Product image of Haloperidol Decanoate Richter (Haloperidol Decanoate) supplied by GNH India

Haloperidol Decanoate Richter

Active Ingredient:
Haloperidol Decanoate
Origin:
EU

Haloperidol Decanoate Richter (Haloperidol Decanoate)

Haloperidol Decanoate Richter is a prescription‑only intramuscular injection containing the butyrophenone antipsychotic haloperidol decanoate. Formulated as an oil suspension, it is marketed in the European Union for the long‑acting management of psychotic disorders. The product delivers haloperidol in a depot form, allowing sustained plasma concentrations after a single injection, which supports maintenance therapy in conditions such as schizophrenia and schizoaffective disorder and related mood disturbances.

Manufacturer / TM Owner

Gedeon Richter Plc.

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Indications & Clinical Uses

Haloperidol Decanoate Richter is indicated for several psychiatric indications where long‑acting antipsychotic coverage is desired. The depot formulation provides steady drug levels for weeks after injection, facilitating stable symptom control.

  • Acute psychosis and severe agitation requiring rapid control.
  • Maintenance therapy for schizophrenia to reduce relapse risk.
  • Schizoaffective disorder when oral therapy is insufficient.
  • Adjunctive treatment in patients with poor adherence to daily oral antipsychotics.
  • Off‑label use in certain cases of bipolar disorder under specialist supervision.

Side Effects

Side effects of Haloperidol Decanoate Richter reflect its dopamine antagonism and can vary in frequency and severity.

Common

  • Extrapyramidal symptoms such as tremor, rigidity, or akathisia.
  • Sedation or drowsiness.
  • Dry mouth and increased salivation.
  • Constipation or gastrointestinal discomfort.
  • Weight gain or metabolic changes.

Serious

  • Neuroleptic malignant syndrome, a life‑threatening reaction.
  • Tardive dyskinesia with prolonged use.
  • Significant cardiac arrhythmias, including QT prolongation.

Precautions & Warnings

When prescribing Haloperidol Decanoate Richter, clinicians should evaluate patient history and monitor for specific safety concerns.

  • Assess for a history of cardiovascular disease or prolonged QT interval.
  • Use cautiously in patients with Parkinson’s disease or other movement disorders.
  • Monitor for signs of depression or suicidal thoughts, especially during early treatment.
  • Evaluate liver and renal function before initiating therapy.
  • Educate patients about the risk of orthostatic hypotension and falls.
  • Consider pregnancy and lactation status; use only if benefits outweigh risks.

Avoid Interactions

Haloperidol Decanoate Richter may interact with several medications that affect its metabolism or cardiac safety profile.

Avoid

  • Concurrent use with other dopamine antagonists or high‑potency antipsychotics.
  • Medications that significantly prolong the QT interval (e.g., certain antiarrhythmics, macrolide antibiotics).
  • Strong CYP3A4 inhibitors such as ketoconazole or clarithromycin.

Use with caution

  • CYP3A4 inducers like rifampin, carbamazepine, or phenytoin, which may reduce haloperidol levels.
  • Central nervous system depressants, including benzodiazepines and opioids, which can increase sedation.
  • Anticholinergic agents that may mask extrapyramidal symptoms.

Frequently Asked Questions

It is prescribed for schizophrenia, acute psychosis, maintenance therapy of schizophrenia, schizoaffective disorder, and severe agitation when a long‑acting antipsychotic is needed.

The oil‑based intramuscular injection releases haloperidol slowly over weeks, maintaining therapeutic plasma concentrations without daily dosing.

Common side effects include extrapyramidal symptoms (tremor, rigidity, akathisia), sedation, dry mouth, constipation, and modest weight gain.

The injection is typically given every 2 to 4 weeks, depending on the prescribed dosing interval and patient response.

Patients with known QT prolongation or significant cardiac arrhythmias should be evaluated carefully, and the drug may be avoided or used with close cardiac monitoring.

Regular assessment of movement disorders, mental status, ECG for QT interval, liver and renal function, and metabolic parameters such as weight and glucose is recommended.

No specific dietary restrictions are required, but patients should avoid excessive alcohol, which can increase sedation and other central nervous system effects.

Strong CYP3A4 inhibitors can raise haloperidol plasma levels, potentially increasing the risk of side effects; dose adjustments or alternative therapies may be considered.

They should seek immediate medical attention, as neuroleptic malignant syndrome is a medical emergency requiring prompt discontinuation of the drug and supportive care.

The safety in pregnancy has not been established; it should only be used if the potential benefit justifies the potential risk to the fetus.

The depot injection provides sustained drug release over weeks, reducing the need for daily oral dosing and improving adherence, whereas oral haloperidol requires multiple daily doses.

Clinicians may prescribe anticholinergic agents, adjust the dose, or switch to a different antipsychotic if extrapyramidal symptoms become problematic.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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