Product image of Haloperidol Esteve (Haloperidol) supplied by GNH India

Haloperidol Esteve

Active Ingredient:
Haloperidol
Origin:
EU

Haloperidol Esteve (Haloperidol)

Haloperidol Esteve is a prescription medication that contains the active ingredient haloperidol, a butyrophenone antipsychotic. It is supplied in an oral dosage form, though specific strength details are not disclosed in the provided data. Marketed in the European Union, the product is classified under ATC code N05AD01 and is intended for use under medical supervision for various psychiatric conditions, and long‑term management, in adult patients and adolescents.

Manufacturer / TM Owner

Esteve Pharmaceuticals, S.A.

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Indications & Clinical Uses

Haloperidol Esteve is indicated for several psychiatric disorders where dopamine blockade can reduce symptoms.

  • Schizophrenia, including maintenance therapy for chronic illness.
  • Acute psychotic episodes, such as those associated with bipolar disorder or substance‑induced psychosis.
  • Manic episodes in bipolar I disorder when rapid control of agitation is required.
  • Severe agitation or aggression that poses a risk to the patient or others.
  • Tourette syndrome, particularly for patients with disabling motor or vocal tics.
  • Adjunctive treatment of certain refractory cases of obsessive‑compulsive disorder (off‑label).

Side Effects

The safety profile of Haloperidol Esteve reflects its pharmacologic activity on multiple neurotransmitter receptors.

Common

  • Drowsiness or sedation
  • Extrapyramidal symptoms such as tremor, rigidity, or akathisia
  • Dry mouth and constipation
  • Blurred vision
  • Weight gain or increased appetite

Serious

  • Neuroleptic malignant syndrome, a life‑threatening reaction
  • Tardive dyskinesia, characterized by involuntary movements
  • Severe hypotension or orthostatic dizziness
  • Cardiac arrhythmias, including QT prolongation
  • Agranulocytosis or severe leukopenia

Precautions & Warnings

Before prescribing Haloperidol Esteve, clinicians should evaluate patient history and monitor for potential risks associated with its antipsychotic activity.

  • Assess for cardiovascular disease, as haloperidol may cause QT prolongation.
  • Use caution in patients with a history of seizures or epilepsy.
  • Evaluate liver and renal function; dose adjustments may be needed in impairment.
  • Monitor for signs of extrapyramidal side effects, especially in the elderly.
  • Avoid use during pregnancy unless benefits outweigh risks, due to limited safety data.
  • Screen for diabetes or metabolic syndrome, as weight changes can occur.
  • Consider baseline and periodic blood counts to detect rare hematologic effects.

Avoid Interactions

Haloperidol Esteve can interact with other medications that influence its metabolism or amplify its pharmacodynamic effects.

Avoid

  • Other dopamine antagonists or antipsychotics, which may increase extrapyramidal risk.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) that raise haloperidol plasma levels.
  • Medications that prolong the QT interval, such as certain antiarrhythmics or macrolide antibiotics.

Use with caution

  • CNS depressants including benzodiazepines or opioids, which can enhance sedation.
  • Antihypertensive agents, because additive hypotensive effects may occur.
  • Drugs that affect electrolyte balance (e.g., diuretics) increasing risk of cardiac arrhythmias.

Frequently Asked Questions

Haloperidol Esteve is used for schizophrenia, acute psychosis, manic episodes of bipolar disorder, severe agitation, and Tourette syndrome, among other conditions.

It acts as an antagonist of dopamine D2 receptors and also blocks D1, alpha‑1 adrenergic, histamine H1, and muscarinic receptors, reducing dopaminergic neurotransmission.

No, Haloperidol Esteve is classified as a prescription‑only (Rx) medication and must be prescribed by a qualified healthcare professional.

The pregnancy category is listed as unknown; it should only be used if the potential benefits justify the potential risks to the fetus.

Common adverse effects include drowsiness, extrapyramidal symptoms such as tremor or rigidity, dry mouth, constipation, blurred vision, and weight gain.

Serious reactions include neuroleptic malignant syndrome, tardive dyskinesia, severe hypotension, QT‑interval prolongation leading to arrhythmias, and agranulocytosis.

Avoid combining with other dopamine antagonists, strong CYP3A4 inhibitors, and drugs known to prolong the QT interval.

Monitoring should include cardiovascular assessment, evaluation for extrapyramidal symptoms, liver and kidney function tests, blood counts, and metabolic parameters.

Dose adjustments may be required in hepatic or renal impairment; clinicians should assess organ function before initiating therapy.

Yes, but the combination should be used with caution because both agents can increase sedation and respiratory depression.

The ATC code for haloperidol is N05AD01, indicating its placement in the antipsychotic subgroup.

Haloperidol Esteve is marketed in the European Union and is produced by the pharmaceutical company Esteve.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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