ARCOXIA 90/MG FC TAB 28/FC TAB

Indications

Approved Uses

Symptomatic treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and acute gouty arthritis; and short‑term treatment of acute pain and primary dysmenorrhea (where locally approved).

Dosage & Administration

Dosing by Condition

Osteoarthritis: 30 mg once daily (some patients may require 60 mg once daily); Rheumatoid arthritis: 60 mg once daily (may increase to 90 mg once daily if needed, then down‑titrate when stable); Ankylosing spondylitis: 60 mg once daily (may increase to 90 mg once daily if needed); Acute gouty arthritis: 120 mg once daily for up to 8 days; Acute pain/primary dysmenorrhea: 120 mg once daily for short‑term use only (typically up to 3 days for acute pain).

Initial Dose

90mg once daily for rheumatoid arthritis and ankylosing spondylitis

Maintenance Dose

30-90mg once daily depending on indication

Maximum Dose

120mg per day (short-term acute indications only); 90mg per day for chronic conditions

Children's Dosage

Safety and effectiveness in patients under 18 years have not been established.

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: headache, dizziness, hypertension, edema/fluid retention, dyspepsia/heartburn, nausea, abdominal pain, diarrhea (± constipation), fatigue/asthenia, influenza‑like symptoms; less commonly palpitations and liver enzyme elevations.

Safety & Warnings

Contraindications

Hypersensitivity to etoricoxib or excipients; history of hypersensitivity reactions (e.g., asthma/bronchospasm, urticaria, rhinitis, angioedema) to aspirin/other NSAIDs; active peptic ulcer or gastrointestinal bleeding; severe hepatic impairment (Child-Pugh ≥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; pregnancy (especially 3rd trimester).

Warnings & Precautions

Use the lowest effective dose for the shortest duration; increased risk of CV thrombotic events-avoid in established atherosclerotic disease/CHF and monitor BP; risk of GI ulcer/bleeding-higher in elderly/history of ulcer and with aspirin/anticoagulants; renal risk-monitor renal function in at-risk patients (elderly, dehydration, diuretics/ACEi/ARB); fluid retention/edema-caution in hypertension/heart failure; hepatic risk-monitor if symptoms/LFT concerns; discontinue at first sign of serious skin reaction or hypersensitivity; may mask fever/inflammation.

Age Restriction

Not approved under 16 years.

Special Populations

Children

Safety and effectiveness in patients under 18 years have not been established.

Elderly

Standard adult dosing; use lowest effective dose with close monitoring of renal function, blood pressure, and cardiovascular status

Storage & Patient Advice

Monitoring Requirements

Monitor blood pressure (check within ~2 weeks of initiation and periodically thereafter); monitor renal function in at‑risk patients (elderly, dehydration, CKD, heart failure, cirrhosis, or on ACEi/ARB/diuretic); consider liver function tests if symptoms/risk factors; monitor INR closely if co‑administered with warfarin/VKAs.

Pharmacology

Mechanism of Action

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

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; elimination is mainly as metabolites in urine and feces.

Protein Binding

Approximately 92%.

Product Information

Available Dosage Forms

Film-coated tablet

Composition per Dose

Each film-coated tablet: Etoricoxib 90mg

OTC Alternatives

OTC options for mild-moderate pain include ibuprofen (e.g., 200-400 mg per dose) or naproxen (where OTC), and paracetamol/acetaminophen; avoid combining with other NSAIDs and consider GI/CV/renal risk.

Pain Type

Joint, Muscular

Nsaid

Yes

Opioid

No

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