Schedule H

Oral

• Tablets: 5 mg, 10 mg, 20 mg

• Oral drops/solution: 5 mg/mL (limited availability)

• Note: Fixed-dose combinations with clonazepam available — use with caution, specialist supervision preferred

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Major Depressive Disorder (MDD)

Adults:

Parameter Recommendation

Starting dose 10 mg once daily (morning or evening)

Titration May increase to 20 mg/day after ≥1 week if inadequate response

Usual maintenance dose 10–20 mg/day

Maximum dose 20 mg/day

Clinical notes:

• Evaluate response after 4–6 weeks of adequate dosing

• Continue for minimum 6–9 months after remission to prevent relapse

• For recurrent depression, longer maintenance (≥2 years) may be required

1. Generalised Anxiety Disorder (GAD)

Adults:

Parameter Recommendation

Starting dose 10 mg once daily (may start at 5 mg in sensitive patients)

Titration Increase to 10–20 mg/day based on response after 2–4 weeks

Usual maintenance dose 10 mg/day

Maximum dose 20 mg/day

Clinical notes:

• Anxiolytic effect may take 2–4 weeks to manifest

• Long-term treatment often necessary; taper gradually when discontinuing

1. Panic Disorder (with or without Agoraphobia)

Adults:

Parameter Recommendation

Starting dose 5 mg once daily for first week

Titration Increase to 10 mg/day after 1 week; further increase to 15–20 mg/day after 1 month if needed

Usual maintenance dose 10–15 mg/day

Maximum dose 20 mg/day

Clinical notes:

• Initial worsening of anxiety may occur — warn patient

• Slower titration essential to improve tolerability

• Cognitive behavioural therapy (CBT) recommended as adjunct

1. Obsessive-Compulsive Disorder (OCD)

Adults:

Parameter Recommendation

Starting dose 10 mg once daily

Titration May increase to 20 mg/day after 2–4 weeks

Usual maintenance dose 10–20 mg/day

Maximum dose 20 mg/day

Clinical notes:

• Higher doses may be needed; some specialists use up to 30 mg/day (off-label, specialist only)

• Long-term treatment usually required (≥1–2 years)

• Consider augmentation with antipsychotics in partial responders

1. Social Anxiety Disorder (Social Phobia)

Adults:

Parameter Recommendation

Starting dose 10 mg once daily

Titration May increase to 20 mg/day after 2–4 weeks if needed

Usual maintenance dose 10–20 mg/day

Maximum dose 20 mg/day

Clinical notes:

• Response may take 8–12 weeks for full effect

• Combine with exposure therapy for optimal outcomes

Secondary Indications — Adults Only (Off-label)

Indication Dose Duration Notes

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Major Depressive Disorder — Adolescents (12–17 years)

Parameter Recommendation

Starting dose 5 mg once daily

Titration May increase to 10 mg/day after 1 week

Usual maintenance dose 10 mg/day

Maximum dose 20 mg/day

Safety monitoring:

• ⚠️ Black box warning equivalent: Increased risk of suicidal ideation in early weeks of treatment

• Weekly face-to-face review for first 4 weeks, then fortnightly for next month

• Monitor for behavioural activation, agitation, self-harm ideation

Secondary Indications — Paediatrics (Off-label)

Indication Age Dose Notes

OCD — OFF-LABEL ≥7 years Children: 5 mg/day; Adolescents: 10 mg/day; Max: 20 mg/day Specialist only; monitor for behavioural activation, sleep disturbance, weight changes

Anxiety disorders — OFF-LABEL ≥12 years 5–10 mg/day; Max: 20 mg/day Limited Indian paediatric data; specialist supervision mandatory

Paediatric Safety Statement

⚠️ Not recommended in children <12 years for depression or <7 years for any indication except under specialist supervision with documented informed consent regarding suicide risk.

Severe impairment (eGFR <30) Start at 5 mg/day; titrate cautiously

Haemodialysis No specific data; use with caution at low doses

• Known hypersensitivity to escitalopram, citalopram, or any SSRI

• Concurrent use with MAO inhibitors (including moclobemide, linezolid, methylene blue) or within 14 days of MAOI discontinuation

• Congenital long QT syndrome or known QT prolongation

• Concurrent use with pimozide

• Concurrent use with other drugs that prolong QT interval in patients with additional risk factors

• History of seizure disorder — may lower seizure threshold

• Bipolar disorder — risk of manic switch; use with mood stabiliser

• History of suicidal ideation or self-harm — close monitoring essential

• Elderly patients — increased risk of hyponatraemia and QT prolongation

• Patients at risk of bleeding (concurrent anticoagulants, NSAIDs, antiplatelet agents)

• Narrow-angle glaucoma — may precipitate acute attack

• Hepatic impairment — reduced clearance

• Severe renal impairment

• Patients with electrolyte disturbances (hypokalaemia, hypomagnesaemia)

• Concomitant use of drugs affecting serotonin (risk of serotonin syndrome)

Aspect Guidance

Overall safety Low teratogenic risk based on available data; one of the preferred SSRIs in pregnancy

First trimester No consistent evidence of major malformations; may continue if clinically indicated

Third trimester Risk of neonatal adaptation syndrome (jitteriness, irritability, respiratory distress, feeding difficulties)

Preferred alternatives Sertraline generally considered first choice in Indian obstetric psychiatry; escitalopram acceptable alternative

When to use If clear maternal benefit; untreated severe depression carries significant risks

Monitoring Neonatal observation for 48–72 hours post-delivery if used near term

Aspect Guidance

Compatibility Compatible with breastfeeding

Excretion in milk Low (relative infant dose <5%)

Preferred alternatives Sertraline may be preferred, especially for preterm or low-birth-weight infants

