Monograph Details

Musculoskeletal Disorders > Arthritis/rheumatic disorders
EC-NAPROSYN
Manufacturer
Roche Laboratories
Legal Classification
Rx
Generic Name
Naproxen 375mg, 500mg; e-c tabs.
Also
NAPROSYN
NAPROSYN SUSPENSION
Indications
Rheumatoid arthritis. Osteoarthritis. Ankylosing spondylitis. JRA.
Children
<2yrs: not recommended. ≥2yrs: use susp form.
Adults
Swallow whole. 375–500mg twice daily.
Contraindications
Aspirin allergy. Coronary artery bypass graft surgery.
Precautions
Advanced renal disease: not recommended. Active peptic ulcer. History of GI or inflammatory bowel disease. Impaired renal or hepatic function. Heart failure. Edema. Hypertension. Preexisting asthma. Bleeding disorders. Monitor blood, hepatic, renal, and ocular function in chronic use. Elderly. Debilitated. Pregnancy (Cat.C); avoid in late pregnancy. Nursing mothers: not recommended.
Interactions
Avoid concomitant aspirin. May potentiate protein-bound drugs (eg, hydantoins, sulfonamides, sulfonylureas). Monitor oral anticoagulants. Increased risk of GI bleeding with oral corticosteroids, SSRIs, smoking, alcohol. May antagonize diuretics, β-blockers, other antihypertensives. Increased renal toxicity with ACE inhibitors. Methotrexate excretion reduced. Increases serum lithium levels. Probenecid increases plasma levels and delays elimination. Concomitant H2 blockers, sucralfate, intensive antacid therapy: use immediate-release forms of naproxen. Cholestyramine may delay absorption.
Adverse Reactions
GI bleeding, peptic ulcer, constipation, heartburn, abdominal pain, nausea, headache, dizziness, drowsiness, pruritus, rash (discontinue if occurs), tinnitus, edema, nephritis, nephrotic syndrome, jaundice, hepatitis. See literature re: risk of cardiovascular events.
How Supplied
Tabs—100
Susp—pt
EC—100
Additional Resources
Related Prescribing Note