Aspirin Tablets Bp 300mg
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Soluble Aspirin Tablets B.P. 300mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Soluble Aspirin Tablets contain 300mg of Aspirin B.P.
3 PHARMACEUTICAL FORM
Compressed Tablets
White, flat circular tablets with bevelled edge with breakline on one face.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief of Analgesic (headache), Antipyretic, migraine, rheumatic pains, neuralgia, period pain, toothache and symptoms of colds and influenza.
For oral administration.
4.2 Posology and method of administration:
Route of administration: Dose is dispersed in water and given orally.
Adults and children over 16 years: 1 to 3 tablets daily.
Should not be given to children under 16 except on medical advice.
This dose may be taken if necessary up 4 times a day at intervals of not less than 4 hours.
The dosage should not be continued for more than 3 days without consulting a doctor.
Do not give to children under 16 years, unless specifically indicated (e.g. for Kawasaki’s disease).
Elderly: There is no need or dosage reduction in the elderly.
Contra-indications:
4.3
A history of, or active peptic ulceration. Haemophilia or other clotting disorders, gout, asthma, angiodema, urticaria, hypertension, rhinitis or other evidence of hypersensitivity to aspirin or non steroidal antiinflammatory drugs. Aspirin should be avoided in severe renal or hepatic impairment. Breast feeding is contraindicated at high doses.
4.4 Special warnings and precautions for use:
Do not exceed stated dose except under medical advice and supervision of a doctor. Do not give to children under 16 except on medical advice.
There is a possible association between aspirin and Reyes Syndrome when administered to children with a fever. Reye's syndrome is a very rare disease, which affects the brain and liver, and can be fatal. For this reason it should not normally be given to children under 16 years of age except on medical advice. (E.g. for Kawasaki's disease)
Keep all medicines out of the reach of children.
4.5 Interaction with other medicaments and other forms of interaction:
Alcohol and corticosteroids may enhance the effects of aspirin on the gastrointestinal tract. Aspirin may enhance the effects of coumarin anticoagulants and oral hypoglycaemics of the sulphonylurea type. The toxicity of methotrexate may be enhanced by concomitant use of aspirin. Aspirin diminishes the action of uricosurics.
4.6 Fertility, pregnancy and lactation
Use during pregnancy, particularly of chronic or intermittent high doses should be avoided. Use in the third trimester should be avoided since the drug may affect maternal and newborn haemostatic mechanisms, leading to an increased risk of haemorrhage. Aspirin may also delay the onset and increase the duration of labour. With high doses there may be premature closure of the ductus arteriosus, leading possibly to persistent pulmonary hypertension.
Aspirin should be avoided during lactation because of the possible risk of Reye's syndrome. Regular use of high doses could impair platelet function and produce hypoprothrombinaemia in infants, if neonatal vitamin K stores are low.
Aspirin may displace bilirubin from plasma albumin and may lead to kernicterus in jaundiced neonates.
4.7. Effects on ability to drive and use machines
None stated.
4.8
Undesirable Effects:
Dyspepsia, nausea and vomiting. Less commonly irritation of the gastrointestinal mucosa may lead to erosion, ulceration and gastrointestinal bleeding. Hypersensitivity reactions including urticaria rhinitis, angioneurotic oedema (gout) and severe bronchospasm.
May cause tinnitus at high doses and induce asthma attacks in susceptible subjects.
4.9 Overdose:
Salicylate poisoning is usually associated with plasma concentrations>350mg/L (2.5mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L (5.1mmol/L). Single doses less than 100mg/kg are unlikely to cause serious poisoning.
Common features of salicylate poisoning 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 of salicylate poisoning 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.
Give activated charcoal if an adult presents within one hour of ingestion of more than 250mg/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>700mg/L (5.1mmol/L), or lower concentrations associated with severe clinical or metabolic features. Patients under 10 years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.
Restoration of acid base balance may be necessary.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Aspirin has analgesic, antipyretic and antiinflammatory actions which are considered to be due to inhibition of the synthesis of prostaglandins.
5.2 Pharmacokinetic properties:
Absorption of non-ionised aspirin occurs in the stomach and intestine. Some aspirin is hydrolysed to salicylate in the gut wall. After absorption aspirin is rapidly converted to salicylate but during the first 20 minutes following oral administration, aspirin is the predominant form of the drug in the plasma. Aspirin is bound to plasma proteins and is widely distributed. Plasma aspirin concentrations decline rapidly (half life 15-20 minutes) as plasma salicylate concentrations increase.
Salicylate is mainly eliminated by hepatic metabolism; the metabolites including salicyluric acid, salicyl phenolic glucuronide, salicylic acyl glucuronide, gentisic acid and gentisuric acid. The formation of the major metabolites, salicyluric acid and salicyl phenolic glucuronide is easily saturated and follows michaelis-menten kinetics; the other metabolic routes are first-order processes. As a result, steady-state plasma-salicylate concentrations increase disproportionately with dose. Following a 325-mg aspirin dose, elimination is a first order process and the plasma salicylate half-life is about 2 to 3 hours; at high aspirin doses, the half-life increases to 15 to 30 hours. Salicylate is also excreted unchanged in the urine; the amount excreted by this route increases with increasing dose and also depends on urinary pH, about 30% of a dose being excreted in alkaline urine compared with 2% of a dose in acidic urine. Renal excretion involves glomerular filtration, active renal tubular secretion and passive tubular reabsorption.
5.3. Preclinical safety data
Not applicable.
6. Pharmaceutical Particulars
6.1. List of excipients
Citric Acid Calcium Carbonate Saccharin Sodium Lactose (Anhydrous)
Maize Starch Purified Talc Sodium Lauryl Sulphate
6.2.
Incompatibilities
None stated.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Store in a cool, dry place protected from bright light.
6.5. Nature and contents of container
Dispensing pack - A polypropylene container with snap lid. Supplied in packs of 50, 100, 250, 500 and 1000. (POM).
OTC packs - A polypropylene container with snap lid. Supplied in packs of 24 and 25. (P).
GSL pack - A polypropylene container with snap lid. Supplied in packs of 12 and 16. (GSL).
6.6. Instruction for use, handling and disposal
Dose is dispersed in water and given orally.
7 MARKETING AUTHORISATION HOLDER
Pharmvit Limited 177 Bilton Road,
Perrivale
Greenford
Middlesex UB6 7HQ
8. MARKETING AUTHORISATION NUMBER
PL 4556/0014
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30th November 1990
Renewel Date: 29th January 2004
10 DATE OF REVISION OF THE TEXT
30/04/2013