TEMAZEPAM capsule

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Preferred Pharmaceuticals Inc.

INN (International namn):

TEMAZEPAM

Sammansättning:

TEMAZEPAM 30 mg

Receptbelagda typ:

PRESCRIPTION DRUG

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

TEMAZEPAM- TEMAZEPAM CAPSULE
PREFERRED PHARMACEUTICALS INC.
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TEMAZEPAM CAPSULES, USP C-IV
RX ONLY
DESCRIPTION
Temazepam, USP 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, USP is a white, crystalline substance, very slightly
soluble in water and sparingly soluble
in alcohol, USP.
Each capsule for oral administration contains either 7.5 mg, 15 mg,
22.5 mg or 30 mg temazepam, USP.
The inactive ingredients include: ammonia, black iron oxide, butyl
alcohol, croscarmellose sodium,
dehydrated alcohol, gelatin, isopropyl alcohol, lactose monohydrate,
magnesium stearate, polyethylene
glycol, potassium hydroxide, propylene glycol, shellac, and titanium
dioxide. Additionally, the 7.5 mg
capsule contains D&C Red #28 and FD&C Blue #1 and the 15 mg and 22.5
mg capsules contain FD&C
Blue #1, FD&C Red #40 and FD&C Yellow #6.
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
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 limiting
step in the biodisposition of
temazepam. There is no accumulation of metabolites. A
dose-proportional relationship has been
established for the area under the plasma concentration/time curve
over the 15 to 30 mg dose range.
Temazepam was completely metabolized throu