|
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 ≥30 kg/m2or a body mass index ≥27 kg/m2 with other risk factors (eg, high blood pressure,
diabetes, elevated cholesterol).
IMPORTANT SAFETY INFORMATION
People with the following medical conditions should not take ADIPEX-P®: Those with a
history of cardiovascular disease (hardening of the arteries, stroke, congestive heart
failure, and/or moderate to severe high blood pressure) , overactive thyroid, glaucoma
(increased pressure in the eyes), hypersensitivity to stimulants, agitation, those with a
history of drug abuse, those who are pregnant or nursing, and those who have used a
monoamine oxidase inhibitor drug (MAOI) within the past 14 days. 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 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.
You are encouraged to report negative side effects of prescription drugs to the FDA at
www.fda.gov/medwatch or call 1-800-FDA-1088.
|
|