DIETHYLPROPION HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lannett Company, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Diethylpropion hydrochloride tablets USP, 25 mg are 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/m2 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 × 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 tablets USP, 25 mg are indicated for use as monotherapy only. Pulmonary hypertension, advanced arteriosclerosis, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sy

Product summary:

Diethylpropion Hydrochloride Tablets USP, 25 mg are supplied in bottles of 100 (NDC 0527-1475-01). Each white to off-white round flat-faced beveled edge tablet is debossed "LCI" on one side and "1475" on the other side. Keep tightly closed. Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Protect from excessive heat. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136  CIB70602D Rev. 12/19

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIETHYLPROPION HYDROCHLORIDE- DIETHYLPROPION HYDROCHLORIDE TABLET
LANNETT COMPANY, INC.
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DIETHYLPROPION HYDROCHLORIDE TABLETS USP, 25 MG
CIV
RX ONLY
DESCRIPTION
Diethylpropion Hydrochloride Tablets USP, 25 mg are available for oral
administration as tablets
containing 25 mg diethylpropion hydrochloride, USP. The inactive
ingredients in each tablet are:
microcrystalline cellulose, lactose monohydrate, mannitol, tartaric
acid, povidone, talc, and zinc
stearate.
Diethylpropion hydrochloride is a sympathomimetic agent. The chemical
name for diethylpropion
hydrochloride is 1-phenyl-2-diethyl-amino-1-propanone hydrochloride.
Its chemical structure is:
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 establishe