Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
DIETHYLPROPION HYDROCHLORIDE (UNII: 19V2PL39NG) (DIETHYLPROPION - UNII:Q94YYU22B8)
KVK-TECH, INC
DIETHYLPROPION HYDROCHLORIDE
DIETHYLPROPION HYDROCHLORIDE 25 mg
ORAL
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
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 Прочетете целия документ