Two new monographs, Flecainide acetate 10 mg/mL oral solution and Valaciclovir 20 mg/mL oral solution, elaborated by the European Paediatric Formulary (PaedF) working party have been added to the European Paediatric Formulary (Formulary) after a successful public consultation phase. The Formulary now comprises nine monographs.
The formulations described in the two monographs, which are not legally binding, were selected on the basis of the inclusion and evaluation criteria established for the Formulary that were adopted at the end of 2015.
For the flecainide acetate oral solution monograph, experts in the PaedF working party chose the 10 mg/mL strength to support typical single doses of 2-8 mg/kg. The working party also intends to develop a monograph for a 2 mg/mL strength, which would be even more appropriate for neonates. The experts are aware that concentrations ranging from 2 to 20 mg/mL are prepared throughout Europe. The original qualitative and quantitative composition of the solution, preparation instructions and validated analytical procedures were provided by Dr Zanon from the Institute for Maternal and Child Health IRCCS, Burlo Garofolo, Trieste, Italy.
For the valaciclovir oral solution monograph, experts in the PaedF working party preferred a strength of 20 mg/mL, as it was the only known formulation that did not contain a commercial vehicle. Concentrations ranging from 20 to 50 mg/mL are prepared throughout Europe. Valaciclovir is prescribed with reference to the anhydrous base, with the formulations prepared using a suitable mass of valaciclovir hydrochloride or valaciclovir hydrochloride hydrate. The formulation is based on valaciclovir hydrochloride hydrate because the hydrate is easier for pharmacies to source from suppliers. The original qualitative and quantitative composition of the solution, preparation instructions and validated analytical procedures were provided by the Dutch Pharmacist’s Formulary (FNA).
Both the Formulary and Pharmeuropa PaedForm are available free of charge and can be accessed online after creating an account.
See also:
- Access the European Paediatric Formulary and the public consultation platform
- More about the European Paediatric Formulary