TEMAZEPAM capsule

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

SpecGx LLC

INN (इंटरनेशनल नाम):

TEMAZEPAM

रचना:

TEMAZEPAM 7.5 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Temazepam Capsules USP 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 USP 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 contain temazepam, a Schedule IV controlled substance. Temazepam capsules are 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 stro

उत्पाद समीक्षा:

Blue and pink capsules, with the pink body imprinted “FOR SLEEP” on one side and  on the other side in red, and a blue cap imprinted “7.5 mg” twice in red. Bottle of 100 . . . . . . . . .NDC 0406-9960-01 Maroon and pink capsules, with the pink body imprinted “FOR SLEEP” on one side and  on the other side in red, and a maroon cap imprinted “15 mg” twice in white. Bottle of 100. . . . . . . . .NDC 0406-9961-01 Opaque blue capsules, with the opaque blue body imprinted “FOR SLEEP” on one side and  on the other side in red, and an opaque blue cap imprinted “22.5 mg” twice in red. Bottle of 30 . . . . . . . . . .NDC 0406-9959-03 Maroon and blue capsules, with the blue body imprinted “FOR SLEEP” on one side and  on the other side in red, and a maroon cap imprinted “30 mg” twice in white. Bottle of 100. . . . . . . . .NDC 0406-9962-01 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]. Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo,  and other brands are trademarks of a Mallinckrodt company. © 2023 Mallinckrodt. Rev 01/2023 Mallinckrodt™ Pharmaceuticals An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20T06.pdf or by calling 1-800-778-7898 for alternate delivery options.

प्राधिकरण का दर्जा:

New Drug Application

सूचना पत्रक

TEMAZEPAM- TEMAZEPAM CAPSULE
SpecGx LLC
----------
MEDICATION GUIDE
Temazepam (te-maz'ĕ-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
affects 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,
responses, or expressions, seizures, sudden a

उत्पाद विशेषताएं

TEMAZEPAM- TEMAZEPAM CAPSULE
SPECGX LLC
----------
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 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 Capsules USP are benzodiazepine hypnotic agents. 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 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 mg, are