ETOXA 60/MG FC TAB 30/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).

Off-Label Uses

Chronic low back pain; postoperative pain (e.g., dental or orthopedic) where not included in local labeling.

Dosage & Administration

Dosing by Condition

Osteoarthritis: 30 mg once daily (may increase to 60 mg once daily if needed). Rheumatoid arthritis: 90 mg once daily. Ankylosing spondylitis: 90 mg once daily. Acute gouty arthritis: 120 mg once daily for up to 8 days. Acute pain/primary dysmenorrhea (if approved): typically 120 mg once daily short-term (generally up to 3 days for acute pain).

Initial Dose

Osteoarthritis: 60 mg once daily

Maintenance Dose

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

Maximum Dose

120 mg per day (acute gouty arthritis, short-term only); 90 mg/day for rheumatoid arthritis and ankylosing spondylitis; 60 mg/day for osteoarthritis

Dose Adjustment Notes

Use the lowest effective dose for the shortest duration; hepatic impairment: Child-Pugh 5-6 max 60 mg/day, Child-Pugh 7-9 max 30 mg/day (or 60 mg every other day), Child-Pugh ≥10 contraindicated/not recommended; severe renal impairment (CrCl <30 mL/min) not recommended/avoid and monitor renal function in at-risk patients.

Safety & Warnings

Contraindications

Hypersensitivity to etoricoxib/excipients; history of bronchospasm/asthma, rhinitis, nasal polyps, angioedema or urticaria with aspirin/other NSAIDs; active peptic ulcer or gastrointestinal bleeding; severe hepatic impairment (Child-Pugh >9); 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 IHD/PAD/CVD and monitor/mitigate CV risk; can cause/worsen hypertension-monitor BP (especially early); risk of fluid retention/edema and heart failure-use caution/avoid in CHF; serious GI toxicity can occur-use caution with prior ulcer/GI bleed and with concomitant aspirin/anticoagulants; renal toxicity risk-monitor renal function in elderly, dehydrated, or those on ACEi/ARB/diuretics; hepatic reactions-stop if signs of liver injury; serious skin reactions-stop at first rash/mucosal lesions; not a substitute for low-dose aspirin cardioprotection.

Drug Interactions

Drug Interactions

Warfarin/other vitamin K antagonists (↑INR/bleeding-monitor INR); lithium (↑levels); methotrexate (↑exposure/toxicity-monitor); ACE inhibitors/ARBs and diuretics (↓antihypertensive/diuretic effect and ↑renal risk-monitor BP/renal function); ciclosporin/tacrolimus (↑nephrotoxicity risk); aspirin/other antiplatelets or NSAIDs (↑GI bleeding risk; etoricoxib is not a substitute for aspirin); rifampicin (↓etoricoxib exposure); estrogen-containing oral contraceptives/HRT (↑ethinylestradiol exposure-↑VTE risk consideration).

Food Interaction

No restriction.

Storage & Patient Advice

Patient Counseling

Take once daily exactly as prescribed; swallow whole with water, with or without food. Do not use with other NSAIDs (e.g., ibuprofen/naproxen) and only use aspirin if your prescriber advised (low-dose aspirin may be allowed but increases GI risk). Seek urgent care for chest pain, shortness of breath, weakness/slurred speech (CV events) or black stools/vomiting blood/severe abdominal pain (GI bleeding). Monitor/record blood pressure, and report swelling/rapid weight gain or reduced urine output. Use the lowest effective dose for the shortest duration; store below 30°C.

Monitoring Requirements

Monitor blood pressure (especially after initiation and dose increases), renal function (serum creatinine/eGFR) in at-risk patients or with ACEi/ARB/diuretic use, and assess for GI bleeding; monitor INR closely if used with warfarin/VKAs; consider liver enzymes if symptoms/signs of hepatotoxicity occur.

Pharmacology

Mechanism of Action

Selective cyclooxygenase-2 (COX-2) inhibition, reducing prostaglandin synthesis involved in pain and inflammation, with relatively less COX-1 inhibition at therapeutic doses.

Onset of Action

Analgesic onset typically within ~30-60 minutes, with peak plasma concentrations around ~1 hour (may be delayed with food).

Duration of Effect

Approximately 24 hours.

Half-Life

Approximately 22 hours.

Bioavailability

Approximately 100%.

Metabolism

Extensively hepatic metabolism mainly via CYP3A4 (with minor contribution from other CYPs such as CYP2C9), producing inactive metabolites; elimination is primarily as metabolites in urine and feces.

Protein Binding

Approximately 92% plasma protein binding.

Product Information

Available Dosage Forms

Film-coated tablet.

Composition per Dose

Each film-coated tablet: Etoricoxib 60 mg

Generic Availability

Yes

Pain Type

Joint, Muscular

Nsaid

Yes

Opioid

No

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