Micropirin

/ Dexcel

For oral administration to adults only. Patients should seek the advice of a doctor before commencing therapy for the first time.
Adults: Daily dosage is 75 mg or 100 mg. After the diagnosis of myocardial infarction 150 mg daily is recommended initially. In some circumstances a higher dose may be appropriate, especially in the short term, and up to 300mg a day may be used on the advice of a doctor. The tablets should be swallowed whole with water. They should not be cut, crushed or chewed.
Elderly patients: The risk/benefit ratios in the elderly have not been fully established.
This drug is not indicated for use in children and young people less than 20 years of age There is a risk of Reye’s syndrome when children take aspirin.

Reduction of the risk of coronary heart disease in patients with a 5% risk for coronary heart disease over a 5 year period and the secondary prevention of thrombotic cerebrovascular or cardiovascular disease.

Hypersensitivity to aspirin or to other nonsteroidal anti-inflammatory drug products. Patients with the syndrome of asthma, rhinitis and nasal polyps. Hypoprothrombinaemia, haemophilia and other bleeding disorders. Active peptic ulceration or history of peptic ulceration.

Before commencing long-term therapy with Micropirin for the management of cerebrovascular or cardiovascular disease, patients should consult their doctor who can advise on the relative benefits versus the risks for the individual patient.
Micropirin should be used with caution in patients with a history of peptic ulceration or coagulation defects as it impairs platelet aggregation and increases the risk and severity of hemorrhage in these patients. Patients should report any unusual bleeding symptoms to their physician. physicians should inform patients about the signs and symptoms of gastrointestinal side effects and what steps to take if they occur.
Micropirin Tablets are not indicated for use in children and young people less than 20 years of age. There is a risk of Reye’s syndrome when children take aspirin. Reye’s syndrome is a very rare disease, which affects the brain and liver, and can be fatal.
Aspirin may also precipitate bronchospasm or induce attacks of asthma in susceptible subjects.
Micropirin should be used with caution in patients with impaired hepatic or renal function or in patients who are dehydrated, and should be avoided in patients with severe renal failure (glomerular filtration rate less than 10 ml/minute) or severe hepatic insufficiency.
Patients with hypertension should be carefully monitored.
Micropirin Tablets can increase the risk of bleeding after some surgical interventions such as dental surgery. physicians should inform patients on the need to stop taking Micropirin prior to surgery unless otherwise indicated. Patients who consume three or more alcoholic drinks every day should be counseled about the bleeding risks involved with chronic, heavy alcohol use while taking aspirin.
Laboratory tests: Aspirin has been associated with elevated hepatic enzymes, blood urea nitrogen and serum creatinine, hyperkalemia, proteinuria and prolonged bleeding time.

Most commonly the side-effects associated with aspirin are gastrointestinal disturbances such as nausea, dyspepsia and vomiting. Irritation of the gastric mucosa with slight gastrointestinal blood loss may occur.
More severe reactions including gastric erosions, ulceration and severe bleeding are less common and are often associated with high dose aspirin over prolonged periods. Anaemia may occur following chronic gastrointestinal blood loss or acute haemorrhage.
Aspirin prolongs bleeding time, and bleeding disorders, such as epistaxis, haematuria, purpura, ecchymoses, haemoptysis, gastrointestinal bleeding, haematoma and cerebral haemorrhage have occasionally been reported.
Fatalities have occurred.
Aspirin may precipitate hypersensitivity reactions include skin rashes, urticaria, angioedema, bronchospasm, attacks of asthma in susceptible subjects and rarely, anaphylaxis.
Other side effects: urate kidney stones and tinnitus. The special coating of Micropirin 75mg and 100mg EC Tablets helps to reduce the incidence of side effects resulting from gastric irritation.

