País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
DIETHYLPROPION HYDROCHLORIDE (UNII: 19V2PL39NG) (DIETHYLPROPION - UNII:Q94YYU22B8)
PD-Rx Pharmaceuticals, Inc.
DIETHYLPROPION HYDROCHLORIDE
DIETHYLPROPION HYDROCHLORIDE 25 mg
PRESCRIPTION DRUG
New Drug Application
DIETHYLPROPION HCL IMMEDIATE-RELEASE- DIETHYLPROPION HYDROCHLORIDE TABLET PD-RX PHARMACEUTICALS, INC. ---------- DIETHYLPROPION HCL USP C-IV IMMEDIATE-RELEASE 25 MG TABLETS RX ONLY REV. MARCH 2014 DESCRIPTION Diethylpropion hydrochloride is available for oral administration in immediate-release tablets containing 25 mg diethylpropion hydrochloride and in controlled-release tablets containing 75 mg diethylpropion hydrochloride. The inactive ingredients in each immediate-release tablet are: cornstarch, lactose, magnesium stearate, pregelatinized cornstarch, talc, and tartaric acid. The inactive ingredients in each controlled-release tablet are: carbomer 934P, mannitol, povidone, tartaric acid, zinc stearate. Diethylpropion hydrochloride is a sympathomimetic agent. The chemical name for diethylpropion hydrochloride is 1-phenyl-2-diethylamino-1-propanone hydrochloride. Its chemical structure is: The diethylpropion hydrochloride 75 mg formulation is dispersed in a hydrophilic matrix. On exposure to water, the diethylpropion hydrochloride is released at a relatively uniform rate as a result of slow hydration of the matrix. The result is controlled release of the anorectic agent. CLINICAL PHARMACOLOGY Diethylpropion hydrochloride is a sympathomimetic amine with some pharmacologic activity similar to that of the prototype drugs of this class used in obesity, the amphetamines. Actions include some central nervous system stimulation and elevation of blood pressure. Tolerance has been demonstrated with all drugs of this class in which these phenomena have been looked for. Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics." It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression. For example, other central nervous system actions or metabolic effects may be involved. Adult obese subjects instructed in dietary management and treated with "anorectic" drugs lose more weight on the average than those treated with placeb Leer el documento completo