Benzphetamine

Benzphetamine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Overview

Benzphetamine is a Sympathomimetic amine that is FDA approved for the treatment of exogenous obesity. Common adverse reactions include Increased blood pressure, Palpitations, Tachyarrhythmia, Urticaria, Diarrhea, Nausea, Unpleasant taste in mouth, Xerostomia, Central nervous system stimulation, Overstimulation, Dizziness, Headache, Insomnia, Tremor, Depression following drug withdrawal, Restlessness, Changes in libido.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Benzphetamine Hydrochloride Tablets are indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction. The limited usefulness of agents of this class should be weighed against possible risks inherent in their use such as those described below.

Dosage

• Benzphetamine Hydrochloride Tablets are supplied as follows:

50 mg (peach, round, imprinted with BP 650, scored)

12634-118-56 Bottle of 56

12634-118-44 Bottle of 84

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Benzphetamine in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Benzphetamine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Benzphetamine in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Benzphetamine in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Benzphetamine in pediatric patients.

Contraindications

• Benzphetamine Hydrochloride Tablets are contraindicated in patients with advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to sympathomimetic amines, and glaucoma. Benzphetamine should not be given to patients who are in an agitated state or who have a history of drug abuse.

• Hypertensive crises have resulted when sympathomimetic amines have been used concomitantly or within 14 days following use of monoamine oxidase inhibitors. Benzphetamine Hydrochloride Tablets should not be used concomitantly with other CNS stimulants.

• Benzphetamine Hydrochloride Tablets may cause fetal harm when administered to a pregnant woman. Amphetamines have been shown to be teratogenic and embryotoxic in mammals at high multiples of the human dose. Benzphetamine Hydrochloride Tablets are contraindicated in women who are or may become pregnant. 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 the fetus.

Warnings

• When tolerance to the anorectic effect develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued

Precautions

General

• Insulin requirements in diabetes mellitus may be altered in association with use of anorexigenic drugs and the concomitant dietary restrictions.

• Psychological disturbances have been reported in patients who receive an anorectic agent together with a restrictive dietary regime.

• Caution is to be exercised in prescribing amphetamines for patients with mild hypertension. The least amount feasible

should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Adverse Reactions

Clinical Trials Experience

• The following have been associated with the use of benzphetamine hydrochloride:

Cardiovascular:

• Palpitation, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.

CNS:

• Overstimulation, restlessness, dizziness, insomnia, tremor, sweating, headache; rarely, psychotic episodes at recommended doses; depression following withdrawal of the drug.

Gastrointestinal:

• Dryness of the mouth, unpleasant taste, nausea, diarrhea, other gastrointestinal disturbances.

Allergic:

• Urticaria and other allergic reactions involving the skin.

Endocrine:

• Changes in libido.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Benzphetamine in the drug label.

Drug Interactions

• Hypertensive crises have resulted when sympathamimetic amines have been used concomitantly or within 14 days following use of

monoamine oxidase inhibitors. Benzphetamine hydrochloride tablets should not be used concomitantly with other CNS stimulants.

• Amphetamines may enhance the effects of tricyclic antidepressants.
• Urinary alkalinizing agents increase blood levels and decrease excretion of amphetamines. Urinary acidifying

agents decrease blood levels and increase excretion of amphetamines.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): X

• Benzphetamine Hydrochloride Tablets may cause fetal harm when administered to a pregnant woman. Amphetamines have been shown to be teratogenic and embryotoxic in mammals at high multiples of the human dose. Benzphetamine Hydrochloride Tablets are contraindicated in women who are or may become pregnant. 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 the fetus.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Benzphetamine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Benzphetamine during labor and delivery.

Nursing Mothers

Amphetamines are excreted in human milk. Mothers taking amphetamines should be advised to refrain from nursing.

Pediatric Use

• Use of benzphetamine hydrochloride is not recommended in individuals under 12 years of age.

