Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Available in tablets containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base). It is a blue and white colored, capsule shaped tablet debossed with P22 on one side and scored on the other side. Tablets are packaged in bottles of 100 (NDC: 52605-022-01); and 1000 (NDC 52605-022-10). 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 THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 52605-022-01 Phentermine Hydrochloride Tablets, USP CIV 37.5 mg Rx only USUAL ADULT DOSAGE See package insert for full Prescribing information 100 Tablets NDC 52605-022-10 Phentermine Hydrochloride Tablets, USP CIV 37.5 mg Rx only USUAL ADULT DOSAGE See package insert for full Prescribing information 1000 Tablets phentermine-cont100 phentermine-cont1000
- 16 HOW SUPPLIED/STORAGE AND HANDLING Available in tablets containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base). It is a blue and white colored, capsule shaped tablet debossed with P22 on one side and scored on the other side. Tablets are packaged in bottles of 100 (NDC: 52605-022-01); and 1000 (NDC 52605-022-10). 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 THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 52605-022-01 Phentermine Hydrochloride Tablets, USP CIV 37.5 mg Rx only USUAL ADULT DOSAGE See package insert for full Prescribing information 100 Tablets NDC 52605-022-10 Phentermine Hydrochloride Tablets, USP CIV 37.5 mg Rx only USUAL ADULT DOSAGE See package insert for full Prescribing information 1000 Tablets phentermine-cont100 phentermine-cont1000
Overview
Phentermine hydrochloride USP is a sympathomimetic amine anorectic. It has the chemical name of α,α-Dimethylphenethylamine hydrochloride. The structural formula is as follows: C 10 H 15 N • HCl M.W. 185.7 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 tablets, USP, an anorectic agent for oral administration, is available as a tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base). Phentermine hydrochloride tablets, USP contain the inactive ingredients, Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch (botanical source: maize), Sugar Spheres (consisting of Sucrose, Corn starch, FD&C Blue#1). Phen-Struc
Indications & Usage
INDICATIONS & USAGE Phentermine hydrochloride tablets, USP 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/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 patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. The limited usefulness of agents of this class, including Phentermine hydrochloride tablets, USP [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 tablets, USP 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 tablets, USP, should be measured against possible risk factors inherent in their use. ( 1 ) Phent-BMI
Dosage & Administration
DOSAGE & ADMINISTRATION • 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 tablets, USP 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 one tablet (37.5 mg) daily, as prescribed by the physician, administered before breakfast or 1-2 hours after breakfast. The dosage may be adjusted to the patient’s need. For some patients half tablet (18.75 mg) daily may be adequate, while in some cases it may be desirable to give half tablet (18.75 mg) two times a day. Phentermine hydrochloride tablets, USP is not recommended for use in pediatric patient’s ≤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 hydrochloride tablets, USP is 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m 2 ). Avoid use of Phentermine hydrochloride tablets, USP in patients with eGFR less than 15 mL/min/1.73 m 2 or end-stage renal disease requiring dialysis [See Use in Specific Populations ( 8.6 ) and Clinical Pharmacology (12.3) ].
Warnings & Precautions
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 hydrochloride tablets, USP 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. If this occurs, Phentermine hydrochloride tablets, USP should be discontinued. The recommended dose should not be exceeded. ( 5.4 ) Phentermine hydrochloride tablets, USP may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle. ( 5.5 ) Risk of abuse and dependence. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. ( 5.6 ). Concomitant alcohol use may result in an adverse drug reaction. ( 5.7 ). Use caution in patients with even mild hypertension (risk of increase in blood pressure). ( 5.8 ) A reduction in dose of insulin or oral hypoglycemic medication may be required in some patients. ( 5.9 ) 5.1 Coadministration With Other Drug Products for Weight Loss Phentermine hydrochloride tablets, USP is indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity. The safety and efficacy of combination therapy with Phentermine hydrochloride tablets, USP and any other drug products for weight loss, including prescribed drugs, over-the-counter preparations, and herbal products, or serotonergic agents such as selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, coadministration of Phentermine hydrochloride tablets, USP and these drug products is not recommended. 5.2 Primary Pulmonary Hypertension 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 hydrochloride tablets, USP 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 may 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, and patients should be evaluated for the possible presence of pulmonary hypertension. 5.3 Valvular Heart Disease Serious regurgitant cardiac valvular disease, primarily affecting the mitral, aortic and/or tricuspid valves, has been reported in otherwise healthy persons who had taken a combination of phentermine with fenfluramine or dexfenfluramine for weight loss. The possible role of phentermine in the etiology of these valvulopathies has not been established and their course in individuals after the drugs are stopped is not known. The possibility of an association between valvular heart disease and the use of Phentermine hydrochloride tablets, USP alone cannot be ruled out; there have been rare cases of valvular heart disease in patients who reportedly have taken phentermine alone. 5.4 Development of Tolerance, Discontinuation in Case of Tolerance When tolerance to the anorectant effect develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued. 5.5 Effect on the Ability to Engage in Potentially Hazardous Tasks Phentermine hydrochloride tablets, USP may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly. 5.6 Risk of Abuse and Dependence Phentermine hydrochloride tablets, USP is related chemically and pharmacologically to amphetamine (d-and d/l-amphetamine) and other related stimulant drugs that have been extensively abused. The possibility of abuse of Phentermine hydrochloride tablets, USP should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. See Drug Abuse and Dependence (9) and Overdosage (10) . The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. 5.7 Usage With Alcohol Concomitant use of alcohol with Phentermine hydrochloride tablets, USP may result in an adverse drug reaction. 5.8 Use in Patients with Hypertension Use caution in prescribing Phentermine hydrochloride tablets, USP for patients with even mild hypertension (risk of increase in blood pressure). 5.9 Use in Patients on Insulin or Oral Hypoglycemic Medications for Diabetes Mellitus A reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required.
Contraindications
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 )
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. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact PolyGen Pharmaceuticals Inc. at 1-888-291-7337 and/or FDA at 1-800-FDA-1088; or www.fda.gov/medwatch .
Drug Interactions
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 hydrochloride tablets, USP. ( 7.4 ) 7.1 Monoamine Oxidase Inhibitors Use of Phentermine hydrochloride tablets, USP 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 hydrochloride tablets, USP 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 hydrochloride tablets, USP may decrease the hypotensive effect of adrenergic neuron blocking drugs.
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