Naltrexone (injection)

Naltrexone (injection)
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];

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Overview

Naltrexone (injection) is an opioid antagonist that is FDA approved for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. Common adverse reactions include nausea, vomiting, injection site reactions (including induration, pruritus, nodules and swelling), muscle cramps, dizziness or syncope, somnolence or sedation, anorexia, decreased appetite or other appetite disorders.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Naltrexone (injection) FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Naltrexone (injection) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Naltrexone (injection) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Naltrexone (injection) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Naltrexone (injection) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Naltrexone (injection) in pediatric patients.

Contraindications

There is limited information regarding Naltrexone (injection) Contraindications in the drug label.

Warnings

There is limited information regarding Naltrexone (injection) Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Naltrexone (injection) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Naltrexone (injection) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Naltrexone (injection) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Naltrexone (injection) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Naltrexone (injection) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Naltrexone (injection) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Naltrexone (injection) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Naltrexone (injection) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Naltrexone (injection) in geriatric settings.

Gender

There is no FDA guidance on the use of Naltrexone (injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Naltrexone (injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Naltrexone (injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Naltrexone (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Naltrexone (injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Naltrexone (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Naltrexone (injection) Administration in the drug label.

Monitoring

There is limited information regarding Naltrexone (injection) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Naltrexone (injection) and IV administrations.

Overdosage

There is limited information regarding Naltrexone (injection) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Naltrexone (injection) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Naltrexone (injection) Mechanism of Action in the drug label.

Structure

There is limited information regarding Naltrexone (injection) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Naltrexone (injection) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Naltrexone (injection) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Naltrexone (injection) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Naltrexone (injection) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Naltrexone (injection) How Supplied in the drug label.

Storage

There is limited information regarding Naltrexone (injection) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Naltrexone (injection) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Naltrexone (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Naltrexone (injection) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Naltrexone (injection) 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.