Paracetamol oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of paracetamol.
Drugs List
Therapeutic Indications
Uses
Pain - mild to moderate
Pyrexia
Treatment of post-operative pain
Dosage
A small number of manufacturers recommend a 50% dose reduction in adult patients weighing less than 50kg or in those at risk of hepatotoxicity, including Gilbert's syndrome, dehydration, chronic malnutrition and chronic alcoholism.
Adults
500mg to 1g every 4 to 6 hours to a maximum of 4g in 24 hours.
650mg sachet:
1 sachet every four hours to a maximum of 4 sachets in any 24 hours period.
Children
Children aged 12 to 18 years
(See Dosage; Adult)
Children aged 6 to 12 Years
250mg to 500mg repeated every 4 to 6 hours as necessary, with a maximum of 4 doses in any 24 hour period.
650mg sachet:
Not recommended.
Children under 6 years
Other formulations are more appropriate.
The following alternate dosing schedule may be suitable:
Pain and pyrexia with discomfort
Children aged 16 to 18 years:
500mg to 1g every 4 to 6 hours (maximum 4 doses in 24 hours)
Children aged 12 to 16 years:
480mg to 750mg every 4 to 6 hours (maximum 4 doses in 24 hours)
Children aged 10 to 12 years:
480mg to 500mg every 4 to 6 hours when necessary. (Maximum of 4 doses in 24 hours)
Children aged 8 to 10 years:
360mg to 375mg every 4 to 6 hours when necessary. (Maximum of 4 doses in 24 hours)
Children aged 6 to 8 years:
240mg to 250mg every 4 to 6 hours when necessary. (Maximum of 4 doses in 24 hours)
Post operative pain
Children aged 12 to 18 years:
1g every 4 to 6 hours (maximum 4 doses in 24 hours)
Children aged 6 to 12 years:
20mg/kg to 30mg/kg (maximum 1g) as a single dose then 15mg/kg to 20mg/kg every 4 to 6 hours; maximum 75mg/kg (maximum 4g daily in divided doses).
Patients with Renal Impairment
Alternative sources recommend a reduction to 500mg to 1g every 6 to 8 hours in patients with a GFR less than 10ml per min.
Some manufacturers also recommend the following adjustment:
GFR 10 to 50ml per min: 500mg every 6 hours
GFR less than 10ml per min: 500mg every 8 hours.
Contraindications
Children under 6 years
Precautions and Warnings
Frail elderly patients
Restricted sodium intake
Weight below 50kg
Alcoholism
Dehydration
Gilbert's syndrome
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
Non-cirrhotic alcoholic liver disease
Phenylketonuria
Severe malnutrition
Severe renal impairment
Sodium content of formulation may be significant
Some formulations contain aspartame - caution in phenylketonuria
Not all available brands are licensed for all age groups
Not all formulations are licensed for all uses
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain sucrose
Advise patient to seek medical advice if severe skin reaction occurs
Overdosage causes liver damage
Seek urgent medical advice in event of overdose, even if patient feels well
Discontinue if drug-related rash or other hypersensitivity reactions occur
Advise that alcohol increases the chances of liver damage with paracetamol
Consult doctor if symptoms persist or treatment is required for > 3 days
Patients should not exceed recommended dose
Pregnancy and Lactation
Pregnancy
Paracetamol is considered safe for use in pregnancy.
Manufacturers suggest no adverse effects have been reported using this drug during pregnancy when used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Animal studies do not indicate reproductive toxicity.
Schaefer (2015) suggests paracetamol does cross the placenta, however due to the drugs analgesic and antipyretic properties, it is the preferred drug of choice to use in pregnancy. Briggs (2015) states that paracetamol is commonly used in all stages of pregnancy and the therapeutic doses in short-term are deemed safe, while routine use should be avoided.
Lactation
Paracetamol is considered safe for use in breastfeeding.
Manufacturers suggests there has been no adverse effects on the breastfed infants and newborns when used at therapeutic doses. Schaefer (2015) suggests paracetamol is the analgesic of first choice in breastfeeding. Hale and the Drugs and Lactation Database (LactMed) both suggest the potential amount of paracetamol ingested via breast milk by an infant is likely to be significantly less than the paediatric therapeutic dose.
Side Effects
Abdominal pain
Abnormal vision
Agranulocytosis
Allergic reaction
Anaphylactic reaction
Anaphylactic shock
Angioedema
Blood dyscrasias
Bronchospasm
Changes in hepatic function
Confusion
Depression
Diarrhoea
Dizziness
Erythema multiforme
Haemolytic anaemia
Haemorrhage
Hallucinations
Headache
Hepatic disorders
Hepatic failure
Hepatitis
Hepatotoxicity
Hypoglycaemia
Interstitial nephritis
Jaundice
Leucopenia
Liver damage
Malaise
Nausea
Neutropenia
Oedema
Pancytopenia
Papillary necrosis
Pruritus
Purpura
Pyrexia
Rash
Renal impairment
Sedation
Stevens-Johnson syndrome
Sweating
Thrombocytopenia
Toxic epidermal necrolysis
Tremor
Urticaria
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 ).
Further Information
Last Full Review Date: November 2016
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: Abdine Cold Relief Powder sachets, Bell Sons & Co Ltd, revised July 2015.
Summary of Product Characteristics: Altridexamol 1000mg effervescent tablets. TriOn pharma Ltd. Revised August 2017.
Summary of Product Characteristics: Anadin Paracetamol Tablets. Pfizer Consumer Healthcare. Revised December 2015.
Summary of Product Characteristics: Calpol Six Plus FastMelts. McNeil Ltd. Revised August 2016.
Summary of Product Characteristics: Hedex Tablets. GlaxoSmithKline Consumer Healthcare. Revised November 2015.
Summary of Product Characteristics: Panadol Advance 500mg Tablets. GlaxoSmithKline Consumer Healthcare. Revised August 2012.
Summary of Product Characteristics: Paracetamol 500mg caplets. Crescent Pharma Limited. Revised November 2016.
Summary of Product Characteristics: Paracetamol 500mg Effervescent Tablets. Accord. Revised November 2017.
Summary of Product Characteristics: Panadol Original Tablets. GlaxoSmithKline Consumer Healthcare. Revised August 2014.
Summary of Product Characteristics: Paracetamol Tablets BP 500mg. Actavis UK Ltd. Revised September 2014.
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
Paracetamol Last revised: 31 October 2018
Last accessed: 11 January 2018
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 11 January 2018
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.