Schedule H

Oral, Intramuscular

• Tablet 50 mg

• Tablet 100 mg

• Tablet 200 mg

• Tablet 400 mg

• Injection (IM) 400 mg/2 mL

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Schizophrenia — Acute Phase (Predominantly Positive Symptoms)

Parameter Dosing Details

Starting dose 400–800 mg/day in 1–2 divided doses

Titration May increase after several days based on response

Usual maintenance dose 400–800 mg/day

Maximum dose 1200 mg/day

Key Clinical Notes:

• Higher doses primarily target positive symptoms (hallucinations, delusions)

• Twice-daily dosing preferred for doses >400 mg/day

• Monitor QTc at higher doses

1. Schizophrenia — Chronic Phase (Predominantly Negative Symptoms)

Parameter Dosing Details

Starting dose 50–100 mg/day

Titration Minimal; maintain at lowest effective dose

Usual maintenance dose 100–300 mg/day

Maximum dose 400 mg/day

Key Clinical Notes:

• Lower doses preferred for targeting negative symptoms (apathy, social withdrawal)

• Better tolerability at lower doses with reduced EPS and prolactin elevation

• Can be given as single daily dose

1. Acute Psychotic Agitation (Short-term) — IM Route Only

Parameter Dosing Details

Starting dose 400 mg IM as single dose

Titration Not applicable

Usual maintenance dose Not applicable (short-term use only)

Maximum dose 400 mg within 24 hours

Key Clinical Notes:

• Duration: Short-term use only (maximum 3 days)

• Switch to oral formulation once patient is stabilized

• Monitor for acute dystonia and hypotension post-injection

Secondary Indications — Adults (Off-label, if any)

Indication Dose Duration Notes

Bipolar Depression (OFF-LABEL) Starting: 50 mg/day; Titrate to 100–200 mg/day Short-term; reassess after 6–8 weeks Specialist only; Evidence: International RCTs; Used by some Indian psychiatrists for partial responders; Monitor for EPS

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

⛔ NOT RECOMMENDED in children <18 years — Safety and efficacy not established in paediatric population.

Secondary Indications — Paediatric Doses (Off-label, if any)

Indication Age Dosing Notes

Adolescent Schizophrenia (OFF-LABEL) ≥15 years Starting: 100–200 mg/day; Titrate gradually; Maximum: 800 mg/day Specialist (child psychiatrist) supervision mandatory

Safety Monitoring Required:

• Baseline and periodic ECG (QTc monitoring)

• Extrapyramidal symptoms assessment

• Weight and BMI monitoring

• Fasting glucose and lipid profile

• Prolactin levels (galactorrhoea, menstrual irregularities)

⚠️ Use below 15 years: Not recommended except under specialist supervision with documented justification.

Creatinine Clearance (mL/min) Dose Recommendation

30–60 Use 50% of usual dose

10–30 Use 25% of usual dose

<10 or on dialysis Avoid; if essential, use with extreme caution under specialist supervision

Note: Amisulpride is not significantly dialyzable.

• Known hypersensitivity to amisulpride or any excipients

• Pheochromocytoma

• Prolactin-dependent tumours (e.g., pituitary prolactinoma, prolactin-secreting breast carcinoma)

• Concomitant use with drugs known to prolong QT interval (Class Ia/III antiarrhythmics: quinidine, amiodarone, sotalol)

• Pre-existing significant QT prolongation

• Cardiac disease or risk factors for QT prolongation — baseline and periodic ECG recommended

• Parkinson's disease — may exacerbate extrapyramidal symptoms

• History of hyperprolactinaemia or related symptoms

• Seizure disorder or lowered seizure threshold

• Diabetes mellitus or metabolic syndrome risk factors

• Elderly patients — increased sensitivity to CNS effects

• Renal impairment — mandatory dose reduction

• History of neuroleptic malignant syndrome

Parameter Details

Risk category Limited human data; risk-benefit assessment required

Recommendation Avoid if possible, especially in first trimester; use only if benefits clearly outweigh risks

Preferred alternatives Haloperidol, olanzapine (more established safety data in pregnancy)

Monitoring Fetal growth ultrasound; neonatal monitoring for EPS and withdrawal symptoms if used in third trimester

Parameter Details

Compatibility Not recommended — excreted in breast milk

Expected levels in milk Moderate (specific quantification limited)

Preferred alternatives Risperidone (better established safety profile during lactation)

Infant monitoring Sedation, feeding difficulties, failure to thrive, developmental milestones

