Drugs List

Therapeutic Indications

Uses

Aspirin has analgesic, antipyretic, anti-inflammatory and anti-thrombotic actions.

Relief of mild to moderate pain, including headache, migraine, neuralgia, dysmenorrhoea, dental pain and sore throats.

Reduction of temperature in fever, influenza and colds.

Management of pain and inflammation in acute and chronic rheumatic disorders, sciatica, lumbago, fibrositis, muscular aches and pains

For secondary prophylaxis of thrombosis after myocardial infarction, and in, unstable angina, ischaemic stroke including transient ischaemic attacks and following bypass surgery.

Not all available brands are licensed for all indications

Unlicensed Uses

In children under the age of 16 in Kawasaki's Disease or for antiplatelet action (See Dosage; Children & Neonates, Contraindications and CSM Warnings sections)

Administration

For oral administration with or after food.

Effervescent or dispersible tablets should be dissolved or mixed with water before taking.

Orodispersible tablets disperse on the tongue without water.

Contraindications

Peptic ulceration

History of peptic ulceration

Haemophilia or other clotting disorders

Nasal polyps associated with asthma

Suspected intracranial haemorrhage

Asthma, urticaria, rhinitis or other symptoms resulting from a hypersensitivity to aspirin or non steroidal anti-inflammatory drug.

Due to the risk of Reye's Syndrome, children under 16 years unless specifically indicated as in, for example, Kawasaki's Disease or when used for its antiplatelet action.

Gout

Severe cardiac failure

Severe renal impairment due to risk of sodium and water retention, deterioration in renal function and increased risk of gastrointestinal bleeding.

Severe hepatic impairment due to increased risk of gastrointestinal bleeding.

Breastfeeding (see Lactation)

Precautions and Warnings

Not all brands are licensed for all indications

Mild to moderate hepatic impairment

Mild to moderate renal impairment

Pregnancy (see Pregnancy)

Asthma. Any degree of worsening of asthma may be related to the ingestion of aspirin. ( See CSM Warning section )

Allergic disorders - NSAIDs may provoke bronchospasm/urticaria in susceptible patients

Dehydration

Anaemia

Cardiac failure

Systemic lupus erythematosus

Thyrotoxicosis

Uncontrolled hypertension - monitor patients carefully

Elderly - more likely to experience gastric side effects and tinnitus. Long term use should be avoided due to the increased risk of gastrointestinal bleeding.

Patients with hereditary glucose 6-phosphate dehydrogenase (G6PD) deficiency due to the risk of haemolysis. Use is usually acceptable up to a dose of at least 1g daily in most patients but individual response should be monitored carefully.

Patients taking aspirin present an increased risk for surgery. Discontinuation several days prior to surgery should be discussed with the anaesthetist and surgeon.

There is a 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 aspirin should not be given to children under 16 years unless specifically indicated (e.g. for Kawasaki's disease)

Before commencing long term aspirin therapy for the management of cardiovascular or cerebrovascular disease, patients should consult their doctor who can advise on the relative benefits of aspirin versus the risks for the individual patient.

Aspirin decreases platelet adhesiveness and increases bleeding time, and so patients should be advised to report any unusual bleeding to their doctor

Patients should be advised to consult their doctor if symptoms persist despite treatment

CSM Warnings

Do not give aspirin to children under 16 years unless medically indicated (e.g. for Kawasaki syndrome)

Any degree of worsening of asthma may be related to the ingestion of NSAIDs, either prescribed or (in the case of ibuprofen and others) purchased over the counter.

Pregnancy and Lactation

Pregnancy

This medication should be used with extreme caution during the first and second trimester. This product should not be used during the third trimester. Aspirin has been used for many years during pregnancy, however, the safety of aspirin in pregnancy is still under question. Aspirin crosses the placenta and can accumulate in the foetus due to slow elimination by the foetus. Briggs (2008) states that aspirin used near term may prolong gestation and labour, and increase the risk of haemorrhage during delivery. Premature closure of the ductus arteriosus may occur if aspirin is used late in the pregnancy, with the possibility of the associated complication of persistent pulmonary hypertension of the newborn. Therefore, this product is contraindicated during the third trimester and extreme caution is advised if this product is to be used during the first and second trimesters.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password at ( https://www.toxbase.org/ ) or if this is unavailable at the backup site ( https://www.TOXBASEbackup.org/ ).

