Product Monograph - Aspirin - Children's Size - Tablets
INDICATIONS
ASPIRIN* (acetylsalicylic acid, ASA) is indicated for the relief of pain, fever and
inflammation of a variety of conditions such as influenza, common cold, low back and neck pain, dysmenorrhea, headache, toothache, sprains and strains, fractures, myositis,
neuralgia, synovitis, arthritis, bursitis, burns, injuries, following surgical and dental
procedures. ASPIRIN® Extra Strength is also indicated for relief of migraines including pain and the associated symptoms of photophobia (sensitivity to light) and phonophobia
(sensitivity to sound), and improves overall quality of life.
ASPIRIN* is also 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;
Aspirin 81mg
DIN 02237726;
Aspirin Tablets
325mg
DIN02150328 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.
Aspirin 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.
Aspirin 81mg
DIN 02237726;
Aspirin Tablets
325mg
DIN02150328;
for reducing the risk of morbidity and death in patients with unstable
angina and in those with previous myocardial infarction
Aspirin 81mg
DIN 02237726;
Aspirin Tablets
325mg
DIN02150328; for reducing the risk of transient ischemic attacks (TIA) and for secondary
prevention of atherothrombotic cerebral infarction;
Aspirin 81mg
DIN 02237726;
Aspirin Tablets
325mg
DIN02150328;
for prophylaxis of venous thromboembolism after total hip replacement; Aspirin Tablets
325mg
DIN02150328;
for reducing the adhesive properties of platelets in patients following
carotid endarterectomy to prevent recurrence of TIA and in hemodialysis patients with a silicone rubber arteriovenous cannula.
Aspirin Tablets
325mg
DIN02150328; CONTRAINDICATIONS
- Hypersensitivity to acetylsalicylic acid, to other salicylates, or to any other components of the product; salicylate sensitivity
- Active peptic ulcer;
WARNINGS
ASA is one of the most frequent causes of accidental poisonings in toddlers and infants.
Tablets should be kept well out of the reach of children.
A possible association between Reye's syndrome and the use of salicylates has been suggested but not established. Reye's syndrome has also occurred in many patients not exposed to salicylates. However, caution is advised when prescribing salicylate-containing medications for children and teenagers with influenza or chickenpox.
PRECAUTIONS
Salicylates should be administered cautiously to patients with asthma and other allergic conditions, a history of gastrointestinal ulcerations, bleeding tendencies, significant anemia, hypoprothrombinemia.
Patients taking ASA daily are at an increased risk of developing gastrointestinal bleeding following the ingestion of alcohol.
Caution is necessary when salicylates and anticoagulants are prescribed concurrently, as salicylates can depress the concentration of prothrombin in the plasma.
Diabetics receiving concurrent salicylate and hypoglycemic therapy should be monitored closely: reduction of the sulfonylurea hypoglycemic drug dosage may be necessary, insulin requirements may change.
High doses (3 g daily) of ASA during pregnancy may lengthen the gestation and parturition time.
Salicylates can produce changes in thyroid function tests.
Sodium excretion produced by spironolactone may be decreased by salicylate administration.
Salicylates in large doses are uricosuric agents; smaller amounts may depress uric acid clearance and thus decrease the uricosuric effects of other drugs.
Salicylates retard the renal elimination of methotrexate.
Salicylates may alter valproic acid (VPA) metabolism and may displace VPA from protein binding sites, possibly intensifying the effects of VPA. Caution is recommended when VPA is administered concomitantly with salicylates.
The hyponatremic and hypotensive effects of ACE inhibitors may be diminished by the concomitant administration of ASA due to its indirect effect on the renin-angiotensin conversion pathway. The potential interaction may be related to the dose of ASA (3g/day or more).
ADVERSE EFFECTS
Gastrointestinal: (the frequency and severity of these adverse effects are dose-related):
nausea, vomiting, diarrhea, gastrointestinal bleeding and/or ulceration, dyspepsia, heartburn.
Ear: tinnitus, vertigo, hearing loss.
Hematologic: leukopenia, thrombocytopenia, purpura, anemia.
Dermatologic and hypersensitivity: urticaria, angioedema, pruritus, skin eruptions, asthma, anaphylaxis.
Miscellaneous: mental confusion, drowsiness, sweating, thirst.
SYMPTOMS AND TREATMENT OF OVERDOSAGE
Symptoms: in mild overdosage these may include rapid and deep breathing, nausea, vomiting, vertigo, tinnitus, flushing, sweating, thirst and tachycardia. In more severe cases, acid-base disturbances including respiratory alkalosis and metabolic acidosis can occur.
Severe cases may show fever, hemorrhage, excitement, confusion, convulsions or coma and respiratory failure.
