Etrobax

Etoricoxib

Acute & chronic treatment of signs & symptoms of OA & RA. Ankylosing spondylitis; acute gouty arthritis; primary dysmenorrhea; moderate to severe acute post-op pain associated w/ abdominal gynecological surgery. Relief of chronic musculoskeletal pain including chronic low back pain; acute pain including dental surgery.

OA Recommended dose: 30 mg or 60 mg once daily. Max: Not to exceed 60 mg daily. RA, ankylosing spondylitis Recommended dose: 60 mg or 90 mg once daily. Min effective daily dose: 60 mg once daily, may be increased to 90 mg once daily. Max: Not to exceed 90 mg daily. Chronic musculoskeletal pain including chronic low back pain Recommended dose: 60 mg once daily. Max: Not to exceed 60 mg daily. Acute gouty arthritis Recommended dose: 120 mg once daily. Max: Not to exceed 120 mg daily. Primary dysmenorrhea Recommended dose: 120 mg once daily. Max: Not to exceed 120 mg daily. Post-op dental pain Recommended dose: 90 mg once daily. Max: Not to exceed 90 mg daily. Post-op gynecological pain Recommended dose: 90 mg once daily. Initial dose should be administered shortly prior to surgery. Dose may be increased to a max & not to exceed 120 mg daily. Mild hepatic insufficiency (Child-Pugh score 5-6) Not to exceed 60 mg once daily. Moderate hepatic insufficiency (Child-Pugh score 7-9) Not to exceed 60 mg every other day, may be reduced to 30 mg once daily.

May be taken with or without food.

Hypersensitivity. Patients w/ active peptic ulceration or GI bleeding; who have developed signs of asthma, acute rhinitis, nasal polyps, angioneurotic oedema or urticaria following administration of aspirin or other NSAIDs; inflammatory bowel disease; CHF (NYHA II-IV); HTN w/ inadequately controlled BP; established ischemic heart disease, peripheral arterial &/or cerebrovascular disease (including patients who have recently undergone CABG surgery or angioplasty). Patients w/ severe hepatic dysfunction (Child-Pugh score >9) & estimated CrCl <30 mL/min. Pregnancy & lactation. Childn <16 yr.

Discontinue at 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity; if persistently abnormal LFTs (3x ULN) are detected. Not a substitute for aspirin for CV prophylaxis. Serious skin reactions eg, exfoliative dermatitis, SJS & TEN. New onset or recurrent CHF. Increased risk of thrombotic events (especially MI & stroke). Risk of developing GI complication w/ NSAIDs. Patients w/ significant risk factors for CV events eg, HTN, hyperlipidaemia, DM, smoking; GI ulceration or other complications in concomitant use w/ ASA (even at low doses); considerable dehydration; prior history of GI disease eg, ulceration & GI bleeding; previous acute asthmatic attacks, urticarial, or rhinitis. Fluid retention, edema & HTN in patients w/ pre-existing edema, HTN, or heart failure. More frequent & severe HTN at high doses. May mask sign of infection eg, fever. Periodically re-evaluate patient's need for symptomatic relief & response to therapy. Monitor renal function in patients w/ pre-existing significantly impaired renal function, uncompensated heart failure, or cirrhosis. Monitor BP during treatment. Ensure adequate hydration prior to therapy. Renal papillary necrosis & other renal injury in long-term use. Elevated ALT &/or AST. Not recommended in advanced renal disease (CrCl <30 mL/min). Not recommended to use any drugs inhibiting COX-2 in woman attempting to conceive. Pregnancy. Not to breastfeed during treatment. Elderly.

Asthenia/fatigue, dizziness, oedema/fluid retention, lower extremity edema, flu-like disease, HTN, abdominal pain, flatulence, diarrhea, dyspepsia, heartburn, epigastric discomfort, nausea, headache, increased ALT & AST. SJS, TEN.

Increased prothrombin time INR w/ warfarin. Decreased plasma AUC w/ rifampin. Increased plasma conc & reduced renal clearance of MTX. Diminished antihypertensive effects of diuretics, ACE inhibitors & AIIAs. Increased plasma lithium levels. Increased rate of GI ulceration w/ low-dose aspirin. Increased nephrotoxic effect of cyclosporin or tacrolimus. Increased steady-state AUC of ethinyl estradiol, unconjugated estrone, equilin, 17β-estradiol.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AH05 - etoricoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.

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