Ec-naprosyn Generic Name & Formulations
Naproxen 375mg, 500mg; delayed-release e-c tabs.
NSAID (propionic acid deriv.).
Tabs—100; Susp—473mL; EC—100
Rheumatoid arthritis. Osteoarthritis. Ankylosing spondylitis. JIA.
Ec-naprosyn Dosage and Administration
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.
Ec-naprosyn Boxed Warnings
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.
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.
Ec-naprosyn Adverse Reactions
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.
Ec-naprosyn Clinical Trials
Ec-naprosyn Patient Counseling