ARCOXIA 60/MG FC TAB 28/FC TAB

Indications

Approved Uses

Symptomatic relief of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and the pain and inflammation associated with acute gouty arthritis.

Off-Label Uses

Off‑label (varies by jurisdiction): chronic low back pain and other chronic musculoskeletal pain syndromes; primary dysmenorrhea and post‑operative dental pain are generally considered labeled indications in many markets rather than off‑label.

Dosage & Administration

Dosing by Condition

Osteoarthritis: 30mg once daily, may be increased to 60mg once daily if needed. Rheumatoid Arthritis & Ankylosing Spondylitis: 60mg once daily, may be increased to 90mg once daily if needed. Acute Gouty Arthritis: 120mg once daily for a maximum of 8 days. Post-operative Dental Pain: 90mg once daily for a maximum of 3 days.

Initial Dose

60mg once daily for osteoarthritis; 90mg once daily for rheumatoid arthritis and ankylosing spondylitis

Maintenance Dose

Osteoarthritis: 30-60mg once daily. Rheumatoid Arthritis: 60-90mg once daily.

Maximum Dose

120mg once daily (acute gouty arthritis, short-term only); 90mg once daily for most chronic indications

Children's Dosage

Not approved for children or adolescents under 16 years of age.

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; hepatic impairment-Child‑Pugh 5-6: max 60 mg once daily; Child‑Pugh 7-9: max 30 mg once daily; severe hepatic impairment (Child‑Pugh ≥10): not recommended/contraindicated; renal impairment-no adjustment for mild-moderate, but avoid/contraindicated in severe renal impairment (CrCl <30 mL/min) and in dehydration until corrected.

How to Take

Swallow the film‑coated tablet whole with water; may be taken with or without food; take once daily as prescribed (preferably at the same time each day).

Side Effects

Common Side Effects

Common: dyspepsia/indigestion, abdominal pain, nausea, diarrhea, headache, dizziness, peripheral edema/fluid retention, increased blood pressure; less commonly: palpitations and elevated liver enzymes.

Side Effect Frequency

Very common (≥10%): hypertension and/or edema are among the most consistently reported class effects; Common (1-10%): headache, dizziness, dyspepsia/heartburn, abdominal pain, nausea, diarrhea, peripheral edema/fluid retention, fatigue, and ALT/AST increases; Uncommon/rare: palpitations/arrhythmias, GI ulcer/bleeding, serious skin reactions (e.g., SJS/TEN), hypersensitivity/anaphylaxis, and renal impairment.

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to etoricoxib or any excipient; history of hypersensitivity reactions to aspirin/other NSAIDs (e.g., bronchospasm, acute rhinitis, nasal polyps, angioedema, urticaria); active peptic ulcer or gastrointestinal bleeding; inflammatory bowel disease; severe hepatic impairment (Child-Pugh score ≥10); severe renal impairment (CrCl <30 mL/min); established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease; congestive heart failure (NYHA II-IV); uncontrolled hypertension (persistently >140/90 mmHg and not adequately controlled); pregnancy (especially third trimester). Not recommended/avoid in patients <16 years.

Warnings & Precautions

Use the lowest effective dose for the shortest duration; assess CV risk before prescribing and avoid in established ASCVD/CHF; monitor blood pressure (especially early and periodically) and discontinue if uncontrolled hypertension develops/worsens; consider GI risk (history of ulcer/bleed, elderly, concomitant aspirin/anticoagulants/SSRIs/corticosteroids) and use gastroprotection when indicated; monitor renal function in elderly, dehydrated patients, and those on ACEi/ARB/diuretics or with HF/CKD; watch for fluid retention/edema; monitor liver enzymes if symptoms/signs of hepatic dysfunction occur; discontinue immediately at first sign of serious skin reaction or hypersensitivity; not a substitute for aspirin for cardioprotection.

Age Restriction

Not approved under 16 years of age.

Drug Interactions

Drug Interactions

Clinically important interactions include: warfarin/other vitamin K antagonists (may increase INR-monitor closely); lithium (increased levels-monitor/adjust); methotrexate (increased exposure/toxicity-monitor, especially at higher MTX doses); ACE inhibitors/ARBs and diuretics (reduced antihypertensive/diuretic effect and increased risk of renal impairment-monitor BP/renal function, ensure hydration); ciclosporin/tacrolimus (increased nephrotoxicity risk-monitor renal function); rifampicin (markedly reduces etoricoxib exposure-reduced efficacy); oral contraceptives/estrogens (increased ethinylestradiol exposure-consider VTE risk); low-dose aspirin (allowed if needed but increases GI risk and does not mitigate etoricoxib CV risk). Antacids have no clinically meaningful effect on etoricoxib exposure.

Food Interaction

No restriction

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Contraindicated

Children

Not approved for children or adolescents under 16 years of age.

Liver Impairment

Mild impairment (Child-Pugh 5-6): Do not exceed 60mg once daily. Moderate impairment (Child-Pugh 7-9): Do not exceed 30mg once daily. Severe impairment (Child-Pugh ≥10): Contraindicated.

Storage & Patient Advice

Patient Counseling

Take once daily as prescribed (with or without food) and do not exceed the dose; use the lowest effective dose for the shortest duration; avoid combining with other NSAIDs (e.g., ibuprofen/naproxen) and consult before using aspirin (low‑dose may be continued if prescribed but increases GI risk); seek urgent care for chest pain, shortness of breath, sudden weakness/slurred speech (CV events) or black stools/vomiting blood/severe abdominal pain (GI bleeding); monitor blood pressure during therapy; maintain hydration and report reduced urine output/ankle swelling; inform clinician about pregnancy plans and all interacting medicines (e.g., warfarin, lithium, methotrexate).

Monitoring Requirements

Monitor blood pressure at baseline, within ~2 weeks of initiation, and periodically thereafter; assess renal function (SCr/eGFR) in at‑risk patients (elderly, CKD, diuretics/ACEi/ARB, dehydration) and periodically; monitor for GI bleeding symptoms; check INR more frequently when starting/stopping in patients on warfarin/VKAs; consider LFTs if symptoms/signs of hepatic dysfunction occur.

Pharmacology

Mechanism of Action

Selective cyclooxygenase‑2 (COX‑2) inhibition reduces prostaglandin synthesis mediating pain and inflammation, with relatively minimal COX‑1 inhibition at therapeutic doses.

Onset of Action

Typically within ~30-60 minutes (some patients may experience relief as early as ~25-30 minutes).

Duration of Effect

Approximately 24 hours.

Half-Life

Approximately 22 hours.

Bioavailability

Approximately 100%.

Metabolism

Extensively hepatically metabolized, primarily via CYP3A4 (with minor contributions from other pathways) to inactive metabolites.

Excretion

Eliminated mainly as metabolites: ~70% in urine and ~20% in feces (very little unchanged drug).

Protein Binding

Approximately 92%.

Product Information

Available Dosage Forms

Film-coated tablet

Composition per Dose

Each film-coated tablet: Etoricoxib 60mg

Generic Availability

Yes

Pain Type

Joint/Muscular

Nsaid

Yes

Opioid

No

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