ASA Delayed-release tablet Ref.[50638] Active ingredients: Acetylsalicylic acid

Source: Health Products and Food Branch (CA)  Revision Year: 2022 

Indications and clinical use

ASA is indicated for the following uses, based on its platelet aggregation inhibitory properties:

  • for reducing the risk of vascular mortality in patients with a suspected acute myocardial infarction.
  • for reducing the risk of a first non-fatal myocardial infarction in individuals deemed to be at sufficient risk of such an event by their physician.
    • There is no evidence for a reduction in the risk of first fatal myocardial infarction.
    • ASA does not reduce the risk of either cardiovascular mortality or first strokes, fatal or non-fatal.

The decrease in the risk of first non-fatal myocardial infarction must be assessed
against a much smaller but not insignificant increase in the risk of haemorrhagic
stroke as well as gastrointestinal bleeding.

  • for reducing the risk of morbidity and death in patients with unstable angina and in those with previous myocardial infarction.
  • for reducing the risk of transient ischemic attacks (TIA) and for secondary prevention of atherothrombotic cerebral infarction.
  • for prophylaxis of venous thromboembolism after total hip replacement.

Dosage and administration

ASA tablets should preferably be taken after meals, with plenty of liquid.

Dosing Considerations

Please see below for specific dosing instructions for each indication.

Recommended Dose and Dosage Adjustment

Platelet aggregation inhibitor

Suspected Acute Myocardial Infarction: An initial dose of at least 162 mg chewed or crushed to ensure rapid absorption as soon as a myocardial infarction is suspected. The same dose should be given as maintenance over the next 30 days. After 30 days, consider further therapy based on dosage and administration for prevention of recurrent MI (see Prior Myocardial Infarction).

Prevention of a first non-fatal myocardial infarction: 81-325 mg once daily, according to the individual needs of the patient, as determined by the physician.

Prior Myocardial Infarction or Unstable Angina Pectoris: 81-325 mg daily according to the individual needs of the patient, as determined by the physician.

Transient Ischemic Attack and Secondary Prevention of Atherothrombotic Cerebral Infarction: 81-325 mg daily according to the individual needs of the patient, as determined by the physician.

Prophylaxis of Venous Thromboembolism after total hip replacement: 162-325mg (of ASA) daily according to the individual needs of the patient, as determined by the physician.

Overdosage

Mild Overdose or Early Poisoning - burning in the mouth, lethargy, nausea, vomiting, tinnitus, sweating, thirst, tachycardia or dizziness.

Moderate Overdose - all of the symptoms from mild overdose plus tachypnea, hyperpyrexia, sweating, dehydration, loss of coordination, restlessness, mental confusion.

Severe Overdose - all of the symptoms from moderate overdose plus hypotension, hallucinations, stupor, hypoglycemia, convulsions, cerebral edema, oliguria, renal failure, cardiovascular failure, coma, hemorrhage, metabolic acidosis, respiratory alkalosis and/or failure.

Emergency Management

  1. Immediate transfer to hospital and maintain cardiovascular and respiratory support;
  2. Gastric lavage, administration of activated charcoal;
  3. Check of acid-base balance and correct if necessary;
  4. Alkaline diuresis so as to obtain urine pH between 7.5 and 8 should be considered when plasma salicylate concentration is greater than 500 mg/L (3.6 mmol/L) in adults or 300 mg/L (2.2 mmol/L) in children;
  5. Hemodialysis should be considered in severe poisoning 800 mg/L (5.8 mmol/L) in adults and 700 mg/L (5.0 mmol/L) in children, as renal elimination of salicylates may be slow due to the presence of acidic urine and renal failure. Hemodialysis should also be considered if the patient is experiencing severe systemic metabolic acidosis (arterial pH <7.2), acute renal failure, pulmonary edema or CNS symptoms such as: drowsiness, agitation, coma or convulsions;
  6. Fluid losses should be replaced with hypotonic solution (e.g. half saline) and supplemented with glucose 50 to 100 g/L;
  7. Symptomatic treatment.

Fatal Dose: varies from 10 to 30 g of ASA. However, (in one case) 130 g of ASA was ingested without fatal outcome.

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Storage and stability

Store between 15°C and 30°C.

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