Licensed in pregnancy? - No

Recommended for use in pregnancy? - No

Known human teratogen? - Unknown

Crosses placenta? - Aspirin is known to cross the placenta.

Effects on foetus - There is still a question about the safety of aspirin during the pregnancy, however, use near term is associate with premature closure of the ductus arteriosus, persistent pulmonary hypertension of the newborn, and haemorrhage.

Pregnancy-specific adverse effects on the mother - Aspirin is associated with prolonged gestation and labour, and haemorrhage.

Lactation

The medication is contraindicated while breastfeeding. Aspirin in excreted in breast milk in small amounts, although aspirin clearance from breast milk is slower than that from plasma. High doses of aspirin present a potential risk to the infants platelet function. There is a 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. Aspirin is associated with significant effects on some nursing infants and should be given to nursing mothers with caution. However, Schaefer (2007) and Lee (2000) both suggest that aspirin should not be used chronically in nursing mothers.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Drug excreted in breast milk? - Yes.

Considered suitable or recommended by manufacturer? - No

UK Drugs in Lactation Advisory Service Classification - Aspirin is classified as - insufficient information relating to breast-feeding available to allow classification as a safe drug.

Drug substance licensed in infants? - No

Side Effects

Anaemia
Haemolytic anaemia
Hypoprothrombinaemia
Thrombocytopenia
Aplastic anaemia
Pancytopenia
Prolonged bleeding time
Occult blood loss
Elevated transaminase levels
Agranulocytosis
Gastrointestinal bleeding
Gastric erosions
Gastric ulceration
Gastric irritation
Gastric haemorrhage
Hepatitis
Tinnitus
Dizziness
Deafness
Sweating
Nausea
Vomiting
Headache
Confusion
Rhinitis
Urticaria
Purpura
Stevens-Johnson syndrome
Angioneurotic oedema
Angioedema
Asthma
Bronchospasm
Gastritis
Epistaxis
Haematuria
Ecchymosis
Haemoptysis
Haematoma
Cerebral haemorrhage
Rash
Anaphylaxis
Urate kidney stones
Melaena
Hypersensitivity reactions
Hepatotoxicity
Skin reactions
Blood disorders
Dyspepsia
Dyspnoea

Presentation

Tablets containing aspirin 300mg
Dispersible tablets containing aspirin 300mg
Dispersible tablets containing aspirin 500mg
Orodispersible tablets containing aspirin 300mg
Effervescent tablets containing aspirin 300mg
Enteric coated tablets containing aspirin 300mg

Drugs List

Therapeutic Indications

Uses

Aspirin has analgesic, antipyretic, anti-inflammatory and anti-thrombotic actions.

Relief of mild to moderate pain, including headache, migraine, neuralgia, dysmenorrhoea, dental pain and sore throats.

Reduction of temperature in fever, influenza and colds.

Management of pain and inflammation in acute and chronic rheumatic disorders, sciatica, lumbago, fibrositis, muscular aches and pains

For secondary prophylaxis of thrombosis after myocardial infarction, and in, unstable angina, ischaemic stroke including transient ischaemic attacks and following bypass surgery.

Not all available brands are licensed for all indications

Unlicensed Uses

In children under the age of 16 in Kawasaki's Disease or for antiplatelet action (See Dosage; Children & Neonates, Contraindications and CSM Warnings sections)

Dosage

Not all brands are licensed for all indications.

Adults

Children

Patients with Renal Impairment

Patients with Hepatic Impairment

Administration

For oral administration with or after food.

Effervescent or dispersible tablets should be dissolved or mixed with water before taking.

