ADIPEX-P® (phentermine hydrochloride USP) CIV is used for a short period of time (a few weeks), as part of a weight reduction treatment plan that includes exercise, behavioral changes, and a low-calorie diet, for obese people with a body mass index greater than or equal to 30 kg/m2 or a body mass index greater than or equal to 27 kg/m2 and other risk factors (e.g., controlled high blood pressure, diabetes, high cholesterol).
IMPORTANT SAFETY INFORMATION
Do not take ADIPEX-P if you:
- Have a history of heart disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled high blood pressure)
- Are taking certain medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the past 14 days
- Have thyroid problems (hyperthyroidism)
- Have glaucoma (increased pressure in the eyes)
- Have experienced agitated states or have a history of drug abuse
- Are pregnant or are nursing
- Are allergic to sympathomimetic amines such as phentermine, or any of the ingredients
Use with Other Medicines for Weight Loss. Taking ADIPEX-P with other drugs used for weight loss is not recommended.
Primary Pulmonary Hypertension. A rare but often fatal disease of the lungs, has been reported in patients taking phentermine and phentermine-like products. Tell your doctor if you have shortness of breath, chest or heart pain, or experience fainting or swelling in your lower legs. Contact your doctor immediately if you experience any decrease in the amount of exercise you are normally able to tolerate.
Heart Value Disease. Serious heart valve problems or disease have been reported in patients taking phentermine or other phentermine-like products for weight loss. The possibility of an association cannot be ruled out.
Tolerance. There is the potential for tolerance to develop, where the same dose might not work as well as it did in the beginning. If this happens, the recommended dose should not be increased, but instead the drug should be discontinued.
Motor Impairment. ADIPEX-P may impair your ability to operate machinery or drive a motor vehicle.
Risk of Abuse and Dependence. Keep ADIPEX-P in a safe place to prevent theft, accidental overdose, misuse or abuse.
Use With Alcohol. Do not use ADIPEX-P with alcohol as it may result in an adverse drug reaction.
Patients with High Blood Pressure. ADIPEX-P may cause an increase in blood pressure. Tell your doctor if you have or have had high blood pressure.
Patients with Diabetes. A decrease in the dose of insulin or other oral hypoglycemic medications may be required. Talk to your physician if you are taking medications for diabetes.
Patients with Renal Impairment. Avoid use if you have impaired kidney function or are on dialysis.
Tell your doctor about all of your medical conditions and about all of the medications you are taking, including over-the-counter or herbal treatments.
Some side effects of ADIPEX-P include pulmonary hypertension, heart disease, palpitations, increased heart rate or blood pressure, insomnia, restlessness, dry mouth, diarrhea, constipation, and changes in sexual drive. Tell your healthcare provider if you have any side effect that bothers you or does not go away.
These are not all of the possible side effects of ADIPEX-P. For more information, ask your healthcare provider or pharmacist.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full Prescribing Information.