Nystatin dose update: 1ml QDS

Following discussions with the Medicines and Healthcare products Regulatory Agency (MHRA), the British National Formulary (BNF) has updated the dosage recommendations for nystatin suspension for the treatment of oral candidiasis, to reflect the Summary of Product Characteristics (SPC) for GENERIC nystatin products.

Previous BNF dosage recommendations for nystatin were in line with those in the SPC for Nystan® Oral Suspension.

Recent confusion about the dose of nystatin arose as a result of different dosage recommendations in the respective SPCs, as the one for Nystan® was updated in 2015 to recommend a higher dose for children over 2 years old and adults*, while the one for nystatin wasn’t.

The BNF dosage recommendation has reverted back to the lower dose (in the generic SPC), and is as follows:

  • Adults and children — 100,000 units (1 ml) 4 times a day.

 

References

[1] BNF statement
[2] BNF: Nystatin
[3] Nystatin SPC
[4] Nystan SPC

This change was in alignment with recommendations from a European Public Assessment Report that looked at paediatric studies, and the higher doses used in the US.