SILOMES 100 MG 30 TAB

Indications

Approved Uses

Treatment of schizophrenia (acute and chronic), including cases where positive symptoms and/or negative symptoms are prominent.

Off-Label Uses

Off-label uses reported in practice/literature include dysthymia/depressive symptoms at low dose and Tourette’s syndrome; other psychiatric uses (e.g., agitation in dementia, OCD augmentation) have limited/variable evidence and are not established approvals.

Dosage & Administration

Dosing by Condition

Schizophrenia-acute psychotic episodes (predominantly positive symptoms): 400-800 mg/day, may increase up to 1200 mg/day if needed. Predominantly negative symptoms: 50-300 mg/day. Doses >300 mg/day should be divided; ≤300 mg/day may be once daily.

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. [4, 27]

Dose Adjustment Notes

Renal impairment: dose reduction is required (amisulpride is primarily renally eliminated); hepatic impairment: usually no adjustment needed. Discontinuation: taper gradually when possible to reduce relapse/withdrawal phenomena.

How to Take

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

Side Effects

Common Side Effects

Extrapyramidal symptoms (tremor, rigidity, akathisia), hyperprolactinemia (which can lead to galactorrhea, amenorrhea, gynecomastia), insomnia, anxiety, agitation, weight gain, somnolence, constipation, nausea, vomiting. [10, 27]

Safety & Warnings

Contraindications

Hypersensitivity to amisulpride; pheochromocytoma; prolactin-dependent tumors (e.g., pituitary prolactinoma, breast cancer); concomitant use with levodopa; concomitant use with medicines known to prolong the QT interval/that can cause torsades de pointes (where listed as contraindicated in labeling).

Warnings & Precautions

QT prolongation/torsades risk-avoid other QT-prolonging drugs, correct hypokalemia/hypomagnesemia, consider baseline/periodic ECG in at-risk patients; monitor for NMS; tardive dyskinesia risk with long-term use; hyperprolactinemia (caution/avoid in prolactin-dependent tumors); caution in epilepsy/seizure risk, Parkinson’s disease, cardiovascular disease, and renal impairment; venous thromboembolism risk; increased mortality in elderly patients with dementia-related psychosis.

Drug Interactions

Interaction Severity

MAJOR: Concomitant QT-prolonging drugs (e.g., class IA/III antiarrhythmics, certain macrolides/fluoroquinolones, methadone) due to torsades risk; dopaminergic agents (levodopa/dopamine agonists) due to pharmacodynamic antagonism. MODERATE: CNS depressants (including alcohol, opioids, benzodiazepines) additive sedation; antihypertensives additive hypotension; lithium (increased risk of neurotoxicity/NMS-use caution).

Alcohol Interaction

Avoid

Special Populations

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: use is not recommended/avoid (if used, only with extreme caution and close monitoring).

Liver Impairment

No dose adjustment generally required in hepatic impairment.

Storage & Patient Advice

Patient Counseling

Take exactly as prescribed; do not stop abruptly-consult prescriber for tapering. May cause drowsiness/dizziness-avoid driving until effects known; avoid alcohol; rise slowly to reduce orthostatic dizziness. Seek urgent care for fever/rigidity/confusion (NMS), uncontrolled movements (EPS), or palpitations/syncope (arrhythmia). Inform clinicians about all medicines, especially QT-prolonging drugs; report prolactin-related effects (breast changes, menstrual disturbance).

Monitoring Requirements

Baseline and follow-up: ECG/QTc in patients with risk factors or when using other QT-prolonging drugs; electrolytes (K+, Mg2+); renal function. Ongoing: assess extrapyramidal symptoms, weight/BMI, glucose (and lipids per antipsychotic metabolic monitoring practices), and prolactin if symptomatic.

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 (reducing dopaminergic overactivity linked to positive symptoms).

Duration of Effect

Clinical symptom control is maintained with regular daily dosing; each dose provides pharmacologic activity for roughly 12-24 hours (supports once- or twice-daily dosing depending on total daily dose).

Half-Life

Approximately 12 hours (terminal elimination half-life ~12 h)

Bioavailability

Approximately 48% (oral bioavailability).

Metabolism

Minimal hepatic metabolism; not significantly metabolized by CYP enzymes; a small fraction is converted to inactive metabolites

Excretion

Primarily renal elimination, with a substantial proportion excreted unchanged in urine.

Protein Binding

Low protein binding ~16% (often cited as 16-17%)

Product Information

Available Dosage Forms

Tablet, Oral solution, Injectable solution.

Composition per Dose

Each tablet: 100 mg amisulpride

Generic Availability

Yes

OTC Alternatives

No OTC alternative.

Psych Class

Antipsychotic-Atypical

Controlled Substance

No

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