Schedule H

Oral

Strength Form

20 mg Delayed-release capsule

30 mg Delayed-release capsule

40 mg Delayed-release capsule

60 mg Delayed-release capsule

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Major Depressive Disorder (MDD) — Adults

Parameter Recommendation

Starting dose 30–60 mg once daily

Titration Increase to 60 mg/day after 1–2 weeks if tolerated

Usual maintenance dose 60 mg once daily

Maximum dose 120 mg/day (given as 60 mg twice daily)

Clinical notes:

• Higher doses (>60 mg/day) may benefit partial responders but lack consistent added efficacy

• Therapeutic onset typically 1–2 weeks; full response may require 4–6 weeks

• Best administered in the morning with food

1. Generalised Anxiety Disorder (GAD) — Adults

Parameter Recommendation

Starting dose 30 mg once daily

Titration Increase to 60 mg/day after 1 week

Usual maintenance dose 60–90 mg once daily

Maximum dose 120 mg/day (may divide if tolerability is a concern)

Clinical notes:

• Response assessment recommended at 4–6 weeks

• Consider tapering after 6–12 months of remission

1. Diabetic Peripheral Neuropathic Pain — Adults

Parameter Recommendation

Starting dose 30 mg once daily

Titration Increase to 60 mg/day after 1 week

Usual maintenance dose 60 mg once daily

Maximum dose 120 mg/day (rarely used; increased adverse effects)

Clinical notes:

• Analgesic benefit often seen within first week

• Glycaemic control should be optimised concurrently

1. Fibromyalgia — Adults

Parameter Recommendation

Starting dose 30 mg once daily

Titration Increase to 60 mg/day after 1 week

Usual maintenance dose 60 mg once daily

Maximum dose 120 mg/day (if partial response at 60 mg)

Clinical notes:

• Multimodal therapy recommended (physical therapy, sleep hygiene)

• Assess response at 4–8 weeks before dose escalation

1. Chronic Musculoskeletal Pain (including low back pain, osteoarthritis) — Adults

Parameter Recommendation

Starting dose 30 mg once daily

Titration Increase to 60 mg/day after 1 week

Usual maintenance dose 60 mg once daily

Maximum dose 60 mg/day

Clinical notes:

• Adjunct to physiotherapy and non-pharmacological measures

• Duration of therapy guided by clinical response

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes Evidence

Stress Urinary Incontinence 40–80 mg/day in divided doses Trial of 4–8 weeks OFF-LABEL; Specialist only International RCTs; not CDSCO-approved

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Not applicable. Duloxetine has no approved paediatric indications in India.

Secondary Indications — Paediatric (Off-label)

Indication Age Dose Notes Evidence

Generalised Anxiety Disorder ≥7 years (weight ≥30 kg) Starting: 30 mg once daily OFF-LABEL; Specialist only International RCTs

Maintenance: 30–60 mg/day Monitor for behavioural changes, suicidality

Maximum: 60 mg/day

Important statements:

• Not recommended below 7 years of age under any circumstances

• Use in children and adolescents requires psychiatrist supervision with close monitoring for suicidal ideation, behavioural changes, and growth parameters

• Parental counselling regarding risks is mandatory before initiation

Mild impairment (CrCl >60 mL/min) No adjustment required

Moderate impairment (CrCl 30–60 mL/min) No adjustment required; monitor for adverse effects

Severe impairment (CrCl <30 mL/min) Use with caution; start at 30 mg/day; avoid doses >60 mg/day

• Known hypersensitivity to duloxetine or any excipient

• Concurrent use with MAO inhibitors (including linezolid, intravenous methylene blue) — wait at least 14 days after stopping MAOI; wait 5 days after stopping duloxetine before starting MAOI

• Moderate to severe hepatic impairment (Child-Pugh B or C)

• Uncontrolled narrow-angle glaucoma

• End-stage renal disease (CrCl <30 mL/min on dialysis)

• Hypertension — may elevate blood pressure, especially at higher doses

• History of mania, hypomania, or bipolar disorder — risk of manic switch

• Suicidal ideation — particularly in children, adolescents, and young adults during early treatment

• Seizure disorders — may lower seizure threshold

• Risk of hyponatraemia (SIADH) — particularly in elderly patients

• Bleeding disorders or concurrent antiplatelet/anticoagulant/NSAID therapy

• Severe renal impairment (CrCl <30 mL/min, not on dialysis) — use with caution

• History of alcohol abuse or chronic liver disease

Parameter Recommendation

Overall safety Limited human data; potential risk to fetus — use only if benefit clearly outweighs risk

Preferred alternative Sertraline (more safety data in pregnancy)

When may be used Only if essential; requires shared decision-making with psychiatrist and obstetrician

