Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
DIETHYLPROPION HYDROCHLORIDE (UNII: 19V2PL39NG) (DIETHYLPROPION - UNII:Q94YYU22B8)
Chartwell RX, LLC.
ORAL
PRESCRIPTION DRUG
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 23
Diethylpropion Hydrochloride Extended Release Tablets, 75 mg are supplied in bottles of 30 (NDC 62135-489-30). 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. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71299 Revised 03/2023
Abbreviated New Drug Application
DIETHYLPROPION HYDROCHLORIDE ER- DIETHYLPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE CHARTWELL RX, LLC. ---------- 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 of drug-tr Διαβάστε το πλήρες έγγραφο