Cetirizine reclassification

[calvemjoe]

My DS (19 mnths) was prescribed cetirizine by his allergy consultant in September who said, although it wasn't liscenced for children under 2 yrs, it was perfectly safe for him to have at 17mnths and would cure his allergy problems. Just got his repeat filled today and I noticed it now says it is unsuitable for children under 6yrs. Does any one know why this is and sould I stop giving it to my ds?

[gingernut]

It says here that it's OK for children from 2 years (look at section 4.2).

Where does it say that the medicine is unsuitable for under 6s - on the pharmacy dispensing label or on the actual manufacturer's label/leaflet?

[calvemjoe]

On the manufacturers leaflet. It is a different brand tho, would that make any difference?

[gingernut]

Could do - what brand is it?

[calvemjoe]

Thanks for that info. It looks the same as what was on the leaflet but it just says 'not recommended' for children under 6, however I just checked and it was written in jan 2004. maybe it's changed since then.

[calvemjoe]

Galpharm.

[gingernut]

That information I linked to was dated Jan 2003 though, so a patient leaflet dated Jan 2004 should be more up to date. Will do some more digging.

[calvemjoe]

They relassified it for sale over the counter for children over 6 years (just googled it). Think I may have a sale bottle, there was a price under the name label on the box. Had zirtec last time and that said 2 yrs but came from the hospital.

[gingernut]

I have been googling too, and have found an MHRA paper saying that the manufacturer was requested to provide paediatric data on cetirizine in May 2004. The evidence submitted supported an extension of the age range to cover children over 2 years (the reason for 2 being the cut-off is because of the high sorbitol content which can cause diarrhoea - with effects being more likely in younger children because they are lighter). The manufacturer was therefore requested to apply for a variation to the licence to include children from 2 years of age. My guess is that this variation has been approved, the SPC on the net has been updated but for some reason the date hasn't been changed, and you have an old pack with old information on it.

The paper is here: www.mhra.gov.uk/home/idcplg?IdcService=GET_ FILE&dDocName=con009664&RevisionSelectionMethod=Latest\ (can't get link to work).

HTH (and makes sense).

[calvemjoe]

Thanks gingernut. I really appreciate your help.
Em x

[gingernut]

That's OK (just getting my rusty professional hat on after over 4 years as a SAHM...which is no bad thing because I'm supposed to be going back to work soon).

[bobbybob]

If you are worried about the sorbitol then get the tablets prescribed and crush them up. Ds is 2 and just chews them. He says "taste" which I think means they are bitter - but he's used to it now.

We moved to tablets because ds could get them for free on prescription, whereas zyrtec is not funded. (we are in NZ)

Zyrtec is licensed in the USA from 6 months.

I gave cetirizine for over 1 and half years every day as it's been shown to cut the incidence of asthma in kids with allergies to rye or dust mite and bad excema by a third.

All medicines carry risks and if your consultant has prescribed this your ds should continue to take it.

[gingernut]

bobbybob, the MHRA paper says that the formulation on the market in the US is different to that on the market in the UK and doesn't contain sorbitol, hence the lower age limit. They are trying to encourage the manufacturer to make this formulation available in the UK too.

[bobbybob]

So if the only reason not to have it is the sorbitol - then deffo a case for getting the tablets and crushing them up. The drug itself is fantastic.

[gingernut]

Yes, that's the only reason given. They do say though that they do not consider the tablets to be a suitable formulation for children because of the difficulty in administering the correct dose (but they were talking about breaking the tablet in 2 not being very accurate).

[bobbybob]

And using one of those syringes or a medicine spoon is just soooooooo accurate too! I have a pill cutter.

[gingernut]

I know, I suspect it is partly to do with liability! (it is the manufacturer who makes this comment about breaking the pills not being accurate enough).

[kiera]

Hi calvemjoe, I live near you and tried to email you but mumsnet said I can't. Do contact me if you'd like to meet up (see "contact another talker" at the top of the page).

Abi