TEMAZEPAM capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Mylan Pharmaceuticals Inc.

INN (International Name):

TEMAZEPAM

Sammensetning:

TEMAZEPAM 7.5 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 are available containing 7.5 mg, 15 mg, 22.5 mg or 30 mg of temazepam, USP. The 7.5 mg capsules are hard-shell gelatin capsules with a peach opaque cap and an ivory opaque body filled with an off-white powder blend. The capsules are axially printed with MYLAN over 3110 in black ink on both the cap and the body. They are available as follows: NDC 0378-3110-01 bottles of 100 capsules The 15 mg capsules are hard-shell gelatin capsules with a peach opaque cap and a peach opaque body filled with an off-white powder blend. The capsules are axially printed with MYLAN over 4010 in black ink on both the cap and the body. They are available as follows: NDC 0378-4010-77 bottles of 90 capsules NDC 0378-4010-01 bottles of 100 capsules NDC 0378-4010-05 bottles of 500 capsules The 22.5 mg capsules are hard-shell gelatin capsules with a yellow opaque cap and a peach opaque body filled with an off-white powder blend. The capsules are axially printed with MYLAN over 3120 in black ink on both the cap and the body. They are available as follows: NDC 0378-3120-93 bottles of 30 capsules The 30 mg capsules are hard-shell gelatin capsules with a yellow opaque cap and a yellow opaque body filled with an off-white powder blend. The capsules are axially printed with MYLAN over 5050 in black ink on both the cap and the body. They are available as follows: NDC 0378-5050-77 bottles of 90 capsules NDC 0378-5050-01 bottles of 100 capsules NDC 0378-5050-05 bottles of 500 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. The brands listed are trademarks of their respective owners. PHARMACIST: Dispense a Medication Guide with each prescription.

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Mylan Pharmaceuticals Inc.
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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:
o
driving a car (“sleep-driving”)
o
making and eating food
o
talking on the phone
o
having sex
o
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 capsules are safe and effective in
child

Preparatomtale

TEMAZEPAM- TEMAZEPAM CAPSULE
MYLAN PHARMACEUTICALS INC.
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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:
C H CLN O M.W. = 300.74
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.
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.
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13
2
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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 fr