TEMAZEPAM capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Temazepam Capsules, USP 15 mg Maroon cap / Opaque pink body, size 3, hard gelatin capsules imprinted with “A223” on body in black ink, filled with white to off white powder. NDC: 70518-3605-00 NDC: 70518-3605-01 PACKAGING: 100 in 1 BOX PACKAGING: 1 in 1 POUCH Dispense in a well-closed, light-resistant container with a child-resistant closure. Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TEMAZEPAM- TEMAZEPAM CAPSULE
REMEDYREPACK INC.
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MEDICATION GUIDE
Temazepam (tem az e pam) Capsules, USP CIV
What is the most important information I should know about temazepam
capsules?
• Temazepam capsule 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-threatening side effects, including, unusual
movements, responses, or expressions,
seizures, sudden and severe mental

Summary of Product characteristics

TEMAZEPAM- TEMAZEPAM CAPSULE
REMEDYREPACK INC.
----------
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 CAPSULES, 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 CAPSULES,
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, USP is a benzodiazepine hypnotic agent. The chemical name
is 7-chloro-1,
3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and
the structural
formula is:
C
H
CLN
O MW = 300.7
Temazepam, USP is a white or almost white crystalline powder, freely
slightly soluble in
methanol and methylene chloride.
Temazepam Capsules USP, 7.5 mg, 1