W/draw immediately if peptic ulceration or GI bleeding occurs. Discontinue if symptoms or signs of SJS or TEN (eg, progressive skin rash often w/ blisters of mucosal lesions) occur. Closely monitor for skin reactions. History of HTN &/or mild to moderate CHF as fluid retention & edema; ulcer w/ haemorrhage or perforation; inflammatory bowel disease (ulcerative colitis; Crohn's disease), GI toxicity. Patients w/ CV disease & risk factors (eg, HTN, hyperlipidemia, DM, smoking); uncontrolled HTN, CHF, established ischemic heart, peripheral arterial &/or cerebrovascular disease; risk factors for GI events. Increased risk of arterial thrombotic events, including MI & stroke. Patients having coagulation disorder & receiving therapy interfering hemostasis. GI bleeding, ulceration or perforation. Consider combination therapy w/ protective agents (eg, misoprostol or PPIs) in patients w/ GI disease or those requiring low dose of salicylates or other drugs increasing GI risk. May mask usual signs of infection. Markedly reduced plasma albumin conc. Monitor cardiac, renal (BUN, creatinine, development of edema, wt gain) & hepatic function. Closely monitor BP during initiation of treatment & at regular intervals. Perform ophth evaluation for patients who develop visual disturbances. Avoid concomitant use w/ NSAIDs, including COX-2 selective inhibitors. Concomitant use w/ antihypertensives; oral corticosteroids, anticoagulants (eg, warfarin), SSRIs or anti-platelets eg, salicylates; nephrotoxic medicines, diuretics. May affect ability to drive & use machines. Contraindicated in patients w/ liver dysfunction. May impair fertility. Not recommended in women attempting to conceive. May expose fetus to cardiopulmonary toxicity & renal dysfunction. Contraindicated during pregnancy (3rd trimester). Lactation. Not to be used in childn & adolescents. Elderly &/or debilitated patients.
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