NU-SEALS Tablet Ref.[27728] Active ingredients: Acetylsalicylic acid

Posology

Nu-Seals 75 is for oral administration to adults only.

Patients should seek the advice of a doctor before commencing therapy for the first time.

The usual dosage, for long-term use, is 75-150mg once daily. 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.

For antithrombotic action: 150mg at diagnosis and 75mg daily thereafter. Tablets taken at diagnosis should be chewed in order to gain rapid absorption.

Special populations

The elderly

The risk-benefit ratio of the antithrombotic action of aspirin has not been fully established.

Paediatric population

Do not give to children aged under 16 years, unless specifically indicated (e.g. for Kawasaki’s disease). See ‘Special warnings and precautions for use’.

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.

With the gastro-resistant formulation, peak plasma levels may not occur for up to 12 hours.

Salicylate toxicity (>100 mg/kg/day over 2 days may produce toxicity) may result from chronic, therapeutically acquired, intoxication, or from, potentially life-threatening, acute intoxications (overdose), ranging from accidental ingestions in children to incidental intoxications.

Chronic salicylate poisoning can be insidious as signs and symptoms are non-specific. Mild chronic salicylate intoxication, or salicylism, usually occurs only after repeated use of large doses.

Symptoms

Common features include dizziness, vomiting, dehydration, tinnitus, vertigo, deafness, sweating, headache, confusion, warm extremities with bounding pulses, increased respiratory rate and hyperventilation. Symptoms may be controlled by reducing the dosage. Tinnitus can occur at plasma concentrations of 150 to 300 micrograms/mL. More serious adverse events occur at concentrations above 300 micrograms/mL.

The principle feature of acute intoxication is severe disturbance of the acid-base balance, which may vary with age and severity of intoxication. The most common presentation for a child is metabolic acidosis. The severity of poisoning cannot be estimated from plasma concentration alone. Absorption of acetylsalicylic acid can be delayed due to reduced gastric emptying, formation of concretions in the stomach, or as a result of ingestion of enteric-coated preparations. Management of acetylsalicylic acid intoxication is determined by its extent, stage and clinical symptoms and according to standard poisoning management techniques. Predominant measures should be the accelerated excretion of the drug as well as the restoration of the electrolyte and acid-base metabolism.

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 tachypnoea, diaphoresis, haematemesis, hyperpyrexia, hypoglycaemia or hyperglycaemia (more common in younger children), increased ketone levels, hypokalaemia, hypernatraemia, hypoprothrombinaemia, thrombocytopenia, increased INR/PTR, intravascular coagulation, dehydration, oliguria, renal failure, GI bleeding, non-cardiogenic pulmonary oedema, asphyxiation, respiratory arrest, dysarrhythmias, hypotension, PT prolongation and cardiovascular arrest.

Central nervous system features including toxic encephalopathy with manifestations ranging from confusion, disorientation, lethargy, coma and convulsions are less common in adults than in children.

Management

Consider administration of activated charcoal if an adult present within one hour of ingestion of 125 mg/kg or more. Where the practical expertise exists, gastric lavage can be considered in adults presenting within 1 hour of a potentially life-threatening overdose (500 mg/kg salicylate or more), providing the airway can be protected. The plasma salicylate concentration should be measured for patients who have ingested >125 mg/kg. However, the severity of poisoning cannot be determined from this alone and the clinical and biochemical features must be taken into account. Urea and electrolytes, INR/PTR and blood glucose should be monitored.

Elimination is increased by urinary alkalisation, which is achieved by the administration of intravenous sodium bicarbonate. The urine pH should be monitored and further intravenous sodium bicarbonate may be required to maintain urinary pH 7.5-8.5 (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.

UPVC/Al blisters – 3 years.

HDPE bottles – 2 years.

Do not store above 25°C. Keep containers tightly closed.

Blisters comprising of UPVC on one side and aluminium foil on the other containing 14, 28, 56 or 84 tablets. HDPE bottles with screw caps containing 500 tablets.

None.