INDICATIONS AND USAGE:
Vascular Indications (Ischemic Stroke, TIA, Acute MI, Prevention of Recurrent MI, Unstable Angina Pectoris, and Chronic Stable Angina Pectoris): Aspirin is indicated to:
1- Prophylaxis of stroke in patients who have had ischemic stroke of transient ischemia of the brain due to fibrin platelet emboli.
2- Prophylaxis of suspected acute MI.
3- Prophylaxis of MI in patients with a previous MI or unstable angina pectoris.
4- Prophylaxis of MI in patients with chronic stable angina pectoris.
Revascularization Procedures (Coronary Artery Bypass Graft (CABG), Percutaneous Transluminal Coronary Angioplasty (PTCA), and Carotid Endarterectomy): Aspirin is indicated in patients who have undergone revascularization procedures when there is a preexisting condition for which aspirin is already indicated.
Rheumatologic Disease Indications (Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis, Spondyloarthropathies, Osteoarthritis, and the Arthritis and Pleurisy of Systemic Lupus Erythematosus (SLE)): Aspirin is indicated for the relief of the signs and symptoms of the mentioned conditions.
Aspirin is contraindicated in patients with known allergy to nonsteroidal anti-inflammatory drug products and in patients with the syndrome of asthma, rhinitis, and nasal polyps. Aspirin may cause severe urticaria, angioedema, or bronchospasm (asthma).
Reye' Syndrome: should not be used in children or teenagers for viral infections, with or without fever, because of the risk of Reye' syndrome with concomitant use of aspirin in certain viral illnesses.
Body as a Whole: Fever, hypothermia, thirst.
Cardiovascular: Dysrythmias, hypotension, tachycardia.
Central Nervous System: Agitation, cerebral edema, coma, confusion, dizziness, headache, subdural or intracranial hemorrhage, lethargy, seizures.
Fluid and Electrolyte: Dehydration, hyperkalemia, metabolic acidosis, respiratory alkalosis.
Gastrointestinal: Dyspepsia, GI bleeding, ulceration and perforation, nausea, vomiting, transient elevations of hepatic enzymes, hepatitis, Reye' Syndrome, pancreatitis.
Hematologic: Prolongation of the prothrombin time, disseminated intravascular coagulation, coagulopathy, thrombocytopenia.
Hypersensitivity: Acute anaphylaxis, angioedema, asthma, bronchospasm, laryngeal edema, urticaria.
Metabolism: Hypoglycemia (in children), hyperglycemia.
Reproductive: Prolonged pregnancy and labor, stillbirths, lower birth weight infants, antepartum and postpartum bleeding.
Respiratory: Hyperpnea, pulmonary edema, tachypnea.
Special Senses: Hearing loss, tinnitus. Patients with high frequency hearing loss may have difficulty perceiving tinnitus. In these patients, tinnitus cannot be used as a clinical indicator of salicylism.
Urogenital: Interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency and failure.
DOSAGE AND ADMINISTRATION:
Each dose of aspirin should be taken with a full glass of water unless patient is fluid restricted. Anti-inflammatory and analgesic dosages should be individualized. When aspirin is used in high doses, the development of tinnitus may be used as a clinical sign of elevated plasma salicylate levels except in patients with high frequency hearing loss.
Ischemic Stroke and TIA: 50-325 mg once a day. Continue therapy indefinitely.
Suspected Acute MI: The initial dose of 160-162.5 mg is administered as soon as an MI is suspected. The maintenance dose of 160-162.5 mg a day is continued for 30 days post infarction. After 30 days, consider further therapy based on dosage and administration for prevention of recurrent MI.
Prevention of Recurrent MI: 75-325 mg once a day. Continue therapy indefinitely.
Unstable Angina Pectoris: 75-325 mg once a day. Continue therapy indefinitely.
Chronic Stable Angina Pectoris: 75-325 mg once a day. Continue therapy indefinitely.
Coronary Artery Bypass Graft (CABG): 325 mg daily starting 6 hours post-procedure. Continue therapy for 1 year post-procedure.
Percutaneous Transluminal Coronary Angioplasty (PTCA): The initial dose of 325 mg should be given 2 hours pre-surgery. Maintenance dose is 160-325 mg daily. Continue therapy indefinitely.
Carotid Endarterectomy: Doses of 80 mg once daily to 650 mg twice daily, started presurgery, are recommended. Continue therapy indefinitely.
Rheumatoid Arthritis: The initial dose is 3 g a day in divided doses. Increase as needed for anti-inflammatory efficacy with target plasma salicylate levels of 150-300 mcg/mL. At high doses (i.e., plasma levels of greater than 200 mg/mL), the incidence of toxicity increases.
Juvenile Rheumatoid Arthritis: Initial dose is 90-130 mg/kg/day in divided doses. Increase as needed for anti-inflammatory efficacy with target plasma salicylate levels of 150-300 mcg/mL. At high doses (i.e., plasma levels of greater than 200 mg/mL), the incidence of toxicity increases.
Spondyloarthropathies: Up to 4 g per day in divided doses.
Osteoarthritis: to 3 g per day in divided doses.
Arthritis and Pleurisy of SLE: The initial dose is 3 g a day in divided doses. Increase as needed for anti-inflammatory efficacy with target plasma salicylate levels of 150-300 mcg/mL. At high doses (i.e., plasma levels of greater than 200 mg/mL), the incidence of toxicity increases.
Carton box containing: 20 E. Ctd. Tablets.