Amisulpride is indicated for the management of both acute and chronic schizophrenia. It is effective in treating positive symptoms such as delusions, hallucinations, and disorganized thinking, as well as negative symptoms including reduced emotional expression, social withdrawal, and lack of motivation. It is also suitable for patients in whom negative symptoms are predominant.

Amisulpride is an antipsychotic agent that helps control symptoms of schizophrenia. It selectively binds to dopamine D2 and D3 receptors, with no significant affinity for D4 and D5 receptor subtypes. Unlike many other antipsychotics, amisulpride has minimal interaction with serotonin, alpha-adrenergic, histamine, muscarinic, and sigma receptors. It does not typically cause catalepsy or induce dopamine receptor hypersensitivity after repeated use. Additionally, it preferentially blocks presynaptic D2/D3 receptors, leading to increased dopamine release, which contributes to its beneficial effects on negative symptoms.

Oral dose: For acute psychotic episodes, oral doses between 400 mg/day and 800 mg/day are recommended in individual cases. The daily dose may be increased up to 1200 mg/day. Doses above 800 mg/day have not been shown to be superior to lower doses and may increase the incidence of adverse events. No specific titration is required when initiating the treatment with Amisulpride. Doses should be adjusted according individual response. Dose should preferably be administered before meal. For patients with mixed positive negative symptoms, doses should be adjusted to obtain optimal control of positive symptoms. Maintenance treatment should be established individually with the minimally effective dose. For patients characterized by predominant negative symptoms, oral doses between 50 mg/day and 300 mg/day are recommended. Doses should be adjusted individually.

Injectable dose: The recommended injectable adult dosage of Amisulpride and infusion rate by indication is shown in the table below:

• Prevention of postoperative nausea and vomiting: 5 mg as a single intravenous injection infused over 1 to 2 minutes at the time of induction of anesthesia.
• Treatment of postoperative nausea and vomiting: 10 mg as a single intravenous injection infused over 1 to 2 minutes in the event of nausea and/or vomiting after a surgical procedure.

With medicines: Consumption of alcohol while taking amisulpride may lead to central nervous system (CNS) depression, presenting as confusion, reduced concentration, anxiety, and drowsiness. Therefore, alcohol intake should be avoided during treatment. Drug interactions may occur with medications such as diltiazem, pregabalin, tramadol, amiodarone, quinidine, bromocriptine, and ropinirole. Concomitant use with other antipsychotic drugs may increase the risk of neuroleptic malignant syndrome (NMS). Co-administration with clozapine may increase plasma levels of amisulpride. Amisulpride may enhance the effects of:

• CNS depressants (e.g., narcotics, anesthetics, analgesics, sedating antihistamines, barbiturates, benzodiazepines, and other anxiolytics)
• Clonidine and its derivatives
• Antihypertensive and other hypotensive agents

With food and others: Amisulpride can be taken with or without food, as food does not significantly affect its absorption.

Amisulpride is contraindicated in patients with hypersensitivity to the active substance or any excipients. It should not be used in patients with prolactin-dependent tumors such as pituitary prolactinoma or breast cancer, pheochromocytoma, children before puberty, pregnancy, and during lactation. It is also contraindicated when used in combination with:

• Class I antiarrhythmic drugs (e.g., quinidine, disopyramide)
• Class II antiarrhythmic drugs (e.g., amiodarone, sotalol)
• Other drugs such as bepridil, cisapride, sultopride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparfloxacin, and levodopa In patients with hepatic impairment, its use may be contraindicated due to increased risk of adverse effects.

Common: Tremor, muscle rigidity or spasm, slowed movement, excessive salivation, restlessness, involuntary movements (especially of head, neck, jaw, or eyes), insomnia, anxiety, drowsiness, constipation, nausea, dry mouth, weight gain, hypotension, dizziness, sexual dysfunction, blurred vision, and increased prolactin levels.

Rare: Uncontrolled movements of the face or tongue, osteoporosis or bone weakness, and aspiration pneumonia.

The safety of amisulpride during pregnancy has not been established. It is not recommended unless the potential benefit justifies the risk. If used, the lowest effective dose for the shortest duration should be considered. Amisulpride is excreted into breast milk; therefore, breastfeeding is contraindicated.

Neuroleptic Malignant Syndrome (NMS) is a rare but potentially life-threatening condition associated with antipsychotic drugs, including amisulpride. It is characterized by high fever, muscle rigidity, autonomic instability, and elevated creatine phosphokinase (CPK) levels. If signs suggestive of NMS appear—especially at higher doses—all antipsychotic medications, including amisulpride, should be discontinued immediately. Amisulpride may lower the seizure threshold; therefore, patients with a history of seizures should be closely monitored. Abrupt discontinuation of high doses may lead to withdrawal symptoms. Involuntary movement disorders such as akathisia, dystonia, and dyskinesia have been reported; hence gradual dose reduction is recommended. Amisulpride can increase serum prolactin levels, which may lead to galactorrhea, amenorrhea, gynecomastia, breast discomfort, sexual dysfunction, and impotence.

Use in elderly: Use with caution due to increased risk of hypotension and sedation.

Use in children & adolescents: Safety and efficacy in patients below 18 years are not well established. If necessary, treatment in adolescents (15–18 years) should be supervised by a specialist experienced in this age group.

Use in hepatic impairment: Since amisulpride undergoes minimal metabolism, dose adjustment is generally not required.

Use in renal impairment: As amisulpride is mainly excreted by the kidneys, dose adjustment is necessary. Reduce dose to half in patients with creatinine clearance (30–60 mL/min) and to one-third in patients with (10–30 mL/min). Use with caution in severe renal impairment (CRCL <10 mL/min).

Data on amisulpride overdose is limited. Overdose may exaggerate its pharmacological effects, including drowsiness, sedation, hypotension, extrapyramidal symptoms, and coma. Fatal outcomes have been reported, particularly when combined with other psychotropic medications.

Atypical neuroleptic drugs

Store below 30°C in a cool, dry place, protected from light. Keep out of reach of children.