Geriatic Use

There is no FDA guidance on the use of Benzphetamine with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Benzphetamine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Benzphetamine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Benzphetamine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Benzphetamine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Benzphetamine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Benzphetamine in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

Monitoring

There is limited information regarding Monitoring of Benzphetamine in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Benzphetamine in the drug label.

Overdosage

Manifestations of Overdosage:

• Acute overdosage with amphetamines may result in restlessness, tremor, tachypnea, confusion, assaultiveness and panic states.
• Fatigue and depression usually follow the central stimulation. Cardiovasculas effects include arrhythmias,

hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Hyperpyrexia and rhabdomyolysis have been reported and can lead to a number of associated complications. Fatal poisoning is usually preceded by convulsion and coma.

Treatment of Overdosage:

• Information concerning the effects of overdosage with benzphetamine hydrochloride tablets is extremely limited. The following

is based on experience with other anorexiants.

• Management of acute amphetamine intoxication is largely symptomatic and includes sedation with a barbiturate. If hypertension

is marked, the use of a nitrite or rapidly acting alpha receptor blocking agent should be considered.

• Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard.

• Acidification of the urine increases amphetamine excretion. The oral LD50 is 174 mg/kg in mice and 104 mg/kg in rats. The intraperitioneal LD50 in mice is 153 mg/kg.

DRUG ABUSE AND DEPENDENCE

• Benzphetamine is a controlled substance under the Controlled Substance Act by the Drug Enforcement Administration and has been assigned to Schedule III

• Benzphetamine hydrochloride is related chemically and pharmacologically to the amphetamines. Amphetamines and

related stimulant drugs have been extensively abused, and the possibility of abuse of benzphetamine Hydrochloride Tablets should be kept in mind when evaluating the desirabilityof including a drug as part of a weight reduction program.

• 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 dosage to many times that 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. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophirenia.

Pharmacology

Mechanism of Action

• Benzphetamine hydrochloride is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions 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.

• Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics". It has not been established, however, that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions, or metabolic effects, may be involved.

Structure

• Benzphetamine hyrochloride tablets 50 mg contain the anorectic agent benzphetamine hydrochloride.Benzephet-

amine hydrochloride is a white crystalline powder readily soluble in water and 95% ethanol. The chemical name for benaphetamine hydrochloride is d-N,a-Dimethyl-N-(phenylmethyl)-benzeneethanamine hydrochloride and its moleculas weight is 275.82. The structural formula (dextro form) is represented as follows below:

This image is provided by the National Library of Medicine.

• Each Benzphetamine hydrochloride tablets 50 mg, for oral administration, contains 50 mg of benzphetamine hydrochloride.

Inactive ingredients: Calcium Stearate, Polyethylene Glycol, FD and C Yellow No. 6, Lactose Anhydrous, Sorbitol.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Benzphetamine in the drug label.

Pharmacokinetics

• Adult obese subjects instructed in dietary management and treated with "anorectic" drugs, lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term clinical trials.

• 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 the 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 drug 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 in 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 to be clinically limited.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

• Animal studies to evaluate the potential for carcinogenesis, mutagenesis or impairment of fertility have not been performed.

Clinical Studies

There is limited information regarding Clinical Studies of Benzphetamine in the drug label.

How Supplied

• Benzphetamine Hydrochloride Tablets are supplied as follows:

50 mg (peach, round, imprinted with BP 650, scored)

12634-118-56 Bottle of 56

12634-118-44 Bottle of 84

Storage

• Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).
• Dispense in a tight, light-resistant container as defined in the USP.
• A Schedule CS-III controlled drug substance.

Images

Drug Images

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Package and Label Display Panel

PACKAGE LABEL,PRINCIPAL DISPLAY PANEL

This image is provided by the National Library of Medicine.

Ingredients and Appearance

This image is provided by the National Library of Medicine.

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Patient Counseling Information

• Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or

driving a vehicle; the patient should therefore be cautioned accordingly.

Precautions with Alcohol

• Alcohol-Benzphetamine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• Didrex®

Look-Alike Drug Names

There is limited information regarding Benzphetamine Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.