TEMAZEPAM capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Health Packaging

INN (International Name):

TEMAZEPAM

Composition:

TEMAZEPAM 7.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. Abuse and misuse of benzodiazepines may lead to addiction. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. Benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see WARNINGS, Abuse, Misuse, and Addiction ). The following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. The following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. Death is more often associated with polysubstance use (especially benzodiazepines with other CNS depressants such as opioids and alcohol). Physical Dependence Temazepam capsules may produce physical dependence from continued therapy. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use (see WARNINGS, Dependence and Withdrawal Reactions ). To reduce the risk of withdrawal reactions, use a gradual taper to discontinue temazepam capsules or reduce the dosage (see DOSAGE AND ADMINISTRATION, Discontinuation or Dosage Reduction of Temazepam Capsules and WARNINGS, Dependence and Withdrawal Reactions ). Acute Withdrawal Signs and Symptoms Acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. More severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures, and suicidality. Protracted Withdrawal Syndrome Protracted withdrawal syndrome with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. Protracted withdrawal symptoms may last weeks to more than 12 months. As a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used. Tolerance Tolerance to temazepam capsules may develop from continued therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Tolerance to the therapeutic effect of temazepam capsules may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

Product summary:

Temazepam Capsules USP 7.5 mg 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.    Unit dose packages of 30 (3 x 10) NDC 68084-549-21 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo, and other brands are trademarks of a Mallinckrodt company. © 2023 Mallinckrodt.

Authorization status:

New Drug Application

Patient Information leaflet

American Health Packaging
----------
MEDICATION GUIDE
8254921/1123
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, sudde

Summary of Product characteristics

TEMAZEPAM- TEMAZEPAM CAPSULE
AMERICAN HEALTH PACKAGING
----------
TEMAZEPAM CAPSULES USP CIV
8254921/1123
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