Revised SPC: Clorogen (chloramphenicol) Eye Drops 0.5% w/v
The contraindication to use in children less than 2 years of age due to concerns about boron and impairment of fertility in the future has been removed following MHRA review of available toxicological data.
Source:
electronic Medicines compendium
SPS commentary:
Following a review of data and calculation of daily exposure to boron from a typical dosing regimen, MHRA concluded that the balance between the benefits and risks of chloramphenicol eye drops containing borax or boric acid remains positive for children aged 0 to 2 years. Therefore chloramphenicol eye drops can be safely administered to children aged 0 to 2 years where antibiotic eye drop treatment is indicated.