1 INDICATIONS AND USAGE Phentermine hydrochloride capsules are 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/m 2 , or ≥ 27 kg/m 2 in the presence of other risk factors (e.g., controlled 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 x 0.0254 = meters.

BODY MASS INDEX (BMI), kg/m 2 The limited usefulness of agents of this class, including phentermine, [se e CLINICAL PHARMACOLOGY ( 12.1 , 12.2 )] should be measured against possible risk factors inherent in their use such as those described below.

Phentermine hydrochloride is a sympathomimetic amine anorectic indicated as a short-term adjunct (a few weeks) 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/m 2 , or ≥ 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).

The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use.

BMI

6 ADVERSE REACTIONS 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 identified: Cardiovascular Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevation of blood pressure, ischemic events.

Central Nervous System Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis.

Gastrointestinal Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.

Allergic Urticaria.

Endocrine Impotence, changes in libido.

Adverse events have been reported in the cardiovascular, central nervous, gastrointestinal, allergic, and endocrine systems.

To report SUSPECTED ADVERSE REACTIONS, contact Sunrise Pharmaceutical, Inc.

at 732-382-6085 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.