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We have been contacted by the Pharmacy Department in Laura Lynn (Ireland’s Children’s Hospice) in relation to medication errors that have occurred with Glycopyrronium Bromide Oral Solution for paediatric use following the dispensing of the product in community pharmacies.
Glycopyrronium Bromide is often used in children with neurodisability to control upper airway secretions. There are five different strengths of oral solution commonly dispensed – one licensed product (Sialanar®) contains Glycopyrronium Bromide 0.4mg/ml, and four unlicensed products, which are available in the following strengths: 0.1mg/ml, 0.2mg/ml, 0.5mg/ml and 1mg/ml.
Pharmacists should be aware, and should inform prescribers, that ‘exempt’ medicinal products should not be sourced and supplied if a suitable authorised alternative is available in Ireland. Sialanar®is a licensed and reimbursable product and has been available since 2017. The full name of this product is Sialanar 320 micrograms/ml Oral Solution.
Caution is needed in interpreting the strength of the licensed product. In order to standardise labelling across the EU, the licensed product (Sialanar®) is labelled as Glycopyrronium 320 micrograms/ml. This is equivalent to Glycopyrronium Bromide 400 micrograms/ml (0.4mg/ml). Dosing in the BNF for Children and other paediatric references is often stated as Glycopyrronium Bromide. Unlicensed products may be labelled as Glycopyrrolate, Glycopyrronium Bromide or Glycopyrronium.
Glycopyrrolate 1mg = Glycopyrronium Bromide 1mg = Glycopyrronium 0.8mg.
The HPRA issued an advisory safety notice in September 2019 (interpreting strength in the product name for active substances in their salt form) highlighting the potential for confusion that can occur with different salt forms. You can view the notice here.
