TEMAZEPAM capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

RxChange Co.

INN (International Name):

TEMAZEPAM

Composition:

TEMAZEPAM 15 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Temazepam is indicated for the short-term treatment of insomnia (generally 7 - 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam should be used for short periods of time (7 - 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 resulted in increasing nurs

Product summary:

Temazepam Capsules USP 15 mg — Each #3 capsule with green opaque cap and white opaque body, imprinted with 076 in black ink on both cap and body contains 15 mg of Temazepam, USP. Capsules are supplied in bottles of 100 (NDC 0228-2076-10) and 500 (NDC 0228-2076-50). 30 mg — Each #3 capsule with white opaque cap and body, imprinted with 077 in black ink on both cap and body contains 30 mg of Temazepam, USP. Capsules are supplied in bottles of 100 (NDC 0228 2077-10) and 500 (NDC 0228-2077-50). Dispense in a tight, light-resistant container as defined in the USP. Store at 25(C (77(F); excursions permitted to 15° to 30°C (59° to 86°F). Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA 40-9177 Revised –June 2012

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TEMAZEPAM- TEMAZEPAM CAPSULE
RxChange Co.
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MEDGUIDE
MEDICATION GUIDE
Temazepam Capsules, USP C-IV
Read the Medication Guide that comes with temazepam 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?
After taking temazepam, 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. 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.
Important:
1. Take temazepam exactly as prescribed
• Do not take more temazepam than prescribed.
• Take temazepam right before you get in bed, not sooner.
2. Do not take temazepam 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 with your other
medicines
• cannot get a full night’s sleep
What is temazepam?
Temazepam is a sedative-hypnotic (sleep) medicine. Temazepam 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
• waking up often during the night
Temazepam is not for children.
Temazepam is a federally controlled substance (C-IV) because it can be
abused or lead to dependence.
Keep temazepam in a safe place to prevent misuse and abuse. Selling or
giving away temazepam may
harm others, and is against the law. Tell your doctor if you hav

Summary of Product characteristics

TEMAZEPAM- TEMAZEPAM CAPSULE
RXCHANGE CO.
----------
TEMAZEPAM CAPSULES, USP CIV
40-9177
REVISED – JUNE 2012
RX ONLY
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, or 30 mg, are for oral administration.
_15 MG OR 30 MG CAPSULES_
_Active Ingredient:_ temazepam USP
15 mg — corn starch, colloidal silicon dioxide, D&C yellow #10, FD&C
green #3, FD&C yellow #6
(Sunset Yellow), gelatin, magnesium stearate, microcrystalline
cellulose, silicon dioxide, sodium lauryl
sulfate, titanium dioxide.
30 mg — corn starch, colloidal silicon dioxide, gelatin, magnesium
stearate, microcrystalline cellulose,
silicon dioxide, sodium lauryl sulfate, titanium dioxide.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
In a single and multiple dose absorption, distribution, metabolism,
and excretion (ADME) study, using
H labeled drug, temazepam was 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 -
0.6 hours and the terminal half-life
3
from 3.5 - 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 - 30 mg dose range.
Temazepam was completely metabolized through conjugation prior