OXAZEPAM CAPSULES, USP
DESCRIPTION
Oxazepam is the first of a chemical series of compounds, the 3-hydroxybenzodiazepinones. A therapeutic agent providing versatility and flexibility in control of common emotional disturbances, this product exerts prompt action in a wide variety of disorders associated with anxiety, tension, agitation, and irritability, and anxiety associated with depression. In tolerance and toxicity studies on several animal species, this product reveals significantly greater safety factors than related compounds (chlordiazepoxide and diazepam) and manifests a wide separation of effective doses and doses inducing side effects. Oxazepam is 7 chloro-1,3-dihydro-3-hydroxy-5-phenyl-2 H -1,4-benzodiazepin-2-one, and has the following structural formula:
C15H11ClN2O2 M.W. 286.72
Oxazepam is a white crystalline powder.
Each capsule, for oral administration, contains 10 mg, 15 mg or 30 mg oxazepam. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, polyoxyl 40 stearate, pregelatinized starch. The 10 mg and 30 mg gelatin capsule shells contain the following additional inactive ingredients: 10 mg - FD&C Blue No.1, D&C Red No.28, titanium dioxide; 30 mg - D&C Yellow No.10, FD&C Yellow No.6, titanium dioxide.
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