Registered South Africa · SAHPRA

SOLIAN 200 mg

Amusulpride

34/2.6.5/0117

What it does

Amusulpride is a medication used to treat certain mental health conditions.

Commonly used for: schizophrenia, schizoaffective disorder, depression

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
34/2.6.5/0117
Registration date
2001/06/15
Expiry date
-
Status
Registered
Active ingredient
Amusulpride
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-04-15 21:24:42 · updated 2026-10-28 04:12:24

Disclaimer: This information is sourced from South African Health Products Regulatory Authority (South Africa). Always consult a qualified healthcare professional before using any medication.

About this medicine

Amusulpride is a medication used to treat certain mental health conditions.

What it treats

  • schizophrenia
  • schizoaffective disorder
  • depression

How it works

Amusulpride helps to balance chemicals in the brain that affect mood and behavior.

Who it's for

This medication is for adults who are experiencing symptoms of specific mental health disorders.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: amusulpride

Amisulpride is an atypical antipsychotic that is primarily used in the treatment of schizophrenia and other psychotic disorders. It functions as a selective dopamine D2 and D3 receptor antagonist, which helps to modulate dopaminergic activity in the brain, thereby alleviating symptoms associated with psychosis. Additionally, amisulpride may be used in low doses for the treatment of depressive episodes.

Indications

  • Schizophrenia
  • Acute psychotic episodes
  • Depressive episodes (at low doses)

Dosage

Children: Refer to the appropriate clinical guidelines or product information for specific dosing recommendations.

Adults: Refer to the appropriate clinical guidelines or product information for specific dosing recommendations.

Mechanism of action

Amisulpride selectively blocks dopamine D2 and D3 receptors in the central nervous system. By inhibiting these receptors, amisulpride reduces dopaminergic overactivity, which is thought to contribute to the symptoms of schizophrenia, such as hallucinations and delusions. The drug also has a unique property of enhancing dopaminergic neurotransmission at low doses, which may contribute to its antidepressant effects.

Pharmacodynamics

The pharmacodynamics of amisulpride involve its antagonistic effects on dopamine receptors, leading to decreased dopaminergic signaling in hyperactive pathways while potentially enhancing signaling in hypoactive pathways. This dual action helps stabilize mood and psychotic symptoms. Additionally, amisulpride has minimal affinity for other neurotransmitter receptors, which contributes to its relatively favorable side effect profile compared to other antipsychotics.

Pharmacokinetics

Amisulpride is well absorbed following oral administration, with peak plasma concentrations typically reached within 1 to 3 hours. It has a bioavailability of approximately 48% due to first-pass metabolism. The drug is primarily eliminated via renal excretion, with a half-life of about 12 hours. Its pharmacokinetic profile allows for flexible dosing schedules. Amisulpride does not undergo extensive hepatic metabolism, making it suitable for patients with liver impairment.

Contra-indications

  • Hypersensitivity to amisulpride or any of its components
  • Pheochromocytoma
  • Prolactin-dependent tumors
  • Severe renal impairment

Adverse effects

  • Drowsiness
  • Insomnia
  • Headache
  • Weight gain
  • Extrapyramidal symptoms
  • Hyperprolactinemia
  • Nausea
  • Diarrhea
  • Constipation

Interactions

  • Antihypertensives may have additive effects on blood pressure
  • Other central nervous system depressants may enhance sedation and drowsiness
  • Dopamine agonists may have reduced efficacy

Precautions

  • Use with caution in patients with a history of seizures
  • Monitor for signs of tardive dyskinesia
  • Consider caution in elderly patients or those with cardiovascular disease
  • Regular monitoring of blood pressure is recommended

Pregnancy

Amisulpride should only be used in pregnancy if the benefits outweigh the risks, as it may affect fetal development.

Breast-feeding

Amisulpride is excreted in breast milk, and caution should be exercised when administering to nursing mothers.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Tablets: 400 mg, 600 mg
  • Injectable solution: 400 mg/2 mL

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.