Schedule H

Oral

• Tablets: 30 mg, 60 mg, 90 mg, 120 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

Osteoarthritis 30 mg once daily Increase to 60 mg if inadequate response after 2 weeks 60 mg once daily 60 mg/day Assess cardiovascular and gastrointestinal risk before starting; long-term use requires periodic reassessment

Rheumatoid arthritis 90 mg once daily Not applicable 90 mg once daily 90 mg/day Monitor blood pressure and renal function regularly; combine with DMARDs as per rheumatology protocol

Ankylosing spondylitis 90 mg once daily Not applicable 90 mg once daily 90 mg/day Reassess if no symptomatic improvement within 2 weeks; discontinue if ineffective

Acute gouty arthritis 120 mg once daily Not applicable 120 mg once daily 120 mg/day Limit duration to maximum 8 days; initiate at first sign of flare for best response

Acute pain (post-operative, dental) 120 mg once daily Not applicable 120 mg once daily 120 mg/day Restrict use to 3–7 days; reserve for moderate-severe pain when traditional NSAIDs are unsuitable

Secondary Indications – Adults Only (Off-label, if any)

Indication Dose Duration Notes Evidence Basis

Primary dysmenorrhoea — OFF-LABEL 120 mg once daily during symptomatic days 1–3 days per menstrual cycle Specialist supervision preferred; alternative when mefenamic acid is not tolerated Supported by RCTs; common practice in Indian gynaecology for NSAID-sensitive patients

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Not recommended for patients below 16 years of age.

• Safety and efficacy data in paediatric population are insufficient

• No approved paediatric indications in India as per CDSCO

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

Not applicable — No established off-label paediatric use documented in Indian practice.

Clear Statement:

Etoricoxib should NOT be prescribed to children under 16 years except under specialist supervision in exceptional clinical circumstances or clinical trial settings.

• Known hypersensitivity to etoricoxib, other COX-2 inhibitors, or any excipient

• History of asthma, urticaria, or allergic-type reactions precipitated by aspirin or other NSAIDs

• Active peptic ulcer disease or gastrointestinal bleeding

• Inflammatory bowel disease with active flare

• Severe hepatic dysfunction (Child-Pugh Class C)

• Severe renal impairment (CrCl <30 mL/min)

• Established ischaemic heart disease, peripheral arterial disease, or cerebrovascular disease (including prior stroke or TIA)

• Uncontrolled hypertension (persistently >140/90 mmHg despite treatment)

• Post-coronary artery bypass graft (CABG) surgery setting

• Pregnancy (especially third trimester)

• Lactation

• Patients with cardiovascular risk factors (diabetes mellitus, hypertension, hyperlipidaemia, smoking)

• Controlled hypertension — blood pressure may increase; monitor and discontinue if significant elevation occurs

• Prior history of peptic ulcer or GI bleeding (healed)

• Elderly patients — higher susceptibility to adverse effects

• Concurrent corticosteroid, anticoagulant, or antiplatelet therapy

• Fluid retention or oedema

• Prolonged use — avoid unless no therapeutic alternatives exist; reassess regularly

• Volume-depleted states (risk of acute kidney injury)

Parameter Details

Overall Safety Not recommended throughout pregnancy

Third Trimester Risk Contraindicated — risk of premature closure of ductus arteriosus, oligohydramnios, delayed labour

First/Second Trimester Avoid; use only if no alternative and under specialist guidance with informed consent

Preferred Alternatives Paracetamol for analgesia/antipyresis

Monitoring If inadvertent exposure occurs: fetal echocardiography and amniotic fluid volume assessment

Parameter Details

Compatibility Not recommended during breastfeeding

Milk Excretion Unknown whether excreted in human breast milk

Preferred Alternatives Paracetamol, ibuprofen (short-term, if needed)

Infant Monitoring If inadvertent use: observe for gastrointestinal disturbance, feeding difficulty

Parameter Recommendation

Starting Dose Use lowest effective dose (30–60 mg/day range preferred)

Titration Slow; assess tolerability before increasing

Special Risks Increased susceptibility to renal impairment, gastrointestinal bleeding, cardiovascular events, fluid retention

Monitoring Baseline and periodic: renal function, blood pressure, haemoglobin

General Advice Consider non-pharmacological measures and alternative analgesics in frail elderly or those with polypharmacy

Interacting Drug Effect / Mechanism Management

Warfarin/Acenocoumarol Increased INR and bleeding risk Monitor INR closely at initiation and dose changes

Lithium Elevated plasma lithium levels due to reduced renal clearance Monitor lithium levels; may need dose reduction

