Arcoxia/Arcoxia Ac

Acute & chronic treatment of signs & symptoms of OA & RA. Ankylosing spondylitis, acute gouty arthritis & primary dysmenorrhea. Relief of chronic low back pain (CLBP) & acute pain. Moderate to severe acute post-op pain associated w/ dental surgery & abdominal gynecological surgery.

OA 30 mg or 60 mg once daily. Do not exceed a dose of 60 mg daily. RA & ankylosing spondylitis 60 mg or 90 mg once daily. Do not exceed a dose of 90 mg daily. CLBP 60 mg daily. Do not exceed a dose of 60 mg daily. Acute pain 90 mg or 120 mg once daily, limited to a max of 8 days. Do not exceed a dose of 120 mg daily. Acute gouty arthritis & primary dysmenorrhea 120 mg once daily. Do not exceed a dose of 120 mg daily. Post-op dental pain 90 mg once daily. Do not exceed a dose of 90 mg daily. Post-op gynecological pain 90 mg once daily. Max: 120 mg once daily. Do not exceed a dose of 120 mg daily. Mild hepatic insufficiency (Child-Pugh score 5-6) 60 mg once daily. Moderate hepatic insufficiency (Child-Pugh 7-9) Dose should be reduced, should not exceed 60 mg every other day.

May be taken with or without food.

Hypersensitivity. Patients w/ history of CVA, MI, CABG. Active peptic ulceration or GI bleeding. Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic edema, urticaria, or allergic-type reactions after taking ASA or NSAIDs including COX-2 inhibitors. Severe hepatic dysfunction (serum albumin <25 g/L or Child-Pugh score ≥10). Estimated renal CrCl <30 mL/min. Inflammatory bowel disease. CHF (NYHA II-IV). Patients w/ HTN whose BP has not been adequately controlled. Established ischemic heart disease, peripheral arterial &/or cerebrovascular disease. Pregnancy & lactation. Childn & adolescents <16 yr.

Not to be given to patients w/ allergy to NSAIDs. Patients w/ ischemic heart disease & those w/ risk factors for heart disease; & patients w/ peripheral arterial disease. Stop intake of COX-2 inhibitors w/ appearance of skin rash & signs of hypersensitivity. Use the shortest duration possible & the lowest effective daily dose as CV risks may increase w/ dose & duration of exposure. Re-evaluate patient's need for symptomatic relief & response to therapy periodically. Treat patients w/ significant risk factors for CV events (eg, HTN, hyperlipidemia, DM, smoking) only after careful consideration. Not a substitute for aspirin for CV prophylaxis because of lack of effect on platelets; do not discontinue antiplatelet therapies. May cause reduction in prostaglandin formation &, secondarily, in renal blood flow, & thereby impair renal function under conditions of compromised renal perfusion. Monitor renal function in patients w/ pre-existing significantly impaired renal function, uncompensated heart failure, or cirrhosis. Caution when initiating treatment in patients w/ dehydration; rehydrate patients prior to starting therapy. Possibility of fluid retention, edema or HTN in patients w/ pre-existing edema, HTN, or heart failure. Pay special attention to BP monitoring during treatment. Consider alternative treatment if BP rises significantly. May develop upper GI ulcers/ulcer complications irrespective of treatment; patients w/ prior history of GI perforation, ulcers & bleeding & patients >65 yr are known to be at higher risk for GI perforation, ulcers & bleeding. Evaluate patient w/ symptoms &/or signs suggesting liver dysfunction, or in whom abnormal LFT has occurred for persistently abnormal LFTs. Discontinue if persistently abnormal LFTs (3x ULN) are detected; at the 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. May mask fever, which is a sign of infection. Patients w/ renal, hepatic, or cardiac dysfunction. Not recommended in women attempting to conceive. Discontinue use if a woman becomes pregnant during treatment. Women who use etoricoxib must not breastfeed. Elderly.

Asthenia/fatigue, dizziness, lower extremity edema, HTN, dyspepsia, heartburn, nausea, headache, increased ALT & AST. Thrombocytopenia; hypersensitivity reactions, including anaphylactic/anaphylactoid reactions including shock; hyperkalemia; anxiety, insomnia, confusion, hallucinations, depression, restlessness; dysgeusia, somnolence, intracranial hemorrhage; blurred vision; CHF, palpitations, angina, arrhythmia; hypertensive crisis, DVT; bronchospasm, pulmonary embolism; abdominal pain, oral ulcers, peptic ulcers including perforation & bleeding (mainly in elderly), vomiting, diarrhea; hepatitis, jaundice, hepatic failure; angioedema, pruritus, erythema, rash, SJS, TEN, urticaria, fixed-drug eruption; renal insufficiency, including renal failure.

Increased prothrombin time INR in subjects stabilized on chronic warfarin therapy or patients receiving similar agents. Decreased plasma AUC w/ rifampin. Increased MTX plasma conc & reduced renal clearance of MTX. May diminish the antihypertensive effect of diuretics, ACE inhibitors & AIIA. May increase plasma lithium levels. Increased rate of GI ulceration or other complications w/ concomitant administration of low-dose aspirin. Increase in ethinyl estradiol exposure can increase incidence of adverse events associated w/ OCs (eg, venous thromboembolic events in women at risk). Increased mean steady state AUC_0-24hr of unconjugated estrone, equilin, & 17-β-estradiol w/ HRT consisting of conjugated estrogens.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

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

Rx