DIETHYLPROPION HYDROCHLORIDE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Chartwell RX, LLC.

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Diethylpropion hydrochloride tablets, 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/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 × 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

Περίληψη προϊόντος:

Diethylpropion Hydrochloride Tablets, USP, 25 mg are supplied in bottles of 90 (NDC 62135-488-90). 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. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71297 Revised 03/2023

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

DIETHYLPROPION HYDROCHLORIDE- DIETHYLPROPION HYDROCHLORIDE TABLET
CHARTWELL RX, LLC.
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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 established