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Nystatin dose changes in the BNF and SPC

28th April 2017

The dose for oral candidosis in the BNF and all the SPCs for nystatin 100,000units/mL oral suspension, is now 1mL PO q.d.s.. There has been recent confusion over the authorized dose with generic and proprietary SPCs including differing dose schedules. The dose in the Nystan (Sqibb) SPC was increased in September 2016 from 1mL to 4−6mL q.d.s., but has now been changed back to 1mL q.d.s. This was after further discussion with the MHRA who re-assessed the evidence and did not find it robust enough to support the dose increase. 

Editor’s note: PCF has always recommended a higher dose of nystatin oral suspension 100,000units/mL of 5mL PO q.d.s. for oral candidosis. Nystatin is a topical treatment and few people have the oral dexterity to cover the relevant areas with just 1mL, i.e. it is an issue of volume and not the dose itself. The authorized dose in the USA is 4−6mL q.d.s.

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