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EtOH content of ranitidine

Up to Soluble prednisolone
November 20. 2017
Niamh O'Connell

What are different trusts policies/approach with regards to alcohol content in liquid meds?

I have had the following information sent through to me from a GP practice pharmacist:

She is concerned with the amount of alcohol contained within Ranitidine after reading the this article in the PJ:

http://www.pharmaceutical-journal.com/learning/learning-article/how-to-identify-and-manage-problem-excipients-in-medicines-for-children/20203121.article

For the two licensed ranitidine 75 mg/5 ml liquid preparations:

  • Concordia brand has an alcohol content of 800 mg per 10 ml.  The SPC for this product says that each 5 ml of solution has an alcohol content which is equivalent to 8 ml of beer or 3 ml of wine.
  • Rosemont brand has an alcohol content of 810 mg per 10 ml.  The SPC for this product says that each 5 ml of solution has an alcohol content which is equivalent to 11 ml of beer or 5 ml of wine.

 Neither of these products is licensed for use below 3 years of age.

 An example she used was:

 Currently this Practice has a 22 week old child prescribed ranitidine liquid, for a 3 mg/kg dose and a weight of 5.46 kg, they were recommended to have a 15 mg (1 ml) dose by the Consultant Paediatrician.  If you applied the EMA guidance for children aged less than 6 years of age whereby the blood alcohol concentration should not exceed 1 mg/100 ml (a dose of 6 mg/kg) – then for a 5 kg child this would be 30 mg of alcohol.  Within the 1 ml of liquid, depending on the brand dispensed there is either 80 or 81 mg of alcohol.

An alcohol free 75 mg/5 ml ranitidine liquid can be sourced, but this will be an unlicensed special order product and cost significantly more than the licensed product, which is laden with alcohol and not licensed for children at the age it is being prescribed.

 

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