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/m2 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” 140272523211918 150292724222019 160312826242220 170333028252321 180353229272523 190373431282624 200393632302725 210413734312926 220433936333028 230454137343129 240474339363330 250494440373431 The usefulness of agents of this class (seeCLINICAL 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 amines, glaucoma, severe hypertension.

(SeePRECAUTIONS.)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.

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Pulmonary Hypertension -- Increased VASCULAR RESISTANCE in the PULMONARY CIRCULATION, usually secondary to HEART DISEASES or LUNG DISEASES.

Arteriosclerosis -- Thickening and loss of elasticity of the walls of ARTERIES of all sizes. There are many forms classified by the types of lesions and arteries involved, such as ATHEROSCLEROSIS with fatty lesions in the ARTERIAL INTIMA of medium and large muscular arteries.

Hyperthyroidism -- Hypersecretion of THYROID HORMONES from the THYROID GLAND. Elevated levels of thyroid hormones increase BASAL METABOLIC RATE.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Glaucoma -- An ocular disease, occurring in many forms, having as its primary characteristics an unstable or a sustained increase in the intraocular pressure which the eye cannot withstand without damage to its structure or impairment of its function. The consequences of the increased pressure may be manifested in a variety of symptoms, depending upon type and severity, such as excavation of the optic disk, hardness of the eyeball, corneal anesthesia, reduced visual acuity, seeing of colored halos around lights, disturbed dark adaptation, visual field defects, and headaches. (Dictionary of Visual Science, 4th ed)

Hypertensive disease -- Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.

Hypertensive Crisis --

Diethylpropion hydrochloride 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.

Under these circumstances, diethylpropion hydrochloride should be immediately discontinued, and the patient should be evaluated for the possible presence of pulmonary hypertension.Valvular heart disease associated with the use of some anorectic agents such as fenfluramine and dexfenfluramine has been reported.

Possible contributing factors include use for extended periods of time, higher than recommended dose, and/or use in combination with other anorectic drugs.

Valvulopathy has been very rarely reported with diethylpropion hydrochloride monotherapy, but the causal relationship remains uncertain.

The potential risk of possible serious adverse effects such as valvular heart disease and pulmonary hypertension should be assessed carefully against the potential benefit of weight loss.

Baseline cardiac evaluation should be considered to detect preexisting valvular heart diseases or pulmonary hypertension prior to initiation of diethylpropion hydrochloride treatment.

Diethylpropion hydrochloride is not recommended in patients with known heart murmur or valvular heart disease.

Echocardiogram during and after treatment could be useful for detecting any valvular disorders which may occur.To limit unwarranted exposure and risks, treatment with diethylpropion hydrochloride should be continued only if the patient has satisfactory weight loss within the first 4 weeks of treatment (e.g., weight loss of at least 4 pounds, or as determined by the physician and patient).Diethylpropion hydrochloride is not recommended for patients who used any anorectic agents within the prior year.If tolerance develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.

Diethylpropion hydrochloride may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.Prolonged use of diethylpropion hydrochloride may induce dependence with withdrawal syndrome on cessation of therapy.

Hallucinations have occurred rarely following high doses of the drug.

Several cases of toxic psychosis have been reported following the excessive use of the drug and some have been reported in which the recommended dose appears not to have been exceeded.

Psychosis abated after the drug was discontinued.When central nervous system active agents are used, consideration must always be given to the possibility of adverse interactions with alcohol.