Phentermine

Phentermine Hydrochloride · Capsule · Oral

Prescription (Rx) Sympathomimetic Amine Anorectic 1 recall

Uses

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 greater than or equal to 30 kg/m 2 , or greater than or equal to 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 Height ( fe et , 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 greater than or equal to 30 kg/m2, or greater than or equal to 27 kg/m2 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 Capsules USP, should be measured against possible risk factors inherent in their use. ( 1 )

Dosage and 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 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 patient’s≤16 years of age. Late evening medication should be avoided because of the possibility of resulting insomnia. With dry hands, gently remove the Phentermine Hydrochloride Capsule from the bottle. Immediately place the Phentermine Hydrochloride Capsule on top of the tongue where it will dissolve, then swallow with or without water. 2.2 Dosage in Patients with Renal Impairment The recommended maximum dosage of Phentermine Hydrochloride Capsule is 15 mg daily for patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73m 2 ). Avoid use of Phentermine Hydrochloride Capsule 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) ]

Dosage forms and strengths

Capsules containing 15 mg or 30 mg phentermine hydrochloride (equivalent to 12 mg or 24 mg phentermine base respectively) 15 mg Capsules: white to off-white powder filled in Size ‘3’ gray opaque/yellow opaque capsules, imprinted with “U47” on cap and body in black ink. 30 mg Capsules: white to off-white powder filled in Size ‘3’ yellow opaque/yellow opaque capsules, imprinted with “U48” on cap and body in black ink. Capsules containing 15 mg or 30 mg phentermine Hydrochloride ( 3 )

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 )

Warnings and 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 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 should be discontinued. The recommended dose should not be exceeded. ( 5.4 ) Phentermine 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 Capsules are indicated only as short-term (a few weeks) 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 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 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 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 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 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 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 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 may result in an adverse drug reaction. 5.8 Use in Patients with Hypertension Use caution in prescribing phentermine 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. 5.10 Risk of Allergic Reactions This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Side effects

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 Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Drug interactions

Use of phentermine is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis. · 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.

Use in specific populations

Nursing mothers: Discontinue drug or nursing taking into consideration importance of drug to mother. ( 4 , 8.3 ) Pediatric use: Safety and effectiveness not established. ( 8.4 ) Geriatric use: Due to substantial renal excretion, use with caution. ( 8.5 ) Renal Impairment: Avoid use in patients with eGFR less than 15 mL/min/m 2 or end-stage renal disease requiring dialysis) ( 8.6 ) 8.1 Pregnancy Pregnancy Category X Phentermine is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to obligatory weight gain that occurs in maternal tissues during pregnancy. Phentermine has pharmacologic activity similar to amphetamine (d- and d/l-amphetamine) [see Clinical Pharmacology (12.1) ]. Animal reproduction studies have not been conducted with phentermine. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. 8.3 Nursing Mothers It is not known if phentermine is excreted in human milk; however, other amphetamines are present in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. Because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended. 8.5 Geriatric Use In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. 8.6 Renal Impairment Based on the reported excretion of phentermine in urine, exposure increases can be expected in patients with renal impairment [see Clinical Pharmacology (12.3) ]. Use caution when administering Phentermine to patients with renal impairment. In patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73m 2 ), limit the dosage of Phentermine to 15 mg daily [see Dosage and Administration (2.2) ]. Phentermine has not been studied in patients with eGFR less than 15 mL/min/1.73m 2 , including end-stage renal disease requiring dialysis; avoid use in these populations.

Pregnancy

8.1 Pregnancy Pregnancy Category X Phentermine is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to obligatory weight gain that occurs in maternal tissues during pregnancy. Phentermine has pharmacologic activity similar to amphetamine (d- and d/l-amphetamine) [see Clinical Pharmacology (12.1) ]. Animal reproduction studies have not been conducted with phentermine. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Pediatric use

8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. Because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended.

Geriatric use

8.5 Geriatric Use In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Overdosage

10.1 Acute Overdosage Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmia, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Overdosage of pharmacologically similar compounds has resulted in fatal poisoning usually terminates in convulsions and coma. Management of acute phentermine hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard.Acidification of the urine increases phentermine excretion. Intravenous phentolamine (Regitine ® , CIBA) has been suggested on pharmacologic grounds for possible acute, severe hypertension, if this complicates overdosage. 10.2 Chronic Intoxication Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia. See Drug Abuse and Dependence (9.3) .

