PHENTERMINE HYDROCHLORIDE

Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows: Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether. Phentermine hydrochloride capsules USP is available as an oral capsule containing 15 mg or 30 mg of phentermine hydrochloride (equivalent to 12 mg or 24 mg of phentermine base). Each phentermine hydrochloride capsule contains the following inactive ingredients: starch 1500, lactose monohydrate and magnesium stearate. Phentermine hydrochloride capsules 15 mg also contain D&C yellow No. 10, FD&C red No. 3, FD&C blue No 1, FD&C red No. 40, gelatin and titanium dioxide. Phentermine hydrochloride capsules 30 mg also contain D&C yellow No. 10, FD&C red No. 3, gelatin and titanium dioxide. The imprinting ink for the capsules contains the following ingredients: shellac glaze in ethanol, iron oxide black, n-butyl alcohol, propylene glycol, SDA 3A alcohol, methanol, FD&C blue No. 2, FD&C red No. 40, FD &C blue No. 1, and D&C yellow No. 10. Chemical Structure

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 × 0.0254 = meters. BODY MASS INDEX (BMI), kg/m 2 Height (feet, inches) Weight (pounds) 5'0" 5'3" 5'6" 5'9" 6'0" 6'3" 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31 The limited usefulness of agents of this class, including phentermine, [see 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). ( 1 ) The limited usefulness of agents of this class, including phentermine hydrochloride, should be measured against possible risk factors inherent in their use. ( 1 )

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 capsules can be taken with or without food ( 2.1 ) Limit the dosage to 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m 2 ( 2.2 ) 2.1 Exogenous Obesity Dosage should be individualized to obtain an adequate response with the lowest effective dose. The usual adult dose is 15 mg to 30 mg as prescribed by the physician, at approximately 2 hours after breakfast for appetite control. Administration of one 30 mg capsule daily has been found to be adequate in depression of the appetite for 12 to 14 hours. Phentermine is not recommended for use in pediatric patients ≤ 16 years of age. Late evening medication should be avoided because of the possibility of resulting insomnia. 2.2 Dosage in Patients With Renal Impairment The recommended maximum dosage of phentermine is 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73m 2 ). Avoid use of phentermine in patients with eGFR less than 15 mL/min/1.73m 2 or end-stage renal disease requiring dialysis [ see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ].

History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension) During or within 14 days following the administration of monoamine oxidase inhibitors Hyperthyroidism Glaucoma Agitated states History of drug abuse Pregnancy [see Use in Specific Populations (8.1) ] Nursing [see Use in Specific Populations (8.3) ] Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension) ( 4 ) During or within 14 days following the administration of monoamine oxidase inhibitors ( 4 ) Hyperthyroidism ( 4 ) Glaucoma ( 4 ) Agitated states ( 4 ) History of drug abuse ( 4 ) Pregnancy ( 4 , 8.1 ) Nursing ( 4 , 8.3 ) Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines ( 4 )

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: Adverse events have been reported in the cardiovascular, central nervous, gastrointestinal, allergic, and endocrine systems. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Elite Laboratories, Inc. at 1-888-852-6657 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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.

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. ( 7.4 ) 7.1 Monoamine Oxidase Inhibitors Use of phentermine is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis. 7.2 Alcohol Concomitant use of alcohol with phentermine may result in an adverse drug reaction. 7.3 Insulin and Oral Hypoglycemic Medications Requirements may be altered [see Warnings and Precautions (5.9) ]. 7.4 Adrenergic Neuron Blocking Drugs Phentermine may decrease the hypotensive effect of adrenergic neuron blocking drugs.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Keep out of the reach of children.