SOLIAN 50/MG TAB 30/TAB

Indications

Approved Uses

Treatment of schizophrenia (acute and chronic), including patients with predominantly positive and/or predominantly negative symptoms.

Off-Label Uses

Off-label uses reported include dysthymia/low-dose depressive symptoms and augmentation in treatment-resistant depression; other psychiatric uses (e.g., anxiety/OCD, dementia agitation) are not well-established and depend on local practice and evidence.

Dosage & Administration

Dosing by Condition

Schizophrenia-predominantly negative symptoms: 50-300 mg/day. Acute psychotic episodes/mixed or positive symptoms: 400-800 mg/day (usually divided if >300 mg/day); maximum up to 1200 mg/day.

Initial Dose

Schizophrenia: 400-800mg/day in 2 divided doses; Dysthymia: 50mg once daily

Maintenance Dose

Schizophrenia: 400-800mg/day; Negative symptoms: 50-300mg/day; Dysthymia: 50mg/day

Maximum Dose

1200 mg/day.

How to Take

Swallow tablets whole with water; may be taken with or without food. Doses up to 300 mg/day may be given once daily; doses >300 mg/day should be divided into two doses (morning and evening).

Side Effects

Common Side Effects

Extrapyramidal symptoms (e.g., tremor, rigidity, akathisia), insomnia, anxiety/agitation, somnolence/dizziness, hyperprolactinaemia (galactorrhoea, amenorrhoea, gynaecomastia, sexual dysfunction), weight gain, constipation, nausea.

Side Effect Frequency

Very common (>10%): extrapyramidal symptoms; hyperprolactinaemia. Common (1-10%): insomnia, anxiety/agitation, somnolence/dizziness, GI effects (e.g., constipation, nausea/vomiting, dry mouth), weight gain; endocrine effects related to prolactin (e.g., amenorrhoea/galactorrhoea/gynaecomastia/sexual dysfunction); cardiovascular effects including hypotension/bradycardia and QT prolongation. Uncommon/rare: tardive dyskinesia, seizures, neuroleptic malignant syndrome, venous thromboembolism, blood dyscrasias (e.g., agranulocytosis), hyperglycaemia.

Safety & Warnings

Contraindications

Hypersensitivity to amisulpride; prolactin-dependent tumors (e.g., pituitary prolactinoma, breast cancer); pheochromocytoma; concomitant use with levodopa (and generally dopamine agonists); severe renal impairment (commonly CrCl <10 mL/min) or use not recommended; pediatric use before puberty/children (age cutoffs vary by label).

Warnings & Precautions

QT prolongation/torsades risk-avoid in congenital long-QT, correct electrolytes, consider baseline/periodic ECG in at-risk patients and avoid other QT-prolonging drugs; NMS-stop immediately if suspected; tardive dyskinesia/EPS-use lowest effective dose and reassess regularly; hyperprolactinemia-monitor for clinical effects and avoid in prolactin-dependent tumors; seizures-caution in epilepsy; renal impairment-dose adjust; elderly-higher risk of hypotension/sedation and cerebrovascular events; metabolic effects-monitor weight and glucose (and lipids as clinically indicated); VTE risk-assess risk factors.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major: levodopa/dopamine agonists (pharmacodynamic antagonism; levodopa is contraindicated); QT-prolonging drugs (additive QT prolongation/torsades risk); CNS depressants/alcohol (additive sedation/respiratory/CNS depression); antihypertensives (additive hypotension/bradycardia). Other clinically relevant: lithium (increased neurotoxicity/EPS and possible QT risk-monitor closely).

Interaction Severity

MAJOR/CONTRAINDICATED: Levodopa/dopamine agonists (pharmacodynamic antagonism); other QT-prolonging drugs (e.g., class Ia/III antiarrhythmics, certain fluoroquinolones, methadone, droperidol) due to torsades risk. MODERATE: CNS depressants (additive sedation), antihypertensives (hypotension), lithium (neurotoxicity/QT risk).

Alcohol Interaction

Avoid

Special Populations

Elderly

Use with particular caution due to increased risk of hypotension and sedation. A lower starting dose and dose reduction may be required, especially in the presence of renal impairment.

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 relapse and withdrawal/emergent symptoms (including dyskinesia).

Overdose

Symptoms: somnolence/sedation, hypotension, extrapyramidal symptoms, QT prolongation/arrhythmias (including torsades), and coma. Management: immediate emergency care, supportive treatment with airway/ventilation as needed, activated charcoal if appropriate, continuous ECG/cardiac monitoring and correction of electrolytes; no specific antidote; hemodialysis is of limited value.

Patient Counseling

Take exactly as prescribed; do not stop abruptly. May cause dizziness/somnolence-avoid driving until effects are known; avoid alcohol. Rise slowly to reduce orthostatic symptoms. Seek urgent care for palpitations/syncope, fever/rigidity/confusion (NMS), or troublesome abnormal movements. Report prolactin-related effects (breast discharge, menstrual changes, sexual dysfunction). Inform clinicians before starting new medicines due to QT interaction risk and attend monitoring (ECG/labs) as advised.

Monitoring Requirements

Baseline and follow-up: ECG (QTc) in at-risk patients and as clinically indicated; electrolytes (K+, Mg2+); renal function; weight/BMI; fasting glucose/HbA1c; lipids; prolactin if symptomatic; blood pressure; assess for extrapyramidal symptoms.

Pharmacology

Mechanism of Action

Selective dopamine D2/D3 receptor antagonist; at low doses preferentially blocks presynaptic autoreceptors (increasing dopamine transmission), while at higher doses blocks postsynaptic receptors producing antipsychotic effects; minimal affinity for muscarinic, histaminic, and adrenergic receptors.

Duration of Effect

Clinical antipsychotic effect is maintained with continuous daily dosing; symptomatic benefit persists while treatment is continued. After a single dose, pharmacologic effect lasts about 12-24 hours (supports once- or twice-daily dosing depending on dose and clinical response).

Half-Life

Approximately 12 hours.

Bioavailability

Oral bioavailability is approximately 48%.

Metabolism

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

Excretion

Primarily renal; a large proportion is excreted unchanged in urine (about 50%), with minor fecal elimination.

Protein Binding

Plasma protein binding ranges from 25% to 30%

Product Information

Available Dosage Forms

Tablet, Oral Solution, Injectable Solution.

Composition per Dose

Each tablet: 50mg Amisulpride.

Generic Availability

Yes

OTC Alternatives

No OTC alternative.

Psych Class

Antipsychotic-Atypical

Controlled Substance

No

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