Methotrexate (high-dose) Increased methotrexate toxicity (myelosuppression, hepatotoxicity) Monitor CBC and LFTs; avoid concurrent use if possible

Ciclosporin/Tacrolimus Additive nephrotoxicity Avoid combination or monitor renal function frequently

ACE inhibitors + ARBs + Diuretics ("Triple Whammy") Significantly increased risk of acute kidney injury Avoid triple combination; ensure adequate hydration

Other COX-2 inhibitors No added benefit; increased toxicity Contraindicated — never combine

Interacting Drug Effect / Mechanism Management

Rifampicin Reduced etoricoxib efficacy via CYP3A4 induction Consider alternative NSAID or increased monitoring

Fluconazole/Ketoconazole Increased etoricoxib plasma levels via CYP3A4 inhibition Use lower dose if co-administered

Antihypertensives (all classes) Blunted antihypertensive effect Monitor blood pressure; adjust antihypertensive dose if needed

Other non-selective NSAIDs Increased GI and cardiovascular risk without added efficacy Avoid concurrent use

Low-dose aspirin Increased GI bleeding risk; does not negate cardioprotection of aspirin Use gastroprotection if combination necessary

SSRIs Increased GI bleeding risk Monitor for GI symptoms; consider PPI cover

• Dyspepsia, nausea, abdominal pain

• Headache, dizziness

• Peripheral oedema

• Hypertension (dose-dependent)

• Fatigue, asthenia

• Elevated hepatic transaminases (usually transient)

• Flatulence

Adverse Effect Notes

Myocardial infarction, stroke Risk increases with dose and duration; especially in those with cardiovascular risk factors

Gastrointestinal bleeding/perforation Lower than non-selective NSAIDs but still clinically significant

Acute kidney injury Particularly in volume-depleted, elderly, or those on nephrotoxic drugs

Stevens-Johnson syndrome / Toxic epidermal necrolysis Rare; requires immediate drug discontinuation and hospitalisation

Angioedema / Anaphylaxis Immediate discontinuation; emergency management required

Hepatic failure Rare; discontinue if LFTs significantly elevated or clinical hepatitis develops

→ Immediate discontinuation mandatory for any severe cutaneous reaction, anaphylaxis, or signs of hepatic/renal failure.

1–2 weeks after initiation Blood pressure, symptoms of GI disturbance, oedema

Long-term (every 3–6 months) Blood pressure, renal function, LFTs, haemoglobin; more frequent monitoring if elderly or on concomitant nephrotoxic/hepatotoxic drugs

• Arcoxia (MSD/Organon)

• Nucoxia (Zydus Cadila)

• Etoshine (Sun Pharma)

• Etody (Zydus)

• Toldin (Dr. Reddy's)

• Intacoxia (Intas)

• Etosaid (Glenmark)

Fixed-Dose Combinations (common):

• Etoricoxib + Thiocolchicoside

• Etoricoxib + Paracetamol

Note: Use FDCs cautiously; rational combination therapy preferred.

Strength Approximate Price per Tablet

• NLEM Status: Not included in NLEM 2022; not under NPPA price control

• Government supply availability: Limited

1. Cardiovascular caution paramount: Despite superior GI safety compared to non-selective NSAIDs, cardiovascular risks are significant — avoid in patients with established or high-risk cardiovascular disease.

1. Never combine with other NSAIDs or COX-2 inhibitors — increases toxicity without additional therapeutic benefit.

1. Blood pressure monitoring essential: Etoricoxib can elevate BP; reassess at each visit and discontinue if control worsens significantly.

1. Best response in acute conditions: For gout and dysmenorrhoea, initiate at symptom onset for optimal efficacy.

1. Periodic reassessment for chronic use: If prescribed long-term for arthritis, evaluate need and tolerability every 3–6 months; step down to lowest effective dose.

1. Avoid post-CABG: Clearly contraindicated in perioperative setting of coronary artery bypass surgery.

etoricoxib; COX-2 inhibitor; NSAID; arthritis; pain; gout; cardiovascular-risk; renal-adjustment; hepatic-adjustment; prescription-only; not-pregnancy-safe; Schedule-H

RxIndia v1.0 — 10 Jan 2025

• CDSCO approved product information

• Indian Pharmacopoeia

• NLEM 2022

• API Textbook of Medicine

• AIIMS Drug Formulary and Treatment Guidelines

• Indian Rheumatology Association clinical practice

• Manufacturer's Product Inserts (India)

• Select RCTs for off-label indication (dysmenorrhoea)