SILOMES 200 MG 30 TAB

Indications

Approved Uses

Treatment of schizophrenia (acute and chronic), including both positive symptoms and negative symptoms.

Off-Label Uses

Off-label: dysthymia/low-dose depressive symptoms (in some regions), augmentation in treatment-resistant depression, and delusional disorder (evidence varies).

Dosage & Administration

Dosing by Condition

Schizophrenia-acute psychotic episodes: 400-800 mg/day (often in 2 divided doses), may increase up to 1200 mg/day if needed. Predominantly negative symptoms: 50-300 mg/day (usually once daily up to 300 mg).

Initial Dose

400-800 mg/day in 2 divided doses for acute schizophrenia; 50 mg/day for dysthymia or predominantly negative symptoms

Maintenance Dose

400-800 mg/day for schizophrenia; 50-300 mg/day for negative symptoms

Maximum Dose

1200 mg/day.

Children's Dosage

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

Dose Adjustment Notes

Renal impairment: dose reduction is required (amisulpride is primarily renally eliminated). Hepatic impairment: usually no adjustment needed. Elderly: start low and titrate cautiously due to increased sensitivity and QT/EPS risk.

Side Effects

Common Side Effects

Extrapyramidal symptoms (e.g., tremor, rigidity, akathisia), hyperprolactinemia (e.g., galactorrhea, amenorrhea, gynecomastia, sexual dysfunction), insomnia/anxiety/agitation, somnolence/sedation, weight gain, gastrointestinal effects (nausea/vomiting, constipation).

Safety & Warnings

Contraindications

Hypersensitivity to amisulpride; pheochromocytoma; prolactin-dependent tumors (e.g., pituitary prolactinoma, breast cancer); concomitant use with levodopa; severe renal impairment (CrCl <10 mL/min) generally contraindicated/not recommended; congenital/known QT prolongation or concomitant use with medicines known to cause torsades de pointes (per local labeling).

Warnings & Precautions

QT prolongation risk (baseline ECG and correct K+/Mg2+; avoid in congenital QT prolongation/bradycardia and with torsades-risk drugs); caution in elderly (orthostasis/sedation and dementia-related psychosis mortality warning); monitor for NMS and tardive dyskinesia; seizure risk (epilepsy); hyperprolactinemia; renal impairment requires dose adjustment; caution in Parkinson’s disease; monitor metabolic parameters (weight, glucose, lipids) and consider CBC if clinically indicated.

Age Restriction

Not recommended in children and adolescents under 18 years (safety/efficacy not established).

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major: levodopa (contraindicated); other dopamine agonists (antagonism); drugs that prolong QT or cause torsades (e.g., class IA/III antiarrhythmics, certain antipsychotics, macrolides, fluoroquinolones, methadone) - avoid/contraindicated depending on agent; CNS depressants/alcohol (additive sedation); antihypertensives (additive hypotension); lithium (increased neurotoxicity/NMS risk).

Interaction Severity

MAJOR: Concomitant QT-prolonging drugs (e.g., class IA/III antiarrhythmics such as quinidine/amiodarone/sotalol, certain antipsychotics, methadone) due to torsades risk; dopaminergic agents (levodopa/dopamine agonists) due to pharmacodynamic antagonism (often contraindicated/avoid). MODERATE: CNS depressants including alcohol/opioids/benzodiazepines (additive sedation), antihypertensives (additive hypotension).

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Children

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

Elderly

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

Liver Impairment

No dose adjustment generally required in hepatic impairment.

Storage & Patient Advice

Overdose

Symptoms: sedation/drowsiness, coma, hypotension, extrapyramidal symptoms, QT prolongation/torsades de pointes. Management: urgent emergency care, supportive treatment, consider activated charcoal if appropriate, and continuous ECG/cardiac monitoring; no specific antidote.

Patient Counseling

Take exactly as prescribed and do not stop abruptly without medical advice. May cause drowsiness/dizziness-avoid driving/machinery until effects are known; avoid alcohol and other sedatives unless approved. Seek urgent care for palpitations/fainting, severe dizziness, or signs of NMS (high fever, severe muscle stiffness, confusion). Report involuntary movements and symptoms of high prolactin (menstrual changes, breast changes, sexual dysfunction). Tell your clinician about pregnancy/breastfeeding plans and all other medicines (especially QT-prolongers or levodopa).

Monitoring Requirements

Baseline and follow-up ECG (QTc) in patients with risk factors or when using higher doses/other QT-prolongers; monitor electrolytes (K+, Mg2+) if at risk; renal function; weight/BMI and metabolic parameters (glucose, lipids) as with antipsychotics; assess for EPS and hyperprolactinemia symptoms (consider prolactin if symptomatic); monitor for NMS. CBC/LFTs are not routine but may be checked if clinically indicated.

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 to reduce dopaminergic signaling and treat positive symptoms; minimal affinity for muscarinic/histamine receptors.

Duration of Effect

Antipsychotic effect is maintained with continuous daily dosing; clinical benefit persists while treatment is continued. A single dose provides pharmacologic activity for about 24 hours (supports once- or twice-daily dosing depending on total daily dose).

Half-Life

Approximately 12 hours (terminal elimination half-life)

Bioavailability

Approximately 48% (oral bioavailability).

Metabolism

Minimal hepatic metabolism; not significantly metabolized by CYP enzymes; two inactive metabolites identified

Excretion

Primarily renal elimination, largely as unchanged drug in urine (major route); minor fecal excretion.

Protein Binding

Approximately 16% (low protein binding; sometimes cited as ~16-17%)

Product Information

Available Dosage Forms

Tablet, Injectable solution, Oral solution

Composition per Dose

Each tablet: 200 mg amisulpride

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antipsychotic-Atypical

Controlled Substance

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 03-07-2026