Salicylates may enhance the effects of oral hypoglycaemic agents and may increase the toxicity of phenytoin, valporic acid, methotrexate and sulphonamides. Salicylates inhibit the uricosuric effect of probenecid. Urinary acidifiers may inecrease salicylates toxicity. In large doses, salicylates may also decrease insulin requirements.
Aspirin may potentiate the effect of heparin and increases the risk of bleeding with oral anticoagulants, antiplatelet agents and fibrinolytics.
Patients using enteric-coated aspirin should be advised against ingesting antacids or histamine H2-receptor antagonists simultaneously, to avoid premature drug release.
Aspirin may diminish the hypotensive and hyponatremic effects of angiotensin converting enzyme (ACE) inhibitors, the hypotensive effects of beta blockers and the effectiveness of diuretics.
Plasma salicylate concentrations may be reduced by concurrent use with corticosteroids or urinary alkalizers, and salicylate toxicity may occur following withdrawal of the corticosteroids. The risk of gastrointestinal ulceration and bleeding may be increased when aspirin and corticosteroids are co-administered.
Concurrent administration of carbonic anhydrase inhibitors such as acetazolamide and salicylates may result in severe acidosis and increased central nervous system toxicity.
Concurrent use with other Nonsteroidal Anti-inflammatory Drugs (NSAID’s) should be avoided because this may increase bleeding or lead to decreased renal function.
Simultaneous use with valproic acid may increase the risk of bleeding.
Simultaneous or sequential use of ototoxic medications, especially vancomycin, should be avoided because the potential for ototoxicity.
Antiemetics, including antihistamines and phenothiazines, may mask the symptoms of salicylate-induced ototoxicity.
Aspirin may competitively inhibit the hepatic glucuronidation and decrease the clearance of zidovudine, leading to potentiation of zidovudine toxicity. Aspirin toxicity may also be increased.

Pregnancy: Aspirin does not appear to have teratogenic effects. However, caution should be exercised when considering use in pregnant patients. With high doses there may be premature closure of the foetus ductus arteriosus and possible persistent pulmonary hypertension in the newborn. Salicylate products have been associated with prolonged pregnancy and labour, increased bleeding before and after delivery, decreased birth weight and increased rate of stillbirth have been reported with high blood salicylate levels. Aspirin has the ability to alter platelet function and there may be a risk of haemorrhage in infants whose mothers have consumed aspirin during pregnancy. Analgesic doses of aspirin should be avoided during the last trimester of pregnancy.
Lactation: As aspirin is excreted in breast milk, patients who are breast-feeding should not take Micropirin 75mg or 100 mg EC Tablets. Neonates excrete salicylatesslowly and are more sensitive to the platelet inhibitory effect of aspirin in addition to the possible risk of Reye’s syndrome.

Salicylate poisoning is usually associated with plasma concentrations >350 mg/L (2.5 mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L (5.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning.
Symptoms: Common features include vomiting, dehydration, tinnitus, vertigo, deafness, sweating, warm extremities with bounding pulses, increased respiratory rate and hyperventilation. Some degree of acid-base disturbance is present in most cases. A mixed respiratory alkalosis and metabolic acidosis with normal or high arterial pH (normal or reduced hydrogen ion concentration) is usual in adults and children over the age of 4 years. In children aged 4 years or less, a dominant metabolic acidosis with low arterial pH (raised hydrogen ion concentration) is common. Acidosis may increase salicylate transfer across the blood brain barrier. Uncommon features include haematemesis, hyperpyrexia, hypoglycaemia, hypokalaemia, thrombocytopaenia, increased INR/PTR, intravascular coagulation, renal failure and non-cardiac pulmonary oedema. Central nervous system features including confusion, disorientation, coma and convulsions are less common in adults than in children.
Management: Give activated charcoal if an adult presents within one hour of ingestion of more than 250 mg/kg. The plasma salicylate concentration should be measured, although the severity of poisoning cannot be determined from this alone and the clinical and biochemical features must be taken into account. Elimination is increased by urinary alkalisation, which is achieved by the administration of 1.26% sodium bicarbonate. The urine pH should be monitored. Correct metabolic acidosis with intravenous 8.4% sodium bicarbonate (first check serum potassium). Forced diuresis should not be used since it does not enhance salicylate excretion and may cause pulmonary oedema. Haemodialysis is the treatment of choice for severe poisoning and should be considered in patients with plasma salicylate concentrations >700 mg/L (5.1 mmol/L), or lower concentrations associated with severe clinical or metabolic features. Patients under 10 years and over 70 have increased risk of salicylate toxicity, and may require dialysis at an earlier stage.