Antah Pharma
Concise Prescribing Info
Naproxen Na
Mild to moderate pain, primary dysmenorrhoea. RA, OA, ankylosing spondylitis, tendinitis, bursitis, acute gout.
Dosage/Direction for Use
Rheumatic disorder Initially 275 mg bd, may be increased to 1,100 mg daily in 2 divided doses. Acute gout Initially 825 mg followed by 275 mg 8 hrly. Dysmenorrhoea Initially 550 mg followed by 275 mg 6-8 hrly if needed. Max daily dose: Not ≥1,375 g.
Should be taken with food: Take immediately after meals.
Hypersensitivity. Aspirin- or other NSAID-induced asthma, rhinitis, nasal polyps. Active peptic ulceration.
Special Precautions
Discontinue use at 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity; if abnormal liver test persist or worsen, if clinical signs & symptoms consistent w/ liver disease develops or systemic manifestation occurs. Serious cutaneous adverse events eg, exfoliative dermatitis, TEN & SJS. Patients w/ prior history of GI disease; other risk factors associated w/ PUD eg, alcoholism, smoking, corticosteroid therapy; CV thrombotic events eg, MI; HTN, fluid retention or heart failure. Monitor BP during treatment & at regular intervals thereafter; liver function during therapy. Not to be coadministered w/ other NSAIDs. Concomitant use w/ antihypertensives; diuretics. High-dose & long-term use. Renal impairment, chronic alcoholic liver disease, cirrhosis. Hepatic impairment. Not to be used during late pregnancy. Not recommended in childn <16 yr. Elderly, debilitated patients. FC tab 550 mg: Na-restricted diet.
Adverse Reactions
Constipation, heartburn, abdominal pain, nausea; headache, drowsiness, dizziness; tinnitus; pruritus, skin eruptions or rashes, ecchymoses. Dyspepsia, diarrhea, stomatitis, vomiting, anorexia, flatulence; vertigo, lightheadedness, inability to concentrate, mental depression, nervousness, irritability, fatigue, malaise, insomnia, sleep disorders, dream abnormalities; hearing or visual disturbances; thrombocytopenia, leukocytopenia, granulocytopenia, eosinophilia; inhibit platelet aggregation, prolong bleeding time.
Drug Interactions
GI bleeding & inhibited platelet aggregation w/ anticoagulant or thrombolytic agents. Potentiated effects by probenecid. Severe to fatal toxicity w/ MTX. Decreased clearance & increased serum conc of lithium. Increased central adverse effects w/ quinolone antibiotics. Displaced from binding sites w/ protein-bound drugs eg, oral anticoagulants, hydantoins, salicylates, sulfonamides, sulfonylureas. Inhibited natriuretic effect of furosemide. Reduced antihypertensive effect of propranolol, other β-blockers. Concomitant use w/ prednisolone, frusemide, salicylates.
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.
Sunprox tab 275 mg
Sunprox tab 550 mg
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