Concise Prescribing Info
Naproxen Na
Musculoskeletal & joint disorders eg, ankylosing spondylitis, OA, RA including juvenile idiopathic arthritis. Dysmenorrhea, headache including migraine, post-op pain, soft tissue disorders, acute gout, & to reduce fever.
Dosage/Direction for Use
275-mg tab 1 tab every 6-8 hr or 1 tab every 12 hr. Max: 800 mg daily (equiv to naproxen Na 880 mg). Must not be taken for >10 days. 550-mg tab 1 tab every 24 hr.
May be taken with or without food: Take w/ a glass of water. Absorption may be delayed w/ meals.
Hypersensitivity. History of asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDs. History of GI bleeding or perforation related to previous NSAID therapy. Active, or a history of, recurrent peptic ulcer or hemorrhage. Severe heart failure.
Special Precautions
Not indicated for pain of GI origin. Avoid concomitant use w/ NSAIDs including COX-2 inhibitors. High doses may increase risk of GI bleeding, ulceration or perforation. Patients w/ history of GI toxicity; receiving medications which increased risk of ulceration or bleeding eg, oral corticosteroids, anticoagulants (eg, warfarin), SSRIs or anti-platelet agents (eg, aspirin); w/ history of GI disease (ulcerative colitis, Crohn's disease). Na/fluid retention in CV conditions & peripheral edema; history of HTN &/or heart failure. Arterial thrombotic events (eg, MI or stroke). Serious skin reactions including exfoliative dermatitis, Stevens-Johnson syndrome & toxic epidermal necrolysis. Discontinue use at the 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Severe hepatic reactions, including jaundice & hepatitis. Patients taking any other analgesic; w/ coagulation disturbances or taking drugs that influence hemostasis; on intensive diuretic therapy. May impair female fertility. May interfere w/ urinary analyses of 17-ketogenic steroids & 5-hydroxy indoleacetic acid (5 HIAA). May affect ability to drive & use machines. Severe renal, hepatic &/or cardiac impairment. Pregnancy. Avoid use during lactation. Childn <12 yr. Elderly.
Adverse Reactions
Edema, HTN, cardiac failure. Peptic ulcer, perforation/GI bleeding; nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, exacerbation of colitis & Crohn's disease. Dizziness, headache, light-headedness; heartburn.
Drug Interactions
May increase cyclosporine conc, increasing risk for nephrotoxicity. May increase lithium levels. Elevated conc of methotrexate, increasing risk for toxicity. Increased risk of ulcers & GI bleeding w/ NSAIDs including aspirin, anti-platelet agents, SSRIs & corticosteroids. May attenuate irreversible platelet inhibition induced by ASA. May enhance the effects of anticoagulants eg, warfarin. Reduced efficacy of diuretics & antihypertensive drugs including ACE inhibitors particularly in patients w/ preexisting nephropathy.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AE02 - naproxen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
275 mg:Non-Rx;550 mg:Rx
Sarimax FC tab 275 mg
100's (P10/film-coated tab)
Sarimax FC tab 550 mg
100's (P19/film-coated tab)
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