IMPORTANT SAFETY INFORMATION
ADIPEX-P® (phentermine hydrochloride 37.5 mg, CIV) is indicated as a short-term (a few weeks) adjunct 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 ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia).
Safety Information
ADIPEX-P® is contraindicated in advanced arteriosclerosis, cardiovascular disease, hyperthyroidism, glaucoma, moderate to severe hypertension, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, agitation, drug abuse history, and during or within 14 days use of monoamine oxidase inhibitors (MAOIs). Adverse events include cardiovascular and central nervous system effects, gastrointestinal disturbances, and changes in libido. Exercise caution when prescribing phentermine for patients with even mild hypertension.
The safety and efficacy of combination therapy with phentermine and any other drug products for weight loss, including selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, coadministration of these drug products for weight loss is not recommended. Primary pulmonary hypertension (PPH) has been reported in patients receiving a combination of phentermine and fenfluramine or dexfenfluramine. The possibility of an association between PPH or valvular heart disease and the use of phentermine alone cannot be ruled out.