देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
TEMAZEPAM (UNII: CHB1QD2QSS) (TEMAZEPAM - UNII:CHB1QD2QSS)
Amneal Pharmaceuticals LLC
TEMAZEPAM
TEMAZEPAM 7.5 mg
ORAL
PRESCRIPTION DRUG
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 contain temazepam, 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
Temazepam capsules, USP 7.5 mg are hard gelatin capsules with white opaque body printed radially “583” with black ink and blue opaque cap printed radially “AMNEAL” with black ink. They are available as follows: Bottles of 30: NDC 65162-583-03 Bottles of 100: NDC 65162-583-10 Bottles of 500: NDC 65162-583-50 Bottles of 1000: NDC 65162-583-11 Temazepam capsules, USP 15 mg are hard gelatin capsules with white opaque body printed radially “556” with black ink and blue green opaque cap printed radially “AMNEAL” with black ink. They are available as follows: Bottles of 30: NDC 65162-556-03 Bottles of 100: NDC 65162-556-10 Bottles of 500: NDC 65162-556-50 Bottles of 1000: NDC 65162-556-11 Temazepam capsules, USP 22.5 mg are hard gelatin capsules with white opaque body printed radially “584” with black ink and dark pink opaque cap printed radially “AMNEAL” with black ink. They are available as follows: Bottles of 30: NDC 65162-584-03 Bottles of 100: NDC 65162-584-10 Bottles of 500: NDC 65162-584-50 Bottles of 1000: NDC 65162-584-11 Temazepam capsules, USP 30 mg are hard gelatin capsules with white opaque body printed radially “557” with black ink and white opaque cap printed radially “AMNEAL” with black ink. They are available as follows: Bottles of 30: NDC 65162-557-03 Bottles of 100: NDC 65162-557-10 Bottles of 500: NDC 65162-557-50 Bottles of 1000: NDC 65162-557-11 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]. Manufactured by: Amneal Pharmaceuticals of NY LLC Brookhaven, NY 11719 Distributed by: Amneal Pharmaceuticals LLC Glasgow, KY 42141 Rev. 02-2023-05
Abbreviated New Drug Application
Amneal Pharmaceuticals LLC ---------- MEDICATION GUIDE Temazepam (tem az’ e pam) Capsules, USP CIV 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 and severe पूरा दस्तावेज़ पढ़ें
TEMAZEPAM- TEMAZEPAM CAPSULE AMNEAL PHARMACEUTICALS 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, 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: C H CLN O MW = 300.74 Temazepam, USP 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 for oral ad पूरा दस्तावेज़ पढ़ें