SOLIAN 200MG 30TAB

Indications

Approved Uses

Treatment of schizophrenia, including acute and chronic schizophrenic disorders with prominent positive symptoms and/or negative symptoms.

Off-Label Uses

Off-label uses vary by jurisdiction; evidence exists for adjunctive treatment in depressive disorders (e.g., dysthymia or treatment-resistant depression augmentation) and some other psychiatric conditions, but these are not SFDA-verified indications and should be specialist-directed.

Dosage & Administration

Dosing by Condition

Predominantly negative symptoms: 50-300 mg/day (often once daily). Acute psychotic episodes/mixed symptoms: 400-800 mg/day (usually in 2 divided doses); may be increased up to 1200 mg/day in severe cases per specialist direction; maintenance at the lowest effective dose.

Initial Dose

For acute psychotic episodes, 400-800 mg/day in divided doses. For predominant negative symptoms, 50-100 mg/day.

Maintenance Dose

Should be established individually with the minimally effective dose, typically between 100-600 mg/day.

Maximum Dose

1200 mg/day.

Children's Dosage

Not approved for children. Contraindicated in children before the onset of puberty. Use from puberty to 18 years is not recommended.

Dose Adjustment Notes

Dose reduction is required in renal impairment (amisulpride is primarily renally eliminated); use the lowest effective dose and divide higher daily doses. Avoid abrupt discontinuation when possible-taper gradually to reduce relapse/withdrawal phenomena.

Side Effects

Common Side Effects

Common/clinically important adverse effects include extrapyramidal symptoms (e.g., tremor, rigidity, akathisia), hyperprolactinemia (galactorrhea, amenorrhea, gynecomastia, sexual dysfunction), weight gain, insomnia/anxiety/agitation or somnolence, gastrointestinal effects (constipation, nausea/vomiting), and QT interval prolongation.

Side Effect Frequency

Very common (>10%): hyperprolactinemia (and related effects) and extrapyramidal symptoms; Common (1-10%): insomnia, anxiety/agitation, somnolence, GI effects (e.g., constipation, nausea), weight gain; QT prolongation is a recognized risk/ADR (frequency varies by source).

Safety & Warnings

Contraindications

Hypersensitivity to amisulpride/excipients; pheochromocytoma; prolactin-dependent tumors (e.g., pituitary prolactinoma, breast cancer); concomitant use with levodopa; breastfeeding (lactation); severe renal impairment (CrCl <10 mL/min).

Warnings & Precautions

QT prolongation risk-avoid other QT-prolonging drugs, correct electrolytes, consider baseline/periodic ECG in at-risk patients; risk of NMS-stop immediately if suspected; tardive dyskinesia with long-term use; hyperprolactinemia (monitor for symptoms); lowers seizure threshold; venous thromboembolism risk; caution in cardiovascular disease, Parkinson’s disease, epilepsy, and renal impairment; increased mortality and cerebrovascular adverse events risk in elderly patients with dementia; monitor metabolic parameters (weight/glucose/lipids) as clinically indicated.

Age Restriction

Not approved under 18 years.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major: levodopa/dopamine agonists (mutual antagonism-avoid/contraindicated); QT-prolonging drugs (e.g., class IA/III antiarrhythmics, certain antipsychotics, macrolides/fluoroquinolones, methadone) and drugs causing hypokalemia/hypomagnesemia (e.g., loop/thiazide diuretics, amphotericin B)-increased torsades risk. Moderate: CNS depressants/alcohol (additive sedation); antihypertensives (additive hypotension). Caution: lithium (increased risk of neurotoxicity/NMS).

Interaction Severity

MAJOR/AVOID: concomitant levodopa or dopamine agonists (pharmacodynamic antagonism) and other QT-prolonging drugs (e.g., class IA/III antiarrhythmics such as quinidine/amiodarone/sotalol, certain antipsychotics like thioridazine/droperidol, and QT-prolonging antibiotics like moxifloxacin) due to torsades risk. MODERATE: CNS depressants (additive sedation), agents causing hypokalemia/hypomagnesemia (increased arrhythmia risk), and antihypertensives (additive hypotension).

Special Populations

Pregnancy

Consult Doctor

Children

Not approved for children. Contraindicated in children before the onset of puberty. Use from puberty to 18 years is not recommended.

Elderly

Start at lower doses and titrate slowly; increased sensitivity to extrapyramidal effects, hypotension, and QT prolongation; monitor renal function; not recommended for dementia-related psychosis

Kidney Impairment

CrCl 30-60 mL/min: use 50% of usual dose; CrCl 10-30 mL/min: use one-third of usual dose; CrCl <10 mL/min: contraindicated/avoid.

Liver Impairment

No dose adjustment generally required in hepatic impairment.

Storage & Patient Advice

Stopping the Medicine

Do not stop abruptly; taper gradually under medical supervision to reduce withdrawal symptoms and relapse/recurrence of psychosis.

Overdose

Symptoms: sedation/CNS depression up to coma, hypotension, extrapyramidal symptoms, QT prolongation and torsades de pointes (± bradycardia). Management: immediate emergency care, supportive/symptomatic treatment, consider activated charcoal if early, continuous ECG/cardiac monitoring and correction of electrolytes; no specific antidote; hemodialysis is of limited value.

Patient Counseling

Take exactly as prescribed (oral tablets; store below 30°C per SFDA); do not stop abruptly without medical advice. May cause dizziness/somnolence-avoid driving/machinery until effects are known; avoid alcohol and other sedatives. Seek urgent care for palpitations, fainting, severe dizziness, or signs of neuroleptic malignant syndrome (fever, severe rigidity, confusion). Discuss prolactin-related effects (breast changes, milk secretion, menstrual/sexual changes) and attend recommended follow-up (ECG/electrolytes/renal and other monitoring as advised).

Monitoring Requirements

Baseline and follow-up: ECG/QTc in patients with cardiac disease, risk factors, or when combined with QT-prolonging drugs; monitor potassium and magnesium (and correct abnormalities). Also monitor renal function, weight/BMI and metabolic parameters as clinically indicated, and assess for extrapyramidal symptoms and hyperprolactinemia symptoms (consider prolactin if symptomatic).

Pharmacology

Mechanism of Action

Selective dopamine D2/D3 receptor antagonist: at lower doses preferentially blocks presynaptic autoreceptors (increasing dopamine transmission), while at higher doses blocks postsynaptic D2/D3 receptors to reduce dopaminergic hyperactivity; minimal affinity for serotonin, histamine, muscarinic, and adrenergic receptors.

Onset of Action

Within a few days for initial effects; noticeable improvement usually within 1-2 weeks; full response may take 4-6 weeks or longer.

Duration of Effect

Clinical effect begins within days; meaningful symptom improvement typically within 1-2 weeks; full antipsychotic response may take 4-6 weeks or longer.

Half-Life

Approximately 12 hours (terminal elimination half-life).

Metabolism

Minimal hepatic metabolism; not significantly CYP-mediated; two inactive metabolites have been identified.

Protein Binding

Plasma protein binding ranges from 25% to 30% in the concentration range from 37 to 1850 ng/mL

Product Information

Available Dosage Forms

Tablet, Injectable solution.

Composition per Dose

Each tablet: 200 mg amisulpride

OTC Alternatives

No OTC alternative

Psych Class

Antipsychotic-Atypical

Controlled Substance

No

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