RESTORIL temazepam capsule

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Cardinal Health

INN (Tên quốc tế):

TEMAZEPAM

Thành phần:

TEMAZEPAM 7.5 mg

Loại thuốc theo toa:

PRESCRIPTION DRUG

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

RESTORIL- TEMAZEPAM CAPSULE
CARDINAL HEALTH
----------
RES TORIL™
(TEMAZEPAM)
CAPSULES USP
CIV
RX ONLY
DESCRIPTION
Restoril™ (temazepam) is a benzodiazepine hypnotic agent. 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.
Restoril™ (temazepam) capsules, 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
_7.5 MG CAPSULES_
_Inactive Ingredients:_ FD&C Blue #1, FD&C Red #3, gelatin, lactose,
magnesium stearate, red iron oxide,
titanium dioxide.
_May also include:_ n-butyl alcohol, iron oxide red, shellac, shellac
glaze, SD-35A alcohol.
_15 MG CAPSULES_
_Inactive Ingredients:_ FD&C Blue #1, FD&C Red #3, gelatin, lactose,
magnesium stearate, red iron oxide,
titanium dioxide.
_May also include:_ n-butyl alcohol, FD&C Blue #1 / Brilliant Blue FCF
Aluminum Lake, iron oxide red,
isopropyl alcohol, propylene glycol, shellac, shellac glaze, SD-35A
alcohol, SD-45 alcohol.
_22.5 MG CAPSULES_
_Inactive Ingredients:_ FD&C Blue #1, FD&C Red #3, gelatin, lactose,
magnesium stearate, red iron oxide,
titanium dioxide.
_May also include:_ n-butyl alcohol, FD&C Blue #1 / Brilliant Blue FCF
Aluminum Lake, iron oxide red,
isopropyl alcohol, propylene glycol, shellac, shellac glaze, SD-35A
alcohol, SD-45 alcohol.
_30 MG CAPSULES_
_Inactive Ingredients:_ FD&C Blue #1, FD&C Red #3, gelatin, lactose,
magnesium stearate, red iron oxide,
titanium dioxide.
_May also include:_ n-butyl alcohol, FD&C Blue #1 / Brilliant Blue FCF
Aluminum Lake, iron oxide red,
isopropyl alcohol, propylene glycol, shellac, shellac glaze, SD-35A
alcohol, SD-45 alcohol.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
In a single and multiple dose absorption, distribution, metabolism,
and excretion (ADME) study, using
H labeled drug, Restoril was well absorbed and found to have minimal