Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
temazepam (UNII: CHB1QD2QSS) (temazepam - UNII:CHB1QD2QSS)
Preferred Pharmaceuticals, Inc
temazepam
temazepam 15 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
TEMAZEPAM- TEMAZEPAM CAPSULE PREFERRED PHARMACEUTICALS, INC ---------- 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, 16 13 2 2 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. CLINICAL PHARMACOLOGY PHARMA Прочитать полный документ