DIETHYLPROPION HCL IMMEDIATE-RELEASE- diethylpropion hydrochloride tablet DIETHYLPROPION HCL CONTROLLED-RELEASE- diethylpropion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Keltman 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/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 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 amines, glaucoma, severe h

Product summary:

25 mg immediate-release tablets. Each white, round tablet is debossed Watson over 783. 75 mg controlled-release tablets. Each white, capsule-shaped tablet is debossed Watson 782. They are supplied by Keltman Pharmaceuticals Inc. as follows: 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 This Product was Repackaged For: Keltman Pharmaceuticals Inc. 1 Lakeland Square, Suite A Flowood, MS 39232 United States

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIETHYLPROPION HCL IMMEDIATE-RELEASE - DIETHYLPROPION HYDROCHLORIDE
TABLET
DIETHYLPROPION HCL CONTROLLED-RELEASE - DIETHYLPROPION HYDROCHLORIDE
TABLET
KELTMAN PHARMACEUTICALS INC.
----------
DIETHYLPROPION HCL USP CIV
IMMEDIATE-RELEAS E
25 MG TABLETS
DIETHYLPROPION HCL USP CIV
CONTROLLED-RELEAS E
75 MG TABLETS
RX ONLY
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 instruc