TEMAZEPAM capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Golden State Medical Supply, Inc.

INN (International Name):

TEMAZEPAM

Sammensetning:

TEMAZEPAM 15 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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. Temazepam capsules are a Schedule IV controlled substance. Temazepam is a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, diffic

Produkt oppsummering:

Temazepam capsules, USP are available as follows: 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 60429-506-01) and 500 (NDC 60429-506-05). 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 60429-507-01) and 500 (NDC 60429-507-05). 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. D 2/2023 Marketed/Packaged by: GSMS, Inc. Camarillo, CA USA 93012

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Golden State Medical Supply, Inc.
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Dispense with Medication Guide available at: www.tevausa.com/medguides
MEDICATION GUIDE
Temazepam (tem az' e pam) Capsules C-IV
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)
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, unusua

Preparatomtale

TEMAZEPAM- TEMAZEPAM CAPSULE
GOLDEN STATE MEDICAL SUPPLY, 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
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-2H-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 Ingredi