Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
TEMAZEPAM (UNII: CHB1QD2QSS) (TEMAZEPAM - UNII:CHB1QD2QSS)
St. Mary's Medical Park Pharmacy
ORAL
PRESCRIPTION DRUG
Temazepam Capsules USP 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 USP 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/da
Opaque blue capsules, with the opaque blue body imprinted “FOR SLEEP” on one side and on the other side in red, and an opaque blue cap imprinted “22.5 mg” twice in red. NDC 60760-959-30 BOTTLES OF 30 Dispense in a well-closed, light-resistant container with a child-resistant closure. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. *Romazicon is the trademark of Hoffman-LaRoche Inc. **Trademark of Medical Economics Company, Inc. Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo, and other brands are trademarks of a Mallinckrodt company. © 2018 Mallinckrodt. Rev 12/2018 Mallinckrodt TM Pharmaceuticals An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20T06.pdf or by calling 1-800-778-7898 for alternate delivery options.
New Drug Application
St. Mary's Medical Park Pharmacy ---------- MEDICATION GUIDE Temazepam (te-maz'ĕ-pam) Capsules, C-IV What is the most important information I should know about temazepam capsules? • Temazepam capsules are a 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: o driving a car (“sleep-driving”) o making and eating food o talking on the phone o having sex o 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 are a prescription 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 and waking up often during the night. • Temazepam capsules are 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 are safe and effective in ch Lugege kogu dokumenti
TEMAZEPAM- TEMAZEPAM CAPSULE ST. MARY'S MEDICAL PARK PHARMACY ---------- 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). • 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. DESCRIPTION Temazepam Capsules USP are benzodiazepine hypnotic agents. 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 USP, 7.5 mg and 22.5 mg, are for oral administration. _7.5 MG AND 22.5 MG CAPSULES_ _7.5 MG CAPSULES_ _Inactive Ingredients:_ FD&C Blue #1, FD&C Red #3, gelatin, lactose, magnesium stearate, red iron oxide, titanium dioxide. _May also include:_ n-butyl alcohol, iron oxide red, shellac, shellac glaze, SD-35A alcohol. _22.5 MG CAPSULES_ _Inactive Ingredients:_ FD&C Blue #1, FD&C Red #3, gelatin, lactose, magnesium stearate, red iron oxide, titanium dioxide. _May also include:_ n-butyl alcohol, FD&C Blue #1 / Brilliant Blue FCF Aluminum Lake, iron oxide red, isopropyl alcohol, propylene glycol, shellac, shellac glaze, SD-35A alcohol, SD-45 alcohol. CLINICAL PHARMACOLOGY PHARMACOKINETICS In a single and multiple dose absorption, distribution, metabolism, and excretion (ADME) study, using H labeled drug, Restoril (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 wit Lugege kogu dokumenti