Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
TEMAZEPAM (UNII: CHB1QD2QSS) (TEMAZEPAM - UNII:CHB1QD2QSS)
Proficient Rx LP
TEMAZEPAM
TEMAZEPAM 30 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 are available containing 7.5 mg, 15 mg, 22.5 mg or 30 mg of temazepam, USP. The 30 mg capsule is a hard-shell gelatin capsule with a yellow opaque cap and a yellow opaque body filled with an off-white powder blend. The capsule is axially printed with MYLAN over 5050 in black ink on both the cap and the body. They are available as follows: NDC 63187-324-00 bottles of 100 capsules Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
Abbreviated New Drug Application
Proficient Rx LP ---------- MEDICATION GUIDE FOR TEMAZEPAM CAPSULES, USP 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: • Take temazepam exactly as prescribed ▪ Do not take more temazepam than prescribed. ▪ Take temazepam right before you get in bed, not sooner. • 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 have ever abused or been dependent o Baca dokumen lengkap
TEMAZEPAM- TEMAZEPAM CAPSULE PROFICIENT RX LP ---------- 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. Its structural formula may be represented as follows: C16H13CLN2O2 M.W. = 300.74 C16H13ClN2O2 M.W. = 300.74 Temazepam, USP is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol. Temazepam capsules USP, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. Each capsule contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, powdered cellulose and sodium lauryl sulfate. The empty gelatin capsule shell for all strengths contains FD&C Yellow No. 6, gelatin and titanium dioxide. In addition, the 7.5 mg, 22.5 mg and 30 mg empty gelatin capsules contain D&C Yellow No. 10. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. 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 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 h Baca dokumen lengkap