Each tablet contains:
Naproxen 250 or 500 mg
Osteoarthritis, Rheumatoid Arthritis, gout, pain, primary dysmenorrheal.
Dosage and administration:
Gout, Acute Attack:
Initial: 750mg, then 250mg q8h until attack subsides.
Take the medicine with or just after food, or a meal.
Rheumatoid Arthritis, Osteoarthritis:
250mgor 500mg bid.
Do not take indigestion remedies 2 hours before or after you take this medicine.
Swallow this medicine whole, do not chew or crush.
Titrate: Adjust dose/frequency up or down depending on clinical response; may increase to 1500mg/day for ≤6 months if patient can tolerate lower doses well.
Pain, Primary Dysmenorrhea:
Initial: 500mg, then 500mg q12h or 250mg q6-8h as required
Max: 1250mg/day initially, 1000mg/day thereafter.
Pregnancy & Breastfeeding:
Category C, not for use in nursing.
History of asthma, urticaria, or other allergic-type reactions with ASA or other NSAIDs.
Treatment of perioperative pain in the setting of CABG surgery.
Precaution & warnings:
Use lowest effective dose for the shortest duration possible.
May cause hypertension or worsen preexisting hypertension; monitor BP closely.
Fluid retention and edema reported; caution with fluid retention, hypertension, or HF.
Caution with prior history of ulcer disease, GI bleeding, and risk factors for GI bleeding; monitor for GI ulceration/bleeding and discontinue if serious GI event occurs.
May exacerbate inflammatory bowel disease. Renal injury reported with long-term use; increased risk with renal/hepatic impairment, hypovolemia, HF, salt depletion, and in elderly.
Not recommended with advanced renal disease or moderate to severe renal impairment (CrCl <30mL/min); monitor renal function closely and hydrate adequately.
Discontinue if signs and symptoms consistent with renal disease develop.
Anaphylactoid reactions may occur.
May cause serious skin adverse events (eg, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis); discontinue at 1st appearance of skin rash/hypersensitivity.
Anemia reported; monitor Hgb/Hct if anemia develops. Periodically monitor Hgb if initial Hgb ≤10g and receiving long-term therapy.
Perform ophthalmic studies if visual changes/disturbances occur.
May cause elevations of LFTs or severe hepatic reactions; discontinue if liver disease or systemic manifestations occur, or if abnormal LFTs persist/worsen.
May inhibit platelet aggregation and prolong bleeding time; monitor patients with coagulation disorders.
Monitor CBC and chemistry profile periodically with long-term treatment.
EC-Naproxen is not recommended for initial treatment of acute pain.
Cardiovascular (CV) thrombotic events, MI, stroke, GI adverse events, edema, drowsiness, dizziness, constipation, heartburn, abdominal pain, nausea, headache, tinnitus, dyspnea, pruritus.
Avoid with other naproxen products. Not recommended with ASA.
Risk of renal toxicity with diuretics, ACEIs (angiotensin-converting enzyme inhibitors), and ARBs (angiotensin receptor blockers).
May reduce natriuretic effect of loop (eg, furosemide) or thiazide diuretics; monitor for signs of renal failure and diuretic efficacy.
May diminish antihypertensive effect of ACE inhibitors, ARBs, or β-blockers (eg, propranolol); monitor changes in BP.
May result in deterioration of renal function, including possible acute renal failure with ACE inhibitors or ARBs; monitor closely for signs of worsening renal function.
May enhance methotrexate toxicity; caution with concomitant use.
May increase lithium levels and reduce renal lithium clearance; monitor for lithium toxicity.
Increased risk of GI bleeding with SSRIs, oral corticosteroids, anticoagulants, alcohol, and smoking; monitor carefully.
Synergistic effect on GI bleeding with warfarin.
Potential for interaction with other albumin-bound drugs (eg, coumarin-type anticoagulants, sulfonylureas, hydantoins, other NSAIDs, ASA); dose adjustment with hydantoin, sulfonamide, or sulfonylurea may be required.
Probenecid significantly increases plasma levels and extends T1/2.
Antacids, sucralfate, and cholestyramine can delay absorption.
EC-Naproxen is not recommended with H2-blockers, sucralfate, or intensive antacid therapy.
Store below 30°C, protect from heat and moisture.
Keep out of reach of children.