Treatment consists of prevention and management of acid-base and fluid and electrolyte disturbances. Renal clearance is increased by increasing urine flow and by alkaline diuresis but care must be taken in this approach to not aggravate further the metabolic acidosis that develops and the hypokalemia. Acidemia should be prevented by administration of adequate sodium containing fluids and sodium bicarbonate.
Hypoglycemia is an occasional accompaniment of salicylate overdosage and can be managed by glucose solutions. If a hemorrhagic diathesis is evident, give vitamin K.
Hemodialysis may be useful in complex acid base disturbances particularly in the presence of abnormal renal function.
DOSAGE AND ADMINISTRATION
Analgesic and antipyretic:
Adults: 1-2 tablets (325 mg to 650 mg) orally every 4 hours.
Children under 12: 10 to 15 mg/kg every 6 hours, not to exceed a total daily dose of 2.4 g.
Migraine pain and associated symptoms:
Adults: 1000 mg (2 x 500mg tablets) at onset of pain or symptoms.
Children: Clinical studies to support migraine relief in children have not been conducted with acetylsalicylic acid.
Anti-inflammatory:
Adults: 3 tablets (975 mg) 4 to 6 times a day, up to 30 tablets daily, may be required for optimal anti-inflammatory effect. A blood level between 15 and 30 mg per 100 mL is in the desirable therapeutic range.
Children: 60 to 125 mg/kg daily in 4 to 6 divided doses.
Platelet aggregation inhibitor:
Suspected Acute Myocardial Infarction: An initial dose of at least 160 -162.5 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: 80 - 325 mg once daily, according to the individual needs of the patient, as determined by the physician.
Prior Myocardial Infarction or Unstable Angina Pectoris: 80 - 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: 80 - 325 mg daily according to the individual needs of the patient, as determined by the physician.
Prophylaxis of Venous Thromboembolism after total hip replacement: 650 mg twice a day
(1,300 mg daily), started 1 day before surgery and continued for 14 days.
AVAILABILITY
ASPIRIN* Tablets: Each round, white tablet with the Bayer Cross* on both sides contains
325 mg acetylsalicylic acid. In packages of 12, 24, 50, 100, 115, 200 and 400.
ASPIRIN* Tablets Extra-Strength: Each round, white tablet, with the Bayer Cross* on one side and 500 on the other, contains 500 mg acetylsalicylic acid. In packages of 30, 60 and 100 in a formula containing carnauba wax, corn starch, D&C Red #7, FD&C Blue #2,
FD&C Red #40, hydroxypropyl methylcellulose, powdered cellulose, propylene glycol, shellac, titanium dioxide, triacetin. Store between 15-25°C.
ASPIRIN* Caplets: Each white capsule-shaped tablet (caplet), with BAYER on one side and score on the other, contains 325 mg acetylsalicylic acid. In packages of 50 and 100. Coated ASPIRIN* Caplets: Each pale yellow enteric coated caplet, with BAYER 325 in brown ink on one side and blank on the other, contains 325 mg of acetylsalicylic acid. In packages of 50, 100 and 200.
Coated ASPIRIN* Extra Strength Caplet: Each pale yellow enteric coated caplet, with
BAYER 500 in brown ink on one side and blank on the other, contains 500 mg of acetylsalicylic acid. In packages of 50 and 100.
Coated ASPIRIN* Arthritis Pain Relief Caplets: Each orange enteric coated caplet, with
B embossed on one side and blank on the other, contains 650mg of acetylsalicylic acid.
In packages of 100.
ASPIRIN* With Stomach Guard Tablets: Each round, white, film-coated tablet with
BAYER PLUS in blue ink on one side contains 325 mg acetylsalicylic acid, 160 mg calcium carbonate, 34 mg magnesium carbonate, 63 mg magnesium oxide. In packages of 36.
ASPIRIN* With Stomach Guard Extra Strength Tablets: Each white, film-coated caplet, with BAYER PLUS over 500 on one side in blue ink, contains 500 mg acetylsalicylic acid,
245.2 mg calcium carbonate, 52.5 mg magnesium carbonate and 96.9 mg magnesium oxide. In packages of 30 and 60.
Flavoured Children's Size ASPIRIN*: Each peach coloured tablet, with pleasant orange taste and the Bayer Cross* on one side, with ASPIRIN on the other contains 80 mg (1-1/4 gr) acetylsalicylic acid. In bottles of 24, 60 and 90.
ASPIRIN* 81 mg: Each pale blue coloured enteric coated tablet, with 81 in dark blue ink on one side contains 81 mg (1-1/4 gr) acetylsalicylic acid. In bottles of 24, 120 and 180 tablets.
All Bayer ASA preparations are tartrazine-free.
CHEMISTRY
Structural Formula:
Molecular Formula: C9H804
Molecular Weight: 180.16
Chemical Names: 2-(Acetyloxy) benzoic acid;
salicylic acid acetate.