PHENTERMINE HYDROCHLORIDE- phentermine hydrochloride tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PHENTERMINE HYDROCHLORIDE (UNII: 0K2I505OTV) (PHENTERMINE - UNII:C045TQL4WP)
Available from:
Bryant Ranch Prepack
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Phentermine hydrochloride Tablets 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/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 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. 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. - History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled
Product summary:
Product: 63629-8201 NDC: 63629-8201-1 30 TABLET in a BOTTLE
Authorization status:
Abbreviated New Drug Application
Authorization number:
63629-8201-1

PHENTERMINE HYDROCHLORIDE- phentermine hydrochloride tablet

Bryant Ranch Prepack

----------

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets, USP

safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets, USP.

Phentermine Hydrochloride Tablets, USP CIV for oral use

Initial U.S. Approval: 1959

INDICATIONS AND USAGE

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/m2, or ≥ 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, 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 Tablets 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)

DOSAGE FORMS AND STRENGTHS

Tablets containing 37.5 mg phentermine hydrochloride. (3)

CONTRAINDICATIONS

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)

ADVERSE REACTIONS

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.

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. (7.4)

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 or end-stage renal disease requiring

dialysis). (8.6)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2019

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Exogenous Obesity

2.2 Dosage in Patients With Renal Impairment

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Coadministration With Other Drug Products for Weight Loss

5.2 Primary Pulmonary Hypertension

5.3 Valvular Heart Disease

5.4 Development of Tolerance, Discontinuation in Case of Tolerance

5.5 Effect on the Ability to Engage in Potentially Hazardous Tasks

5.6 Risk of Abuse and Dependence

5.7 Usage With Alcohol

5.8 Use in Patients With Hypertension

5.9 Use in Patients on Insulin or Oral Hypoglycemic Medications for Diabetes Mellitus

6 ADVERSE REACTIONS

7 DRUG INTERACTIONS

7.1 Monoamine Oxidase Inhibitors

7.2 Alcohol

7.3 Insulin and Oral Hypoglycemic Medications

7.4 Adrenergic Neuron Blocking Drugs

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

9.2 Abuse

9.3 Dependence

10 OVERDOSAGE

10.1 Acute Overdosage

10.1 Acute Overdosage

10.2 Chronic Intoxication

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

Phentermine hydrochloride Tablets 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 , or ≥ 27 kg/m 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

Weight

(pounds )

Height (feet, inches)

5'0"

5'3"

5'6"

5'9"

6'0"

6'3"

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.

2 DOSAGE AND ADMINISTRATION

2.1 Exogenous Obesity

Sections or subsections omitted from the full prescribing information are not listed.

2

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 to 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 tablets (18.75 mg) two times a day.

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/1.73m2). Avoid use of phentermine in patients with eGFR less than

15 mL/min/1.73m or end-stage renal disease requiring dialysis [see Use in Specific Populations (8.6) and

Clinical Pharmacology (12.3)].

3 DOSAGE FORMS AND STRENGTHS

Tablets containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base).

Phentermine Hydrochloride Tablets, USP 37.5 mg are white with blue speckles, capsule-shaped tablets,

bisected and debossed with "Є" to the left of bisect and "16" to the right of bisect on one side, and plain

on the other side.

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 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 dll-amphetamine) and

other related stimulant drugs 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.

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.

7 DRUG INTERACTIONS

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.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects

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 dll-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 ), 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 , 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 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:

H 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, 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).

Each tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate,

magnesium stearate, microcrystalline cellulose and blue sugar spheres.

12 CLINICAL PHARMACOLOGY

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 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 phentermine under uncontrolled urinary pH conditions was 62% to

85%.

Systemic exposure of phentermine may increase up to 91%, 45%, and 22% in patients with severe,

moderate, and mild renal impairment, respectively [see Dosage and Administration (2.2) and Use in

Specific Populations (8.6)].

Drug Interactions

In a single-dose study comparing the exposures after oral administration of a combination capsule of 15

mg phentermine and 92 mg topiramate to the exposures after oral administration of a 15 mg phentermine

capsule or a 92 mg topiramate capsule, there is no significant topiramate exposure change in the

presence of phentermine. However in the presence of topiramate, phentermine C

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

Product: 63629-8201

NDC: 63629-8201-1 30 TABLET in a BOTTLE

17 PATIENT COUNSELING 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 (5.1)].

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 (5.7, 5.9) 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.

All trademarks are the property of their respective owners.

For inquiries call TAGI Pharma, Inc. at 1-855-225-8244 or e-mail druginfo@tagipharma.com

Manufactured by:

Elite Laboratories, Inc.

Northvale, NJ 07647

Distributed by:

TAGI Pharma

South Beloit, IL 61080

Issued May 2019

IN0509

PHENTERMINE HCL 37.5 (CIV) TABLET

PHENTERMINE HYDROCHLORIDE

phentermine hydrochloride tablet

Product Information

Product T ype

HUMAN

PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 36 29 -

8 20 1(NDC:51224-10 1)

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PHENTERMINE HYDRO CHLO RIDE (UNII: 0 K2I50 5OTV) (PHENTERMINE -

UNII:C0 45TQL4WP)

PHENTERMINE

HYDROCHLORIDE

37.5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

cro sca rmello se so dium (UNII: M28 OL1HH48 )

la cto se mo no hydra te (UNII: EWQ57Q8 I5X)

ma g nesium stea ra te (UNII: 70 0 9 7M6 I30 )

micro crysta lline cellulo se (UNII: OP1R32D6 1U)

Product Characteristics

Color

WHITE (with blue speckles)

S core

2 pieces

S hap e

OVAL (capsule shaped)

S iz e

10 mm

Flavor

Imprint Code

E;16

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 36 29 -8 20 1-1

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 2/20 19

Bryant Ranch Prepack

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 0 272

0 3/0 8 /20 11

Labeler -

Bryant Ranch Prepack (171714327)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Bryant Ranch Prepack

171714327

REPACK(6 36 29 -8 20 1) , RELABEL(6 36 29 -8 20 1)

Revised: 8/2019

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