Paracetamol parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Infusion solution containing paracetamol.
Drugs List
Therapeutic Indications
Uses
Moderate pain: acute treatment
Pyrexia: acute treatment
Dosage
Take care to avoid dosing errors due to confusion between milligram (mg) and millilitre (ml). Incorrect interpretation could result in accidental overdose and death.
Adults
Adults weighing more than 50kg:
1g paracetamol per administration, up to 4 times a day.
The minimum interval between each administration must be 4 hours.
The maximum daily dose must not exceed 4g.
Adults weighing less than or equal to 50kg:
15mg/kg paracetamol per administration, up to 4 times a day.
The minimum interval between each administration must be 4 hours.
The maximum daily dose must not exceed 60mg/kg (without exceeding 3g).
Children
Infants and children weighing up to or equal to 10kg
7.5mg/kg paracetamol per administration, up to 4 times a day. This equates to 0.75ml/kg of 10mg/ml paracetamol solution for infusion up to four times a day.
The minimum interval between each administration must be 4 hours.
The maximum daily dose must not exceed 30mg/kg.
Children weighing more than 10kg to 33kg
15mg/kg paracetamol per administration, up to 4 times a day. This equates to 1.5ml/kg of 10mg/ml paracetamol solution for infusion up to four times a day.
The minimum interval between each administration must be 4 hours.
The maximum daily dose must not exceed 60mg/kg (without exceeding 2g).
Children weighing more than 33kg to 50kg
15mg/kg paracetamol per administration, up to 4 times a day. This equates to 1.5ml/kg of 10mg/ml paracetamol solution for infusion up to four times a day.
The minimum interval between each administration must be 4 hours.
The maximum daily dose must not exceed 60mg/kg (without exceeding 3g).
Children weighing more than 50kg:
1g paracetamol per administration, up to 4 times a day.
The minimum interval between each administration must be 4 hours.
The maximum daily dose must not exceed 4g.
Alternative dose schedule
For children weighing up to 10kg (unlicensed):
10mg/kg every 4 to 6 hours.
The maximum daily dose must not exceed 30mg/kg.
Neonates
7.5mg/kg paracetamol per administration, up to 4 times a day. This equates to 0.75ml/kg of 10mg/ml paracetamol solution for infusion up to four times a day.
The minimum interval between each administration must be 4 hours.
The maximum daily dose must not exceed 30mg/kg.
Safety and efficacy data is not available for premature neonates.
Neonates (unlicensed)
10mg/kg every 4 to 6 hours up to a maximum of 30mg/kg daily.
Preterm neonate 32 weeks corrected gestational age and above (unlicensed)
7.5mg/kg every 8 hours.
Patients with Renal Impairment
Creatinine clearance 30ml/minute to 50ml/minute
The interval between doses should be at least 4 hours.
Some manufacturers recommend the interval between doses should be increased to at least 6 hours.
Creatinine clearance 30ml/minute or below:
The interval between doses should be at least 6 hours.
Creatinine clearance below 10ml/minute:
The interval between doses should be at least 8 hours.
Patients with Hepatic Impairment
Adults and children weighing 50kg or more with mild to moderate hepatic impairment:
The maximum daily dose must not exceed 3g.
Additional Dosage Information
Adults and children weighing more than 50kg with risk factors for hepatotoxicity (chronic alcoholism, chronic malnutrition or dehydration):
The maximum daily dose must not exceed 3g.
Administration
For intravenous infusion only.
Contraindications
Severe hepatic impairment
Precautions and Warnings
Weight below 50kg
Chronic alcoholism
Dehydration
Hepatic impairment
Pregnancy
Renal impairment - creatinine clearance below 51ml/minute
Severe G6PD deficiency
Severe malnutrition
Not all available products are recommended for all age groups/body weights
Patient should be converted to oral therapy as soon as possible
Additional risks of hepatotoxicity: Dosing adjustment required
Creatinine clearance below or equal to 50ml/min: Dosing adjustment required
Overdosage causes liver damage
May affect results of some laboratory tests
Do not exceed recommended dosages and frequency of administration
Haemolytic anaemia may occur in patients with severe G6PD deficiency.
Pregnancy and Lactation
Pregnancy
Use paracetamol infusion with caution during pregnancy.
Manufacturers recommend intravenous paracetamol should only be used during pregnancy after a careful risk-benefit assessment. The recommended posology and duration must be strictly observed, preferably administering the lowest effective dose for the shortest possible duration.
Clinical experience of the intravenous administration of paracetamol is limited. However the epidemiological data from the use of oral therapeutic doses of paracetamol indicate no undesirable effects in pregnancy or on the health of the foetus/newborn infant.
No reproductive studies with the intravenous form of paracetamol have been performed in animals, however, studies with the oral route did not show any malformation or foetotoxic effects.
Lactation
Paracetamol infusion is considered safe for use during breastfeeding.
The manufacturers states paracetamol infusion may be used safely when breastfeeding.
The drug is excreted into human breast milk in low concentrations, however, paracetamol belongs to the group of analgesics of choice during breastfeeding. Adverse effects in breastfed infants appear to be rare and the quantity of drug that passes into the milk is very small, representing only a small proportion of a normal therapeutic infant dose. However, since metabolism and renal excretion are not fully developed in the newborn, accumulation can not be ruled out in the case of long term treatment. Consideration should also be given to any additional dosages of paracetamol the breastfed infant may be receiving directly, to ensure toxicity does not occur.
Side Effects
Anaphylactic shock
Burning pain at injection site
Erythema
Flushing
Hypersensitivity reactions
Hypotension
Increase of liver transaminases
Leucopenia
Malaise
Neutropenia
Pruritus
Rash
Tachycardia
Thrombocytopenia
Urticaria
Effects on Laboratory Tests
Paracetamol can affect tests for uric acid using phosphotungstic acid and blood sugar tests using glucose-oxidase-peroxidase.
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: December 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: Perfalgan. Bristol-Myers Squibb. Revised: April 2017.
Summary of Product Characteristics: Paracetamol 10mg/ml Solution for Infusion. Actavis UK. Revised: July 2017.
Summary of Product Characteristics: Paracetamol 10mg/ml Solution for Infusion. B. Braun Melsungen AG. Revised: December 2015.
Summary of Product Characteristics: Paracetamol 10mg/ml Solution for Infusion. Fresenius Kabi. Revised: September 2021.
Summary of Product Characteristics: Paracetamol Atlan 10mg/ml solution for infusion. Atlan Pharma Limited. December 2021.
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
Acetaminophen Last revised: 31 October 2018
Last accessed: 05 December 2018
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 05 December 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.