Paracetamol oral liquids and paediatric soluble
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral solutions, oral suspensions and soluble tablets containing paracetamol.
Drugs List
Therapeutic Indications
Uses
Pain - mild to moderate
Post immunisation pyrexia
Pyrexia
Treatment of post-operative pain
Dosage
Individual brands may vary in dose recommendations for different age groups.
Adults
500mg to 1g every 4 to 6 hours to a maximum of 4g daily.
Elderly
(See Dosage; Adult)
The rate and extent of paracetamol absorption is normal in elderly patients, but plasma half life is longer and paracetamol clearance is lower than in younger adults.
Children
The MHRA has issued the following new doses for children's liquid paracetamol to ensure children get the most optimal dose of paracetamol suitable for their age:
Children aged 10 to 12 years
500mg. Maximum of 4 doses in 24 hours.
Alternatively, 480mg to 500mg every 4 to 6 hours. Maximum of 4 doses in 24 hours.
Children aged 8 to 10 years
375mg. Maximum of 4 doses in 24 hours.
Alternatively, 360mg to 375mg every 4 to 6 hours. Maximum of 4 doses in 24 hours.
Children aged 6 to 8 years
250mg. Maximum of 4 doses in 24 hours.
Alternatively, 240mg to 250mg every 4 to 6 hours. Maximum of 4 doses in 24 hours.
Children aged 4 to 6 years
240mg. Maximum of 4 doses in 24 hours.
Children aged 2 to 4 years
180mg. Maximum of 4 doses in 24 hours.
Children aged 6 to 24 months
120mg. Maximum of 4 doses in 24 hours.
Children aged 3 to 6 months
60mg. Maximum of 4 doses in 24 hours.
Individual brands may vary in dose recommendations for different age groups.
Children aged 6 to 12 years
250mg to 500mg every 4 to 6 hours when necessary. Maximum of 4 doses in 24 hours.
Children aged 1 to 6 years
120mg to 250mg every 4 to 6 hours when necessary. Maximum of 4 doses in 24 hours.
Children aged 3 months to 1 year
60mg to 120mg every 4 to 6 hours when necessary. Maximum of 4 doses in 24 hours.
Post immunisation pyrexia in infants
Children aged 2 to 3 months
60mg as a single dose followed by a second dose, if necessary, 6 hours later.
The same two doses may be given for other causes of fever or mild to moderate pain provided that the infant weighs more than 4 kg and was not born before 37 weeks gestation.
The following additional unlicensed doses for use in children under 2 months:
Pain and pyrexia with discomfort
Children aged 1 to 3 months
30 mg to 60 mg every 8 hours when necessary (maximum 60 mg/kg daily in divided doses).
Post operative pain (unlicensed)
Children aged 6 to 12 years
20mg/kg to 30mg/kg as a single dose up to a maximum of 1g. Then 15mg/kg to 20mg/kg every 4 to 6 hours when necessary, up to a maximum of 75mg/kg (4g) daily in divided doses.
Children aged 1 month to 6 years
20mg/kg to 30mg/kg as a single dose. Then 15mg/kg to 20mg/kg every 4 to 6 hours when necessary, up to a maximum of 75mg/kg daily in divided doses.
Adolescents
Pain and pyrexia with discomfort
Children aged 16 to 18 years
500mg to 1g every 4 to 6 hours. Maximum of 4 doses in 24 hours.
Children aged 12 to 16 years
480mg to 750mg every 4 to 6 hours. Maximum of 4 doses in 24 hours.
Post operative pain
Children aged 12 to 18 years
1g every 4 to 6 hours. Maximum of 4 doses in 24 hours.
Neonates
Neonate over 32 weeks corrected gestational age (unlicensed)
20mg/kg as a single dose. Then 10mg/kg to 15mg/kg every 6 to 8 hours when necessary, up to a maximum of 60mg/kg daily in divided doses.
Neonate 28 to 32 weeks corrected gestational age (unlicensed)
20mg/kg as a single dose. Then 10mg/kg to 15mg/kg every 8 to 12 hours when necessary, up to a maximum of 30mg/kg daily in divided doses.
Administration
Oral solutions: an oral syringe should be used to administer the small volumes required to treat post immunisation pyrexia.
