Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
TEMAZEPAM (UNII: CHB1QD2QSS) (TEMAZEPAM - UNII:CHB1QD2QSS)
REMEDYREPACK INC.
ORAL
PRESCRIPTION DRUG
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 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. Benzodiazepines may cause fetal harm when administered to a pregnant woman. An increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. Transplacental distribution has resulted in neonatal CNS depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. Reproduction studies in animals with temazepam were performed in rats and rabbits. In a perinatal-postnatal study in rats, oral doses of 60 mg/kg/day r
Temazepam Capsules USP 22.5 mg Light blue opaque cap and white opaque body, imprinted “22.5 mg” on cap and “Novel 122” on the body in black ink. NDC: 70518-2008-00 PACKAGING: 30 in 1 BOTTLE PLASTIC 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]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Abbreviated New Drug Application
TEMAZEPAM- TEMAZEPAM CAPSULE REMEDYREPACK INC. ---------- MEDICATION GUIDE TEMAZEPAM (tem az' e pam) Capsules, C-IV What is the most important information I should know about temazepam? • temazepam is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system 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 and opioids affects you. • o Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines including temazepam 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. 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 as prescribed by your healthcare provider o Take temazepam exactly as your healthcare provider prescribed. o Do not share your temazepam with other people. o Keep TEMAZEPAM in a safe place and away from children. • Physical dependence and withdrawal reactions. temazepam can cause physical dependence and withdrawal reactions. o Do not suddenly stop taking temazepam. Stopping temazepam suddenly can cause serious and life- threatening side effects, including, unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an ex read_full_document
TEMAZEPAM- TEMAZEPAM CAPSULE REMEDYREPACK INC. ---------- 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. 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 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 is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. _7.5 MG, 15 MG, 22.5 MG AND 30 MG CAPSULES _ Active Ingredient: temazepam USP read_full_document