Infant monitoring Observe for sedation, poor feeding, irritability, weight gain

Clinical note Avoid breastfeeding at peak plasma concentration (4–6 hours post-dose) if concerns

Aspect Recommendation

Starting dose 5 mg once daily

Titration Increase slowly; allow 2 weeks between dose changes

Maximum dose 10 mg/day (due to QT prolongation risk at higher doses)

Extra risks Hyponatraemia (SIADH), QT prolongation, falls, confusion, bleeding

Monitoring Baseline ECG if cardiac history; check sodium at baseline and periodically

Interacting Drug Effect Management

MAO inhibitors (phenelzine, tranylcypromine, moclobemide, linezolid, methylene blue) Serotonin syndrome — potentially fatal CONTRAINDICATED; wait 14 days after stopping MAOI before starting escitalopram

Pimozide Additive QT prolongation; risk of torsades de pointes CONTRAINDICATED

Other QT-prolonging drugs (haloperidol, amiodarone, sotalol, methadone, ondansetron) Additive QT prolongation Avoid combination or use with ECG monitoring

Tramadol Serotonin syndrome risk; lowered seizure threshold Avoid; if essential, use lowest doses with close monitoring

Triptans (sumatriptan, etc.) Serotonin syndrome risk Use with caution; monitor for symptoms

Lithium Increased serotonergic effects Use together cautiously with monitoring

Interacting Drug Effect Management

NSAIDs (ibuprofen, diclofenac) Increased GI bleeding risk Use gastroprotection if chronic use; monitor

Aspirin / Antiplatelet agents Increased bleeding risk Monitor for bruising, bleeding

Warfarin / Acenocoumarol Altered anticoagulant effect; increased bleeding Monitor INR more frequently

Carbamazepine, Phenytoin Enzyme induction — reduced escitalopram levels Monitor clinical response; may need dose increase

Omeprazole, Cimetidine CYP2C19 inhibition — increased escitalopram levels Monitor for adverse effects; consider dose reduction

Alcohol Additive CNS depression Advise avoidance

Metoprolol Increased metoprolol levels (CYP2D6 substrate) Monitor for bradycardia, hypotension

• Nausea (usually transient, improves in 1–2 weeks)

• Headache

• Insomnia or somnolence

• Dry mouth

• Increased sweating

• Diarrhoea or constipation

• Dizziness

• Fatigue

• Sexual dysfunction (decreased libido, anorgasmia, delayed ejaculation) — may persist

Adverse Effect Clinical Notes

QT prolongation / Torsades de pointes Dose-dependent; higher risk at 20 mg/day and in elderly; obtain ECG if risk factors present

Serotonin syndrome Presents with hyperthermia, rigidity, myoclonus, autonomic instability, altered mental status; discontinue immediately; supportive care

Hyponatraemia / SIADH Especially in elderly; presents with confusion, lethargy, seizures; check sodium levels

Suicidal ideation Particularly in adolescents/young adults in early weeks; close monitoring essential

Seizures Rare; dose-related

Manic switch In undiagnosed bipolar disorder; discontinue and reassess diagnosis

Abnormal bleeding GI bleeding, ecchymoses; especially with concurrent anticoagulants/NSAIDs

Phase Parameters

Baseline Mental status assessment, suicidality screening, BP, weight, serum sodium (especially elderly), ECG (if cardiac history, elderly, or QT risk factors)

Early treatment (weeks 1–4) Weekly suicidality assessment; mood, sleep, appetite monitoring

During titration Reassess response and tolerability at 2–4 weeks

Long-term Serum sodium every 6–12 months in elderly; periodic assessment of treatment need; sexual function inquiry

Special populations ECG in elderly receiving >10 mg/day or with cardiac risk factors

• Nexito® (Sun Pharma)

• Cipralex® (Lundbeck India)

• Stalopam® (Lupin)

• Esetalo® (Abbott)

• Rexipra® (Torrent)

• Feliz-S® (Torrent)

• S-Citadep® (Cipla)

• Multiple generic formulations widely available

FDC note: Combinations with clonazepam (e.g., Nexito Plus®, Stalopam Plus®) available — use cautiously; avoid long-term benzodiazepine use

Note: Not under NLEM 2022 as individual agent. Widely available in government and private sectors.

• Escitalopram is the S-enantiomer of citalopram — approximately twice as potent; do not substitute 1:1 with citalopram (10 mg escitalopram ≈ 20 mg citalopram)

• Lowest drug interaction potential among SSRIs — minimal CYP450 inhibition; preferred when polypharmacy is unavoidable

• QT prolongation is dose-dependent — limit to 10 mg/day in elderly and those with cardiac risk factors

• Discontinuation syndrome occurs — taper over 2–4 weeks when stopping; symptoms include dizziness, paraesthesias, irritability, insomnia

• Sexual dysfunction is common and may persist — discuss proactively; consider dose reduction, drug holidays (weekend breaks — controversial), or switching to bupropion/mirtazapine if problematic

• Initial anxiety worsening in panic disorder — start at 5 mg and titrate slowly; short-term benzodiazepine cover may be needed

escitalopram; SSRI; depression; anxiety; panic disorder; OCD; QT prolongation; serotonin syndrome; elderly caution; pregnancy-compatible; suicide-risk monitoring; India

RxIndia v1.0 — 05 May 2025

• CDSCO approved prescribing information

• National Formulary of India (NFI) 2021

• Indian Psychiatric Society Practice Guidelines

• AIIMS Psychiatry Treatment Protocols

• API Textbook of Medicine

• NIMHANS Clinical Guidelines

• IAP Guidelines (paediatric use)

• Published RCTs/meta-analyses (PTSD, PMDD — off-label basis)