TEMAZEPAM capsule

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

TEMAZEPAM (UNII: CHB1QD2QSS) (TEMAZEPAM - UNII:CHB1QD2QSS)

Доступна с:

Qualitest Pharmaceuticals

ИНН (Международная Имя):

TEMAZEPAM

состав:

TEMAZEPAM 7.5 mg

Тип рецепта:

PRESCRIPTION DRUG

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

TEMAZEPAM- TEMAZEPAM CAPSULE
QUALITEST PHARMACEUTICALS
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TEMAZEPAM CAPSULES USP
CIV
RX ONLY
DESCRIPTION
Temazepam capsules USP are benzodiazepine hypnotic agents. The
chemical name is 7-chloro-1, 3-
dihydro-3-hydroxy-1-methyl-5-phenyl-2_H_-1,4-benzodiazepin-2-one, and
the structural formula is:
Temazepam is a white, crystalline substance, very slightly soluble in
water and sparingly soluble in
alcohol USP.
Temazepam capsules USP, 7.5 mg, 15 mg, 22.5 mg, and 30 mg, are for
oral administration.
7.5 MG, 15 MG, 22.5 MG, AND 30 MG CAPSULES
Active Ingredient: temazepam, USP
Each capsule contains the following inactive ingredients: colloidal
silicon dioxide, edetate disodium,
lactose monohydrate, magnesium stearate, microcrystalline cellulose,
pregelatinized starch and sodium
lauryl sulfate. The capsule shells for all strengths contain FD&C Blue
#1, FD&C Red #40, gelatin and
titanium dioxide. In addition, the 7.5 mg, 22.5 mg and 30 mg capsule
shells contain D&C Red #28. The
imprinting ink may contain butyl alcohol, D&C Yellow #10 Aluminum
Lake, FD&C Blue #1 Aluminum
Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, iron
oxide black, propylene
glycol, SD-45 alcohol, SDA-3A alcohol and shellac glaze.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
In a single and multiple dose absorption, distribution, metabolism,
and excretion (ADME) study, using
H labeled drug, temazepam was well absorbed and found to have minimal
(8%) first pass metabolism.
There were no active metabolites formed and the only significant
metabolite present in blood was the
O-conjugate. The unchanged drug was 96% bound to plasma proteins. The
blood level decline of the
3
parent drug was biphasic with the short half-life ranging from 0.4 to
0.6 hours and the terminal half-life
from 3.5 to 18.4 hours (mean 8.8 hours), depending on the study
population and method of determination.
Metabolites were formed with a half-life of 10 hours and excreted with
a half-life of approximately 2
hours. Thus, formation of the major metabolite is the rate limit