Product image of Levobren (Levosulpiride) supplied by GNH India

Levobren

Active Ingredient:
Levosulpiride
Origin:
EU

Levobren (Levosulpiride)

Levosulpiride, the active ingredient in Levobren, is a D2 receptor antagonist (benzamide derivative) presented as oral tablets for oral use. It is employed to manage psychotic symptoms in schizophrenia and related disorders, as well as to improve gastrointestinal motility in functional dyspepsia and gastro‑oesophageal reflux disease.

GNH India supplies Levobren as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality and regulatory compliance.

Manufacturer / TM Owner

Neopharmed Gentili Spa

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Indications & Clinical Uses

Levosulpiride is used in psychiatric and gastrointestinal pathways to treat several recognized conditions.

  • Schizophrenia: reduces positive psychotic symptoms and improves overall mental stability.
  • Depressive disorders: augments antidepressant therapy and alleviates depressive symptoms in certain patients.
  • Functional dyspepsia: enhances gastric emptying and relieves upper abdominal discomfort.
  • Gastroesophageal reflux disease: improves lower esophageal sphincter tone and reduces reflux episodes.
  • Anxiety disorders: mitigates anxiety symptoms associated with dopaminergic dysregulation.

How It Works

  • Levosulpiride selectively blocks dopamine D2 receptors in the central nervous system and peripheral gastrointestinal tract. By antagonizing D2 receptors, it diminishes dopaminergic neurotransmission that contributes to psychotic manifestations, while simultaneously enhancing cholinergic activity in the gut, which promotes gastric motility and accelerates gastric emptying. The drug’s preferential affinity for presynaptic D2 receptors also modulates prolactin release.

Side Effects

Levosulpiride may be associated with a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Nausea: mild stomach upset.
  • Headache: transient cranial discomfort.
  • Dizziness: occasional light‑headedness.
  • Increased prolactin: breast tenderness or galactorrhea.

Serious or Rare Side Effects

  • Neuroleptic malignant syndrome: high fever, muscle rigidity, autonomic instability.
  • Severe extrapyramidal reactions: acute dystonia or parkinsonism.
  • Cardiac arrhythmias: QT interval prolongation.

Precautions & Warnings

When prescribing levosulpiride, clinicians should consider several precautionary measures to ensure safe use.

  • Monitor for extrapyramidal symptoms: assess movement disorders regularly.
  • Check prolactin levels: watch for galactorrhea or menstrual disturbances.
  • Evaluate cardiac risk: obtain baseline ECG if patient has cardiac history.
  • Use cautiously in hepatic impairment: adjust dose or monitor liver function.
  • Avoid abrupt discontinuation: taper gradually to reduce withdrawal effects.
  • Store at ambient temperature: keep below 25 °C in original packaging, protect from moisture.

Avoid Interactions

Levosulpiride can interact with other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • Antipsychotics with strong D2 antagonism: may increase risk of extrapyramidal symptoms.
  • QT‑prolonging agents: can exacerbate cardiac arrhythmia risk.
  • CYP3A4 inhibitors (e.g., ketoconazole): raise levosulpiride plasma concentrations.

Moderate Interactions (Monitor Closely)

  • Anticholinergic drugs: may reduce pro‑kinetic benefit.
  • MAO inhibitors: potential for additive central nervous system effects.
  • CNS depressants (e.g., benzodiazepines): may enhance sedation.

Frequently Asked Questions

Levobren, containing levosulpiride, is indicated for the management of schizophrenia, depressive and anxiety disorders, functional dyspepsia, gastro‑oesophageal reflux disease, and related gastrointestinal motility disturbances.

Levosulpiride selectively antagonises dopamine D2 receptors in the brain and gut. This blockade reduces dopaminergic over‑activity that contributes to psychosis while enhancing cholinergic signalling in the gastrointestinal tract, thereby improving gastric emptying and motility.

The appropriate dose of Levobren is individualized by the prescribing clinician based on the patient’s diagnosis, severity of symptoms, renal and hepatic function, and response to therapy. No fixed regimen is provided here.

Safety data for levosulpiride in pregnancy and lactation are limited. It should only be used if the potential benefit justifies any potential risk to the fetus or infant, and the decision must be made by a qualified healthcare professional.

Enquiries for Levobren are submitted via the product page on gnhindia.com, where you specify the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Compared with other D2 antagonists such as risperidone, levosulpiride has a lower affinity for serotonin receptors, which may result in a different side‑effect profile. In the pro‑kinetic class, it differs from metoclopramide by having less pronounced central anti‑emetic activity but a similar ability to stimulate gastric motility.

Levobren should be stored at ambient temperature, below 25 °C, in its original packaging. Keep the container tightly closed, protect it from moisture and direct sunlight to maintain product stability.

Levobren is supplied as oral tablets and is taken by mouth. It may be swallowed with or without food, according to the prescriber’s instructions. Patients should follow the dosing schedule provided by their healthcare professional.

The most serious adverse events include neuroleptic malignant syndrome, severe extrapyramidal reactions such as acute dystonia or parkinsonism, and cardiac arrhythmias related to QT‑interval prolongation. Prompt medical attention is required if any of these symptoms develop.

Levobren is contraindicated in individuals with known hypersensitivity to levosulpiride or any component of the formulation, in patients with severe hepatic impairment, and in those with a history of neuroleptic malignant syndrome or uncontrolled cardiac arrhythmias.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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