Product image of Haldol (Haloperidol) supplied by GNH India

Haldol

Active Ingredient:
Haloperidol
Origin:
EU

Haldol (Haloperidol)

Haldol is a prescription intramuscular injection that contains the active ingredient haloperidol, a butyrophenone antipsychotic. It is marketed in the European Union and is supplied without a specified strength in this description. Haloperidol works primarily as a dopamine D2 receptor antagonist and is used under medical supervision for certain psychiatric conditions. It is classified under ATC code N05AD01 and is typically administered by a healthcare professional in acute care settings.

Manufacturer / TM Owner

Essential Pharma Limited

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Indications & Clinical Uses

Haloperidol injection is indicated for several acute psychiatric conditions where rapid symptom control is required, particularly when oral administration is impractical or when immediate therapeutic effect is desired.

  • Management of acute exacerbations of schizophrenia.
  • Treatment of acute psychotic episodes, including those associated with substance use.
  • Control of manic episodes in bipolar disorder when oral therapy is not feasible.
  • Rapid calming of severe agitation or aggression in emergency settings.
  • Adjunctive use for pre‑operative sedation in patients at risk of delirium.

Side Effects

Like other antipsychotics, intramuscular haloperidol can produce a range of side effects that vary in frequency and severity.

Common

  • Drowsiness or sedation.
  • Extrapyramidal symptoms such as tremor, rigidity, or restlessness.
  • Dry mouth, constipation, or blurred vision.
  • Elevated prolactin levels causing menstrual changes or breast discomfort.
  • Weight gain or metabolic changes.

Serious

  • Neuroleptic malignant syndrome, a rare but life‑threatening reaction.
  • Torsades de pointes or other significant cardiac arrhythmias.
  • Severe hypotension or syncope.
  • Persistent severe depression or suicidal thoughts.

Precautions & Warnings

Haloperidol injection should be used with caution, and clinicians consider several precautions before prescribing.

  • Assess for a history of cardiovascular disease, as haloperidol may affect heart rhythm.
  • Evaluate for extrapyramidal disorder risk, especially in patients with Parkinsonian features.
  • Use carefully in patients with liver or kidney impairment due to altered drug clearance.
  • Monitor for signs of neuroleptic malignant syndrome during the first few days of therapy.
  • Avoid use in individuals with known hypersensitivity to haloperidol or other butyrophenones.
  • Consider pregnancy and lactation status; safety data are limited.

Avoid Interactions

Haloperidol can interact with other medications, influencing its efficacy or safety profile.

Avoid

  • Other dopamine antagonists or antipsychotics, which may increase extrapyramidal risk.
  • QT‑prolonging agents such as certain antiarrhythmics, macrolide antibiotics, or antimalarials.
  • CNS depressants (e.g., benzodiazepines, opioids) that can enhance sedation.
  • Alcohol, which can potentiate central nervous system depression.

Use with caution

  • Anticholinergic drugs, which may mask early signs of extrapyramidal symptoms.
  • CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) that can raise haloperidol plasma levels.
  • CYP3A4 inducers (e.g., carbamazepine, rifampin) that may reduce therapeutic effect.
  • Lithium, as combined use may increase risk of neurotoxicity.
  • Other QT‑prolonging medications, requiring ECG monitoring.

Frequently Asked Questions

Haloperidol injection is used for acute schizophrenia, acute psychotic episodes, manic episodes of bipolar disorder, severe agitation, and as pre‑operative sedation when rapid control is needed.

Haloperidol blocks dopamine D2 receptors in the brain, reducing dopaminergic neurotransmission that is associated with psychotic symptoms.

Common side effects include drowsiness, extrapyramidal symptoms such as tremor or rigidity, dry mouth, constipation, blurred vision, and elevated prolactin levels.

Serious reactions include neuroleptic malignant syndrome, cardiac arrhythmias like torsades de pointes, severe hypotension, syncope, and persistent severe depression or suicidal thoughts.

Patients with cardiovascular disease should be evaluated because Haloperidol can prolong the QT interval and may precipitate arrhythmias.

It is given as an intramuscular injection by a qualified healthcare professional, typically in a single dose that can be repeated based on clinical response and monitoring.

Safety data are limited; the medication should only be used during pregnancy or lactation if the potential benefit justifies the potential risk and under close medical supervision.

Avoid other dopamine antagonists, QT‑prolonging drugs, CNS depressants, and alcohol, as these can increase the risk of adverse effects.

CYP3A4 inhibitors can raise plasma concentrations of Haloperidol, potentially increasing the likelihood of side effects and requiring dose adjustment or closer monitoring.

Clinicians should monitor vital signs, ECG for QT changes, extrapyramidal symptoms, and signs of neuroleptic malignant syndrome.

Combining antipsychotics can increase the risk of extrapyramidal and cardiac side effects and is generally avoided unless specifically directed by a specialist.

The clinical effect usually begins within 30 minutes and may last several hours to a day, depending on the dose and individual patient factors.

Published by

GNH India Pharmaceuticals Limited

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Last updated:

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