KCK Pharma


Concise Prescribing Info
Relief of mild to moderate pain eg, headache, dysmenorrhea, myalgia, dental pain. Management of pain & inflammation in acute & chronic rheumatic disorders eg, RA, juvenile idiopathic arthritis, OA, ankylosing spondylitis. Minor febrile conditions eg, colds or flu, reduce temp, relieve headache, joint & muscle pains. Initial treatment of CV disorders eg, angina pectoris & MI; prevention of CV events in patients at risk; cerebrovascular disorders eg, stroke.
Dosage/Direction for Use
Adult Mild to moderate pain ie, headache, dysmenorrhea, myalgia, arthralgia, neuralgia, fever 300-900 mg every 4-8 hr. Max: 12 tab daily. Coronary bypass, transluminal angioplasty, strokes, TIA, unstable angina 150 mg preferably at the same time daily.
Should be taken with food: Take after meals to minimise GI irritation. Tab may be swallowed whole or dispersed in water & drunk immediately.
Hypersensitivity to NSAIDs. Reye's syndrome; asthma, rhinitis, nasal polyps.
Special Precautions
History of serious GI events & other risk factors associated w/ PUD eg, alcoholism, smoking, corticosteroid therapy; inherited (hemophilia) or acquired (hepatic disease or vitamin K deficiency) bleeding disorders; bronchial asthma, chronic bronchoconstrictive (obstructive) resp disease, hay fever, nasal polyps. Concomitant use w/ anticoagulants; barbiturates, other sedatives. Renal or hepatic insufficiency. Avoid use 1 wk prior to & during labor & delivery. Avoid during 3rd trimester of pregnancy & lactation. Not to be given in childn <16 yr. Elderly or debilitated patients.
Adverse Reactions
Agitation, cerebral edema, coma, confusion, dizziness, headache, subdural or intracranial hemorrhage, lethargy, seizures; dysrhythmias, hypotension, tachycardia; dehydration, hyperkalemia, metabolic acidosis, resp alkalosis; dyspepsia, GI bleeding, ulceration & perforation, nausea, vomiting, transient elevations of hepatic enzymes, hepatitis, Reye's syndrome, pancreatitis; resp, urogenital, musculoskeletal & reproductive disorders; prothrombin time prolongation, disseminated intravascular coagulation, coagulopathy, thrombocytopenia; acute anaphylaxis, angioedema, asthma, bronchospasm, laryngeal edema, uticaria; hyper- & hypoglycemia; hearing loss, tinnitus.
Drug Interactions
increased risk of bleeding w/ anticoagulants eg, heparin, warfarin. High serum conc & toxicity of acetazolamide. Diminished hyponatremic & hypotensive effects of ACE inhibitors. Diminished hypotensive effects of β-blockers. Decreased total conc of phenytoin. Increased serum valproic acid levels. Inhibited renal clearance of methotrexate. Diminished effectiveness of diuretics. Antagonized uricosuric action of uricosuric agents eg, probenecid, sulfinpyrazone. Increased effectiveness of oral hypoglycemics. Increased bleeding w/ other NSAIDs.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics) / Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) / Analgesics (Non-Opioid) & Antipyretics
ATC Classification
B01AC06 - acetylsalicylic acid ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
N02BA01 - acetylsalicylic acid ; Belongs to the class of salicylic acids and derivatives agents. Used to relieve pain and fever.
Winspirin dispersible tab 300 mg
3 × 10's
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