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

Haloperidol Teva

Active Ingredient:
Haloperidol
Origin:
EU

Haloperidol Teva (Haloperidol)

Haloperidol Teva is a prescription medication that contains the active ingredient haloperidol, a butyrophenone antipsychotic, supplied in oral tablet form. It is marketed in the European Union and is classified under the ATC code N05AD01. As a dopamine D2 receptor antagonist, haloperidol works by modulating neurotransmission in the brain. The product is intended for use under medical supervision and requires a prescription for patients with specific psychiatric conditions.

Manufacturer / TM Owner

Teva Nederland B.V.

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Indications & Clinical Uses

Haloperidol Teva is indicated for several psychiatric disorders where dopamine blockade is beneficial.

  • Management of schizophrenia, including both acute exacerbations and long‑term maintenance therapy.
  • Treatment of acute psychotic episodes that may occur in the context of mood disorders such as bipolar disorder.
  • Control of manic episodes in patients with bipolar I disorder when rapid symptom reduction is needed.
  • Reduction of motor and vocal tics in Tourette syndrome and other tic disorders.
  • Short‑term control of severe agitation or hostility in hospitalized patients.

Side Effects

Haloperidol Teva may cause a range of adverse effects, which are generally categorized by frequency and clinical significance. The frequency and severity of these events can vary based on dose, treatment duration, and individual patient factors. Patients should be monitored regularly for both common and potentially life‑threatening reactions. Any new or worsening symptom should be reported to a healthcare professional promptly.

Common

  • Drowsiness or sedation
  • Extrapyramidal symptoms such as tremor, rigidity, or akathisia
  • Dry mouth
  • Constipation
  • Blurred vision
  • Weight gain
  • Orthostatic hypotension

Serious

  • Neuroleptic malignant syndrome
  • Tardive dyskinesia
  • Cardiac arrhythmias such as QT prolongation
  • Seizures
  • Severe depression or suicidal thoughts
  • Hepatic dysfunction

Precautions & Warnings

When prescribing Haloperidol Teva, clinicians consider several precautionary measures to minimize risk and ensure safe use.

  • Assess patient history for cardiovascular disease, especially arrhythmias or prolonged QT interval.
  • Evaluate for prior extrapyramidal reactions or movement disorders.
  • Use caution in patients with hepatic or renal impairment; dose adjustments may be required.
  • Monitor for signs of neuroleptic malignant syndrome, particularly during dose escalation.
  • Consider pregnancy and lactation status; the safety profile is not well established.
  • Review concomitant medications that may increase the risk of sedation or cardiac effects.

Avoid Interactions

Haloperidol Teva can interact with other medicines, affecting its efficacy or safety profile.

Avoid

  • Other dopamine antagonists or antipsychotics (may increase extrapyramidal risk).
  • Drugs that significantly prolong QT interval (e.g., certain antiarrhythmics, macrolide antibiotics).
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) that raise haloperidol levels.
  • Monoamine oxidase inhibitors (MAOIs) – concurrent use may increase risk of severe hypotension.
  • CYP2D6 substrates that are metabolized by the same pathway (e.g., metoprolol) may have altered plasma levels.

Use with caution

  • CNS depressants such as benzodiazepines or opioids (enhanced sedation).
  • Antihypertensive agents (additive hypotensive effect).
  • Anticholinergic drugs (may mask extrapyramidal symptoms).
  • Antidepressants, particularly SSRIs, may alter haloperidol metabolism.
  • Alcohol consumption can potentiate central nervous system depression.

Frequently Asked Questions

Haloperidol Teva is prescribed for schizophrenia, acute psychotic episodes, manic episodes of bipolar disorder, and Tourette syndrome.

It acts as a dopamine D2 receptor antagonist, reducing dopamine activity that is thought to contribute to psychotic symptoms.

Common side effects include drowsiness, extrapyramidal symptoms such as tremor or rigidity, dry mouth, constipation, blurred vision, weight gain, and orthostatic hypotension.

Serious reactions such as neuroleptic malignant syndrome, tardive dyskinesia, cardiac arrhythmias, seizures, severe depression, or liver dysfunction require immediate medical attention.

The safety of Haloperidol Teva in pregnancy has not been established, so it should be used only if the potential benefit justifies the potential risk.

Haloperidol Teva can be taken with or without food; however, taking it with a meal may reduce gastrointestinal upset for some patients.

Medications that should be avoided include other dopamine antagonists, drugs that prolong the QT interval, strong CYP3A4 inhibitors, MAO inhibitors, and CYP2D6 substrates that share metabolic pathways.

Concurrent use with other antipsychotics can increase the risk of extrapyramidal symptoms and other adverse effects, so such combinations are generally avoided.

Regular monitoring may include assessment of movement disorders, cardiac ECG for QT interval, liver function tests, and observation for signs of neuroleptic malignant syndrome.

Yes, patients with hepatic or renal impairment may require dose adjustments, and clinicians should evaluate organ function before initiating therapy.

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GNH India Pharmaceuticals Limited

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