Phendimetrazine

Phendimetrazine tartrate extended-release capsules 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 greater than or equal to 30 kg/m 2 or greater than or equal to 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia) who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (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.

Since the product is an extended-release dosage form, limit to one extended-release capsule (105 mg phendimetrazine tartrate) in the morning (30 to 60 minutes before morning meal). Each extended-release capsule contains 105 mg phendimetrazine tartrate in a Brown/Clear capsule imprinted E 5254.

• History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension, pulmonary hypertension) • During or within 14 days following the administration of monoamine oxidase inhibitors • Hyperthyroidism • Glaucoma • Agitated states • History of drug abuse • Pregnancy • Nursing • Use in combination with other anorectic agents or CNS stimulants • Known hypersensitivity or idiosyncratic reactions to sympathomimetics

Phendimetrazine tartrate 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 phendimetrazine tartrate, was associated with an increased risk of developing pulmonary hypertension, a rare, but often fatal disorder. The use of anorectic agents for longer than three 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.

The following adverse reactions are described, or described in greater detail, in other sections: • Primary pulmonary hypertension • Valvular heart disease • Effect on the ability to engage in potentially hazardous tasks • Withdrawal effects following prolonged high dosage administration The following adverse reactions to phendimetrazine have been identified: Cardiovascular Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevated blood pressure, ischemic events. Central Nervous System Overstimulation, restlessness, insomnia, agitation, flushing, tremor, sweating, dizziness, headache, psychotic state, blurring of vision. Gastrointestinal Dryness of the mouth, nausea, stomach pain, diarrhea, constipation. Genitourinary Urinary frequency, dysuria, changes in libido.

Monoamine Oxidase Inhibitors Use of phendimetrazine tartrate is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis. Alcohol Concomitant use of alcohol with phendimetrazine tartrate may result in an adverse drug reaction. Insulin and Oral Hypoglycemic Medications Requirements may be altered. Adrenergic Neuron Blocking Drugs Phendimetrazine tartrate may decrease the hypotensive effect of adrenergic neuron blocking drugs.

Store at 20° to 25°C (68° to 77°F). Protect from moisture.