Europe — EMA
Haldol Depot
Haldol Depot is the brand name for the intramuscular injection of haloperidol decanoate, a typical antipsychotic in the butyrophenone class. It is supplied as an oil‑based solution for deep intramuscular administration.…
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What is Haloperidol Decanoate?
Haldol Depot is the brand name for the intramuscular injection of haloperidol decanoate, a typical antipsychotic in the butyrophenone class. It is supplied as an oil‑based solution for deep intramuscular administration. The product is marketed in the European Union and is available by prescription only. Haloperidol decanoate provides sustained plasma concentrations for the management of psychotic disorders in adult patients and may be used as part of a treatment plan.
What is Haloperidol Decanoate used for?
Haldol Depot is indicated for several clinical situations related to schizophrenia and other psychotic conditions.
- Maintenance treatment of schizophrenia in adults, administered at regular intramuscular intervals. - Acute management of exacerbations of psychotic symptoms when oral therapy is not feasible. - Adjunctive therapy for patients with chronic schizophrenia who have demonstrated adherence difficulties with oral antipsychotics. - Short‑term control of acute psychotic episodes in inpatient settings.
What are the side effects of Haloperidol Decanoate?
Side‑effect profile of Haldol Depot reflects the pharmacology of haloperidol decanoate and includes both frequent and less common reactions.
Common: - Sedation or drowsiness. - Extrapyramidal symptoms such as tremor, rigidity, or akathisia. - Dry mouth and constipation. - Weight gain or appetite changes.
Serious: - Neuroleptic malignant syndrome, a rare but life‑threatening condition. - Tardive dyskinesia with prolonged use. - Severe orthostatic hypotension. - Cardiac arrhythmias, including QT prolongation.
What precautions apply to Haloperidol Decanoate?
When prescribing Haldol Depot
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