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

Haloperidol Neuraxpharm

Active Ingredient:
Haloperidol Decanoate
Origin:
EU

Haloperidol Neuraxpharm (Haloperidol Decanoate)

Haloperidol Neuraxpharm is a prescription intramuscular injection containing haloperidol decanoate, a long‑acting butyrophenone antipsychotic. The product is marketed in the European Union and is supplied as a sterile depot formulation for intramuscular administration. It belongs to the typical antipsychotic class and works as a dopamine D2 receptor antagonist. It is indicated for the treatment of schizophrenia and chronic psychotic conditions, for acute psychotic episodes when a long‑acting injectable is appropriate.

Manufacturer / TM Owner

Neuraxpharm Arzneimittel Gmbh

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Indications & Clinical Uses

Haloperidol Neuraxpharm is prescribed for several psychiatric indications where a long‑acting injectable antipsychotic is suitable, offering clinicians a depot option to improve adherence and maintain symptom control.

  • Schizophrenia maintenance therapy in adults.
  • Acute psychotic episodes requiring rapid stabilization.
  • Chronic psychosis where oral adherence is problematic.
  • Adjunctive treatment in patients with treatment‑resistant psychotic disorders.
  • Off‑label use for severe agitation in controlled settings when clinically justified.
  • Long‑term prophylaxis to reduce relapse risk in patients stabilized on oral haloperidol.
  • Use in combination with oral antipsychotics during transition to depot therapy.

Side Effects

The safety profile of haloperidol decanoate includes a range of effects that vary in frequency and clinical significance.

Common

  • Drowsiness or sedation.
  • Extrapyramidal symptoms such as tremor, rigidity, or akathisia.
  • Dry mouth and increased salivation.
  • Constipation or gastrointestinal discomfort.
  • Weight gain or changes in appetite.
  • Blurred vision or other visual disturbances.
  • Orthostatic hypotension.
  • Elevated liver enzymes.
  • Skin rash or pruritus.
  • Elevated prolactin levels leading to sexual dysfunction.

Serious

  • Neuroleptic malignant syndrome, a rare but life‑threatening reaction.
  • Torsades de pointes or other serious cardiac arrhythmias.
  • Hyperprolactinemia with galactorrhea or menstrual disturbances.
  • Severe depression or suicidal thoughts.
  • Significant leukopenia or neutropenia.

Precautions & Warnings

When prescribing haloperidol decanoate, clinicians should consider several precautionary measures to minimize risks and ensure appropriate patient monitoring.

  • Assess for a history of cardiovascular disease, including arrhythmias or prolonged QT interval.
  • Evaluate for prior extrapyramidal reactions or tardive dyskinesia before initiating therapy.
  • Monitor serum prolactin levels in patients who develop galactorrhea, menstrual changes, or sexual dysfunction.
  • Use caution in elderly patients and those with hepatic or renal impairment, adjusting dose as needed.
  • Screen for neuroleptic malignant syndrome signs, especially during the first weeks of treatment.
  • Discuss pregnancy and lactation considerations with women of childbearing potential, as safety data are limited.

Avoid Interactions

Haloperidol decanoate may interact with other medications that affect its metabolism, cardiac conduction, or central nervous system effects, requiring careful review of a patient’s drug regimen.

Avoid

  • Concomitant use with other potent dopamine antagonists, which can exacerbate extrapyramidal symptoms.
  • Co‑administration with QT‑prolonging agents such as certain antiarrhythmics, fluoroquinolones, or macrolide antibiotics.
  • Combining with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) that may increase haloperidol plasma concentrations.

Use with caution

  • Use with other CNS depressants (e.g., benzodiazepines, opioids) as additive sedation may occur.
  • Caution when prescribing with anticholinergic drugs, which can mask early signs of neuroleptic malignant syndrome.
  • Adjust dose when used with CYP3A4 inducers (e.g., rifampin, carbamazepine) that may reduce therapeutic effect.

Frequently Asked Questions

Haloperidol Neuraxpharm blocks dopamine D2 receptors, reducing dopaminergic activity that contributes to psychotic symptoms.

It is given as a deep intramuscular injection, usually into the gluteal muscle, by a qualified healthcare professional.

It is indicated for schizophrenia, acute psychotic episodes, and maintenance therapy for chronic psychosis.

The dosing interval is determined by the prescribing clinician based on clinical response, typically ranging from two to four weeks.

Common adverse effects include sedation, extrapyramidal symptoms, dry mouth, constipation, weight changes, blurred vision, orthostatic hypotension, elevated liver enzymes, skin rash, and prolactin‑related sexual dysfunction.

Serious reactions include neuroleptic malignant syndrome, torsades de pointes or other cardiac arrhythmias, hyperprolactinemia, severe depression or suicidal thoughts, and significant leukopenia or neutropenia.

Clinicians should assess cardiovascular history, prior extrapyramidal reactions, liver and kidney function, prolactin‑related symptoms, and discuss pregnancy risks with women of childbearing potential.

Avoid concurrent use with other dopamine antagonists, QT‑prolonging agents, and strong CYP3A4 inhibitors that can raise haloperidol levels.

Use caution with CNS depressants, anticholinergic drugs, and CYP3A4 inducers that may alter haloperidol exposure.

It can be used, but dose adjustments and close monitoring for sedation, falls, and cardiovascular effects are advised.

Safety data are limited; the drug should only be used if the potential benefit justifies the potential risk to the fetus.

Regular assessments should include psychiatric status, extrapyramidal symptoms, ECG for QT interval, prolactin levels, and complete blood counts.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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