Orodispersible tablets disperse on the tongue without water.

Contraindications

Peptic ulceration

History of peptic ulceration

Haemophilia or other clotting disorders

Nasal polyps associated with asthma

Suspected intracranial haemorrhage

Asthma, urticaria, rhinitis or other symptoms resulting from a hypersensitivity to aspirin or non steroidal anti-inflammatory drug.

Due to the risk of Reye's Syndrome, children under 16 years unless specifically indicated as in, for example, Kawasaki's Disease or when used for its antiplatelet action.

Gout

Severe cardiac failure

Severe renal impairment due to risk of sodium and water retention, deterioration in renal function and increased risk of gastrointestinal bleeding.

Severe hepatic impairment due to increased risk of gastrointestinal bleeding.

Breastfeeding (see Lactation)

Precautions and Warnings

Not all brands are licensed for all indications

Mild to moderate hepatic impairment

Mild to moderate renal impairment

Pregnancy (see Pregnancy)

Asthma. Any degree of worsening of asthma may be related to the ingestion of aspirin. ( See CSM Warning section )

Allergic disorders - NSAIDs may provoke bronchospasm/urticaria in susceptible patients

Dehydration

Anaemia

Cardiac failure

Systemic lupus erythematosus

Thyrotoxicosis

Uncontrolled hypertension - monitor patients carefully

Elderly - more likely to experience gastric side effects and tinnitus. Long term use should be avoided due to the increased risk of gastrointestinal bleeding.

Patients with hereditary glucose 6-phosphate dehydrogenase (G6PD) deficiency due to the risk of haemolysis. Use is usually acceptable up to a dose of at least 1g daily in most patients but individual response should be monitored carefully.

Patients taking aspirin present an increased risk for surgery. Discontinuation several days prior to surgery should be discussed with the anaesthetist and surgeon.

There is a 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 aspirin should not be given to children under 16 years unless specifically indicated (e.g. for Kawasaki's disease)

Before commencing long term aspirin therapy for the management of cardiovascular or cerebrovascular disease, patients should consult their doctor who can advise on the relative benefits of aspirin versus the risks for the individual patient.

Aspirin decreases platelet adhesiveness and increases bleeding time, and so patients should be advised to report any unusual bleeding to their doctor

Patients should be advised to consult their doctor if symptoms persist despite treatment

CSM Warnings

Do not give aspirin to children under 16 years unless medically indicated (e.g. for Kawasaki syndrome)

Any degree of worsening of asthma may be related to the ingestion of NSAIDs, either prescribed or (in the case of ibuprofen and others) purchased over the counter.

Pregnancy and Lactation

Pregnancy

This medication should be used with extreme caution during the first and second trimester. This product should not be used during the third trimester. Aspirin has been used for many years during pregnancy, however, the safety of aspirin in pregnancy is still under question. Aspirin crosses the placenta and can accumulate in the foetus due to slow elimination by the foetus. Briggs (2008) states that aspirin used near term may prolong gestation and labour, and increase the risk of haemorrhage during delivery. Premature closure of the ductus arteriosus may occur if aspirin is used late in the pregnancy, with the possibility of the associated complication of persistent pulmonary hypertension of the newborn. Therefore, this product is contraindicated during the third trimester and extreme caution is advised if this product is to be used during the first and second trimesters.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password at ( https://www.toxbase.org/ ) or if this is unavailable at the backup site ( https://www.TOXBASEbackup.org/ ).

Licensed in pregnancy? - No

Recommended for use in pregnancy? - No

Known human teratogen? - Unknown

Crosses placenta? - Aspirin is known to cross the placenta.

Effects on foetus - There is still a question about the safety of aspirin during the pregnancy, however, use near term is associate with premature closure of the ductus arteriosus, persistent pulmonary hypertension of the newborn, and haemorrhage.

Pregnancy-specific adverse effects on the mother - Aspirin is associated with prolonged gestation and labour, and haemorrhage.

