TEMAZEPAM capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

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:

NDC: 71335-0527-1: 30 Capsules in a BOTTLE NDC: 71335-0527-2: 20 Capsules in a BOTTLE NDC: 71335-0527-3: 100 Capsules in a BOTTLE NDC: 71335-0527-4: 60 Capsules in a BOTTLE NDC: 71335-0527-5: 90 Capsules in a BOTTLE NDC: 71335-0527-6: 28 Capsules in a BOTTLE NDC: 71335-0527-7: 10 Capsules in a BOTTLE NDC: 71335-0527-8: 45 Capsules in a BOTTLE NDC: 71335-0527-9: 120 Capsules in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Bryant Ranch Prepack
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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.
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)
Do not drive or operate heavy machinery until you know how taking
temazepam capsules and opioids affect you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with benzodiazepines including temazepam
capsules
which can lead to overdose and serious side effects including coma and
death. Serious side effects including coma and death have
happened in people who have abused or misused benzodiazepines,
including temazepam capsules. These serious side effects may also
include delirium, paranoia, suicidal thoughts or actions, seizures,
and difficulty breathing. Call your healthcare provider or go to the
nearest
hospital emergency room right away if you get any of these serious
side effects.
•
You can develop an addiction even if you take temazepam capsules as
prescribed by your healthcare provider
•
Take temazepam capsules exactly as your healthcare provider
prescribed.
•
Do not share your temazepam capsules with other people.
•
Keep temazepam capsules in a safe place and away from children.
•
Physical dependence and withdrawal reactions. Temazepam capsules can
cause physical dependence and withdrawal reactions.
•
Do not suddenly stop taking temazepam capsules. Stopping temazepam
capsules suddenly can cause serious and life-threatening side
effects, including, unusual movements, respo

Summary of Product characteristics

TEMAZEPAM- TEMAZEPAM CAPSULE
BRYANT RANCH PREPACK
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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
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).
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:
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 Ingredient:_ temazepam,