TEMAZEPAM capsule

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Alembic Pharmaceuticals Inc.

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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. Controlled Substance Temazepam capsule contains temazepam, a Schedule IV controlled substance. Abuse Temazepam capsule 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 ma

Sommarju tal-prodott:

Temazepam Capsules, USP 7.5 mg   Opaque blue cap / Opaque pink body, size 3, hard gelatin capsules imprinted with “A222” on body in black ink, filled with white to off white powder.  NDC 62332-379-30                Bottle of 30 capsules NDC 62332-379-31                Bottle of 100 capsules 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 62332-380-30                Bottle of 30 capsules NDC 62332-380-90                Bottle of 90 capsules NDC 62332-380-31                Bottle of 100 capsules NDC 62332-380-71                Bottle of 500 capsules 22.5 mg Opaque blue cap / Opaque blue body, size 3, hard gelatin capsules imprinted with “A224” on body in black ink, filled with white to off white powder.  NDC 62332-381-30                Bottle of 30 capsules  30 mg   Maroon cap / Opaque blue body, size 3, hard gelatin capsules imprinted with “A225” on body in black ink, filled with white to off white powder.  NDC 62332-382-30                Bottle of 30 capsules NDC 62332-382-90                Bottle of 90 capsules NDC 62332-382-31                Bottle of 100 capsules NDC 62332-382-71                Bottle of 500 capsules  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].  Medication Guide available at http://www.alembicusa.com/medicationguide.aspx or call 1-866-210-9797.                Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India  Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Revised: 02/2023

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Fuljett ta 'informazzjoni

Alembic Pharmaceuticals Inc.
----------
MEDICATION GUIDE
Temazepam (tem az e pam)
Capsules, USP C-IV
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.
o 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 or nervous sys

Karatteristiċi tal-prodott

TEMAZEPAM - TEMAZEPAM CAPSULE
ALEMBIC PHARMACEUTICALS 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