Product image of Isofredil (Amisulpride) supplied by GNH India

Isofredil

Active Ingredient:
Amisulpride
Origin:
EU

Isofredil (Amisulpride)

Amisulpride, the active ingredient in Isofredil, is a benzamide antipsychotic presented as an oral tablet for oral use. It is employed in the management of schizophrenia and certain depressive disorders, acting on dopamine pathways to modulate symptoms in adult patients.

GNH India supplies Isofredil as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides regulatory documentation to support import and distribution. Customers benefit from reliable lead times and dedicated technical support.

Manufacturer / TM Owner

Vocate Φαρμακευτικη Αε

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Indications & Clinical Uses

Isofredil (amisulpride) acts on dopaminergic pathways and is indicated for several psychiatric conditions.

  • Schizophrenia: reduces positive and negative symptoms and improves overall functioning.
  • Depressive disorders (e.g., dysthymia): alleviates persistent low mood and associated symptoms.
  • Psychotic symptoms in mood disorders: helps control hallucinations and delusions when they occur alongside depressive or bipolar episodes.

How It Works

  • Amisulpride selectively antagonizes dopamine D2 and D3 receptors. At low oral doses it preferentially blocks presynaptic autoreceptors, enhancing dopamine release, while at higher doses it blocks postsynaptic receptors, diminishing dopaminergic neurotransmission and thereby reducing psychotic and depressive symptomatology.

Side Effects

Amisulpride may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Headache: transient cranial discomfort.
  • Insomnia: difficulty initiating or maintaining sleep.
  • Anxiety: heightened nervousness or tension.
  • Weight gain: modest increase in body weight.
  • Extrapyramidal symptoms: tremor, rigidity, or akathisia.

Serious or Rare Side Effects

  • Hyperprolactinemia: elevated prolactin leading to galactorrhea or menstrual disturbances.
  • QT interval prolongation: potential cardiac arrhythmia risk.
  • Neuroleptic malignant syndrome: rare but life‑threatening reaction with fever and muscle rigidity.
  • Severe extrapyramidal reactions: persistent dystonia or parkinsonism.
  • Agranulocytosis: marked reduction in white blood cells.
  • Severe hypotension: sudden drop in blood pressure, especially on standing.

Precautions & Warnings

Before initiating therapy with Isofredil, clinicians should consider several safety measures.

  • Monitor prolactin levels: assess for signs of hyperprolactinemia during treatment.
  • Evaluate cardiac function: obtain baseline ECG and monitor QT interval, especially in patients with cardiac risk factors.
  • Adjust for renal impairment: dose may need modification in reduced kidney function.
  • Avoid abrupt discontinuation: taper gradually to minimise withdrawal or relapse.
  • Check for hypersensitivity: discontinue if allergic reactions occur.
  • Store at ambient temperature: keep in the original container, protect from moisture and light.

Avoid Interactions

Amisulpride can interact with other medicines, requiring careful management.

Major Interactions (Avoid)

  • Concurrent QT‑prolonging agents: increase risk of cardiac arrhythmias.
  • Strong CYP2D6 inhibitors (if co‑administered): may raise plasma concentrations.
  • Other dopamine antagonists: amplify extrapyramidal side effects.

Moderate Interactions (Monitor Closely)

  • Anticholinergic drugs: may worsen cognitive side effects.
  • Diuretics: can affect electrolyte balance and influence QT interval.
  • CNS depressants (e.g., benzodiazepines): may enhance sedation.
  • Antihistamines: potential additive anticholinergic burden.

Frequently Asked Questions

Isofredil contains amisulpride and is prescribed for the treatment of schizophrenia and certain depressive disorders such as dysthymia. It may also be used to manage psychotic symptoms that appear in mood disorders when a clinician determines it is appropriate.

Amisulpride works by selectively blocking dopamine D2 and D3 receptors. At lower doses it blocks presynaptic receptors, increasing dopamine release, while at higher doses it blocks postsynaptic receptors, reducing dopaminergic activity and helping to control psychotic and depressive symptoms.

The exact dose of Isofredil is determined by the prescribing clinician based on the individual’s diagnosis, severity of symptoms, age, renal function and other clinical factors. Patients should follow the dosage instructions provided by their healthcare professional.

Safety data for amisulpride in pregnancy and lactation are limited. The drug 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 provider.

To order Isofredil, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Isofredil (amisulpride) is a benzamide antipsychotic that primarily targets dopamine D2/D3 receptors, offering a distinct side‑effect profile compared with atypical agents such as risperidone or olanzapine. It may cause fewer metabolic disturbances but can be associated with higher rates of prolactin elevation and QT prolongation.

Isofredil should be stored at ambient temperature, below 25 °C, in its original packaging. Keep the product away from moisture, direct sunlight and excessive heat to maintain its stability and potency.

Isofredil is taken orally, usually as a tablet, with or without food as directed by the prescriber. The exact administration schedule (once daily, twice daily, etc.) is individualized based on the therapeutic plan.

Serious risks include hyperprolactinemia, which can cause hormonal disturbances; QT interval prolongation, which may lead to cardiac arrhythmias; neuroleptic malignant syndrome, a rare but life‑threatening condition; and severe extrapyramidal reactions such as dystonia or parkinsonism.

Isofredil should be avoided in patients with known hypersensitivity to amisulpride or any component of the formulation, in those with significant cardiac conduction abnormalities that predispose to QT prolongation, and in individuals where the risk‑benefit ratio is unfavorable as judged by their healthcare provider.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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