Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
TEMAZEPAM (UNII: CHB1QD2QSS) (TEMAZEPAM - UNII:CHB1QD2QSS)
AvKARE
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. 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 resul
Temazepam capsules USP 7.5 mg White opaque/turquoise opaque capsules imprinted "Mutual 866". 15 mg White opaque/green opaque capsules imprinted "Mutual 867". 22.5 mg White opaque/light green opaque capsules imprinted "Mutual 868". 30 mg White opaque/white opaque capsules imprinted "Mutual 869". Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
Abbreviated New Drug Application
TEMAZEPAM- temazepam capsule AvKARE ---------- MEDICATION GUIDE TEMAZEPAM CAPSULES USP C-IV 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: 1. 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. 2. 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. Keep temazepam capsules in a safe place to Baca dokumen lengkap
TEMAZEPAM- TEMAZEPAM CAPSULE AVKARE ---------- TEMAZEPAM CAPSULES USP CIV 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, 7.5 mg, 15 mg, 22.5 mg, and 30 mg, are for oral administration. _Active Ingredient: _temazepam USP _Inactive Ingredients: _croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The capsule shell contains gelatin and titanium dioxide. The capsule shell for the 7.5 mg also contains FD&C Blue #1 and FD&C Red #40; the capsule shell for 15 mg and 22.5 mg also contains D&C Yellow #10, FD&C Blue #1 and FD&C Yellow #6. The imprinting ink contains: D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black and propylene glycol. 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 3 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 Baca dokumen lengkap