TEMAZEPAM- temazepam capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Sandoz Inc

INN (International Name):

TEMAZEPAM

Sammensetning:

TEMAZEPAM 15 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

Temazepam capsules, USP for oral administration are available as: 15 mg: Green and white capsules, imprinted GG 531 and supplied as: NDC 0781-2201-01 bottles of 100 NDC 0781-2201-05 bottles of 500 30 mg: White capsules, imprinted GG 532 and supplied as: NDC 0781-2202-01 bottles of 100 NDC 0781-2202-05 bottles of 500 Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Sandoz Inc
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MEDICATION GUIDE
Temazepam Capsules, USP CIV
(teh-MAZ-eh-pam)
What is the most important information I should know about temazepam
capsules?
•
Temazepam capsules are 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 is a prescription sleep medicine. Temazepam
capsules is 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 is 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 capsules is safe and effective in
children.
•
It

Preparatomtale

TEMAZEPAM- TEMAZEPAM CAPSULE
SANDOZ INC
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TEMAZEPAM CAPSULES, USP CIV
RX ONLY
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]_.
•
•
•
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, 15 mg and 30 mg, are for oral administration.
Active ingredient: temazepam, USP
Inactive ingredients: corn starch, hypromellose, lactose monohydrate,
magnesium stearate, and sodium
lauryl sulfate. The capsule shells and imprinting inks contain: benzyl
alcohol, butylparaben, edetate
calcium disodium, gelatin, iron oxide black, methylparaben, potassium
hydroxide, propylene glycol,
propylparaben, shellac, sodium lauryl sulfate, sodium propionate,
strong ammonia solution and titanium
dioxide. The 15 mg capsules also contain D&C Yellow #10 and FD&C Blue
#1.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
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.
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.