Acetylsalicylic acid

Therapeutic Indications

Acetylsalicylic acid is indicated for:

Prophylaxis of deep vein thrombosis and pulmonary embolism

Irrespective of gender only Adults (18 years old or older)

Prophylaxis of deep vein thrombosis and pulmonary embolism.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 80-200mg/day

Treatment 2: Oral - 300-325mg every second day

Prophylaxis after coronary interventions or surgery

Irrespective of gender only Adults (18 years old or older)

Prevention of graft occlusion after Coronary Artery Bypass Grafting (CABG). Coronary angioplasty, except during the acute phase (PCI). Prevention of arteriovenous anastomosis for renal dialysis.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 75-160 mg once daily

Stable and unstable angina pectoris

Irrespective of gender only Adults (18 years old or older)

History of unstable angina pectoris, except during the acute phase.

Prevention of cardiovascular morbidity in patients suffering from stable angina pectoris.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 75-160 mg once daily

Transient ischaemic attacks

Irrespective of gender only Adults (18 years old or older)

Secondary prevention of transient ischaemic attacks (TIA) and ischaemic cerebrovascular accidents (CVA), provided intracerebral haemorrhages have been ruled out.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 75-325 mg once daily

Secondary prevention of myocardial infarction

Irrespective of gender only Adults (18 years old or older)

Secondary prevention of myocardial infarction.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 75-160 mg once daily

Fever, pain

Irrespective of gender only Adults (18 years old or older)

Acetylsalicylic acid has analgesic, antipyretic and anti-inflammatory actions. It is indicated for the relief of headache, toothache, migraine, neuralgia, sore throat, dysmenorrhoea and the symptomatic relief of influenza, feverishness, rheumatic pains, sciatica, lumbago, fibrositis, muscular aches and pain.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 300-900 mg every 4 to 6 hours

Migraine with or without aura

Irrespective of gender only Adults (18 years old or older)

Migraine with or without aura.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 1000-3000mg

Acute myocardial infarction

Irrespective of gender only Adults (18 years old or older)

The recommended loading dose is 150-450 mg. The loading dose is administered as soon as possible after onset of symptoms.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 150-450 mg once daily

Rheumatic fever, rheumatoid arthritis, osteoarthritis (adults)

Irrespective of gender only Adults (18 years old or older)

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 5-8 mg per day

Pain

Irrespective of gender only Adolescents (12 years - 18 years old)

Acetylsalicylic acid has analgesic and anti-inflammatory actions. It is indicated for the relief of headache, toothache, migraine, neuralgia, sore throat, dysmenorrhoea and the symptomatic relief of influenza, rheumatic pains, sciatica, lumbago, fibrositis, muscular aches and pain.

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 10-15 mg/kg every 4 hours

Juvenile rheumatoid arthritis, osteoarthritis

Irrespective of gender only Adolescents (12 years - 18 years old)

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 80 mg/kg body weight daily

Rheumatic fever

Irrespective of gender only Adolescents (12 years - 18 years old)

For this indication, the medical literature mentions below treatments (click for details):

Treatment 1: Oral - 100 mg/kg body weight

Contraindications

Active ingredient Acetylsalicylic acid is contraindicated in the following cases:

Severe renal impairment

No gender/age discrimination

Acetylsalicylic acid is contraindicated in severe renal impairment.

Severe cardiac failure

No gender/age discrimination

Acetylsalicylic acid is contraindicated in severe cardiac failure.

Severe hepatic impairment

No gender/age discrimination

Acetylsalicylic acid is contraindicated in severe hepatic impairment.

Contraindications for acetylsalicylic acid administration

No gender/age discrimination

Contraindications for acetylsalicylic acid:

  • Active, or history of recurrent peptic ulcer and/or gastric/intestinal haemorrhage, or other kinds of bleeding such as cerebrovascular haemorrhages.
  • Haemorrhagic diathesis; coagulation disorders such as haemophilia and thrombocytopenia.

Pregnancy and lactation

No gender/age discrimination

Low doses (up to 100 mg/day): Clinical studies indicate that doses up to 100 mg/day for restricted obstetrical use, which require specialised monitoring, appear safe.

Doses of 100- 500 mg/day: There is insufficient clinical experience regarding the use of doses above 100 mg/day up to 500 mg/day. Therefore, the recommendations below for doses of 500 mg/day and above apply also for this dose range.

Doses of 500 mg/day and above: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development.

Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, acetylsalicylic acid should not be given unless clearly necessary. If acetylsalicylic acid is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:

  • cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
  • renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;

the mother and the neonate, at the end of pregnancy, to:

  • possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.
  • inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, acetylsalicylic acid at doses of 100 mg/day and higher is contraindicated during the third trimester of pregnancy.

Probenecid, benzbromarone, sulfinpyrazone

No gender/age discrimination

Acetylsalicylic acid reduces uricosurics effects of probenecid, benzbromarone, sulfinpyrazone. Salicylates reverse the effect of probenecid. The combination should be avoided.

Heparin therapy

No gender/age discrimination

Acetylsalicylic acid should not be used in patients undergoing heparin therapy.

Methotrexate

No gender/age discrimination

Methotrexate (used at doses >15 mg/week): The combined drugs, methotrexate and acetylsalicylic acid, enhance haematological toxicity of methotrexate due to the decreased renal clearance of methotrexate by acetylsalicylic acid.

Methotrexate (used at doses <15 mg/week): The combined drugs, methotrexate and acetylsalicylic acid, may increase haematological toxicity of methotrexate due to decreased renal clearance of methotrexate by acetylsalicylic acid. Weekly blood count checks should be done during the first weeks of the combination. Enhanced monitoring should take place in the presence of even mildly impaired renal function, as well, as in elderly.

Severe glucose 6-phosphate dehydrogenase deficiency (G6PD) deficiency

No gender/age discrimination

Acetylsalicylic acid is not recommended for use in patients with severe glucose 6-phosphate dehydrogenase deficiency (G6PD) deficiency, as acetylsalicylic acid may cause haemolysis or haemolytic anemia. Factors that may increase the risk of hemolysis are e.g. high dosage, fever or acute infections.

Haemophilia and thrombocytopenia

No gender/age discrimination

Acetylsalicylic acid should not be used in haemophilia and thrombocytopenia.