TEMAZEPAM capsule

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Aidarex Pharmaceuticals LLC

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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

Ringkasan produk:

Temazepam Capsules, USP are 15 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: 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.

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

TEMAZEPAM- TEMAZEPAM CAPSULE
Aidarex Pharmaceuticals LLC
----------
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 temazepa

Ciri produk

TEMAZEPAM- TEMAZEPAM CAPSULE
AIDAREX PHARMACEUTICALS LLC
----------
TEMAZEPAM USP
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:
STRUCTURAL FORMULA
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.
16
13
2
2
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