ETOXA 120/MG FC TAB 7/FC TAB

Indications

Approved Uses

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

Off-Label Uses

Off-label use varies by jurisdiction; examples include postoperative pain (e.g., dental/orthopedic) and certain chronic musculoskeletal pain syndromes (e.g., chronic low back pain) when other options are unsuitable.

Dosage & Administration

Initial Dose

120 mg once daily for acute pain or acute gout

Maximum Dose

Maximum dose is 120 mg orally once daily; for acute gout, 120 mg once daily should be limited to a short course (commonly up to 8 days).

How to Take

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

Safety & Warnings

Contraindications

Contraindications include: hypersensitivity to etoricoxib or to aspirin/other NSAIDs (including history of NSAID-induced bronchospasm/aspirin-exacerbated respiratory disease); active peptic ulceration or gastrointestinal bleeding; 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; use in the peri-operative pain setting of CABG surgery; pregnancy in the third trimester. (Not recommended/avoid: age <16 years; breastfeeding-avoid due to limited safety data.)

Warnings & Precautions

Warnings/precautions: use the lowest effective dose for the shortest duration; increased risk of CV thrombotic events-avoid in established CV disease/CHF and use caution with CV risk factors; increased risk of serious GI events-higher risk in elderly, prior ulcer/GI bleed, and with aspirin/anticoagulants; may increase blood pressure-check before initiation and monitor during therapy; risk of renal toxicity-use caution with dehydration, CKD, diuretics/ACEi/ARB and monitor renal function; risk of fluid retention/edema and heart failure exacerbation; monitor liver enzymes if symptoms/signs of hepatic dysfunction; discontinue immediately if rash or signs of SJS/TEN or hypersensitivity occur; not a substitute for aspirin for cardioprotection.

Drug Interactions

Food Interaction

No restriction

Pharmacology

Mechanism of Action

Selective cyclooxygenase-2 (COX-2) inhibition, reducing prostaglandin synthesis involved in pain and inflammation (relative sparing of COX-1 at therapeutic doses).

Duration of Effect

Approximately 24 hours.

Half-Life

Approximately 22 hours.

Bioavailability

Approximately 100% (near-complete oral bioavailability).

Protein Binding

Approximately 92% plasma protein bound.

Product Information

Composition per Dose

Each film-coated tablet: Etoricoxib 120 mg

Generic Availability

Yes

Pain Type

Joint/Muscular

Nsaid

Yes

Opioid

No

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