Europe — EMA
Haloperidol Esteve
Haloperidol Esteve is an oral antipsychotic for schizophrenia, acute psychosis, mania, Tourette syndrome and severe agitation. Learn uses, side effects, and precautions.
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What is 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.
What is Haloperidol used for?
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).
What are the side effects of Haloperidol?
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
What precautions apply to Haloperidol?
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.
What does Haloperidol interact with?
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
What psychiatric conditions can be treated with Haloperidol Esteve?+
How does Haloperidol Esteve work at the molecular level?+
Is Haloperidol Esteve available without a prescription in the EU?+
Can Haloperidol Esteve be used during pregnancy?+
What are the most common side effects of Haloperidol Esteve?+
What serious adverse reactions require immediate medical attention?+
Which medications should be avoided while taking Haloperidol Esteve?+
How should clinicians monitor patients on Haloperidol Esteve?+
Is dose adjustment necessary for patients with liver or kidney impairment?+
Can Haloperidol Esteve be combined with benzodiazepines for agitation?+
What is the ATC classification code for Haloperidol Esteve?+
Where is Haloperidol Esteve manufactured and marketed?+
Product details
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