TEMAZEPAM capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvKARE

INN (International Name):

Temazepam

Composition:

Temazepam 7.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment. Benzodiazepines may cause fetal harm when administered to a pregnant woman. An increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. Transplacental distribution has resulted in neonatal CNS depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. Reproduction studies in animals with temazepam were performed in rats and rabbits. In a perinatal- postnatal study in rats, oral doses of 60 mg/kg/day resul

Product summary:

Temazepam capsules USP 7.5 mg White opaque/turquoise opaque capsules imprinted "Mutual 866". 15 mg White opaque/green opaque capsules imprinted "Mutual 867". 22.5 mg White opaque/light green opaque capsules imprinted "Mutual 868". 30 mg White opaque/white opaque capsules imprinted "Mutual 869". Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TEMAZEPAM- temazepam capsule
AvKARE
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MEDICATION GUIDE
TEMAZEPAM CAPSULES USP C-IV
Read the Medication Guide that comes with temazepam capsules before
you start taking it and each time you
get a refill. There may be new information. This Medication Guide does
not take the place of talking to your
doctor about your medical condition or treatment.
What is the most important information I should know about temazepam
capsules?
After taking temazepam capsules, you may get up out of bed while not
being fully awake and do an activity
that you do not know you are doing. The next morning, you may not
remember that you did anything during
the night. You have a higher chance for doing these activities if you
drink alcohol or take other medicines
that make you sleepy with temazepam capsules. Reported activities
include:
•
driving a car ("sleep-driving")
•
making and eating food
•
talking on the phone
•
having sex
•
sleep-walking
Call your doctor right away if you find out that you have done any of
the above activities after taking
temazepam capsules.
Important:
1. Take temazepam capsules exactly as prescribed
•
Do not take more temazepam capsules than prescribed.
•
Take temazepam capsules right before you get in bed, not sooner.
2. Do not take temazepam capsules if you:
•
drink alcohol
•
take other medicines that can make you sleepy. Talk to your doctor
about all of your medicines. Your
doctor will tell you if you can take temazepam capsules with your
other medicines
•
cannot get a full night's sleep
What are temazepam capsules?
Temazepam capsules are a sedative-hypnotic (sleep) medicine. Temazepam
capsules are used in adults for
the short-term (usually 7 to 10 days) treatment of a sleep problem
called insomnia. Symptoms of insomnia
include:
•
trouble falling asleep
•
waking up often during the night
Temazepam capsules are not for children.
Temazepam capsules are a federally controlled substance (C-IV) because
it can be abused or lead to
dependence. Keep temazepam capsules in a safe place to

Summary of Product characteristics

TEMAZEPAM- TEMAZEPAM CAPSULE
AVKARE
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TEMAZEPAM CAPSULES USP CIV
RX ONLY
DESCRIPTION
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.
Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg, and 30 mg, are for oral
administration.
_Active Ingredient: _temazepam USP
_Inactive Ingredients: _croscarmellose sodium, lactose monohydrate,
magnesium stearate,
microcrystalline cellulose, sodium lauryl sulfate. The capsule shell
contains gelatin and
titanium dioxide. The capsule shell for the 7.5 mg also contains FD&C
Blue #1 and FD&C
Red #40; the capsule shell for 15 mg and 22.5 mg also contains D&C
Yellow #10, FD&C
Blue #1 and FD&C Yellow #6. The imprinting ink contains: D&C Yellow
#10, FD&C Blue
#1, FD&C Blue #2, FD&C Red #40, iron oxide black and propylene glycol.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
In a single and multiple dose absorption, distribution, metabolism,
and excretion (ADME)
study, using
H labeled drug, temazepam capsules were 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
3
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