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

Haloperidol Richter

Active Ingredient:
Haloperidol
Origin:
EU

Haloperidol Richter (Haloperidol)

Haloperidol Richter is a prescription intramuscular injection containing the active ingredient haloperidol, a butyrophenone antipsychotic. Marketed in the European Union, this formulation delivers haloperidol in a sterile solution for rapid systemic absorption. It is classified under ATC code N05AD01 and works as a dopamine D2 receptor antagonist. The product is intended for use under medical supervision in appropriate clinical settings and may be administered by trained healthcare professionals.

Manufacturer / TM Owner

Gedeon Richter Plc.

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Indications & Clinical Uses

Haloperidol Richter is indicated for several acute psychiatric conditions where rapid control of symptoms is required.

  • Schizophrenia, particularly during acute exacerbations when rapid symptom control is needed.
  • Acute psychotic episodes associated with mood disorders or substance use, requiring swift intramuscular intervention.
  • Severe agitation or aggression that poses a risk to self or others, often in emergency or inpatient settings.
  • Tourette syndrome with disabling motor or vocal tics that have not responded adequately to oral therapy.
  • Pre‑operative sedation in patients with known psychotic disorders to reduce peri‑operative stress and emergence phenomena.

Side Effects

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

Common

  • Drowsiness or sedation, which may affect alertness and the ability to perform tasks requiring concentration.
  • Extrapyramidal symptoms such as tremor, muscular rigidity, akathisia, or dystonia, reflecting dopamine blockade in the nigrostriatal pathway.
  • Anticholinergic effects including dry mouth, constipation, blurred vision, and occasional urinary retention.
  • Headache, which may be mild to moderate in intensity and usually transient.

Serious

  • Neuroleptic malignant syndrome, a rare but fatal reaction with high fever, muscle rigidity, autonomic instability, and altered mental status.
  • Tardive dyskinesia, a late‑onset movement disorder causing repetitive, involuntary facial or limb movements after prolonged use.
  • Severe cardiovascular effects such as marked hypotension, arrhythmias, or QT‑interval prolongation, increasing the risk of cardiac events.
  • Seizures, especially in patients with a history of epilepsy or other risk factors.

Precautions & Warnings

When prescribing Haloperidol Richter, clinicians should consider several precautions to minimize risks and ensure safe use.

  • Assess cardiovascular status, especially for patients with known arrhythmias or low blood pressure.
  • Evaluate for a history of extrapyramidal reactions or tardive dyskinesia before initiating therapy.
  • Use caution in patients with hepatic or renal impairment, as metabolism and clearance may be altered.
  • Monitor pregnant or breastfeeding women closely; the safety profile in pregnancy is not well established.
  • Avoid abrupt discontinuation to reduce the chance of withdrawal or rebound psychosis.

Avoid Interactions

Haloperidol Richter may interact with other medicines; recognizing these interactions helps prevent adverse effects or reduced efficacy.

Avoid

  • Other dopamine antagonists or high‑potency antipsychotics, which can increase the risk of extrapyramidal symptoms and cardiac toxicity.
  • QT‑prolonging agents such as certain antiarrhythmics, macrolide antibiotics, or antimalarials, which may exacerbate cardiac conduction delays.

Use with caution

  • CNS depressants (e.g., benzodiazepines, opioids) that may enhance sedation and respiratory depression.
  • Anticholinergic medications, which can compound dry mouth, constipation, and blurred vision.
  • CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) that may raise haloperidol plasma levels.
  • Medications that lower seizure threshold (e.g., bupropion, tramadol) may increase the risk of seizures when combined with haloperidol.

Frequently Asked Questions

Haloperidol Richter is a prescription intramuscular injection that contains the antipsychotic haloperidol. It is given by a healthcare professional directly into a muscle for rapid systemic absorption.

It is used to manage schizophrenia, acute psychotic episodes, severe agitation, and Tourette syndrome when quick symptom control is needed.

Haloperidol blocks dopamine D2 receptors in the brain, reducing dopamine neurotransmission that is associated with psychotic symptoms and motor disturbances.

Common adverse effects include drowsiness, extrapyramidal symptoms such as tremor or rigidity, anticholinergic effects like dry mouth and constipation, and occasional headache.

Intramuscular haloperidol is preferred when rapid onset is required, such as in emergency settings, severe agitation, or when a patient cannot take oral medication.

Patients with known arrhythmias, low blood pressure, or a history of QT‑interval prolongation should be evaluated carefully, and cardiac monitoring may be advisable.

The safety of haloperidol in pregnancy and lactation has not been fully established; clinicians should weigh potential risks and benefits and monitor mother and infant closely.

Co‑administration with other dopamine antagonists, high‑potency antipsychotics, or QT‑prolonging agents should be avoided because of increased risk of cardiac and neurological toxicity.

Key signs include sudden high fever, severe muscle rigidity, autonomic instability (e.g., rapid heart rate, blood pressure changes), and altered mental status; immediate medical attention is required.

Patients should be observed for sedation, extrapyramidal symptoms, vital‑sign changes, and any signs of cardiac arrhythmia or neuroleptic malignant syndrome, especially during the first few hours after injection.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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