELIMINATION
Across various studies in healthy women, after single or multiple
intravaginal administration of
terconazole as th