Ecoxib Special Precautions

ECOXIB should be administered for the shortest duration possible and the lowest effective daily dose should be used, to reduce risk of serious gastrointestinal (GI) and cardiovascular adverse events.
Serious (some fatal) upper GI complications including perforations, ulcers, and bleeding have occurred. Use caution with a history of GI disease (bleeding or ulcers), concurrent therapy with aspirin or other NSAIDs, anticoagulants and/or corticosteroids, smoking, alcohol, and the elderly or debilitated patients. When used concomitantly with aspirin (even at low doses), gastroprotective therapy (eg, proton pump inhibitors, misoprostol) is recommended.
NSAIDs are associated with an increased risk of serious (and potentially fatal) adverse cardiovascular thrombotic events, including MI and stroke. Risk may be increased with long-term use or preexisting cardiac risk factors (eg, hypertension, hyperlipidemia, diabetes, smoking). Carefully evaluate individual cardiovascular profiles prior to prescribing and periodically re-evaluate the need for symptomatic relief and response to therapy.
Risk of MI and stroke may be increased with use following coronary artery bypass graft (CABG) surgery; NSAIDs, including COX-2 selective inhibitors, are not recommended for treatment of perioperative pain in the setting of CABG.
New-onset or worsening hypertension may occur; maintain blood pressure <140/90 mm Hg prior to initiation and monitor carefully throughout therapy. New-onset or worsening edema and heart failure may occur; use caution with preexisting edema (any cause), left ventricular dysfunction, or NYHA class I heart failure; use is contraindicated with NYHA class II-IV heart failure. Discontinue use if worsening heart failure, edema, or uncontrolled/severe hypertension occurs; consider alternate therapies for high-risk patients.
Serious hypersensitivity reactions, including anaphylaxis, angioedema, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been (rarely) reported with etoricoxib; discontinue use at first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Do not use in patients who experience bronchospasm, asthma, rhinitis, or urticaria with NSAID or aspirin therapy.
Use with caution in mild-to-moderate hepatic impairment, dosage adjustment recommended. Use is contraindicated in severe hepatic impairment. Elevations in transaminases (>3 times the upper limit of normal) may occur; monitor hepatic function closely in patients with previous abnormal hepatic function tests or signs/symptoms of hepatic dysfunction. Severe hepatic reactions (eg, hepatitis, jaundice, liver failure) have (rarely) occurred with use; discontinue if signs or symptoms of hepatic disease develop, if systemic manifestations occur, or with persistent or worsening abnormal hepatic function tests.
NSAID use may compromise existing renal function through a dose-dependent decrease in prostaglandin synthesis, resulting in a reduction in renal blood flow which may cause renal decompensation (usually reversible). Patients with impaired renal function, dehydration, heart failure, liver dysfunction, those taking diuretics, ACE inhibitors, angiotensin II receptor blockers, and the elderly are at greater risk for renal toxicity. Patients should be adequately hydrated prior to initiation of therapy. Monitor renal function closely; discontinue use with persistent or worsening abnormal renal function tests. Use is contraindicated with severe renal impairment (CrCl <30 mL/minute). Long-term NSAID use may result in renal papillary necrosis.