schedule H

Oral

• Immediate-release tablets: 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg

• Extended-release tablets (XR/SR): 50 mg, 150 mg, 200 mg, 300 mg, 400 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Schizophrenia (Adults)

Parameter Immediate-Release (IR) Extended-Release (XR)

Starting dose 25 mg twice daily 300 mg once daily (evening)

Titration Increase by 25–50 mg twice daily on Days 2–4 Increase by 50–100 mg/day as tolerated

Usual maintenance dose 300–450 mg/day in divided doses 400–800 mg once daily

Maximum dose 750 mg/day 800 mg/day

Clinical notes:

• XR formulation should be administered in the evening without food or with a light meal

• Monitor for sedation and orthostatic hypotension during initial titration

• Response typically seen within 1–2 weeks; full effect may take 4–6 weeks

1. Bipolar Disorder — Acute Manic Episodes (Adults)

Parameter Dosing

Starting dose 50 mg twice daily (Day 1)

Titration Day 2: 100 mg twice daily → Day 3: 150 mg twice daily → Day 4: 200 mg twice daily

Usual maintenance dose 400–800 mg/day in two divided doses

Maximum dose 800 mg/day

Clinical notes:

• May be used as monotherapy or adjunct to lithium or valproate

• More rapid titration acceptable in acute mania compared to schizophrenia

• IR formulation preferred for acute episodes

1. Bipolar Depression (Adults)

Parameter Dosing

Starting dose 50 mg at bedtime (Day 1)

Titration Day 2: 100 mg → Day 3: 200 mg → Day 4: 300 mg (all at bedtime)

Usual maintenance dose 300 mg once daily at bedtime

Maximum dose 600 mg/day

Clinical notes:

• Both IR and XR formulations may be used

• Administer at bedtime to minimise daytime sedation

• Lower doses effective compared to schizophrenia or mania

Secondary Indications — Adults (Off-label)

1. Adjunctive Treatment in Major Depressive Disorder (Unipolar)

• Dose: Start 50 mg at bedtime; titrate to 150–300 mg/day based on response

• Duration: As per clinical response; reassess periodically

• Specialist only: Yes — Psychiatry

• OFF-LABEL

• Evidence basis: Supported by multiple RCTs; used in Indian psychiatry specialist practice as add-on to SSRIs/SNRIs when partial response

1. Generalised Anxiety Disorder

• Dose: 25–150 mg/day at bedtime

• Duration: Short-term use preferred; reassess after 4–8 weeks

• Specialist only: Yes — Psychiatry

• OFF-LABEL

• Evidence basis: RCTs demonstrate dose-dependent anxiolytic effect; sedation is dose-limiting; not first-line

1. Severe Treatment-Resistant Insomnia

• Dose: 25–100 mg at bedtime

• Duration: Short-term only; use after failure of standard hypnotics

• Specialist only: Yes

• OFF-LABEL

• Evidence basis: Based on Indian psychiatry practice; avoid in elderly; not recommended as first-line hypnotic

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Schizophrenia and Bipolar Disorder in Adolescents (Age ≥13 years)

Parameter Dosing

Starting dose 25 mg at bedtime

Titration Increase by 25–50 mg/day over 4–5 days

Usual maintenance dose 300–600 mg/day in divided doses

Maximum dose 800 mg/day

Clinical notes:

• Use IR formulations; XR not well-studied in paediatrics

• Start low and titrate slowly

• Monitor for metabolic effects, excessive sedation, and behavioural activation

• Not recommended below 13 years except under specialist supervision with documented benefit-risk assessment

Secondary Indications — Paediatric Doses (Off-label)

1. Irritability Associated with Autism Spectrum Disorder

• Dose: 25–100 mg/day (once or twice daily)

• Duration: As clinically indicated; regular reassessment required

• Specialist only: Yes — Child Psychiatry

• OFF-LABEL

• Evidence basis: Limited RCT data; not recommended as first-line by IAP; risperidone preferred

1. Severe Insomnia in Neurodevelopmental Disorders

• Dose: 12.5–25 mg at bedtime

• Duration: Short-term; reassess frequently

• Specialist only: Yes — Child Psychiatry/Developmental Paediatrics

• OFF-LABEL

• Evidence basis: Indian specialist practice; melatonin should be tried first

Safety monitoring in paediatrics:

• Baseline and periodic: Weight, BMI, fasting glucose, lipid profile

• Monitor for excessive sedation, mood changes, extrapyramidal symptoms

• Counsel regarding metabolic risks

Use with caution in severe renal impairment due to potential accumulation of inactive metabolites; clinical monitoring advised.

