Product image of Haldol Decanoas (Haloperidol Decanoate) supplied by GNH India

Haldol Decanoas

Active Ingredient:
Haloperidol Decanoate
Origin:
EU

Haldol Decanoas (Haloperidol Decanoate)

Haldol Decanoas is a prescription medication that contains the active ingredient haloperidol decanoate, a long‑acting butyrophenone antipsychotic. It is supplied as an intramuscular injection intended for use in the European market. The formulation provides a depot delivery system that releases haloperidol over several weeks, facilitating maintenance therapy for chronic psychiatric conditions. No specific strength is listed in the available product information currently publicly widely distributed.

Manufacturer / TM Owner

Essential Pharma Limited

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Indications & Clinical Uses

Haloperidol decanoate is indicated for several psychiatric conditions where long‑acting antipsychotic therapy is appropriate.

  • Schizophrenia, including maintenance treatment after stabilization.
  • Acute psychotic episodes when oral therapy is not feasible.
  • Tourette syndrome as an adjunctive option.
  • Chronic psychotic disorders requiring depot injection.
  • Situations where patient adherence to daily oral medication is a concern.

Side Effects

The safety profile of haloperidol decanoate includes both frequent and rare adverse events that clinicians monitor during treatment.

Common

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

Serious

  • Neuroleptic malignant syndrome
  • Tardive dyskinesia
  • Severe hypotension or cardiovascular collapse
  • Seizures
  • Agranulocytosis or severe leukopenia

Precautions & Warnings

Before initiating haloperidol decanoate, healthcare providers should evaluate several clinical factors to minimize risks.

  • History of cardiovascular disease, arrhythmias, or prolonged QT interval.
  • Existing movement disorders or prior episodes of tardive dyskinesia.
  • Hepatic or renal impairment that may affect drug metabolism.
  • Pregnancy, lactation, or plans for conception, given limited safety data.
  • Concomitant use of other central nervous system depressants.
  • Elderly patients, especially those with dementia-related psychosis, due to increased sensitivity.
  • Need for regular monitoring of blood pressure, ECG, and metabolic parameters.

Avoid Interactions

Haloperidol decanoate can interact with other medications, altering its efficacy or safety profile.

Avoid

  • Other dopamine antagonists or high‑potency antipsychotics.
  • Drugs 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 carbamazepine, rifampin, or phenytoin.
  • Central nervous system depressants, including benzodiazepines and opioids.
  • Anticholinergic agents that may mask extrapyramidal symptoms.

Frequently Asked Questions

Haloperidol decanoate works primarily as an antagonist at dopamine D2 receptors, reducing dopaminergic neurotransmission, and to a lesser extent it blocks certain serotonin receptors.

The injection is typically given every 2 to 4 weeks, depending on the individual’s clinical response and the prescribing physician’s assessment.

Yes, it may be used when rapid control of symptoms is needed and oral administration is not feasible, but clinicians often combine it with short‑acting agents during the initial phase.

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

Haloperidol decanoate is a long‑acting depot formulation administered intramuscularly, providing sustained drug levels for weeks, whereas oral haloperidol requires daily dosing and has more fluctuating plasma concentrations.

Safety data in pregnancy are limited, and the product is classified as having an unknown pregnancy category; therefore, it should be used only if the potential benefit justifies the potential risk to the fetus.

Regular assessment of blood pressure, ECG for QT interval, metabolic parameters (weight, glucose, lipids), and observation for movement disorders or signs of neuroleptic malignant syndrome are advised.

Drugs that strongly prolong the QT interval, other dopamine antagonists, and potent CYP3A4 inhibitors such as ketoconazole should be avoided.

Yes, tardive dyskinesia is a recognized serious adverse effect of long‑term typical antipsychotic therapy, including haloperidol decanoate.

The product should be stored at controlled room temperature, protected from light, and the vial should be inspected for particulate matter before intramuscular administration.

A single intramuscular dose generally provides therapeutic plasma concentrations for approximately 2 to 4 weeks, depending on dose and individual metabolism.

Elderly patients, especially those with dementia‑related psychosis, may be more sensitive to sedation, orthostatic hypotension, and extrapyramidal symptoms, requiring lower starting doses and close monitoring.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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