Lactation

The medication is contraindicated while breastfeeding. Aspirin in excreted in breast milk in small amounts, although aspirin clearance from breast milk is slower than that from plasma. High doses of aspirin present a potential risk to the infants platelet function. There is a 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. Aspirin is associated with significant effects on some nursing infants and should be given to nursing mothers with caution. However, Schaefer (2007) and Lee (2000) both suggest that aspirin should not be used chronically in nursing mothers.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Drug excreted in breast milk? - Yes.

Considered suitable or recommended by manufacturer? - No

UK Drugs in Lactation Advisory Service Classification - Aspirin is classified as - insufficient information relating to breast-feeding available to allow classification as a safe drug.

Drug substance licensed in infants? - No

Effects on Ability to Drive and Operate Machinery

None known

Counselling

Aspirin decreases platelet adhesiveness and increases bleeding time, and so patients should be advised to report any unusual bleeding to their doctor

Patients should be advised to consult their doctor if symptoms persist despite treatment or if they are considering self-medication for anti-thrombotic effect.

Side Effects

Anaemia
Haemolytic anaemia
Hypoprothrombinaemia
Thrombocytopenia
Aplastic anaemia
Pancytopenia
Prolonged bleeding time
Occult blood loss
Elevated transaminase levels
Agranulocytosis
Gastrointestinal bleeding
Gastric erosions
Gastric ulceration
Gastric irritation
Gastric haemorrhage
Hepatitis
Tinnitus
Dizziness
Deafness
Sweating
Nausea
Vomiting
Headache
Confusion
Rhinitis
Urticaria
Purpura
Stevens-Johnson syndrome
Angioneurotic oedema
Angioedema
Asthma
Bronchospasm
Gastritis
Epistaxis
Haematuria
Ecchymosis
Haemoptysis
Haematoma
Cerebral haemorrhage
Rash
Anaphylaxis
Urate kidney stones
Melaena
Hypersensitivity reactions
Hepatotoxicity
Skin reactions
Blood disorders
Dyspepsia
Dyspnoea

Effects on Laboratory Tests

Large doses of aspirin may interfere with thyroid function tests.

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

The MHRA have produced 'generic' overdose sections for the top ten drugs for which the NPIS received the greatest number of queries about management of overdose in 2002. This information is attached below:

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 (95.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning.

Signs and 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.

Treatment

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.

Shelf Life and Storage

Storage requirements vary according to brand

Further Information

Last full review: May 2011

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 8th edition (2008) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Martindale: The Complete Drug Reference, 36th edition (2009) ed. Sweetman, S. Pharmaceutical Press, London.

Medications and Mother's Milk, 12th edition (2006) Hale, T.W. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Aspirin tablets 300mg. Actavis UK Ltd. Revised October 2010.
Summary of Product Characteristics: Disprin Direct. Reckitt Benckiser Healthcare. Revised January 2009.
Summary of Product Characteristics: Disprin. Reckitt Benckiser Healthcare. Revised January 2009.
Summary of Product Characteristics: Nu-Seals 300. Alliance Pharmaceuticals. Revised August 2010.

Therapeutics in Pregnancy and Lactation (2000) Lee, A., Inch, S. and Finnigan, D. Radcliffe Medical Press, Abingdon.

MHRA 19th September 2005
https://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Informationforlicenceapplicants/Guidance/OverdosesectionsofSPCs/Genericoverdosesections/index.htm
Last accessed: 9th May 2011

UK Drugs in Lactation Advisory Service.
Available at: https://www.ukmicentral.nhs.uk/drugpreg/qrg_p1.asp
Last accessed: March 9, 2009.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Aspirin Last revised: December 27, 2007.
Last accessed: March 9, 2009.

Interpretation of Diagnostic Tests 4th Ed. Wallach et al. Little, Brown and Co.

SIGN Guideline 13: Management of patients with stroke
Section 4. pp 12-13.
URL: https://www.sign.ac.uk/pdf/sign13.pdf
Last accessed 24/08/06

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 18 August 2017