Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
TEMAZEPAM (UNII: CHB1QD2QSS) (TEMAZEPAM - UNII:CHB1QD2QSS)
NCS HealthCare of KY, Inc dba Vangard Labs
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 0615-7808-39 blistercards of 30 30 mg: White capsules, imprinted GG 532 and supplied as: NDC 0615-7809-39 blistercards of 30 Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container.
Abbreviated New Drug Application
TEMAZEPAM- TEMAZEPAM CAPSULE NCS HealthCare of KY, Inc dba Vangard Labs ---------- MEDICATION GUIDE Temazepam Capsules, USP CIV Read the Medication Guide that comes with temazepam capsules 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 capsules? 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 doctor right away if you find out that you have done any of the above activities after taking temazepam capsules. Important: • Take temazepam capsules exactly as prescribed • Do not take more temazepam capsules than prescribed. • Take temazepam capsules right before you get in bed, not sooner. • Do not take temazepam capsules 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 capsules with your other medicines • cannot get a full night’s sleep What are temazepam capsules? Temazepam capsules are a sedative-hypnotic (sleep) medicine. Temazepam capsules are 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 capsules are not for children. Temazepam capsules are a federally controlled substance (C-IV) because it can be abused or lead to dependence. Baca dokumen lengkapnya
TEMAZEPAM- TEMAZEPAM CAPSULE NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- TEMAZEPAM CAPSULES, USP CIV 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: 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: gelatin, iron oxide black, shellac, propylene glycol, titanium dioxide, methylparaben, butylparaben, propylparaben, benzyl alcohol, sodium propionate and edetate calcium disodium. The 15 mg capsules also contain D&C Yellow #10 and FD&C Blue #1. CLINICAL PHARMACOLOGY 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 8.8 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 to 30 mg dose range. 3 Temazepam was completely metabolized through conjugation prior to exc Baca dokumen lengkapnya