DIETHYLPROPION HYDROCHLORIDE ER tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Apotheca Inc.

INN (International Nazwa):

DIETHYLPROPION HYDROCHLORIDE

Skład:

DIETHYLPROPION HYDROCHLORIDE 75 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 idiosyncrasy to the sympathomimetic

Podsumowanie produktu:

75 mg controlled-release tablets in bottles of 100. Each white, capsule-shaped tablet is debossed Watson 782 .They are supplied as follows: NDC 12634-691-00 Bottles of 10 NDC 12634-691-01 Bottles of 100 NDC 12634-691-09 Bottles of 35 NDC 12634-691-12 Bottles of 120 NDC 12634-691-18 Bottles of 180 NDC 12634-691-40 Bottles of 40 NDC 12634-691-42 Bottles of 42 NDC 12634-691-45 Bottles of 45 NDC 12634-691-50 Bottles of 50 NDC 12634-691-52 Blister Pack of 12 NDC 12634-691-54 Blister Pack of 14 NDC 12634-691-57 Blister Pack of 20 NDC 12634-691-59 Blister Pack of 30 NDC 12634-691-60 Bottles of 60 NDC 12634-691-61 Blister Pack of 10 NDC 12634-691-63 Blister Pack of 3 NDC 12634-691-66 Blister Pack of 6 NDC 12634-691-67 Blister Pack of 7 NDC 12634-691-69 Blister Pack of 9 NDC 12634-691-71 Bottles of 30 NDC 12634-691-74 Bottles of 24 NDC 12634-691-78 Bottles of 28 NDC 12634-691-79 Bottles of 25 NDC 12634-691-80 Bottles of 20 NDC 12634-691-81 Bottles of 21 NDC 12634-691-82 Bottles of 12 NDC 12634-691-84 Bottles of 14 NDC 12634-691-85 Bottles of 15 NDC 12634-691-90 Bottles of 90 NDC 12634-691-91 Blister Pack of 1 NDC 12634-691-92 Bottles of 2 NDC 12634-691-93 Bottles of 3 NDC 12634-691-94 Bottles of 4 NDC 12634-691-95 Bottles of 5 NDC 12634-691-96 Bottles of 6 NDC 12634-691-97 Bottles of 7 NDC 12634-691-98 Bottles of 8 NDC 12634-691-99 Bottles of 9 Keep tightly closed. Store at room temperature, below 30°C (86°F). Rx only Repackaged & Distributed By: Apotheca, Inc. Phoenix, AZ 85006 Manufactured By: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA Content Updated: March 2014 70025263

Status autoryzacji:

New Drug Application

Charakterystyka produktu

DIETHYLPROPION HYDROCHLORIDE ER- DIETHYLPROPION HYDROCHLORIDE ER
TABLET
APOTHECA INC.
----------
DIETHYLPROPION HCL USP C-IV
CONTROLLED-RELEASE
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 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 re