TEMAZEPAM capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Temazepam (UNII: CHB1QD2QSS) (Temazepam - UNII:CHB1QD2QSS)

Tilgjengelig fra:

Proficient Rx LP

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 resul

Produkt oppsummering:

Temazepam capsules USP 7.5 mg White opaque/turquoise opaque capsules imprinted "Mutual 866". Bottle of 15 NDC 63187-718-15 Bottle of 20 NDC 63187-718-20 Bottle of 30 NDC 63187-718-30 Bottle of 60 NDC 63187-718-60 Bottle of 90 NDC 63187-718-90 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

TEMAZEPAM- TEMAZEPAM CAPSULE
Proficient Rx LP
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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

Preparatomtale

TEMAZEPAM- TEMAZEPAM CAPSULE
PROFICIENT RX LP
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TEMAZEPAM CAPSULES USP CIV
RX ONLY
DES CRIPTION
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:
C16H13CIN2O2 MW = 300.74
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 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
concentra