Diethylpropion

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.

Diethylpropion Hydrochloride Extended Release Tablets, 75 mg: One extended-release 75 mg tablet daily, swallowed whole, in midmorning. Geriatric use: 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.

Pulmonary hypertension, advanced arteriosclerosis, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma, severe hypertension. Agitated states. Patients with a history of drug abuse. Use in combination with other anorectic agents is contraindicated. During or within 14 days following the administration of monoamine oxidase inhibitors, hypertensive crises may result.

Diethylpropion hydrochloride extended release tablets, 75 mg should not be used in combination with other anorectic agents, including prescribed drugs, over-the-counter preparations, and herbal products. In a case-control epidemiological study, the use of anorectic agents, including diethylpropion, was associated with an increased risk of developing pulmonary hypertension, a rare, but often fatal disorder. The use of anorectic agents for longer than 3 months was associated with a 23-fold increase in the risk of developing pulmonary hypertension. Increased risk of pulmonary hypertension with repeated courses of therapy cannot be excluded. The onset or aggravation of exertional dyspnea, or unexplained symptoms of angina pectoris, syncope, or lower extremity edema suggest the possibility of occurrence of pulmonary hypertension.

Cardiovascular: Precordial pain, arrhythmia (including ventricular), ECG changes, tachycardia, elevation of blood pressure, palpitation and rare reports of pulmonary hypertension. Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine, both independently and especially when used in combination, have been reported. Valvulopathy has been very rarely reported with diethylpropion hydrochloride extended release tablets, 75 mg monotherapy, but the causal relationship remains uncertain.

Because diethylpropion hydrochloride extended release tablets, 75 mg are monoamines, hypertension may result when either agent is used with monoamine oxidase (MAO) inhibitors. Efficacy of diethylpropion with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems, therefore, the concomitant use with other anorectic agents is contraindicated. Antidiabetic drug requirements (i.e., insulin) may be altered. Concurrent use with general anesthetics may result in arrhythmias. The pressor effects of diethylpropion and those of other drugs may be additive when the drugs are used concomitantly, conversely, diethylpropion may interfere with antihypertensive drugs (i.e., guanethidine, a-methyldopa). Concurrent use of phenothiazines may antagonize the anorectic effect of diethylpropion.

Store at 20 to 25°C (68 to 77°F). Keep tightly closed and protect from excessive heat.