Source: FDA, National Drug Code (US) Revision Year: 2019
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/m² | ||||||
| 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 |
| 230 | 45 | 41 | 37 | 34 | 31 | 29 |
| 240 | 47 | 43 | 39 | 36 | 33 | 30 |
| 250 | 49 | 44 | 40 | 37 | 34 | 31 |
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 extended release tablets, 75 mg are indicated for use as monotherapy only.
Diethylpropion Hydrochloride Extended Release Tablets, 75 mg:
One extended-release 75 mg tablet daily, swallowed whole, in midmorning.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (See PRECAUTIONS, Geriatric Use).
Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, and mydriasis. Fatigue and depression usually follow the central stimulation.
Cardiovascular effects include tachycardia, arrhythmias, hypertension or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Overdose of pharmacologically similar compounds has resulted in convulsions, coma and death.
The reported oral LD50 for mice is 600 mg/kg, for rats is 250 mg/kg and for dogs is 225 mg/kg.
Management of acute diethylpropion hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard. Intravenous phentolamine has been suggested on pharmacologic grounds for possible acute, severe hypertension, if this complicates diethylpropion hydrochloride extended release tablets, 75 mg overdosage.
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