Contraindications
None known
Precautions and Warnings
Children under 2 months
Alcoholic liver disease
Hereditary fructose intolerance
Severe hepatic impairment
Severe renal impairment
Not all available brands are licensed for all age groups
May contain polysorbate
May contain sodium benzoate: mild mucous membrane irritant
Oral solution with maltitol unsuitable in hereditary fructose intolerance
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain hydroxybenzoate
Some formulations may contain sugar
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
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.
Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.
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
Paracetamol is considered safe for use in breastfeeding.
Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breastfeeding.
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
Acute pancreatitis
Agranulocytosis
Anaphylactic reaction
Blood dyscrasias
Hepatic necrosis
Hypersensitivity reactions
Leucopenia
Methaemoglobinaemia
Nephrotoxicity
Neutropenia
Papillary necrosis
Rash
Thrombocytopenia
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 represented below:
Liver damage is possible in patients who have taken 75 mg/kg or more of paracetamol in less than an hour, and these patients should be referred to hospital. To avoid underestimating the potentially toxic paracetamol dose ingested by obese patients who weigh more than 110 kg, a bodyweight of 110 kg (rather than the actual bodyweight) should be used to calculate the total dose of paracetamol ingested in mg/kg.
Signs and Symptoms
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Treatment
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines.
Treatment with activated charcoal should be considered if the overdose in excess of 150 mg/kg has been taken within 1 hour. Treatment with acetylcysteine is used up to, and possibly beyond, 24 hours of ingesting paracetamol. It is most effective if given within 8 hours of ingestion, after which effectiveness declines. If required, the patient should be given intravenous acetylcysteine, in line with the established dosage schedule. Giving acetylcysteine by mouth (unlicensed route) is an alternative if intravenous access is not possible. Acetylcysteine can be given irrespective of the plasma paracetamol concentration:
in circumstances where the overdose is staggered or there is doubt over the time of paracetamol ingestion; or in overdose with a timed plasma paracetamol concentration on or above a single treatment line joining points of 100 mg/L at 4 hours and 15 mg/L at 15 hours nomogram (https://www.mhra.gov.uk/home/groups/pl-p/documents/drugsafetymessage/con184396.pdf), regardless of risk factors of hepatotoxicity.
Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentration are unreliable). If vomiting is not a problem, and overdose has been taken within 10 to 12 hours, oral methionine may be a suitable alternative for remote areas outside hospital. Management of patients who present beyond 24 hours from ingestion or with serious hepatic dysfunction should be discussed with the NPIS (https://www.npis.org/) or a liver unit.
Further Information
Last Full Review Date: March 2016
Reference Sources
Summary of Product Characteristics: Calpol Six Plus sugar-free suspension. McNeil Products Ltd. Revised November 2014
Summary of Product Characteristics: Calpol Six Plus suspension. McNeil Products Ltd. Revised November 2014
Summary of Product Characteristics: Calpol Infant sugar free colour free 120mg/5ml oral suspension. McNeil Products Ltd. Revised November 2014
Summary of Product Characteristics: Calpol Infant suspension sachets. McNeil Products Ltd. Revised November 2014
Summary of Product Characteristics: Calpol Infant suspension. McNeil Products Ltd. Revised November 2014
Summary of Product Characteristics: Junior Parapaed 120mg/5ml oral suspension. Pinewood Laboratories. Revised June 2015.
Summary of Product Characteristics: Mandanol 120mg/5ml and 250mg/5ml sugar free suspension. Pinewood Laboratories. date of partial revision of text: May 2000.
Summary of Product Characteristics: Medinol Paediatric suspension. SSL International. Revised January 2012
Summary of Product Characteristics: Medinol Over 6 suspension. SSL International. Revised January 2012
Summary of Product Characteristics: Paracetamol Oral solution. Mercury Pharmaceuticals Ltd. Revised October 2013.
The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.
MHRA 10th September 2012
https://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Informationforlicenceapplicants/Guidance/OverdosesectionsofSPCs/Genericoverdosesections/Paracetamol/index.htm
Last accessed: 10 March 2016
MHRA 6th June 2011 - More exact paracetamol dosing in children
https://www.mhra.gov.uk/NewsCentre/Pressreleases/CON120251
Last accessed: June 20th, 2011
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 07 September 2017
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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