Phentermine

Phentermine Hydrochloride, USP 15 mg and 30 mg 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 greater than or equal to 30 kg/m 2, or greater than or equal to 27 kg/m 2in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).

Dosage should be individualized to obtain an adequate response with the lowest effective dose. ( 2.1) Late evening administration should be avoided (risk of insomnia). ( 2.1) Phentermine Hydrochloride can be taken with or without food.

The following adverse reactions are described, or described in greater detail, in other sections: Primary pulmonary hypertension [ see Warnings and Precautions ( 5.2) ] Valvular heart disease [ see Warnings and Precautions ( 5.3) ] Effect on the ability to engage in potentially hazardous tasks [ see Warnings and Precautions ( 5.5) ] Withdrawal effects following prolonged high dosage administration [ see Drug Abuse and Dependence ( 9.3) ] The following adverse reactions to phentermine have been…

Coadministration with other drugs for weight loss is not recommended (safety and efficacy of combination not established). ( 5.1) Rare cases of primary pulmonary hypertension have been reported. Phentermine should be discontinued in case of new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema. ( 5.2) Rare cases of serious regurgitant cardiac valvular disease have been reported. ( 5.3) Tolerance to the anorectic effect usually develops within a few weeks.

Monoamine oxidase inhibitors: Risk of hypertensive crisis. ( 4, 7.1) Alcohol: Consider potential interaction ( 7.2) Insulin and oral hypoglycemics: Requirements may be altered. ( 7.3) Adrenergic neuron blocking drugs: Hypotensive effect may be decreased by phentermine.