|Drug Name:||Phentermine Hydrochloride|
|Other Info:||Manufactured for:QUALITEST PHARMACEUTICALSHuntsville, AL 358118181482R12/07-R2|
Phentermine hydrochloride 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).Below is a chart of Body Mass Index (BMI) based on various heights and weights.BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared.Metric conversions are as follows: pounds ÷ 2.2 = kg, inches × 0.0254 = meters.The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.
Phentermine hydrochloride is indicated only as short-term monotherapy for the management of exogenous obesity.
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)—a rare, frequently fatal disease of the lungs—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 phentermine alone cannot be ruled out; there have been rare cases of PPH in patients who reportedly have taken phentermine alone.
The initial symptom of PPH is usually dyspnea.
Other initial symptoms include: angina pectoris, syncope or lower extremity edema.
Patients should be advised to report immediately any deterioration in exercise tolerance.Treatment should be discontinued in patients who develop new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema.