Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
TEMAZEPAM (UNII: CHB1QD2QSS) (TEMAZEPAM - UNII:CHB1QD2QSS)
NuCare Pharmaceuticals,Inc.
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 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 r
Temazepam Capsules USP 15 mg Blue opaque cap and white opaque body, imprinted “15 mg” on cap and “Novel 121” on the body in black ink. Bottles of 30 NDC 68071-2581-3 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 registered trademark of Hoffman-LaRoche Inc. **Trademark of PDR Network, LLC Manufactured by: Novel Laboratories Inc. Somerset, NJ 08873 Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054
Abbreviated New Drug Application
TEMAZEPAM- TEMAZEPAM CAPSULE NuCare Pharmaceuticals,Inc. ---------- MEDICATION GUIDE TEMAZEPAM (tem az' e pam) Capsules, C-IV What is the most important information I should know about TEMAZEPAM? • TEMAZEPAM is 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, 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: 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. • Do not take TEMAZEPAM 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 than prescribed. What is TEMAZEPAM? • TEMAZEPAM is a prescription 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 and waking up often during the night. • TEMAZEPAM is a federal 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 healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs. • It is not known if TEMAZEPAM is safe and effective in children. • It is not known if TEMAZEPAM is safe and effective for use longer than 2 weeks. Do not take TEMA Lugege kogu dokumenti
TEMAZEPAM- TEMAZEPAM CAPSULE NUCARE PHARMACEUTICALS,INC. ---------- 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 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: C H ClN O MW = 300.74 Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. 16 13 2 2 Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration. _7.5 MG, 15 MG, 22.5 MG AND 30 MG CAPSULES _ Active Ingredient: temazepam USP _7.5 MG CAPSULES _ _Inactive Ingredients: _Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. _May also include: _sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. _15 MG CAPSULES_ _Inactive Ingredients: _Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. _May also include: _sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. _22.5 MG CAPSULES_ _Inactive Ingredients: _Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. _May also include: _sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isop Lugege kogu dokumenti