Haloperidol (injection)

Haloperidol (injection)
Black Box Warning
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: Shanshan Cen, M.D. [2]

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Black Box Warning

WARNING See full prescribing information for complete Boxed Warning. Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. HALDOL Injection is not approved for the treatment of patients with dementia-related psychosis

Overview

Haloperidol (injection) is an antipsychotic agent that is FDA approved for the treatment of schizophrenia. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hypotension, constipation, xerostomia, akathisia, dystonia, extrapyramidal disease, somnolence, and blurred vision.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Haloperidol (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 Haloperidol (injection) in adult patients.

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Haloperidol (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 Haloperidol (injection) in pediatric patients.

Non–Guideline-Supported Use

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

Contraindications

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

Warnings

WARNING See full prescribing information for complete Boxed Warning. Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. HALDOL Injection is not approved for the treatment of patients with dementia-related psychosis

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

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

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

Monitoring

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

IV Compatibility

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

Overdosage

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

Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

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

Storage

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

Precautions with Alcohol

Alcohol-Haloperidol (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 Haloperidol (injection) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Haloperidol (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.