Aspirin oral formulations (75mg)
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of low dose aspirin.
Drugs List
Therapeutic Indications
Uses
Thrombotic cardiovascular disease: secondary prevention
Thrombotic cerebrovascular disease: secondary prevention
Thrombus formation after cardiac surgery: prevention
Unlicensed Uses
Kawasaki syndrome
Dosage
Adults
75mg to 150mg once a day.
If considered necessary, doses up to 300mg may be administered.
Antithrombotic action
Initial dose: 150mg.
75mg once a day thereafter.
Children
Children aged 16 to 18 years
(See Dosage; Adult)
The following alternative dosing schedule may be suitable:
Kawasaki's disease
Children aged 1 month to 12 years (unlicensed)
Initial dose: 7.5mg/kg to 12.5mg/kg four times a day for 2 weeks or until afebrile.
Maintenance dose: 2mg/kg to 5mg/kg once a day for 6 to 8 weeks.
Discontinue treatment or seek specialist advice after 8 weeks if there is no evidence of coronary lesions.
Antiplatelet, prevention of thrombus formation after cardiac surgery
Children aged 12 to 16 years (unlicensed)
75mg once a day.
Children aged 1 month to 12 years (unlicensed)
1mg/kg to 5mg/kg once a day.
Maximum dose of 75mg a day.
Neonates
Kawasaki's disease
Children under 1 month (unlicensed)
Initial dose: 8mg/kg four times a day for 2 weeks or until afebrile.
Maintenance dose: 5mg/kg once a day for 6 to 8 weeks.
Discontinue treatment or seek specialist advice after 8 weeks if there is no evidence of coronary lesions.
Antiplatelet, prevention of thrombus formation after cardiac surgery
Children under 1 month (unlicensed)
1mg/kg to 5mg/kg once a day.
Contraindications
Cerebrovascular haemorrhage
Coagulopathy
Galactosaemia
Gastrointestinal haemorrhage
Gout
Peptic ulcer
Severe hepatic impairment
Severe renal impairment
Thrombocytopenia
Precautions and Warnings
Allergic disposition
Children under 16 years
Conditions where bleeding would be hazardous
Elderly
Surgery
Anaemia
Asthma
Breastfeeding
Dehydration
G6PD deficiency
Glucose-galactose malabsorption syndrome
Hepatic impairment
History of gastrointestinal ulceration
Lactose intolerance
Menorrhagia
Pregnancy
Renal impairment
Uncontrolled hypertension
Adjustment of hypoglycaemic therapy may be necessary in diabetes mellitus
NSAIDs may provoke or exacerbate asthma
Some formulations contain lactose
Discontinue if signs of gastro-intestinal bleeding occur
Monitor patients with pre-existing hypertension
Advise on the need to report unusual bleeding
Discontinue if signs of gastro-intestinal ulceration occur
May precipitate acute rhinitis
NSAIDs may provoke bronchospasm/urticaria in susceptible patients
May interfere with thyroid function tests
Discontinue prior to surgery
Discontinue treatment if skin rash or other allergic reaction occurs
Not licensed for all indications in all age groups
Alcohol may enhance side effects
Aspirin has variable effects on uric acid excretion and may increase plasma rate concentrations.
Pregnancy and Lactation
Pregnancy
Use aspirin with caution in pregnancy.
Whilst animal studies have shown adverse outcomes, clinical studies of human exposure indicate that doses up to 100mg per day for restricted obstetrical use, which require specialised monitoring appear safe.
Caution is advised during the third trimester as aspirin may cause prolonged gestation and labour, cause premature closure of the ductus arteriosus and contribute to neonatal and maternal bleeding.
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
Use aspirin with caution in breastfeeding.
Low quantities of salicylates and of their metabolites are excreted into the breastmilk. Since adverse effects for the infant have not been reported up to now, short term use of the recommended dose does not require suspending lactation. In case of long term use and/or administration of higher doses, breastfeeding should be discontinued.
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
Anaemia
Anaphylactic reaction
Anaphylaxis
Angioedema
Aplastic anaemia
Asthma
Bleeding disorders
Bronchospasm
Cerebral haemorrhage
Diarrhoea
Dyspepsia
Dyspnoea
Ecchymosis
Epistaxis
Erythema multiforme
Erythema nodosum
Gastritis
Gastro-intestinal disturbances
Gastro-intestinal perforation
Gastro-intestinal ulceration
Gastrointestinal bleeding
Gingival bleeding
Granulocytosis
Haematemesis
Haematoma
Haematuria
Haemoptysis
Headache
Hearing disturbances
Hepatic impairment
Hypersensitivity reactions
Hyperuricaemia
Impaired renal function
Increased bleeding tendency
Increased coagulation time
Iron deficiency anaemia
Lyell's syndrome
Melaena
Menorrhagia
Nausea
Purpura
Rash
Rhinitis
Shock
Sodium/water retention
Stevens-Johnson syndrome
Thrombocytopenia
Tinnitus
Urate kidney stones
Urticaria
Vasculitis
Vertigo
Vomiting
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 ).
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.
Further Information
Last Full Review Date: August 2018
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Aspirin 75mg Gastro-Resistant Tablets. Dexcel Pharma Ltd. Revised July 2018.
Summary of Product Characteristics: Danamep. Ecogen Europe Ltd. Revised March 2018.
Summary of Product Characteristics: Mandaprin 75mg Dispersible Tablets. M&A Pharmachem Ltd. Revised March 2018.
Summary of Product Characteristics: Nu-Seals 75. Alliance Pharmaceuticals. Revised February 2013.
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: 02 May 2017
Last accessed: 31 July 2018
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 31 July 2018
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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