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ARCOXIA is indicated in adults and adolescents 16 years of age and older for the symptomatic relief of osteoarthritis OA, rheumatoid arthritis RA, ankylosing spondylitis, and the pain and signs of inflammation associated with acute gouty arthritis. ARCOXIA is indicated in adults and adolescents 16 years of age and older for the short-term treatment of moderate pain associated with dental surgery. The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall decadron 2mg tablets see sections 4. As the cardiovascular risks of etoricoxib may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.

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It is required before any medicine is allowed on the market in Europe. It is designed to assist doctors and pharmacists in prescribing and supplying the product. Reasons for updating Change to section 6 - date of revision Change of distributor details. Reasons for updating New SmPC for new product. Reasons for updating New PIL for new product.

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These principal metabolites either demonstrate no measurable activity or are only weakly active as COX-2 inhibitors. None of these metabolites inhibit COX Steady state concentrations of etoricoxib are reached within seven days of once-daily administration of mg, with an accumulation ratio of approximately 2, corresponding to an accumulation half-life of approximately 22 hours.

Treatment of ankylosing spondylitis AS. Treatment of acute gouty arthritis. Osteoarthritis: The recommended dose is 30 mg or 60 mg once daily. Rheumatoid Arthritis: The recommended dose is 60 mg or 90 mg once daily. The minimum effective daily dose is 60 mg once daily. In some patients, 90 mg once daily may provide increased therapeutic benefit. Ankylosing Spondylitis: The recommended dose is 60 mg or 90 mg once daily. Primary Dysmenorrhea: The recommended dose is mg once daily.

Minor Dental Procedures: The recommended dose is 90 mg once daily. Doses greater than those recommended for each indication have either not demonstrated additional efficacy or have not been studied. Therefore: The dose for OA should not exceed 60 mg daily. The dose for RA should not exceed 90 mg daily. The dose for ankylosing spondylitis should not exceed 90 mg daily. The dose for acute gout should not exceed mg daily. The dose for acute pain and primary dysmenorrhea should not exceed mg daily.

The dose for minor dental procedures should not exceed 90 mg daily. As the cardiovascular risks of selective COX-2 inhibitors may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. Hepatic Insufficiency: In patients with mild hepatic insufficiency Child-Pugh score, a dose of 60 mg once daily should not be exceeded.

In patients with moderate hepatic insufficiency Child-Pugh score, the dose should be reduced; a dose of 60 mg every other day should not be exceeded, administration of 30 mg once daily can also be considered. The most frequently observed adverse experience were consistent with the safety profile for etoricoxib. Etoricoxib is not dialyzable by hemodialysis; it is not known whether etoricoxib is dialyzable by peritoneal dialysis. Patients with hypertension whose blood pressure has not been adequately controlled.

Although minor upper GI problems e. Studies to date have not identified any subset of patients not at risk of developing peptic ulceration and bleeding. Patients with prior history of serious adverse events and other risk factors associated with peptic ulcer disease e. Clinical trials suggest that the selective COX-2 inhibitor class of drugs may be associated with an increased risk of thrombotic events especially MI and stroke, relative to placebo and some NSAIDs naproxen.

Patients with significant risk factors for cardiovascular events e.

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