Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
TEMAZEPAM (UNII: CHB1QD2QSS) (TEMAZEPAM - UNII:CHB1QD2QSS)
Cardinal Health
TEMAZEPAM
TEMAZEPAM 7.5 mg
PRESCRIPTION DRUG
New Drug Application
RESTORIL- TEMAZEPAM CAPSULE CARDINAL HEALTH ---------- RES TORIL™ (TEMAZEPAM) CAPSULES USP CIV RX ONLY DESCRIPTION Restoril™ (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: Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Restoril™ (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:_ 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. _15 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. _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. _30 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 was well absorbed and found to have minimal Prečítajte si celý dokument