Parameter Recommendation

Starting dose 50–100 mg/day

Titration Slow; increase by 50–100 mg every 5–7 days as tolerated

Maximum dose Generally ≤400 mg/day unless compelling indication

Extra risks Falls, orthostatic hypotension, excessive sedation, extrapyramidal symptoms, QT prolongation

Monitoring Frequent clinical assessment; periodic ECG; renal function

Interacting Drug/Class Effect Management

QT-prolonging drugs (quinidine, amiodarone, sotalol, erythromycin, haloperidol) Additive QT prolongation — risk of torsades de pointes AVOID combination

Levodopa Mutual antagonism at dopamine receptors AVOID co-administration

Dopamine agonists (cabergoline, bromocriptine, pramipexole) Pharmacological antagonism Avoid unless benefit clearly outweighs risk

Alcohol Enhanced CNS depression Counsel patient to avoid

Interacting Drug/Class Effect Management

Antihypertensives Additive hypotensive effect Monitor blood pressure; adjust doses if needed

CNS depressants (benzodiazepines, opioids, antihistamines) Enhanced sedation Use lower doses; monitor for excessive sedation

Citalopram/Escitalopram Additive QT prolongation risk Monitor ECG if co-prescribed

Ketoconazole, itraconazole CYP inhibition may increase amisulpride exposure Use with caution; monitor for adverse effects

Rifampicin Potential reduction in amisulpride levels Monitor clinical response

• Extrapyramidal symptoms (akathisia, tremor, rigidity) — dose-related

• Insomnia

• Somnolence

• Hyperprolactinaemia (galactorrhoea, amenorrhoea, gynaecomastia)

• Constipation

• Dry mouth

• Weight gain

• Anxiety or agitation

• Nausea

Adverse Effect Clinical Action

QT prolongation / Torsades de pointes Discontinue immediately; ECG monitoring; cardiology consultation

Neuroleptic malignant syndrome (hyperthermia, rigidity, autonomic instability, altered consciousness) Immediate discontinuation; supportive care; ICU if severe

Seizures Discontinue; evaluate for alternative aetiology

Tardive dyskinesia Consider dose reduction or switch to alternative antipsychotic

Severe hyperglycaemia / New-onset diabetes Monitor glucose; consider switch if persistent

Severe hyperprolactinaemia with complications Dose reduction or switch to prolactin-sparing antipsychotic

Phase Parameters

Baseline ECG (QTc), renal function (eGFR/creatinine), fasting glucose, lipid profile, weight/BMI, prolactin level, psychiatric assessment

After initiation/dose change Weekly for first month: sedation, EPS assessment, QTc if high dose or cardiac risk factors

Long-term Every 3–6 months: weight, fasting glucose, lipid profile, prolactin (if symptomatic), EPS/tardive dyskinesia screening; Annual: ECG, renal function

• Solian (Sanofi)

• Amify (Torrent)

• Amazeo (Sun Pharma)

• Amipride (Intas)

• Sulpitac (Sun Pharma)

• Amisul (Mankind)

• Various other generics

• Not included in NLEM 2022

• Not under NPPA price control

1. Dose-dependent action: Lower doses (50–300 mg/day) preferentially block presynaptic D2/D3 autoreceptors, enhancing dopamine transmission and targeting negative symptoms; higher doses (400–1200 mg/day) block postsynaptic receptors for positive symptom control.

1. Prolactin consideration: Amisulpride causes significant hyperprolactinaemia compared to other atypicals — always enquire about menstrual irregularities, galactorrhoea, and sexual dysfunction.

1. Metabolic advantage: Lower risk of weight gain and metabolic syndrome compared to olanzapine and clozapine, making it preferable in patients with metabolic concerns.

1. Renal dosing is critical: Unlike most antipsychotics, amisulpride is primarily renally excreted — always calculate eGFR before prescribing and adjust accordingly.

1. QT monitoring: Essential at doses >800 mg/day or in patients with cardiac risk factors; avoid combination with other QT-prolonging medications.

1. Specialist use preferred: Reserve for psychiatrist-initiated therapy; not recommended for generalist use in non-psychotic conditions or minor behavioural disturbances.

amisulpride; schizophrenia; antipsychotic; atypical; QT-prolongation; hyperprolactinaemia; renal-dose-adjust; negative-symptoms; psychiatry-specialist; non-NLEM

RxIndia v1.1 — 12 Jan 2025

• CDSCO approved product labelling

• Indian Pharmacopoeia

• API Textbook of Medicine

• AIIMS Psychiatry Department protocols

• Indian Psychiatric Society clinical practice recommendations

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• International RCTs (for off-label bipolar depression — clearly demarcated)