DIETHYLPROPION HCL CONTROLLED-RELEASE- diethylpropion hydrochloride tablet

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

DIETHYLPROPION HYDROCHLORIDE (UNII: 19V2PL39NG) (DIETHYLPROPION - UNII:Q94YYU22B8)

Доступно од:

Blenheim Pharmacal, Inc.

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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

Резиме производа:

25 mg immediate-release tablets in bottles of 100. Each white, round tablet is debossed Watson over 783. Keep tightly closed. Store at room temperature, below 30°C (86°F). 75 mg controlled-release tablets in bottles of 100. Each white, capsule-shaped tablet is debossed Watson 782. Keep tightly closed. Store at room temperature, below 30°C (86°F). Rx only Manufactured for: Watson Laboratories, Inc. Corona, CA 92880 USA Manufactured by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA Rev. March 2007 S0307 70015427

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

DIETHYLPROPION HCL CONTROLLED-RELEASE- DIETHYLPROPION HYDROCHLORIDE
TABLET
BLENHEIM PHARMACAL, INC.
----------
70015427
DIETHYLPROPION HCL USP CIV
IMMEDIATE-RELEASE
25 MG TABLETS
DIETHYLPROPION HCL USP CIV
CONTROLLED-RELEASE
75 MG TABLETS
Rev. March 2007 RX ONLY
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 placebo and diet, as
determined in relatively short-term
clinical trials. The magnitude of increased weight loss of
drug-treated patients over placebo-treated
patients averages some fraction of a pound a week. However, individual
weight loss may vary
substantially from patient to patient. The rate of weight loss is
greatest in the first weeks of therapy for
both drug and placebo subjects and tends to decrease in succeeding
weeks. The possible origins of the
increased weight loss due to the various drug effects are not
established. The amount of weight loss
associated with the use of an "anorectic" drug varies from trial to
trial, and the increased weight loss
appears to be related in part to variables other than the drug
prescribed, such as the
physician/investigator relationship, the population treated, and the
diet prescribed. Studies do not permit
conclusions as to the relative importance of the drug and non-drug
facto