Haloperidol
Generic Name: haloperidol
Brand Names:
Haloperidol Lactate
Description Haloperidol is the first of the butyrophenone series of major antipsychotics. The chemical designation is 4-[4-(p-chlorophenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula: Haloperidol, USP is a white or slightly yellowish crystalline powder. Haloperidol injection, USP is available as a sterile parenteral form for intramuscular injection.
Overview
Description Haloperidol is the first of the butyrophenone series of major antipsychotics. The chemical designation is 4-[4-(p-chlorophenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula: Haloperidol, USP is a white or slightly yellowish crystalline powder. Haloperidol injection, USP is available as a sterile parenteral form for intramuscular injection.
Uses
INDICATIONS AND USAGE Haloperidol Injection, USP is indicated for use in the treatment of schizophrenia.
Dosage
DOSAGE AND ADMINISTRATION There is considerable variation from patient to patient in the amount of medication required for treatment. As with all drugs used to treat schizophrenia, dosage should be individualized according to the needs and response of each patient. Dosage adjustments, either upward or downward, should be carried out as rapidly as practicable to achieve optimum therapeutic control. To determine the initial dosage, consideration should be given to the patient’s age, severity of illness, previous response to other antipsychotic drugs, and any concomitant medication or disease state. Debilitated or geriatric patients, as well as those with a history of adverse reactions to antipsychotic drugs, may require less haloperidol.
Side Effects
ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: •WARNINGS, Increased Mortality in Elderly Patients with Dementia-Related Psychosis •WARNINGS, Cardiovascular Effects •WARNINGS, Tardive Dyskinesia •WARNINGS, Neuroleptic Malignant Syndrome •WARNINGS, Hypersensitivity Reactions •WARNINGS, Falls •WARNINGS, Usage in Pregnancy •WARNINGS, Combined Use of Haloperidol and Lithium •WARNINGS, General •PRECAUTIONS, Leukopenia, Neutropenia, and Agranulocytosis •PRECAUTIONS, Withdrawal Emergent Dyskinesia •PRECAUTIONS, Other Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical tr...
Warnings
BOXED WARNING 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. WARNINGS 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. Haloperidol injection is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING). Cardiovascular Effects Cases of sudden death, QTc interval-prolongation, and Torsades de Pointes have been reported in patients receiving haloperidol (see ADVERSE REACTIONS ). Higher than recommended doses of any formulation and intravenous administration of haloperidol appear to be associated with a higher risk of QTc interval-prolongation and Torsades de Pointes. Also, a QTc interval that exceeds 500 msec is associated with an increased risk of Torsades de Pointes. CONTRAINDICATIONS Haloperidol is contraindicated in patients with: • Severe toxic central nervous system depression or comatose states from any cause. • Hypersensitivity to this drug – hypersensitivity reactions have included anaphylactic reaction and angioedema (see WARNINGS, Hypersensitivity Reactions and ADVERSE REACTIONS).
Storage
HOW SUPPLIED Haloperidol injection, USP (For Immediate Release) equivalent to 5 mg haloperidol per mL (as the lactate) is supplied as follows: NDC 67457-426-12 1 mL (5 mg) vial, 25 vials per carton. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Do not freeze.
Frequently Asked Questions
What is Haloperidol used for?▼
INDICATIONS AND USAGE Haloperidol Injection, USP is indicated for use in the treatment of schizophrenia.
What are the side effects of Haloperidol?▼
ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: •WARNINGS, Increased Mortality in Elderly Patients with Dementia-Related Psychosis •WARNINGS, Cardiovascular Effects •WARNINGS, Tardive Dyskinesia •WARNINGS, Neuroleptic Malignant Syndrome •WARNINGS, Hypersensitivity Reactions •WARNINGS, Falls •WARNINGS, Usage in Pregnancy •WARNINGS, Combined Use of Haloperidol and Lithium •WARNINGS, General •PRECAUTIONS, Leukopenia, Neutropenia, and Agranulocytosis •PRECAUTIONS, Withdrawal Emergent Dyskinesia •PRECAUTIONS, Other Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical tr...
What are the important warnings for Haloperidol?▼
BOXED WARNING 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. WARNINGS 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. Haloperidol injection is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING). Cardiovascular Effects Cases of sudden death, QTc interval-prolongation, and Torsades de Pointes have been reported in patients receiving haloperidol (see ADVERSE REACTIONS ). Higher than recommended doses of any formulation and intravenous administration of haloperidol appear to be associated with a higher risk of QTc interval-prolongation and Torsades de Pointes. Also, a QTc interval that exceeds 500 msec is associated with an increased risk of Torsades de Pointes. CONTRAINDICATIONS Haloperidol is contraindicated in patients with: • Severe toxic central nervous system depression or comatose states from any cause. • Hypersensitivity to this drug – hypersensitivity reactions have included anaphylactic reaction and angioedema (see WARNINGS, Hypersensitivity Reactions and ADVERSE REACTIONS).
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.