Schedule H

Oral

Form Available Strengths

Tablets 20 mg, 40 mg, 80 mg, 120 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Schizophrenia (Adults)

Parameter Recommendation

Starting dose 40 mg orally once daily with food (≥350 kcal meal required for absorption)

Titration Increase by 40 mg/day at intervals of ≥7 days based on clinical response and tolerability

Usual maintenance dose 40–80 mg/day

Maximum dose 160 mg/day (specialist discretion only; rarely used in Indian practice due to increased EPS risk)

Clinical Notes:

• Efficacy plateau observed at 40–80 mg range

• Higher doses (>80 mg) associated with significantly more extrapyramidal symptoms without additional efficacy benefit

• Response assessment recommended at 4–6 weeks before major dose adjustments

1. Bipolar Depression (Bipolar I Disorder — Monotherapy or Adjunctive Therapy)

Parameter Recommendation

Starting dose 20 mg orally once daily with food

Titration Increase to 40 mg/day after 1 week; may further increase to 80 mg/day if needed

Usual maintenance dose 20–80 mg/day

Maximum dose 80 mg/day (higher doses have not demonstrated additional benefit in clinical trials)

Clinical Notes:

• Can be used as monotherapy or adjunct to lithium/valproate

• Lower starting dose (20 mg) preferred in bipolar depression compared to schizophrenia

• Assess for treatment-emergent mania during titration

Secondary Indications — Adults Only (Off-label)

Indication Dose Duration Prescriber Level Evidence Basis

Generalised Anxiety Disorder (OFF-LABEL) Starting: 20 mg/day; Max: 40 mg/day Short-term (≤6 weeks) Specialist only Limited; Phase II RCTs; not standard practice in India

Behavioural symptoms in dementia (OFF-LABEL) NOT RECOMMENDED — — Increased stroke and mortality risk in elderly; avoid use

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Schizophrenia (Age 13–17 years)

Parameter Recommendation

Starting dose 40 mg orally once daily with food

Titration May increase after ≥7 days based on response

Usual maintenance dose 40–80 mg/day

Maximum dose 80 mg/day

1. Bipolar Depression (Age 10–17 years)

Parameter Recommendation

Starting dose 20 mg orally once daily with food

Titration Increase to 40–80 mg/day based on clinical response after ≥7 days

Usual maintenance dose 20–80 mg/day

Maximum dose 80 mg/day

Safety Monitoring in Paediatrics:

• Weight and BMI at baseline and every visit

• Extrapyramidal symptoms assessment (AIMS scale)

• Fasting glucose and lipid profile at baseline, 3 months, then annually

• Mood symptoms and suicidality screening (especially during titration)

Age Restrictions:

• Schizophrenia: Not recommended below 13 years

• Bipolar Depression: Not recommended below 10 years

• Use in younger children only in clinical trial settings under specialist supervision

Secondary Indications — Paediatrics (Off-label)

Not recommended. No established off-label paediatric indications supported by evidence in Indian practice.

Renal Function Starting Dose Maximum Dose

Moderate impairment (CrCl 30–50 mL/min) 20 mg/day 80 mg/day

Severe impairment (CrCl <30 mL/min) 20 mg/day 40 mg/day

ESRD / Dialysis Use with caution; no data on dialysis clearance; start at 20 mg/day 40 mg/day

Hepatic Function Starting Dose Maximum Dose

Mild impairment (Child-Pugh A) 20 mg/day 80 mg/day

Moderate impairment (Child-Pugh B) 20 mg/day 80 mg/day

Severe impairment (Child-Pugh C) 20 mg/day 40 mg/day

• Known hypersensitivity to lurasidone or any excipients

• Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin)

• Concomitant use with strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital)

• History of seizures or conditions lowering seizure threshold

• Suicidal ideation — heightened risk during initial treatment and dose titration

• Parkinson's disease or Lewy body dementia — potential worsening of motor symptoms

• Pre-existing cardiovascular disease — QT interval monitoring required

• Diabetes mellitus or risk factors for metabolic syndrome — may worsen glycaemic control

• Dysphagia or aspiration risk — antipsychotics may impair oesophageal motility

• Avoid abrupt discontinuation — taper gradually to prevent withdrawal symptoms

Parameter Recommendation

Risk Category Not formally assigned; limited human data; animal studies suggest risk at high doses

General Recommendation Use only if potential benefit justifies potential fetal risk; avoid in first trimester if alternatives exist

Preferred Alternative Olanzapine (more extensive safety data in Indian obstetric practice)

Monitoring Fetal growth surveillance; neonatal monitoring for extrapyramidal/withdrawal symptoms if used near term

Parameter Recommendation

Excretion in Breast Milk Likely excreted; extent unknown

Expected Drug Levels Low-to-moderate (qualitative estimate)

Compatibility Not recommended due to insufficient infant safety data

Preferred Alternative Olanzapine or Quetiapine (if antipsychotic required during breastfeeding)

Infant Monitoring Sedation, feeding difficulties, irritability, developmental milestones

