IMPORTANT SAFETY INFORMATION
Indication
ADIPEX-P^® (phentermine hydrochloride USP, 37.5 mg CIV) is used to treat obesity for a short period of time (a few weeks), as part of a treatment plan that includes exercise, behavioral changes, and a low-calorie diet, for people with a body mass index >e; ≥30 kg/m2 or a body mass index ≥27 kg/m2 with other risk factors (e.g., high blood pressure, diabetes, elevated cholesterol).

Safety Information
People with the following medical conditions should not take ADIPEX-P^®: Advanced arteriosclerosis (hardening of the arteries), heart disease, overactive thyroid, moderate to severe high blood pressure, glaucoma (increased pressure in the eyes), hypersensitivity to stimulants, agitation, drug abuse history, or use within 14 days of taking a monoamine oxidase inhibitor drug (MAOI). Some side effects of ADIPEX-P^® include elevated blood pressure, insomnia, restlessness, dry mouth, diarrhea, or changes in sexual drive. Primary pulmonary hypertension (PPH), a rare fatal lung disease, has been reported in patients taking both phentermine and fenfluramine or dexfenfluramine. The possible association between phentermine use alone and PPH or valvular heart disease cannot be ruled out. There have been rare cases of PPH or valvular heart disease cannot be ruled out. There have been rare cases of PPH or valvular heart disease in patients who reportedly have taken phentermine alone. The safety and benefit of taking other drugs with ADIPEX-P^® for weight loss have not been established.

PI Rev. S 7/2005