Description

Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is a,a,-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 capsule USP is available as an oral capsule containing 15 mg or 30 mg phentermine hydrochloride (equivalent to 12 mg or 24 mg of phentermine base) Powder-filled capsules containing 15 mg phentermine hydrochloride (equivalent to 12 mg phentermine) or 30 mg phentermine hydrochloride (equivalent to 24 mg phentermine) and inactive ingredients: lactose monohydrate, magnesium stearate, iron oxide black, Shellac Glaze, N-Butyl alcohol, Isopropyl alcohol, propylene Glycol and Ammonium Hydroxide. In addition, the 15 mg capsules contain gelatin, titanium dioxide, D&C yellow # 10, FD&C yellow # 6, FD&C red # 40, FD&C blue # 1 and FD&C yellow # 5; the 30 mg capsules contain gelatin, titanium dioxide, iron oxide yellow and iron oxide red. Structural Formula

Mechanism of action

12.1 Mechanism of Action Phentermine is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and d/l-amphetamine). Drugs of this class used in obesity are commonly known as “anorectics” or “anorexigenics.” It has not been established that the primary action of such drugs in treating obesity is one of appetite suppression since other central nervous system actions, or metabolic effects, may also be involved.

How supplied

Phentermine Hydrochloride Capsules USP, 15 mg are white to off-white powder filled in Size ‘3’ gray opaque/yellow opaque capsules, imprinted with “U47” on cap and body in black ink. Bottles of 30 NDC 13107-105-30 Bottles of 100 NDC 13107-105-01 Phentermine Hydrochloride Capsules USP, 30 mg are white to off-white powder filled in Size ‘3’ yellow opaque/yellow opaque capsules, imprinted with “U48” on cap and body in black ink. Bottles of 30 NDC 13107-106-30 Bottles of 100 NDC 13107-106-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep out of the reach of children.

Patient information

Patients must be informed that phentermine hydrochloride is 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, and that coadministration of phentermine with other drugs for weight loss is not recommended [see Indications and Usage (1) and Warnings and Precautions (5) ]. Patients must be instructed on how much phentermine to take, and when and how to take it [see Dosage and Administration (2) ]. Advise pregnant women and nursing mothers not to use phentermine [see Use in Specific Populations ( 8.1 , 8.3) ] . Patients must be informed about the risks of use of phentermine (including the risks discussed in Warnings and Precautions), about the symptoms of potential adverse reactions and when to contact a physician and/or take other action. The risks include, but are not limited to: Development of primary pulmonary hypertension [see Warnings and Precautions (5.2) ] Development of serious valvular heart disease [see Warnings and Precautions (5.3) ] Effects on the ability to engage in potentially hazardous tasks [see Warnings and Precautions (5.5) ] The risk of an increase in blood pressure [see Warnings and Precautions (5.8) and Adverse Reactions (6) ] The risk of interactions [see Contraindications (4) , Warnings and Precautions (5) and Drug Interactions (7) ] See also, for example, Adverse Reactions (6) and Use in Specific Populations (8) . The patients must also be informed about the potential for developing tolerance and actions if they suspect development of tolerance [see Warnings and Precautions (5.4) ] and the risk of dependence and the potential consequences of abuse [see Warnings and Precautions (5.6) , Drug Abuse and Dependence (9) , and Overdosage (10) ]. Tell patients to keep phentermine in a safe place to prevent theft, accidental overdose, misuse or abuse. Selling or giving away phentermine may harm others and is against the law. Revised:03/2017

Label text from the FDA structured product label by Aurolife Pharma, LLC (revised Jan 4, 2019). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Phentermine Hydrochloride in 3 products

Phentermine NDC products (3)

NDC	Strength & form	Labeler	Type
13107-105	Phentermine Hydrochloride 15 mg/1 Capsule	Aurolife Pharma, LLC	ANDA · DEA CIV
13107-106	Phentermine Hydrochloride 30 mg/1 Capsule	Aurolife Pharma, LLC	ANDA · DEA CIV
17224-890	Phentermine Hydrochloride 37.5 mg/1 Capsule	Calvin Scott & Co., Inc.	ANDA · DEA CIV

Phentermine recalls

D-1236-2020 Apr 22, 2020 · Class II · Terminated
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Frequently asked questions

What is Phentermine used for?

What are the side effects of Phentermine?

Who makes Phentermine?

Phentermine is listed by 2 labelers in the FDA NDC directory, including Aurolife Pharma, LLC, Calvin Scott & Co., Inc..

Has Phentermine been recalled?

The FDA enforcement database lists 1 recall for Phentermine, most recently D-1236-2020 (class ii): CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed