TEMAZEPAM capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Institutional Inc.

INN (International Name):

TEMAZEPAM

Composition:

TEMAZEPAM 15 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 result

Product summary:

Temazepam Capsules, USP are available containing 15 mg or 30 mg of temazepam, USP. The 15 mg capsule is a hard-shell gelatin capsule with a peach opaque cap and a peach opaque body filled with an off-white powder blend. The capsule is axially printed with MYLAN over 4010 in black ink on both the cap and the body. They are available as follows: NDC 51079-418-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each). The 30 mg capsule is a hard-shell gelatin capsule with a yellow opaque cap and a yellow opaque body filled with an off-white powder blend. The capsule is axially printed with MYLAN over 5050 in black ink on both the cap and the body. They are available as follows: NDC 51079-419-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. The brands listed are trademarks of their respective owners. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TEMAZEPAM- TEMAZEPAM CAPSULE
Mylan Institutional Inc.
----------
MEDICATION GUIDE
Temazepam Capsules, USP CIV
(tem az' e pam)
What is the most important information I should know about temazepam
capsules?
•
Temazepam capsules are a benzodiazepine medicine. Taking
benzodiazepines with opioid medicines,
alcohol, or other central nervous system depressants (including street
drugs) can cause severe
drowsiness, breathing problems (respiratory depression), coma and
death.
•
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 healthcare provider right away if you find out that you have
done any of the above activities after
taking temazepam capsules.
•
Do not take temazepam capsules unless you are able to stay in bed a
full night (7 to 8 hours) before
you must be active again.
•
Do not take more temazepam capsules than prescribed.
What are temazepam capsules?
•
Temazepam capsules are a prescription 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 and waking up often during the
night.
•
Temazepam capsules are a federal controlled substance (C-IV) because
it can be abused or lead to
dependence. Keep temazepam capsules in a safe place to prevent misuse
and abuse. Selling or giving
away temazepam capsules may harm others, and is against the law. Tell
your healthcare provider if
you have ever abused or been dependent on alcohol, prescription
medicines or street drugs.
•
It is not known if temazepam cap

Summary of Product characteristics

TEMAZEPAM- TEMAZEPAM CAPSULE
MYLAN INSTITUTIONAL INC.
----------
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound
sedation, respiratory
depression, coma, and death (see WARNINGS and Drug Interactions).
Reserve concomitant prescribing of these drugs for use in patients for
whom alternative
treatment options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and
sedation.
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, USP is a white, crystalline substance, very slightly
soluble in water and sparingly soluble
in alcohol.
Temazepam capsules USP, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral
administration.
Each capsule contains the following inactive ingredients: colloidal
silicon dioxide, FD&C Yellow No.
6, gelatin, magnesium stearate, microcrystalline cellulose, powdered
cellulose, sodium lauryl sulfate
and titanium dioxide. In addition, the 7.5 mg, 22.5 mg and 30 mg empty
gelatin capsules contain D&C
Yellow No. 10.
The imprinting ink contains black iron oxide, D&C Yellow No. 10
Aluminum Lake, FD&C Blue No. 1
Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum
Lake, propylene
glycol and shellac glaze.
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 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), dependin