Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
DIETHYLPROPION HYDROCHLORIDE (UNII: 19V2PL39NG) (DIETHYLPROPION - UNII:Q94YYU22B8)
NuCare Pharmaceuticals, Inc.
DIETHYLPROPION HYDROCHLORIDE
DIETHYLPROPION HYDROCHLORIDE 25 mg
ORAL
PRESCRIPTION DRUG
Diethylpropion hydrochloride is indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2 or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of BMI based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds divided by 2.2 = kg; inches x 0.0254 = meters. The usefulness of agents of this class (see CLINICAL PHARMACOLOGY ) should be measured against possible risk factors inherent in their use such as those described below. Diethylpropion hydrochloride is indicated for use as monotherapy only. Pulmonary hypertension, advanced arteriosclerosis, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic
25 mg immediate-release tablets in bottles of 30 and 90. Each white, round tablet is debossed Watson over 783 . Keep tightly closed. Store at room temperature, below 30°C (86°F). Rx only Distributed By: Actavis Pharma, Inc. Parsippany, NJ 07054 Manufactured By: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA Content Updated: March 2014 70025263
New Drug Application
DIETHYLPROPION HCL IMMEDIATE-RELEASE- DIETHYLPROPION HYDROCHLORIDE TABLET NUCARE PHARMACEUTICALS, INC. ---------- 70025263 DIETHYLPROPION HCL USP C-IV IMMEDIATE-RELEASE 25 MG TABLETS DIETHYLPROPION HCL USP C-IV CONTROLLED-RELEASE 75 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 "anorecti Прочетете целия документ