Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
temazepam (UNII: CHB1QD2QSS) (temazepam - UNII:CHB1QD2QSS)
Proficient Rx LP
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/
Temazepam Capsules USP 30 mg White opaque cap and body, imprinted “30 mg” on cap and “Novel 123” on the body in black ink. Bottle of 30........ NDC 63187-497-30 Bottle of 60........ NDC 63187-497-60 Bottle of 90........ NDC 63187-497-90 Bottle of 100........NDC 63187-497-00 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 Medical Economics Company, Inc. Manufactured by: Distributed by: Novel Laboratories, Inc. ASCEND Laboratories, LLC Somerset, NJ 08873 Montvale, NJ 07645 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320
Abbreviated New Drug Application
Proficient Rx LP ---------- MEDICATION GUIDE TEMAZEPAM Capsules, USP C-IV (temazepam) 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: 1. Take TEMAZEPAM exactly as prescribed • Do not take more TEMAZEPAM than prescribed. • Take TEMAZEPAM right before you get in bed, not sooner. 2. 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 Perskaitykite visą dokumentą
TEMAZEPAM- TEMAZEPAM CAPSULE PROFICIENT RX LP ---------- 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: C H CIN O MW = 300.74 Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam Capsules, USP, 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. _sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol,_ _shellac, potassium hydroxide, propylene glycol, and black iron oxide.May also include:_ _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, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. _30 MG CAPSULES_ _Inactive Ingredients:_ Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, 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. 16 13 2 2 CLINICAL PHARMACOLOGY PHARMACOKINETICS In Perskaitykite visą dokumentą