Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
TEMAZEPAM (UNII: CHB1QD2QSS) (TEMAZEPAM - UNII:CHB1QD2QSS)
RxChange Co.
TEMAZEPAM
TEMAZEPAM 15 mg
ORAL
PRESCRIPTION DRUG
Temazepam is indicated for the short-term treatment of insomnia (generally 7 - 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam should be used for short periods of time (7 - 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 resulted in increasing nurs
Temazepam Capsules USP 15 mg — Each #3 capsule with green opaque cap and white opaque body, imprinted with 076 in black ink on both cap and body contains 15 mg of Temazepam, USP. Capsules are supplied in bottles of 100 (NDC 0228-2076-10) and 500 (NDC 0228-2076-50). 30 mg — Each #3 capsule with white opaque cap and body, imprinted with 077 in black ink on both cap and body contains 30 mg of Temazepam, USP. Capsules are supplied in bottles of 100 (NDC 0228 2077-10) and 500 (NDC 0228-2077-50). Dispense in a tight, light-resistant container as defined in the USP. Store at 25(C (77(F); excursions permitted to 15° to 30°C (59° to 86°F). Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA 40-9177 Revised –June 2012
Abbreviated New Drug Application
TEMAZEPAM- TEMAZEPAM CAPSULE RxChange Co. ---------- MEDGUIDE MEDICATION GUIDE Temazepam Capsules, USP C-IV Read the Medication Guide that comes with temazepam before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT TEMAZEPAM? After taking temazepam, 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. Reported activities include: • driving a car (“sleep-driving”) • making and eating food • talking on the phone • having sex • sleep-walking Call your doctor right away if you find out that you have done any of the above activities after taking temazepam. Important: 1. Take temazepam exactly as prescribed • Do not take more temazepam than prescribed. • Take temazepam right before you get in bed, not sooner. 2. Do not take temazepam if you: • drink alcohol • take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take temazepam with your other medicines • cannot get a full night’s sleep What is temazepam? Temazepam is a sedative-hypnotic (sleep) medicine. Temazepam 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 • waking up often during the night Temazepam is not for children. Temazepam is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep temazepam in a safe place to prevent misuse and abuse. Selling or giving away temazepam may harm others, and is against the law. Tell your doctor if you hav Прочитать полный документ
TEMAZEPAM- TEMAZEPAM CAPSULE RXCHANGE CO. ---------- TEMAZEPAM CAPSULES, USP CIV 40-9177 REVISED – JUNE 2012 RX ONLY 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, or 30 mg, are for oral administration. _15 MG OR 30 MG CAPSULES_ _Active Ingredient:_ temazepam USP 15 mg — corn starch, colloidal silicon dioxide, D&C yellow #10, FD&C green #3, FD&C yellow #6 (Sunset Yellow), gelatin, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium lauryl sulfate, titanium dioxide. 30 mg — corn starch, colloidal silicon dioxide, gelatin, magnesium stearate, microcrystalline cellulose, silicon dioxide, sodium lauryl sulfate, titanium dioxide. CLINICAL PHARMACOLOGY PHARMACOKINETICS In a single and multiple dose absorption, distribution, metabolism, and excretion (ADME) study, using H labeled drug, temazepam was 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 - 0.6 hours and the terminal half-life 3 from 3.5 - 18.4 hours (mean 8.8 hours), depending on the study population and method of determination. Metabolites were formed with a half-life of 10 hours and excreted with a half-life of approximately 2 hours. Thus, formation of the major metabolite is the rate limiting step in the biodisposition of temazepam. There is no accumulation of metabolites. A dose-proportional relationship has been established for the area under the plasma concentration/time curve over the 15 - 30 mg dose range. Temazepam was completely metabolized through conjugation prior Прочитать полный документ