Arthoxib-120

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 30 mg or 60 mg once daily. Max: 60 mg daily. RA & ankylosing spondylitis 60 mg or 90 mg once daily. Min effective dose: 60 mg once daily. Max: 90 mg daily. Chronic musculoskeletal pain including chronic low back pain Recommended & max dose: 60 mg once daily. Acute pain 90 mg or 120 mg once daily, to max of 8 days. Max: 120 mg daily. Acute gouty arthritis & primary dysmenorrhea Recommended & max dose: 120 mg once daily. Post-op dental pain Recommended & max dose: 90 mg once daily. Post-op gynecological pain Administer initial dose shortly before surgery. Recommended dose: 90 mg once daily. May be increased to max of 120 mg once daily. Mild hepatic insufficiency (Child-Pugh score 5-6) Max: 60 mg once daily. Moderate hepatic insufficiency (Child-Pugh score 7-9) 30 mg once daily or max of 60 mg every other day.

May be taken with or without food.

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

Serious hypersensitivity (eg, anaphylaxis & angioedema) & skin (eg, exfoliative dermatitis, SJS & TEN) reactions. Discontinue treatment at 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity; if persistent abnormal LFTs (3x ULN) are detected; if patient w/ renal, hepatic, or cardiac dysfunction deteriorates during treatment. Not a substitute for aspirin for CV prophylaxis. Increased risk of thrombotic events (MI & stroke); GI adverse effects (GI ulceration or other GI complications). Renal papillary necrosis & other renal injury w/ long-term administration. Elevated ALT &/or AST. May mask fever (sign of infection). Patients w/ risk factors for CV events (eg, HTN, hyperlipidaemia, DM & smoking); dehydration; pre-existing edema, heart failure; at risk of developing GI complication w/ NSAIDs or w/ prior history of GI disease eg, ulceration & GI bleeding; previous acute asthmatic attacks, urticaria, or rhinitis. Re-evaluate periodically the need for symptomatic relief & response to therapy. Monitor renal function in patients w/ pre-existing significantly impaired renal function, uncompensated heart failure or cirrhosis; BP during treatment. Rehydrate patients prior to starting therapy. Evaluate patient w/ signs or symptoms suggesting liver dysfunction for abnormal LFTs. Concomitant use w/ NSAID or ASA. Severe hepatic insufficiency (Child-Pugh score >9). Not recommended in advanced renal disease (CrCl <30 mL/min). Not recommended in women attempting to conceive. Discontinue use during 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 effect of diuretics, ACE inhibitors & AIIA. Further deterioration of renal function including possible acute renal failure w/ ACE inhibitors or AIIA in some patients w/ compromised renal function. Increased plasma lithium levels. Increased rate of GI ulceration or other complications w/ low-dose aspirin. May increase nephrotoxic effect of cyclosporin or tacrolimus. Increased steady state AUC_0-24hr of OC containing ethinyl estradiol & norethindrone; unconjugated estrone, equilin & 17-β-estradiol. Concomitant use w/ other drugs primarily metabolised by human sulfotransferases eg, oral salbutamol & minoxidil.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

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

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