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 (see CLINICAL PHARMACOLOGY) 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

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

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

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

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

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

• Intravenous

Monitoring

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

• Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

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

Pharmacology

There is limited information regarding Benzphetamine Pharmacology in the drug label.

Mechanism of Action

Structure

File:Benzphetamine01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

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

Storage

There is limited information regarding Benzphetamine Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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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

• A® — B®

Drug Shortage Status

Price

References

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

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