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

Haloperidol Decanoat Richter

Active Ingredient:
Haloperidol
Origin:
EU

Haloperidol Decanoat Richter (Haloperidol)

Haloperidol Decanoat Richter is a prescription intramuscular injection containing the active ingredient haloperidol decanoate, a long‑acting butyrophenone antipsychotic. It is marketed in the European Union and is classified under ATC code N05AD01. The formulation delivers haloperidol in a depot form, allowing sustained plasma concentrations after a single injection. It is intended for use under medical supervision in patients requiring antipsychotic therapy and long‑term management of schizophrenia.

Manufacturer / TM Owner

Gedeon Richter Plc.

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Indications & Clinical Uses

Haloperidol Decanoat Richter is indicated for several psychiatric conditions where sustained antipsychotic coverage is desired, particularly when adherence to daily oral medication is challenging.

  • Schizophrenia, including maintenance therapy after stabilization.
  • Acute psychotic episodes when oral therapy is not feasible.
  • Schizoaffective disorder requiring long‑acting treatment.
  • Adjunctive therapy in patients with treatment‑resistant psychosis.
  • Prevention of relapse in patients who have responded to oral haloperidol.
  • Use in combination with other antipsychotics under specialist supervision when monotherapy is insufficient.

Side Effects

Side‑effect profiles for haloperidol decanoate reflect its dopamine‑blocking activity and can range from mild, frequently observed reactions to rare but potentially life‑threatening events. Patients and clinicians should be aware of both common and serious adverse effects when initiating or continuing therapy.

Common

  • Extrapyramidal symptoms such as tremor, rigidity, or akathisia
  • Sedation, drowsiness, or fatigue
  • Dry mouth and reduced salivation
  • Constipation or gastrointestinal slowing

Serious

  • Neuroleptic malignant syndrome, a medical emergency
  • Tardive dyskinesia, potentially irreversible movement disorder
  • QT‑interval prolongation with risk of cardiac arrhythmia
  • Severe hypotension or syncope, especially after injection

Precautions & Warnings

Haloperidol Decanoat Richter requires careful assessment before use, and several precautions should be observed to minimize risk.

  • Evaluate cardiovascular status; avoid in patients with known QT prolongation.
  • Monitor for signs of extrapyramidal reactions, especially in early treatment.
  • Assess liver and renal function periodically during long‑term therapy.
  • Use caution in patients with a history of seizures or neuroleptic malignant syndrome.
  • Discuss potential prolactin elevation with women of childbearing age and consider fertility implications.
  • Avoid abrupt discontinuation; taper under medical guidance to prevent withdrawal phenomena.
  • Consider pregnancy and lactation status; use only if benefits outweigh potential risks.

Avoid Interactions

Haloperidol decanoate can interact with other medications, altering its efficacy or safety profile. Recognizing key interactions helps clinicians manage therapy appropriately.

Avoid

  • Concurrent use with other dopamine antagonists or high‑potency antipsychotics, which may increase extrapyramidal risk.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) that can raise haloperidol plasma levels.
  • QT‑prolonging agents such as certain antiarrhythmics, macrolide antibiotics, or antipsychotics.

Use with caution

  • CYP3A4 inducers (e.g., carbamazepine, rifampin) that may reduce drug exposure.
  • CNS depressants, including benzodiazepines or opioids, which can enhance sedation.
  • Anticholinergic drugs that may mask extrapyramidal symptoms.

Frequently Asked Questions

Haloperidol Decanoat Richter works by antagonizing dopamine D2 receptors, thereby reducing dopaminergic neurotransmission in the brain.

It is prescribed for schizophrenia, acute psychosis, maintenance therapy for schizophrenia, and situations where long‑acting antipsychotic coverage is needed.

The product is given as an intramuscular injection, typically into the gluteal muscle, by a healthcare professional.

Pregnancy safety has not been established; it should be used only if the potential benefits justify the potential risks to the fetus.

Common adverse effects include extrapyramidal symptoms such as tremor or rigidity, sedation, dry mouth, and constipation.

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

Yes, haloperidol can increase prolactin; monitoring is advisable, especially in women of childbearing age.

Avoid concurrent use with strong CYP3A4 inhibitors, other dopamine antagonists, and medications that prolong the QT interval.

Impaired hepatic or renal function may alter drug clearance; periodic monitoring and dose adjustments may be required under medical supervision.

Abrupt discontinuation can lead to withdrawal phenomena; tapering under a clinician’s guidance is recommended.

Combination therapy may be considered in specialist settings when monotherapy is insufficient, but it increases the risk of side effects.

Regular assessment of cardiovascular status, liver and renal function, movement disorders, and prolactin levels is advised.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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