DIETHYLPROPION HYDROCHLORIDE tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

KVK-TECH, INC

INN (Tarptautinis Pavadinimas):

DIETHYLPROPION HYDROCHLORIDE

Sudėtis:

DIETHYLPROPION HYDROCHLORIDE 25 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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

Produkto santrauka:

25 mg immediate-release tablets in bottles of 30, 60 and 100. Bottles of 30, NDC 10702-044-03 Bottles of 60, NDC 10702-044-06 Bottles of 100, NDC 10702-044-01 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 Manufactured by: KVK-TECH, INC. 110 Terry Dr. Suite 200 Newtown, PA 18940-1850 Item ID # 6129/03        01/11 Manufacturer’s Code: 10702

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

DIETHYLPROPION HYDROCHLORIDE- DIETHYLPROPION HYDROCHLORIDE TABLET
KVK-TECH, 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 amount of weight