Press release: More exact paracetamol dosing for children to be introduced

Press release

Date:	Monday 6 June 2011
Time:	11:00
Contact:	Press Office 020 3080 7651 or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189

Updated dosing for children’s liquid medicines containing paracetamol has been developed to ensure children get the most effective amount, and to support giving it to them in the best way.

The updated dosing will have a larger number of narrower age bands and will define a single dose per age band.

Paracetamol continues to be an acceptably safe and effective method of short-term pain and fever relief in children when used according to the patient information supplied with the medicine.

MHRA Director of Vigilance and Risk Management of Medicines, Dr June Raine said: “The change is to ensure children get the most optimal dose of paracetamol suitable for their age.

 “This updated dosing advice will clarify the doses, making it easier for parents and carers to know exactly how much paracetamol they should give their children.

“The change is not because of safety concerns and parents/carers should not be worried that they have done anything wrong.

” The current dosage system has a single age band 6 - 12 years. In the updated system, this will be divided into three separate age bands of 6 - 8 years, eight - 10 years, and 10 - 12 years.

Paracetamol products for children currently on the market should have the updated dosage instructions by the end of 2011. In the meantime, parents and carers can still follow the current dosing and should follow the advice on the packaging, making sure not to exceed the recommended dose."

Notes to Editor

1. There are two different strengths of liquid paracetamol formulations for children and the changes apply to both:

Infant paracetamol suspension (120 mg/5ml)

Current			Upcoming
Age	Dose	How often (in 24 hours)	Age	Dose	How often (in 24 hours)
3 months to under one year	2.5 ml	Four times	3 - 6 months	2.5 ml	Four times
1 year to under 6 years	5 to 10 ml	Four times	6 - 24 months	5 ml	Four times
			2 - 4 years	7.5 ml	Four times
			4 - 6 years	10 ml	Four times

Paracetamol six plus suspension (240/250 mg/5ml)

Current			Upcoming
Age	Dose	How often (in 24 hours)	Age	Dose	How often (in 24 hours)
6 - 12 years	5 - 10 ml	Four times	6 - 8 years	5 ml	Four times
			8 - 10 years	7.5 ml	Four times
			10 - 12 years	10 ml	Four times

2. Parents and carers can safely supply paracetamol to children by following the medicine’s full label directions as usual. For paracetamol supplied on prescription, the label the pharmacists put on the bottle will give the new doses; for over-the-counter medicines, parents should follow the dosage on the label. When the new packs are in stock, parents or carers with any questions can always ask a pharmacist or healthcare professional, or ring NHS Direct for more information.

3. For safety, all medicines for children will be supplied with a dosing device, such as a plastic spoon, cap or measuring syringe, which parents and carers should always use to ensure uniform doses are provided. It is also important to shake the bottle vigorously before measuring the required dose, to ensure the paracetamol is divided equally into each dose.

4. In the UK, all patient information leaflets have been tested to ensure they are clear and understandable. At the MHRA, we continually monitor the safety, quality and efficacy of all medicines, so that prompt action can be taken to protect people when appropriate. The MHRA and Commission for Human Medicines (CHM) continue to monitor closely the safety of paracetamol, as well as all marketed drugs.

5. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.

6. The changes to paediatric paracetamol dosing have not altered the dose of paracetamol recommended for the treatment of post vaccination symptoms in children aged 2-3 months. Paracetamol (120mg/5mL) is licensed for the treatment of post vaccination symptoms in children from 2-3 months of age at a dose of 2.5mL. If necessary a second 2.5mL dose can be given after 4-6 hours. No further doses should be given. If symptoms persist, parents/carers should seek professional healthcare advice.