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Haloperidol Crescent Pharma International

Active Ingredient:
Haloperidol
Origin:
EU

Haloperidol Crescent Pharma International (Haloperidol)

Haloperidol Crescent Pharma International is a prescription oral medication containing the active ingredient haloperidol, a butyrophenone antipsychotic. The product is manufactured by Crescent Pharma International for the European market and is supplied in tablet form, though specific strength information is not disclosed. It is classified under ATC code N05AD01 and acts as a dopamine D2 receptor antagonist used in the management of certain psychiatric conditions.

Manufacturer / TM Owner

Crescent Pharma International Limited

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Indications & Clinical Uses

Haloperidol Crescent Pharma International is indicated for the treatment of several psychiatric disorders where dopamine blockade is therapeutic.

  • Management of schizophrenia, including both chronic maintenance and acute exacerbations.
  • Treatment of acute psychotic episodes associated with bipolar disorder or major depressive disorder.
  • Reduction of motor and vocal tics in patients with Tourette syndrome.
  • Control of severe agitation or aggression in inpatient or emergency settings when rapid symptom relief is required.
  • Adjunctive use for psychosis secondary to neurological diseases such as Huntington’s disease or Parkinson’s disease medication‑induced psychosis.

Side Effects

The safety profile of haloperidol includes a range of neurological, cardiovascular and metabolic effects that vary in frequency.

Common

  • Extrapyramidal symptoms such as tremor, rigidity, and akathisia.
  • Drowsiness or sedation.
  • Dry mouth and increased salivation.
  • Constipation or gastrointestinal discomfort.

Serious

  • Tardive dyskinesia, a potentially irreversible movement disorder.
  • Neuroleptic malignant syndrome, characterized by fever, muscle rigidity, and autonomic instability.
  • QT interval prolongation leading to cardiac arrhythmias.

Precautions & Warnings

Clinicians should evaluate patient‑specific factors and monitor for adverse events when prescribing haloperidol.

  • Assess cardiovascular risk, especially in patients with known QT prolongation or electrolyte disturbances.
  • Use the lowest effective dose and limit duration to reduce risk of tardive dyskinesia.
  • Monitor for signs of neuroleptic malignant syndrome, particularly during dose escalation.
  • Caution in patients with hepatic or renal impairment, as clearance may be altered.
  • Evaluate for potential worsening of Parkinsonian symptoms in individuals with pre‑existing movement disorders.
  • Consider pregnancy and lactation status; haloperidol crosses the placenta and is excreted in breast milk.

Avoid Interactions

Haloperidol may interact with several medications that affect its metabolism or cardiac conduction.

Avoid

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

Use with caution

  • CYP3A4 inducers like carbamazepine or rifampin, which may reduce efficacy.
  • CNS depressants including benzodiazepines, opioids, or alcohol, which can enhance sedation.
  • Anticholinergic agents, which may mask early signs of extrapyramidal symptoms.

Frequently Asked Questions

It is prescribed for schizophrenia, acute psychotic episodes, and Tourette syndrome, among other psychiatric conditions where dopamine blockade is indicated.

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

Yes, the product is supplied as an oral tablet, although specific strength information is not publicly disclosed.

The safety of haloperidol in pregnancy has not been fully established; clinicians should weigh potential risks and benefits and consider alternative therapies when possible.

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

Serious reactions include tardive dyskinesia, neuroleptic malignant syndrome, and significant QT interval prolongation that may lead to arrhythmias.

Dose adjustments may be necessary in hepatic impairment, and clinicians should monitor plasma levels and clinical response closely.

Drugs that also prolong the QT interval, strong CYP3A4 inhibitors, and other high‑potency antipsychotics should generally be avoided.

Regular assessment of cardiac rhythm (ECG), movement disorders, and metabolic parameters is recommended, especially during dose changes.

Benzodiazepines may be used with caution to manage agitation, but the combined sedative effect should be monitored.

Some antidepressants, particularly those that affect CYP3A4 or prolong QT interval, may interact and require dose adjustments or monitoring.

Patients should take the missed dose as soon as they remember unless the next scheduled dose is near; they should not double the dose and should follow their prescriber’s instructions.

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GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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