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:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

DIETHYLPROPION HYDROCHLORIDE

Composition:

DIETHYLPROPION HYDROCHLORIDE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 idiosyncra

Product summary:

25 mg immediate-release tablets in bottles of 7, 14, 21, 28, 30, 56, 60, 90, 100 and 180. Each white to off white, round flat tablets debossed “K 44” on one side and plain on the other side. Keep tightly closed. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Rx only

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIETHYLPROPION HYDROCHLORIDE- DIETHYLPROPION HYDROCHLORIDE TABLET
PD-RX PHARMACEUTICALS, INC.
----------
DIETHYLPROPION HCL USP CIV 25 MG TABLETS
RX ONLY
DESCRIPTION
Diethylpropion hydrochloride is available for oral administration in
immediate-release
tablets containing 25 mg diethylpropion hydrochloride. The inactive
ingredients in each
immediate-release tablet are: crospovidone, lactose anhydrous,
magnesium stearate,
starch pregelatinized and tartaric acid. Diethylpropion hydrochloride
is a
sympathomimetic agent. The chemical name for diethylpropion
hydrochloride is 1-
phenyl-2-diethylamino-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 established. The am