Country: United States
Language: English
Source: NLM (National Library of Medicine)
TEMAZEPAM (UNII: CHB1QD2QSS) (TEMAZEPAM - UNII:CHB1QD2QSS)
Sandoz Inc
TEMAZEPAM
TEMAZEPAM 15 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. 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 result
Temazepam capsules, USP for oral administration are available as: 15 mg: Green and white capsules, imprinted GG 531 and supplied as: NDC 0781-2201-01 bottles of 100 NDC 0781-2201-05 bottles of 500 30 mg: White capsules, imprinted GG 532 and supplied as: NDC 0781-2202-01 bottles of 100 NDC 0781-2202-05 bottles of 500 Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container.
Abbreviated New Drug Application
Sandoz Inc ---------- MEDICATION GUIDE Temazepam Capsules, USP CIV (teh-MAZ-eh-pam) What is the most important information I should know about temazepam capsules? • Temazepam capsules are 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. • After taking temazepam capsules, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with temazepam capsules. Reported activities include: • driving a car (“sleep-driving”) • making and eating food • talking on the phone • having sex • sleep-walking Call your healthcare provider right away if you find out that you have done any of the above activities after taking temazepam capsules. • Do not take temazepam capsules unless you are able to stay in bed a full night (7 to 8 hours) before you must be active again. • Do not take more temazepam capsules than prescribed. What are temazepam capsules? • Temazepam capsules is a prescription sleep medicine. Temazepam capsules is used in adults for the short-term (usually 7 to 10 days) treatment of a sleep problem called insomnia. Symptoms of insomnia include trouble falling asleep and waking up often during the night. • Temazepam capsules is a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep Temazepam capsules in a safe place to prevent misuse and abuse. Selling or giving away temazepam capsules may harm others, and is against the law. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs. • It is not known if temazepam capsules is safe and effective in children. • It Read the complete document
TEMAZEPAM- TEMAZEPAM CAPSULE SANDOZ INC ---------- TEMAZEPAM CAPSULES, USP CIV RX ONLY WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death _[see Warnings and Drug Interactions]_. • • • DESCRIPTION Temazepam is a benzodiazepine hypnotic agent. 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, 15 mg and 30 mg, are for oral administration. Active ingredient: temazepam, USP Inactive ingredients: corn starch, hypromellose, lactose monohydrate, magnesium stearate, and sodium lauryl sulfate. The capsule shells and imprinting inks contain: benzyl alcohol, butylparaben, edetate calcium disodium, gelatin, iron oxide black, methylparaben, potassium hydroxide, propylene glycol, propylparaben, shellac, sodium lauryl sulfate, sodium propionate, strong ammonia solution and titanium dioxide. The 15 mg capsules also contain D&C Yellow #10 and FD&C Blue #1. CLINICAL PHARMACOLOGY PHARMACOKINETICS Reserve concomitant prescribing of these drugs for use 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. PHARMACOKINETICS In a single and multiple dose absorption, distribution, metabolism, and excretion (ADME) study, using H labeled drug, temazepam capsules were well absorbed and found to have minimal (8%) first pass metabolism. There were no active metabolites formed and the only significant metabolite present in blood was the O-conjugate. The unchanged drug was 96% bound to plasma proteins. The blood level decline of the parent drug was biphasic with the short half-life ranging from 0.4 to 0.6 hours and the terminal half-life from 3.5 to 18.4 hours (mean 8. Read the complete document