• Known hypersensitivity to quetiapine or any formulation excipient

• Concurrent use with strong CYP3A4 inhibitors without appropriate dose reduction (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin)

• History of seizures or conditions lowering seizure threshold

• Cardiovascular disease, particularly QT prolongation, heart failure, recent myocardial infarction

• Diabetes mellitus or risk factors for metabolic syndrome

• Elderly patients with dementia-related psychosis (increased risk of cerebrovascular events and mortality)

• Hypothyroidism (may exacerbate thyroid dysfunction)

• Narrow-angle glaucoma

• History of neutropenia or leukopenia

• Risk factors for venous thromboembolism

• Conditions predisposing to hypotension (dehydration, hypovolaemia, antihypertensive therapy)

Parameter Information

Risk category Category C (US FDA); limited human data

Safety statement Use only if potential benefit clearly outweighs fetal risk

Preferred alternatives Haloperidol may be preferred in 2nd/3rd trimester for psychosis if antipsychotic essential

When it may be used Continuation may be considered if patient stable on quetiapine pre-pregnancy; decision with specialist input

What to monitor Fetal growth; neonatal extrapyramidal symptoms and withdrawal if used near term

Parameter Information

Compatibility Present in breast milk in low levels; generally considered compatible with breastfeeding

Drug levels in milk Low

Preferred alternatives Olanzapine has more breastfeeding data; discuss with patient

What to monitor in infant Sedation, feeding difficulties, irritability, weight gain

• Starting dose: 25 mg once daily (IR or XR)

• Titration: Increase slowly in increments of 25–50 mg/day with minimum 2–3 day intervals

• Extra risks:

• Increased sensitivity to orthostatic hypotension (fall risk)

• Enhanced CNS and anticholinergic effects (confusion, sedation)

• Avoid use in dementia-related psychosis due to increased stroke and mortality risk (black box warning equivalent)

Interacting Drug/Class Effect Recommendation

Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, clarithromycin) Markedly increased quetiapine levels → toxicity Contraindicated; if unavoidable, reduce quetiapine dose to 1/6th

Strong CYP3A4 inducers (phenytoin, carbamazepine, rifampicin) Reduced quetiapine efficacy May require quetiapine dose increase up to 5-fold; monitor clinical response

QT-prolonging drugs (Class IA/III antiarrhythmics, macrolides, fluoroquinolones, methadone) Additive QT prolongation → arrhythmia risk Avoid combination; if essential, ECG monitoring mandatory

CNS depressants (benzodiazepines, opioids, alcohol) Enhanced sedation and respiratory depression Avoid or use with caution; monitor closely

Interacting Drug/Class Effect Recommendation

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

SSRIs/SNRIs Potential additive QT effects; possible increased sedation Monitor; generally safe to combine

Lithium Safe combination; commonly co-prescribed in bipolar disorder Monitor for CNS effects

Valproate Safe combination for bipolar disorder Monitor sedation

Anticholinergic drugs Increased anticholinergic burden (constipation, urinary retention, confusion) Use with caution; monitor elderly patients

Moderate CYP3A4 inhibitors (fluconazole, erythromycin) Modest increase in quetiapine levels Consider dose reduction; monitor for adverse effects

• Sedation and somnolence (dose-dependent)

• Dizziness

• Orthostatic hypotension

• Dry mouth

• Constipation

• Weight gain

• Increased appetite

• Dyslipidaemia (elevated triglycerides, cholesterol)

• Headache

• Mild extrapyramidal symptoms (lower incidence than typical antipsychotics)

• Neuroleptic Malignant Syndrome (NMS): Discontinue immediately; medical emergency

• QT prolongation and torsades de pointes: Rare; ECG monitoring in at-risk patients

• Severe neutropenia/agranulocytosis: Rare; discontinue if ANC <1000/mm³

• Suicidal ideation: Monitor closely in young adults and adolescents, especially during initial treatment

• Severe hyperglycaemia and diabetic ketoacidosis: May occur even without prior diabetes

• Hepatotoxicity: Rare; monitor LFTs if symptomatic

• Tardive dyskinesia: Risk increases with prolonged use

• Venous thromboembolism: Rare

After initiation/dose change Blood pressure (including orthostatic), sedation level, extrapyramidal symptoms (at each visit for first 2–4 weeks)

Every 3 months (first year) Weight, fasting glucose, lipid profile

Every 6–12 months (maintenance) Glucose, HbA1c, lipid profile, LFTs, CBC

Annually ECG (if ongoing cardiac risk); assess for tardive dyskinesia

• Qutipin, Qutipin SR (Sun Pharma)

• Qutan (Intas)

• Quel, Quel SR (Torrent)

• Seroquin (Various)

• Q-Mind (Mankind)

• Psyquel (Cadila)

• Quinorm (Cipla)

• Multiple other generics widely available

• Not currently under NPPA price control

• Generic versions significantly cheaper than branded products

• Prices vary by manufacturer and region

• XR formulation allows once-daily dosing but must be swallowed whole and taken without food or with light meal only

• Sedation can be therapeutically useful in agitated patients or those with comorbid insomnia

• Metabolic monitoring is essential from treatment initiation — weight gain and dyslipidaemia develop early

• Among atypical antipsychotics, quetiapine has lower EPS risk but higher sedation and metabolic liability

• Gradual taper recommended when discontinuing to avoid withdrawal symptoms (insomnia, nausea, anxiety)

• In bipolar depression, lower doses (300 mg) are effective — avoid unnecessary dose escalation

antipsychotic; atypical antipsychotic; schizophrenia; bipolar disorder; bipolar depression; metabolic risk; sedation; CYP3A4 substrate; QT prolongation; psychiatry; India

RxIndia v1.0 — 10 Jan 2025

• CDSCO product information

• Indian Pharmacopoeia

• NLEM 2022

• API Textbook of Medicine

• AIIMS Psychiatry Treatment Protocols

• IAP Guidelines (paediatric usage)

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Harrison's Principles of Internal Medicine

• Select RCTs and meta-analyses for off-label indications (GAD, MDD augmentation, insomnia)