Drugs List

Therapeutic Indications

Uses

Pain - mild to moderate
Pyrexia (adjunctive treatment)

The product may be recommended as an analgesic and antipyretic for: The symptomatic relief of influenza, feverishness, chills and colds, including feverish colds.
The relief of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains, rheumatic pain and muscular aches and pains.

Contraindications

Children under 16 years
Breastfeeding
Coagulopathy
Haemophilia
History of peptic ulcer
Nasal polyps associated with bronchospasm and NSAIDs
Peptic ulcer
Renal impairment - creatinine clearance below 10ml/minute
Severe cardiac failure
Severe hepatic impairment
Third trimester of pregnancy

Precautions and Warnings

Allergic disposition
Elderly
Anaemia
Asthma
Dehydration
First trimester of pregnancy
G6PD deficiency
Galactosaemia
Glucose-galactose malabsorption syndrome
Lactose intolerance
Mild hepatic impairment
Mild renal impairment
Second trimester of pregnancy
Thyrotoxicosis
Uncontrolled hypertension

NSAIDs may provoke or exacerbate asthma
Sodium content of formulation may be significant
Some formulations contain lactose
Discontinue if signs of gastro-intestinal bleeding occur
Risk of gastrointestinal haemorrhage
Advise on the need to report unusual bleeding
Discontinue if signs of gastro-intestinal ulceration occur
NSAIDs may provoke bronchospasm/urticaria in susceptible patients
May interfere with thyroid function tests
Discuss discontinuation prior to surgery
Discontinue if hypersensitivity reactions occur
Advise patient not to exceed stated dose
Advise patient to consult a doctor if symptoms persist despite treatment

Product should be discontinued if pain gets worse or lasts more than 10 days (or lasts more than 3 days for fever).
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).

Pregnancy and Lactation

Pregnancy

Use aspirin with caffeine with caution in pregnancy.

This product should not be used during the third trimester and should only be used with extreme caution during the first and second trimester were the dose should be the lowest possible and the duration of treatment as short as possible. 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.

Caffeine is also not recommended for use during pregnancy due to the possible increased risk of spontaneous abortion and low birth weight associated with total caffeine consumption above 200 mg per day.

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 to 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 on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Aspirin with caffeine is contraindicated during 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. However, Schaefer (2007) suggest that aspirin should not be used chronically in nursing mothers. Lactmed also suggests if low doses are being taken waiting 1 to 2 hours after a dose to minimize antiplatelet effects in the infant is acceptable, though an alternate drug is preferred over continuous high-dose of aspirin.

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

Side Effects

Abdominal pain
Angioedema
Anxiety
Blood disorders
Bronchospasm
Confusion
Diarrhoea
Dizziness
Dyspepsia
Dyspnoea
Ecchymosis
Fluid retention
Gastric discomfort
Gastric erosions
Gastric irritation
Gastric ulceration
Gastritis
Gastro-intestinal haemorrhage
Gastroesophageal reflux
Gout
Haematemesis
Headache
Hearing disturbances
Hepatotoxicity
Hypersensitivity reactions
Hypoprothrombinaemia
Increase in aminotransferase level
Increased uric acid level
Induces asthma attacks
Insomnia
Iron deficiency anaemia
Irritability
Melaena
Nausea
Nervousness
Palpitations
Prolonged bleeding
Renal disorders
Restlessness
Reye's syndrome
Rhinitis
Skin reactions
Sodium retention
Subconjunctival haemorrhage
Sweating
Thrombocytopenia
Tinnitus
Tremor
Urticaria
Vomiting

Presentation

Powders and tablets containing aspirin and caffeine

Drugs List

Therapeutic Indications

Uses

Pain - mild to moderate
Pyrexia (adjunctive treatment)

The product may be recommended as an analgesic and antipyretic for: The symptomatic relief of influenza, feverishness, chills and colds, including feverish colds.
The relief of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains, rheumatic pain and muscular aches and pains.

Dosage

Adults

Elderly

Children

Contraindications

Children under 16 years
Breastfeeding
Coagulopathy
Haemophilia
History of peptic ulcer
Nasal polyps associated with bronchospasm and NSAIDs
Peptic ulcer
Renal impairment - creatinine clearance below 10ml/minute
Severe cardiac failure
Severe hepatic impairment
Third trimester of pregnancy

Precautions and Warnings

Allergic disposition
Elderly
Anaemia
Asthma
Dehydration
First trimester of pregnancy
G6PD deficiency
Galactosaemia
Glucose-galactose malabsorption syndrome
Lactose intolerance
Mild hepatic impairment
Mild renal impairment
Second trimester of pregnancy
Thyrotoxicosis
Uncontrolled hypertension

NSAIDs may provoke or exacerbate asthma
Sodium content of formulation may be significant
Some formulations contain lactose
Discontinue if signs of gastro-intestinal bleeding occur
Risk of gastrointestinal haemorrhage
Advise on the need to report unusual bleeding
Discontinue if signs of gastro-intestinal ulceration occur
NSAIDs may provoke bronchospasm/urticaria in susceptible patients
May interfere with thyroid function tests
Discuss discontinuation prior to surgery
Discontinue if hypersensitivity reactions occur
Advise patient not to exceed stated dose
Advise patient to consult a doctor if symptoms persist despite treatment

Product should be discontinued if pain gets worse or lasts more than 10 days (or lasts more than 3 days for fever).
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).

Pregnancy and Lactation

Pregnancy

Use aspirin with caffeine with caution in pregnancy.

This product should not be used during the third trimester and should only be used with extreme caution during the first and second trimester were the dose should be the lowest possible and the duration of treatment as short as possible. 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.

Caffeine is also not recommended for use during pregnancy due to the possible increased risk of spontaneous abortion and low birth weight associated with total caffeine consumption above 200 mg per day.

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 to 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 on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Aspirin with caffeine is contraindicated during 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. However, Schaefer (2007) suggest that aspirin should not be used chronically in nursing mothers. Lactmed also suggests if low doses are being taken waiting 1 to 2 hours after a dose to minimize antiplatelet effects in the infant is acceptable, though an alternate drug is preferred over continuous high-dose of aspirin.

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

Side Effects

Abdominal pain
Angioedema
Anxiety
Blood disorders
Bronchospasm
Confusion
Diarrhoea
Dizziness
Dyspepsia
Dyspnoea
Ecchymosis
Fluid retention
Gastric discomfort
Gastric erosions
Gastric irritation
Gastric ulceration
Gastritis
Gastro-intestinal haemorrhage
Gastroesophageal reflux
Gout
Haematemesis
Headache
Hearing disturbances
Hepatotoxicity
Hypersensitivity reactions
Hypoprothrombinaemia
Increase in aminotransferase level
Increased uric acid level
Induces asthma attacks
Insomnia
Iron deficiency anaemia
Irritability
Melaena
Nausea
Nervousness
Palpitations
Prolonged bleeding
Renal disorders
Restlessness
Reye's syndrome
Rhinitis
Skin reactions
Sodium retention
Subconjunctival haemorrhage
Sweating
Thrombocytopenia
Tinnitus
Tremor
Urticaria
Vomiting

Effects on Laboratory Tests

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 ).

Further Information

Last Full Review Date: July 2015

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, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on 13 July 2015.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications Accessed on 13 July 2015.

Summary of Product Characteristics: Beechams Powders. Beecham Group plc. Revised January 2011.

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
Caffeine Last revised: 07 September 2013
Last accessed: 13 July 2015

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
Caffeine Last revised: 02 June 2015
Last accessed: 13 July 2015