DIETHYLPROPION HYDROCHLORIDE ER- diethylpropion hydrochloride tablet, extended release

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 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Diethylpropion hydrochloride extended release tablets, 75 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/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. Body Mass Index (BMI), kg/m 2 Weight (pounds) Height (feet, inches) 5’0” 5’3” 5’6” 5’9” 6’0” 6’3” 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33

Product summary:

Diethylpropion Hydrochloride Extended Release Tablets, 75 mg are supplied in bottles of 7 (NDC 43063-532-07) 14 (NDC 43063-532-14) 21 (NDC 43063-532-21) 28 (NDC 43063-532-28) 30 (NDC 43063-532-30 Each white to off-white capsule-shaped tablet is debossed “LCI” on one side and “1477” on the other side. Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Keep tightly closed and protect from excessive heat.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DIETHYLPROPION HYDROCHLORIDE ER- DIETHYLPROPION HYDROCHLORIDE TABLET,
EXTENDED RELEASE
PD-RX PHARMACEUTICALS, INC.
----------
DIETHYLPROPION HYDROCHLORIDE EXTENDED RELEASE TABLETS, 75 MG
CIV
RX ONLY
DESCRIPTION
Diethylpropion Hydrochloride Extended Release Tablets, 75 mg are
available for oral
administration as extended release tablets containing 75 mg
diethylpropion
hydrochloride, USP. The inactive ingredients in each extended release
tablet are:
mannitol, carbomer homopolymer, tartaric acid, hydroxypropyl
methylcellulose,
povidone, and magnesium 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:
In diethylpropion hydrochloride extended release tablets, 75 mg,
diethylpropion
hydrochloride 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
"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 o