Indications for EC-NAPROSYN:
Rheumatoid arthritis. Osteoarthritis. Ankylosing spondylitis. JIA.
Use lowest effective dose for shortest duration. Swallow whole. 375–500mg twice daily. Renal or hepatic impairment, elderly: consider lower doses.
<18yrs: not studied.
Aspirin allergy. Coronary artery bypass graft surgery.
Risk of serious cardiovascular and gastrointestinal events.
Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure, advanced renal disease; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Hypertension; monitor BP closely. Hepatic or renal impairment. Discontinue if signs/symptoms of liver disease develop, or if abnormal LFTs persist or worsen. Dehydration. Hypovolemia. Moderate to severe renal impairment (CrCl <30mL/min): not recommended. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, renal, and ocular function in long-term therapy. Pre-existing asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Elderly. Debilitated. Labor & delivery. May be associated with a reversible delay in ovulation in females of reproductive potential. Pregnancy (avoid during ≥30 weeks gestation): increased risk of premature closure of the fetal ductus arteriosus; (20–30 weeks gestation): may cause fetal renal dysfunction/oligohydramnios; if treatment needed, limit dose and duration of use. Nursing mothers.
NSAID (propionic acid deriv.).
Concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs: not recommended. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Avoid antacids, sucralfate, cholestyramine. Serum levels increased by probenecid. May potentiate protein-bound drugs (eg, phenytoin, sulfonylureas, sulfonamides). May interfere with 5HIAA urinary assays or Porter-Silber tests.
Dyspepsia, abdominal pain, nausea, headache, rash, ecchymosis, and edema; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, serious skin reactions (eg, Stevens-Johnson Syndrome, toxic epidermal necrolysis), Drug Reaction with Eosinophilia and Systemic Symptoms (discontinue if occurs), anemia.
Generic Drug Availability:
Tabs—100; Susp—473mL; EC—100