What to monitor Neonate — withdrawal syndrome, respiratory distress, poor feeding, irritability

Parameter Recommendation

Compatibility Avoid if possible; limited data

Preferred alternative Sertraline

Drug levels in milk Low to moderate

Infant monitoring Sedation, feeding difficulties, irritability, weight gain

Parameter Recommendation

Starting dose 30 mg once daily

Titration Slower up-titration advised

Special risks Hyponatraemia (SIADH), orthostatic hypotension, falls, confusion

Additional considerations Renal function declines with age — monitor creatinine clearance; assess baseline sodium levels

Interacting Drug Effect / Risk Recommendation

MAO inhibitors (selegiline, phenelzine, linezolid, IV methylene blue) Serotonin syndrome — potentially fatal Contraindicated

Thioridazine QT prolongation, arrhythmia risk Avoid combination

Strong CYP1A2 inhibitors (ciprofloxacin, fluvoxamine) Markedly increased duloxetine exposure Avoid or reduce duloxetine dose

Heavy alcohol use Increased risk of hepatotoxicity Avoid

Other serotonergic drugs (SSRIs, SNRIs, triptans, fentanyl) Serotonin syndrome risk Avoid or use with extreme caution

Interacting Drug Effect / Risk Recommendation

NSAIDs, aspirin, antiplatelet agents Increased bleeding risk Monitor for bleeding; use gastroprotection if needed

Antihypertensives Duloxetine-induced BP elevation may reduce antihypertensive efficacy Monitor BP regularly

Tramadol Increased seizure risk; serotonin syndrome potential Use with caution; consider alternatives

CYP2D6 substrates (metoprolol, tamoxifen, risperidone) Duloxetine inhibits CYP2D6 → increased substrate levels Monitor for toxicity; may need dose adjustment of substrate

Warfarin Possible increased INR Monitor INR closely when initiating or stopping duloxetine

• Nausea

• Dry mouth

• Dizziness

• Constipation

• Insomnia or somnolence

• Fatigue

• Hyperhidrosis (excessive sweating)

• Decreased appetite

• Weight loss

• Sexual dysfunction (decreased libido, erectile dysfunction)

Adverse Effect Notes

Hepatotoxicity Monitor LFTs if jaundice, dark urine, or abdominal pain develops; discontinue if suspected

Serotonin syndrome Especially with interacting drugs — agitation, hyperthermia, tremor, clonus; requires immediate cessation

Stevens-Johnson Syndrome / TEN Rare; discontinue immediately if rash with mucosal involvement appears

Hyponatraemia Elderly at higher risk; monitor sodium in susceptible patients

Suicidal ideation Particularly in adolescents and young adults; close monitoring in first 1–2 months

Severe hypertension Especially at high doses; monitor BP

Discontinuation syndrome Taper gradually to avoid withdrawal symptoms

Ongoing / Long-term Weight, BP periodically; LFTs if hepatic symptoms emerge; serum sodium in elderly on long-term therapy

• Duzela (Sun Pharma)

• Symbal (Sun Pharma)

• Dulane (Torrent)

• Dulojoy (Torrent)

• Depnon (Intas)

• Cymbalta (Eli Lilly — limited availability)

• Senerata (Unichem)

• Duxet (Mankind)

Notes:

• Prices vary by brand and procurement source

• Not listed under NLEM 2022 — not price-controlled under NPPA

• Government supply availability is limited

1. Dual benefit: One of few SNRIs effective for both mood disorders and neuropathic/chronic pain — useful when depression coexists with pain conditions

1. Avoid abrupt discontinuation: Taper gradually over 1–2 weeks to prevent withdrawal symptoms (dizziness, paraesthesia, irritability, insomnia)

1. Take with food: Reduces nausea, especially during initial weeks

1. Monitor blood pressure: Particularly at doses ≥60 mg/day; reassess antihypertensive regimen if needed

1. SSRI failure: Consider duloxetine when SSRIs are ineffective or when fatigue/pain symptoms predominate

1. Hepatic caution paramount: Never use in moderate-to-severe liver disease — risk of significantly increased exposure and hepatotoxicity

duloxetine; SNRI; depression; generalised-anxiety-disorder; neuropathic-pain; diabetic-neuropathy; fibromyalgia; chronic-pain; hepatic-caution; renal-adjustment; antidepressant; psychiatry

RxIndia v1.0 — 30 Apr 2025

• CDSCO-approved prescribing information

• Indian Pharmacopoeia

• API Textbook of Medicine

• AIIMS institutional formulary

• Goodman & Gilman's The Pharmacological Basis of Therapeutics, 13th edition

• Indian Psychiatric Society clinical statements

• NLEM 2022 (for formulary inclusion check)

• International RCTs / meta-analyses (for off-label indications — annotated)