TEMAZEPAM capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Temazepam is 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 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 resulted in increasing nu

Product summary:

Temazepam capsules, USP are available as follows: 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; Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. C 10/2021 Repackaged By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Preferred Pharmaceuticals Inc.
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Dispense with Medication Guide available at: www.tevausa.com/medguides
MEDICATION GUIDE
Temazepam (tem az' e pam) Capsules CIV
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 (CNS) depressants (including
street drugs) can cause severe
drowsiness, breathing problems (respiratory depression), coma and
death. Get emergency help right
away if any of the following happens:
•
shallow or slowed breathing
•
breathing stops (which may lead to the heart stopping)
•
excessive sleepiness (sedation)
NaN
Do not drive or operate heavy machinery until you know how taking
temazepam capsules and opioids
affect you.
Call your healthcare provider right away if you find out that you have
done any of the above activities after
taking temazepam capsules.
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 (CIV) because
they contain temazepam that
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
children.
•
It is not known if temazepam capsules are safe and effective for use
longer than 2 weeks.
Do not take temazepam capsules if you:
•
are allergic to temazepam or any of the ingredients in temazepam
capsules. See the end of this
Medication Guide for a complete list of ingredients in temaz

Summary of Product characteristics

TEMAZEPAM- TEMAZEPAM CAPSULE
PREFERRED PHARMACEUTICALS INC.
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TEMAZEPAM CAPSULES, USP CIV
RX ONLY
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
•
•
•
DESCRIPTION
Temazepam, USP 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:
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN
PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH.
RESERVE CONCOMITANT PRESCRIBING OF THESE DRUGS 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
(_SEE _WARNINGS _AND _PRECAUTIONS). THE USE OF BENZODIAZEPINES, INCLUDING TEMAZEPAM, EXPOSES USERS
TO RISKS OF ABUSE, MISUSE, AND ADDICTION, WHICH CAN LEAD TO OVERDOSE
OR DEATH. ABUSE AND MISUSE OF BENZODIAZEPINES COMMONLY INVOLVE
CONCOMITANT USE OF OTHER MEDICATIONS, ALCOHOL, AND/OR ILLICIT
SUBSTANCES, WHICH IS ASSOCIATED WITH AN INCREASED FREQUENCY OF
SERIOUS ADVERSE OUTCOMES. BEFORE PRESCRIBING TEMAZEPAM AND
THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE,
MISUSE, AND ADDICTION (_SEE _WARNINGS). THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING TEMAZEPAM, MAY
LEAD TO CLINICALLY SIGNIFICANT PHYSICAL DEPENDENCE. THE RISKS OF
DEPENDENCE AND WITHDRAWAL INCREASE WITH LONGER TREATMENT DURATION
AND HIGHER DAILY DOSE. ABRUPT DISCONTINUATION OR RAPID DOSAGE
REDUCTION OF TEMAZEPAM AFTER CONTINUED USE MAY PRECIPITATE ACUTE
WITHDRAWAL REACTIONS, WHICH CAN BE LIFE-THREATENING. TO REDUCE THE
RISK OF WITHDRAWAL REACTIONS, USE A GRADUAL TAPER TO DISCONTINUE
TEMAZEPAM OR REDUCE THE DOSAGE (_SEE _DOSAGE AND
ADMINISTRATION _AND _WARNINGS).
Temazepam, USP is a white, crystalline substance, very slightly
soluble in water and
sparingly soluble in alcohol, USP.
Temazepam capsules USP, 15 mg and 30 mg, are for oral administration.
_Active