TEMAZEPAM capsule

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

TYA Pharmaceuticals

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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

Rezumat produs:

NDC:64725-2202-1 in a CONTAINER of 30 CAPSULES Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container.

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

TEMAZEPAM- TEMAZEPAM CAPSULE
TYA Pharmaceuticals
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MEDICATION GUIDE
Temazepam Capsules, USP CIV
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?
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: 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.
•
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

Caracteristicilor produsului

TEMAZEPAM- TEMAZEPAM CAPSULE
TYA PHARMACEUTICALS
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TEMAZEPAM CAPSULES, USP CIV
DESCRIPTION
Temazepam is a benzodiazepine hypnotic agent. The chemical name is
7-chloro-1,3-dihydro-3-hydroxy-
1-methyl-5-phenyl-2H-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:
gelatin, iron oxide black, shellac,
propylene glycol, titanium dioxide, methylparaben, butylparaben,
propylparaben, benzyl alcohol, sodium
propionate and edetate calcium disodium. The 15 mg capsules also
contain D&C Yellow #10 and FD&C
Blue #1.
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
concentration/time curve over the 15 to
30 mg dose range.
3
Temazepam was completely metabolized through conjugation prior to
excretion; 80% to 90% of t