Atnahs Pharma
Concise Prescribing Info
Naproxen Na
Relief of mild to moderate pain. Primary dysmenorrhea. Relief/prophylaxis of migraine headache. Symptomatic treatment of mild to moderately severe, acute or chronic musculoskeletal & soft tissue inflammation, acute gout.
Dosage/Direction for Use
Adult Acute conditions Initially 550 mg followed by 275 mg every 6-8 hr. Acute gout Initially 825 mg followed by 275 mg every 8 hr as needed. Menorrhalgia 825-1,375 mg daily in 2 doses on 1st day of menstrual bleeding. Max: Not to exceed 1,100 mg daily. Acute migraine headache 825 mg at 1st symptom. Additional dose of 275-550 mg or 250-500 mg daily. Prophylaxis of migraine 550 mg bd. Total daily dose: Not to exceed 1,375 mg daily.
Should be taken with food: Take w/ meals &/or antacids. May be taken in fasting state.
Hypersensitivity. Aspirin or other NSAID/analgesic-induced asthma, rhinitis or nasal polyps. Active or history of GI bleeding or perforation; peptic ulcer/hemorrhage. Severe heart failure. Childn <2 yr.
Special Precautions
Discontinue use at 1st appearance of skin rash, mucosal lesions or other sign of hypersensitivity. Serious skin reactions eg, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis. Anaphylactic reactions. Risk of GI ulceration, bleeding & perforation. Risk factors associated w/ PUD. History of inflammatory bowel disease; GI toxicity & disease; HTN; conditions leading to blood vol &/or renal blood flow reduction; hypovolemia, heart failure, salt depletion; established ischemic heart disease, peripheral arterial disease, cerebrovascular disease; coagulation disorders. Observe closely for adrenal insufficiency & arthritis symptoms exacerbation. Perform ophth exam in patients who develop visual disturbance during treatment. Restricted Na intake. Avoid concomitant use w/ COX-2 selective inhibitors. Concomitant use w/ oral corticosteroids, anticoagulants eg, warfarin, SSRIs or anti-platelet agents eg, aspirin. Not recommended in combination w/ other NSAIDs. May affect ability to drive & use machines. Not recommended in patients w/ baseline CrCl <30 mL/min. Renal impairment or history of kidney disease. Severe hepatic reactions including jaundice, hepatitis. Not recommended in women of childbearing potential, labour & delivery. Not to be used during pregnancy. Not recommended during lactation. Not recommended in childn <16 yr. Elderly &/or debilitated patients.
Adverse Reactions
GI disorders; aseptic meningitis; agranulocytosis, aplastic & hemolytic anemia, eosinophilia, leucopenia, thrombocytopenia; anaphylactoid reactions; hyperkalemia; depression, abnormal dreams, insomnia; dizziness, drowsiness, headache, lightheadedness, retrobulbar optic neuritis, convulsion, cognitive dysfunction, inability to concentrate; eye, ear & labyrinth disorders; palpitations, cardiac failure; HTN, vasculitis; dyspnea, pulmonary edema, asthma, eosinophilic pneumonitis; hepatitis, jaundice; ecchymoses, itching, purpura, skin eruptions, sweating, alopecia, epidermal necrolysis; myalgia, muscle weakness; hematuria, interstitial nephritis, nephrotic syndrome, renal disease, failure & papillary necrosis; female infertility; oedema, thirst, pyrexia, malaise; abnormal liver function tests, raised serum creatinine.
Drug Interactions
Delayed absorption w/ antacid, cholestyramine; food. Enhanced anticoagulants effects eg, warfarin. Increased plasma conc by probenecid. Reduced methotrexate clearance. Reduced antihypertensive effects of β-blockers, ACE inhibitors, ARBs. Inhibited furosemide natriuretic effect. Increased plasma lithium conc. Increased risk of GI bleeding w/ anti-platelet agents & SSRIs.
ATC Classification
M01AE02 - naproxen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.
Synflex FC tab 275 mg
Synflex FC tab 550 mg
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