Haloperidol (injection)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Shanshan Cen, M.D. [2]
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
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 {{{adverseReactions}}}.
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
{{#ask: Page Name::Haloperidol (injection) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Haloperidol (injection) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
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.