Parameter Recommendation

Starting dose 20 mg/day

Titration Slower titration advised (increase by 20 mg/week)

Key Risks Orthostatic hypotension, falls, sedation, cerebrovascular adverse events

Special Warning Avoid use in dementia-related psychosis — associated with increased mortality risk (black box warning equivalent)

Interacting Drug/Class Effect Management

Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, clarithromycin) Markedly increased lurasidone plasma levels CONTRAINDICATED — do not co-administer

Strong CYP3A4 inducers (rifampicin, carbamazepine, phenytoin, phenobarbital) Substantially reduced lurasidone efficacy CONTRAINDICATED — do not co-administer

QT-prolonging drugs (haloperidol, amiodarone, sotalol, ondansetron, fluoroquinolones) Additive QT prolongation risk Avoid combination; if unavoidable, obtain baseline and periodic ECG

CNS depressants (benzodiazepines, opioids, alcohol) Enhanced sedation and respiratory depression Limit doses of both agents; close monitoring required

Interacting Drug/Class Effect Management

Moderate CYP3A4 inhibitors (diltiazem, verapamil, fluconazole, erythromycin) Moderate increase in lurasidone levels Monitor for adverse effects; consider dose reduction if ADRs occur

Grapefruit juice Inhibits intestinal CYP3A4; may increase lurasidone absorption Avoid large quantities during treatment

Valproate / Lithium No significant pharmacokinetic interaction Monitor for additive sedation and EPS; combination used in bipolar disorder

Antihypertensives Additive hypotensive effect Monitor blood pressure; dose adjustments may be needed

Antidiabetic agents May counteract glycaemic control Monitor blood glucose more frequently

• Somnolence / sedation

• Akathisia

• Nausea

• Extrapyramidal symptoms (dystonia, parkinsonism, tremor)

• Insomnia

• Agitation

• Mild weight gain (lower than olanzapine)

• Dizziness

Adverse Effect Clinical Action

Neuroleptic malignant syndrome Discontinue immediately; supportive care; may require ICU

Tardive dyskinesia Consider dose reduction or discontinuation; risk increases with prolonged use

Hyperglycaemia / Diabetic ketoacidosis Monitor glucose; may require antidiabetic adjustment or drug discontinuation

Agranulocytosis (rare) Obtain urgent CBC; discontinue if confirmed

QT prolongation / Torsades de pointes Avoid in patients with cardiac risk; ECG monitoring

Suicidal ideation Heightened risk in adolescents; close monitoring during initiation and titration

Severe hypersensitivity reactions Discontinue; do not rechallenge

Timepoint Parameters

Baseline CBC, fasting glucose, HbA1c, lipid profile, LFTs, weight/BMI, ECG (if cardiovascular risk factors present)

First 4–6 weeks EPS assessment, weight, suicidality screening, metabolic parameters

Every 3 months (first year) Weight, fasting glucose, EPS evaluation

Long-term (every 6–12 months) Lipid panel, HbA1c, LFTs, tardive dyskinesia screening (AIMS scale)

• Lurpax (Sun Pharma)

• Luramax (Intas)

• Lurasid (Zydus Cadila)

• Lurakem (Alkem)

• Latuda (Lupin)

• Lurafic (Cipla)

• Luradone (Torrent)

Strength Approximate Price per Tablet

Note: Lurasidone is NOT included in NLEM (2022); prices vary across brands and pharmacies. Not available under government supply schemes.

1. Food requirement is mandatory — Lurasidone must be taken with a meal containing at least 350 kcal; bioavailability doubles with food compared to fasting state.

1. Metabolically favourable profile — Lower weight gain and dyslipidaemia risk compared to olanzapine, clozapine, and quetiapine; preferred in patients with metabolic concerns.

1. Early EPS recognition — Akathisia and parkinsonism often appear within first 2 weeks; consider dose reduction or add benztropine/trihexyphenidyl if troublesome.

1. CYP3A4 interaction vigilance — Always review concomitant medications; common drugs like rifampicin (TB treatment) and ketoconazole (fungal infections) are absolutely contraindicated.

1. Bipolar depression advantage — One of few atypical antipsychotics with specific approval and evidence for bipolar depression as monotherapy.

1. Elderly caution — Start low (20 mg), go slow; avoid entirely in dementia-related psychosis due to mortality risk.

lurasidone; schizophrenia; bipolar depression; atypical antipsychotic; EPS risk; metabolic-safe; CYP3A4-sensitive; adolescent-approved; benzisothiazole; psychiatry

RxIndia v1.1 — 02 Jun 2025

• CDSCO approved product inserts

• Indian Pharmacopoeia 2018

• AIIMS Psychiatry Drug Formulary

• API Textbook of Medicine (11th Edition)

• ICMR Guidelines for Mental Health (National Mental Health Programme)

• Indian Psychiatric Society Position Statements

• WHO Model List of Essential Medicines (supportive reference for paediatric indications)

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (mechanism and pharmacology)