TEMAZEPAM capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Solco Healthcare U.S., LLC

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 7.5 mg Opaque Blue and Opaque pink capsules, with the opaque pink body imprinted “7.5mg” in black, and opaque blue cap imprinted “S611” in black. The capsules are supplied in bottles of 100 (43547-611-10). 15 mg Opaque Scarlet and Opaque pink capsules, with the Opaque pink body imprinted “15mg” in black, and Opaque Scarlet cap imprinted “S612” in black. The capsules are supplied in bottles of 100 (43547-612-10) and 500 (43547-612-50). 22.5 mg Opaque Blue capsules, with the Opaque Blue body imprinted “22.5mg” in black, and Opaque Blue cap imprinted “S613” in black. The capsules are supplied in bottles of 30 (43547-613-03). 30 mg Opaque Scarlet and Opaque blue capsules, with the opaque blue body imprinted “30mg” in black, and Opaque scarlet cap imprinted “S614” in black. The capsules are supplied in bottles of 100 (43547-614-10) and 500 (43547-614-50). Dispense in a well-closed, light-resistant container with a child-resistant closure. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense with Medication Guide available at: www.solcohealthcare.com/medguide/temazepam-capsules.pdf

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TEMAZEPAM- TEMAZEPAM CAPSULE
Solco Healthcare U.S., LLC
----------
MEDICATION GUIDE
Temazepam Capsules, USP
(təˈmæzɪpæm)
Dispense with Medication Guide available at:
www.solcohealthcare.com/medguide/temazepam-capsules.pdf
What is the most important information I should know about temazepam
capsules?
•
Temazepam capsules is 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:
o
shallow or slowed breathing
o
breathing stops (which may lead to the heart stopping)
o
excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
temazepam capsules and opioids
affects you.
o
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.
o
You can develop an addiction even if you take temazepam capsules as
prescribed by your
healthcare provider.
o
Take temazepam capsules exactly as your healthcare provider
prescribed.
o
Do not share your temazepam capsules with other people.
o
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.
o
Do not suddenly stop taking temazepam capsules. Stopping temazepam
capsules suddenly can
cause serious and life-threat

Summary of Product characteristics

TEMAZEPAM- TEMAZEPAM CAPSULE
SOLCO HEALTHCARE U.S., LLC
----------
TEMAZEPAM CAPSULES USP
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 CAPSULES
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 CAPSULES 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 CAPSULES OR REDUCE THE
DOSAGE (SEE DOSAGE AND ADMINISTRATION AND WARNINGS).
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 MW = 300.74
Temazepam is a white, crystalline substance, very slightly soluble in
water and sparingly
soluble in alcohol USP.
Temazepam capsules USP, 7.5 mg, 15 mg, 22.5 mg, and 30 m