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Aspirin oral formulations (75mg)

Presentation

Oral formulations of low dose aspirin.

Drugs List

  • aspirin 75mg dispersible tablet
  • aspirin 75mg gastro-resistant tablets
  • aspirin 75mg tablets
  • NU-SEALS ASPIRIN EC 75mg tablets
  • 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

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