PHENTERMINE HYDROCHLORIDE tablet

Phentermine hydrochloride by

Drug Labeling and Warnings

Phentermine hydrochloride by is a Prescription medication manufactured, distributed, or labeled by POLYGEN PHARMACEUTICALS INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 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/m2,or ≥27 kg/m2 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.

    Phent-BMI

    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.

  • 2 DOSAGE & ADMINISTRATION

    2.1 Exogenous Obesity

    Dosage should be individualized to obtain an adequateresponse with the lowest effective dose.

    The usual adult dose is one tablet (37.5 mg) daily, asprescribed 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 togive half tablet (18.75 mg) two times a day.

    Phentermine hydrochloride tablets, USP is notrecommended for use in pediatric patient’s ≤16 years of age.

    Late evening medication should be avoided because of thepossibility of resulting insomnia.

    2.2 Dosage in Patients with Renal Impairment

    The recommended maximum dosage of Phenterminehydrochloride tablets, USP is 15 mg daily for patients with severe renalimpairment (eGFR 15 to 29 mL/min/1.73 m2). Avoid use of Phenterminehydrochloride tablets, USP in patients with eGFR less than 15 mL/min/1.73m2 or end-stage renal disease requiring dialysis [See Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

  • 3 DOSAGE FORMS & STRENGTHS

    Tablets containing 37.5 mg phentermine hydrochloride. (3)

  • 4 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
  • 5 WARNINGS AND PRECAUTIONS

    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.

  • 6 ADVERSE REACTIONS

     The following adverse reactions are described, or described in greater detail, in other sections:

    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.

  • 7 DRUG INTERACTIONS

    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.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Teratogenic Effects
    Pregnancy category X

    Phentermine hydrochloride tablets, USP 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 dll-amphetamine) [seeClinical 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 hydrochloride tablets, USP 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. [seeClinical Pharmacology (12.3)].
    Use caution when administering Phentermine hydrochloride tablets, USP to patients with renal impairment. In patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73m2), limit the dosage of Phentermine hydrochloride tablets, USP to 15 mg daily [See Dosage and Administration (2.2)]. Phentermine hydrochloride tablets, USP has not been studied in patients with eGFR less than 15 mL/min/1.73m2, including end-stage renal disease requiring dialysis; avoid use in these populations.  

  • 9 DRUG ABUSE AND DEPENDENCE

    9.1 Controlled Substance

    Phentermine is a Schedule IV controlled substance.

    9.2 Abuse

    Phentermine is related chemically and pharmacologically to the amphetamines. Amphetamines and other stimulant drugs have been extensively abused and 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.

    9.3 Dependence

    Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage of these drugs to many times than recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. A severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.

  • 10 OVERDOSAGE

    The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of 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 tachycardia, 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 ).

  • 11 DESCRIPTION

    Phentermine hydrochloride USP is a sympathomimetic amine anorectic. It has the chemical name of α,α-Dimethylphenethylamine hydrochloride. The structural formula is as follows:

    Phen-Struc

    C10H15N 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).

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    Phentermine hydrochloride tablets, USP is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and dll-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.

    12.2 Pharmacodynamics

    Typical actions of amphetamines include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.

    12.3 Pharmacokinetics

    Following the administration of phentermine, phentermine reaches peak concentrations (Cmax) after 3 to 4.4 hours.

    Specific Populations

    Renal Impairment

    Cumulative urinary excretion of phentermineunder uncontrolled urinary pH conditions was 62% to 85%.

    Systemic exposure of phentermine may increaseup to 91%, 45%, and 22% in patients with severe, moderate, and mild renalimpairment, respectively [See Dosage andAdministration (2.2) and Use inSpecific Populations (8.6)].


    Drug Interactions

    Ina single-dose study comparing the exposures after oral administration of acombination capsule of 15 mg phentermine and 92 mg topiramate to the exposuresafter oral administration of a 15 mg phentermine capsule or a 92 mg topiramatecapsule, there is no significant topiramate exposure change in the presence of phentermine. However in the presence of topiramate, phentermine Cmax and AUC increase 13% and 42%, respectively.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis & Mutagenesis & Impairment Of Fertility

    Studies have not been performed with phentermine to determine the potential for carcinogenesis, mutagenesis or impairment of fertility.

  • 14 CLINICAL STUDIES

    In relatively short-term clinical trials, adult obese subjects instructed in dietary management and treated with “anorectic” drugs lost more weight on the average than those treated with placebo and diet.

    The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an “anorectic” drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drugs prescribed, such as the physician-investigator, the population treated and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.

    The natural history of obesity is measured over several years, whereas the studies cited are restricted to a few weeks duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.

  • 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.

  • 17 PATIENT COUNSELING INFORMATION

    Patients must be informed that Phentermine hydrochloride tablets, USP 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 co-administration 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 hydrochloride tablets, USP to take, and when and how to take it [see  Dosage and Administration (2)].

    Advise pregnant women and nursing mothers not to use Phentermine hydrochloride tablets, USP [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:

    See also, for example, Adverse Reactions (6)and Use in Specific Populations (8).

    The patients must also be informed about

    Tell patients to keep Phentermine hydrochloride tablets, USP in a safe place to prevent theft, accidental overdose, misuse or abuse. Selling or giving away Phentermine hydrochloride tablets, USP may harm others and is against the law.

    All trademarks are the property of their respective owners.

    Manufactured by: 

    PolyGen Pharmaceuticals  Inc.

    Edgewood, NY 11717


    Distributed by:

    PolyGen Pharmaceuticals  Inc.

    Edgewood, NY 11717


    Revised: 04/2017

    LBS0023






  • 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



    phentermine-cont100



    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-cont1000
  • INGREDIENTS AND APPEARANCE
    PHENTERMINE HYDROCHLORIDE 
    phentermine hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 52605-022
    Route of AdministrationORALDEA ScheduleCIV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENTERMINE HYDROCHLORIDE (UNII: 0K2I505OTV) (PHENTERMINE - UNII:C045TQL4WP) PHENTERMINE HYDROCHLORIDE37.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SUCROSE (UNII: C151H8M554)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorBLUE, WHITEScore2 pieces
    ShapeCAPSULESize10mm
    FlavorImprint Code P22
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 52605-022-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2016
    2NDC: 52605-022-101000 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20634211/18/2016
    Labeler - POLYGEN PHARMACEUTICALS INC. (962415720)
    Establishment
    NameAddressID/FEIBusiness Operations
    POLYGEN PHARMACEUTICALS INC.962415720MANUFACTURE(52605-022) , PACK(52605-022)
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