ASPIRIN Tablets BP 300mg Ref.[4772] Active ingredients: Acetylsalicylic acid

Posology

Adults including elderly: 1-2 tablets (300-600mg) every 3-4 hours as required, to a maximum of 12 tablets (3.6g) daily in divided doses.

Children: Do not give to children aged under 16 years, unless specifically indicated (e.g. for Kawasaki’s disease).

Antithrombotic action: For its antithrombotic effect following myocardial infarction, transient ischaemic attack, or in patients with unstable angina, the recommended dose is 300mg daily.

Method of Administration

For oral administration.

Although considerable inter-individual variations are involved, it can be considered that the toxic dose is about 200 mg/kg in adults and 100 mg/kg in children. The lethal dose of acetylsalicylic acid is 25-30 grams. Salicylate poisoning is usually associated with plasma concentrations >350 mg/L (2.5 mmol/L). Plasma concentrations above 500 mg/l in adults and 300 mg/l in children generally cause severe toxicity. 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.

Plasma salicylate concentrations should be measured urgently for patients who are thought to have ingested more than 125 mg/kg of aspirin. The sample should be taken at least 2 hours (symptomatic patients) or 4 hours (asymptomatic patients) after ingestion, since it may take several hours for peak plasma concentrations to occur and up to 12 hours for enteric-coated preparations. A repeat sample should be taken in ALL symptomatic patients and those with concentrations greater than 500 mg/L after a further 2 hours because of the possibility of continuing absorption. Under these circumstances, measurements should be repeated every 3 hours until concentrations are falling.

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 four years. In children aged four 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.

Other symptoms may include: headache, nausea, or abdominal pain.

Central nervous system features including confusion, restlessness, hallucinations, disorientation, coma, cardiovascular collapse, respiratory arrest and convulsions are less common in adults than in children.

Management

If a toxic dose has been ingested, hospital admission is required.

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 alkalinisation, 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 ten years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.

Other symptoms to be treated symptomatically.

Shelf life: Three years from the date of manufacture.

Shelf-life after dilution/reconstitution: Not applicable.

Shelf-life after first opening: Not applicable.

Store below 25°C in a dry place.

OTC Packs: The product containers are polyethylene snap-safe vials (CRC) or, as an alternative, amber glass bottles with clic-loc caps both with integral seal, cotton wool or polyfoam wad headspace filler.

Dispensing Packs: The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers with polyfoam wad or polyethylene ullage filler and snap-on polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps and polyfoam wad or cotton wool. An alternative closure for polyethylene containers is a polypropylene, twist on, push down and twist off child-resistant, tamper-evident lid.

The product may also be supplied in blister packs in cartons:

a) Carton: Printed carton manufactured from white folding box board.

b) Blister pack: (i) 250µm white rigid PVC. (ii) Surface printed 20µm hard temper aluminium foil with 5-6g/M² PVC and PVdC compatible heat seal lacquer on the reverse side.

c) Child Resistant Blister Pack: (i) 250µm white rigid PVC. (ii) 9µm soft aluminium / 35g/m² glassine paper.

Pack sizes:

GSL: 7’s, 8’s, 10’s, 14’s, 16’s

P: 20’s, 21’s, 25’s, 28’s, 30’s, 32’s,

POM: 40’s, 48’s, 50’s, 56’s, 60’s, 84’s, 90’s, 100’s, 112’s, 500’s, 1000’s.

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs are included for temporary storage of the finished product before final packaging into the proposed marketing containers.

Maximum size of bulk packs: 50,000.

Not applicable.