Aspirin Tablets Bp 300mg
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aspirin Tablets BP 300mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Aspirin 300mg For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness.
Mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains.
4.2 Posology and method of administration
To be swallowed orally.
Usual single dose 300 - 1000mg.
Maximum daily dose 4g in divided doses.
Dosage instructions should include:-
a) Time intervals between doses (4-6 hours)
b) Maximum daily dose in number of tablets (4 doses, 12 tablets)
Do not give to children under 16 years, unless specifically indicated (e.g. Kawasaki’s disease).
4.3 Contraindications
“Do not take if you have a stomach ulcer.”
4.4 Special warnings and precautions for use
Caution should be exercised in patients with asthma, allergic disease, impairment of hepatic or renal function (avoid if severe) and dehydration.
Do not take if you have, or have had, a stomach ulcer.
If symptoms persist for more than 3 days consult your doctor.
Medicines should not be taken in pregnancy without consulting your doctor. Keep out of the reach of children.
Do not give to children under 16 years of age unless on the advice of your doctor.
There is possible association between Aspirin and Reye’s syndrome when given to children. Reye’s syndrome is a very rare disease which affects the brain and liver and can be fatal. For this reason it should not be given to children under 16, unless specifically indicated (e.g. Kawasaki’s disease).
4.5 Interaction with other medicinal products and other forms of interaction
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(i) |
May enhance the effects of anticoagulants, and oral hypoglycaemic agents. |
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(ii) |
May enhance the effects of phenytoin and sodium valproate. |
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(iii) |
The activity of methotrexate may be markedly enhanced and its toxicity increased. |
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(iv) |
May inhibit action of uricosurics. |
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(v) |
The toxicity of sulphonamides may also be increased. |
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(vi) |
May reduce the efficacy of antihypertensive drugs. |
4.6 Pregnancy and lactation
There is clinical and epidemiological evidence of safety in human pregnancy. Aspirin may prolong labour and contribute to maternal and neonatal bleeding, and is best avoided at term and during breast feeding -possible risk of Reye's syndrome. Regular use of high doses could impair platelet function and produce hypoprothrombinaemia in the infant if neonatal Vitamin K stores are low.
4.7 Effects on ability to drive and use machines
Aspirin does not usually affect the ability to drive or operate machinery.
4.8 Undesirable effects
Aspirin may precipitate bronchospasm, and induce attacks of asthma in susceptible subjects. It may induce gastro-intestinal haemorrhage, occasionally major.
4.9 Overdose
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 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.
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 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 10 years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Aspirin is an analgesic and antipyretic with anti-inflammatory properties. Aspirin inhibits prostaglandin synthetase.
5.2 Pharmacokinetic properties
Absorption: Aspirin is rapidly absorbed after oral administration, with some hydrolysis to salicylate before absorption. Absorption is delayed by the presence of food and is impaired in patients suffering migraine attacks. Absorption is more rapid in patients with achlorhydria and also following administration of polysorbates and antacids.
Blood Concentration: Peak plasma concentrations of approximately 45
mcg/ml are attained 1-2 hours after an oral dose of 640mg, but stabilise at approximately 270 mcg/ml after oral doses of 3g daily. After an oral dose of about 2g, peak plasma concentrations of approximately 15mcg/ml of aspirin are attained in about one hour and peak plasma concentrations of approximately 130mcg/ml of salicylate are attained in 2 to 4 hours.
Half Life:
Plasma/Aspirin Approximately 17 minutes
Plasma/Salicylate Low doses 2-4 hours, High doses up to 19 hours
Distribution: Aspirin is found in the saliva, milk, plasma and synovial fluid at concentrations less than blood and crosses the placenta.
Salicylate/extensive protein building.
Aspirin/protein binding to a small extent.
Metabolism: In the blood, rapid hydrolysis to salicylate acid; glucuronic
acid/glycine conjugation to form glucuronides and salicyluronic acid; oxidation of a small proportion.
Excretion: Excreted in the urine mainly as salicyluronic acid. Salicylate
reabsorbed by renal tubules in acid urine, and alkaline diuresis will increase the rate of excretion; 85% of dose excreted as free salicylate.
5.3 Preclinical safety data
Not applicable.
PHARMACEUTICAL PARTICULARS
6
6.1 List of excipients
Maize Starch B.P.
6.2 Incompatibilities
Aspirin is pharmaceutically incompatible with iron salts and alkalis.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Do not store above 25 °C and protect from light.
6.5 Nature and contents of container
16 blister packs (pvc - polyvinyl chloride)
Tablet containers: Cope Allman Plastics snapsafe vial fitted snapsafe childproof closure.
GSL pack 16
6.6 Special precautions for disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
Zanza Laboratories (Holdings) Limited Unit 2
Olympic Way Sefton Business Park LIVERPOOL
L30 1RD
8 MARKETING AUTHORISATION NUMBER(S)
PL 39874/0021
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
30 March 2006
10 DATE OF REVISION OF THE TEXT
15/11/2011