PONSTAN SF 500MG CAPSULE (CAPSULE)

Dosage / Direction for Use Mild to moderate pain/RA/OA Adult & adolescent ≥14 yr 500 mg tid. Dysmenorrhea, menorrhagia & premenstrual syndrome 500 mg tid at the onset of symptoms. Still's disease or antipyretic action Infant & childn >6 mth-14 yr 19.5-25 mg/kg/day tid in divided doses. Administration Should be taken with food: Take immediately after meals. Contraindications Hypersensitivity. Patients in whom aspirin or other NSAIDs induce symptoms of bronchospasm, allergic rhinitis, or urticaria. bronchospasms, allergic rhinitis or urticaria w/ aspirin or other NSAIDs. Active ulceration or chronic GI inflammation of either the upper or lower GI tract should be avoided in patients w/ preexisting renal disease. Treatment of peri-operative pain in the setting of CABG surgery. Severe renal, hepatic & heart failure. Special Precautions Risk of serious CV thrombotic events, MI & stroke in patients w/ known CV disease or risk factors. Onset of new HTN or worsening of preexisting HTN. Patients w/ compromised cardiac function & other conditions predisposing to, or worsened by fluid retention; preexisting CHF or HTN. Discontinue if GI bleeding or ulceration occurs. Patients ingesting alcohol, history of active GI disease eg, ulceration, GI bleeding or inflammatory conditions. Discontinue at the 1st appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. False +ve reaction for urinary bile using the diazo tab test. Avoid concomitant use w/ systemic non-aspirin NSAIDs including COX-2 inhibitors. Concomitant use w/ warfarin/coumarin-type & novel oral anticoagulants (eg, apixaban, dabigatran, rivaroxaban); aspirin, corticosteroids, SSRIs. Patients w/ decreased renal blood flow & vol; heart failure, liver cirrhosis, nephrotic syndrome, overt renal disease. Renal impairment. Discontinue if abnormal liver tests persist or worsen, if clinical signs & symptoms consistent w/ liver disease develop or if systemic manifestations occur. Not recommended during pregnancy & lactation. Elderly. Side Effects / Adverse Reactions Abdominal pain, diarrhea, nausea w/ or w/o vomiting. Agranulocytosis, aplastic anemia, autoimmune hemolytic anemia, bone marrow hypoplasia, decreased hematocrit, eosinophilia, leukopenia, pancytopenia, thrombocytopenic purpura, platelet aggregation inhibition; anaphylaxis; glucose intolerance, hyponatremia, fluid retention; nervousness; aseptic meningitis, blurred vision, convulsions, dizziness, drowsiness, headache, insomnia; eye irritation, reversible loss of color vision; ear pain; palpitation; hypotension, HTN; asthma, dyspnea; GI inflammation, hemorrhage, ulcer, perforation; angioedema, larynx & facial edema, erythema multiforme, Lyell's syndrome, perspiration, pruritus, rash, Stevens-Johnson syndrome, urticaria, dermatitis exfoliative; dysuria, hematuria, renal failure including papillary necrosis, tubulointerstitial nephritis, glomerulonephritis, nephrotic syndrome; urobilinogen urine (false +ve), liver function test abnormal. Hypothermia in childn. Interactions Interferes w/ the anti-platelet effect of low dose aspirin. Displaces warfarin from protein binding sites & may enhance response to oral anticoagulants. Reduced efficacy of diuretics & other antihypertensive drugs including ACE inhibitors, AIIA, β blockers. Increased risk of GI ulceration or bleeding w/ corticosteroids. Increased risk of nephrotoxicity w/ cyclosporine & tacrolimus. Changes in the effects of oral hypoglycemic agents. Produced an elevation of plasma levels & reduced renal clearance of lithium. Increased plasma levels of methotrexate