TERCONAZOLE suppository

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Taro Pharmaceuticals U.S.A., Inc.

Пут администрације:

VAGINAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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.

Резиме производа:

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].

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

TERCONAZOLE- TERCONAZOLE SUPPOSITORY
TARO PHARMACEUTICALS U.S.A., INC.
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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