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Prescribing Information

Important Safety Information

Suprenza is a sympathomimetic amine anoretic indicated as a short-term adjunct (a few weeks) in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index of greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 in the presence of other risk factors (eg, controlled hypertension, diabetes, hyperlipidemia). The limited usefulness of this class, including Suprenza should be measured against possible risk factors inherent in their use.

Suprenza is contraindicated in patients with a history of cardiovascular disease (eg, coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension), during or within 14 days following the administration of monoamine oxidase inhibitors, hyperthyroidism, glaucoma, agitated states, history of drug abuse, pregnancy, nursing, known hypersensitivity, or idiosyncracy to the sympathomimetic amines.

Coadministration of Suprenza with other drugs for weight loss is not recommended. Primary pulmonary hypertension (PPH) has been reported to occur in patients receiving a combination of phentermine with fenfluramine or dexfenfluramine. The possibility of an association between PPH and the use of Suprenza alone cannot be ruled out; there have been rare cases of PPH in patients who reportedly have taken phentermine alone. Serious regurgitant cardiac valvular disease, primarily affecting the mitral, aortic and/or tricuspid valves, has been reported in otherwise healthy persons who had taken a combination of phentermine with fenfluramine or dexfenfluramine for weight loss. The possible role of phentermine in the etiology of these valvulopathies has not been established and their course in individuals after the drugs are stopped is not known. The possibility of the association between valvular heart disease and the use of Suprenza alone cannot be ruled out; there have been rare cases of valvular heart disease in patients who reportedly have taken phentermine alone.

The following adverse reactions to phentermine have been identified: Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevation of blood pressure, ischemic events, overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis, dryness of mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances, urticaria, impotence, changes in libido.

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Suprenza is a registered trademark of Citius Pharmaceuticals, LLC.
Marketed by Prenzamax, LLC. Distributed by Akrimax Pharmaceuticals, LLC.