There has been an update to the summary of product characteristics (SPC) for the Prescription Only Medicine (POM) form of chloramphenicol 0.5% multi-dose eye drops. This relates to a change in posology, where it can now only be given to adults and children over 2 years of age.
The Medicines and Healthcare Regulatory Agency (MHRA) are reviewing the evidence for this change. We will notify members regarding the outcome of this review. In the meantime we have temporarily updated the Optometrists' Formulary.
This change does not apply to the SPCs for chloramphenicol 1% eye ointment (POM), or chloramphenicol 0.5% minims eye drops (POM), which can be given to adults and children over 1 month old. However, as the minim form also contains the same boron based excipients as the multi-dose eye drop form, we recommend that this too should not be used in children under 2 years old.
The posology for the Pharmacy only (P) form of chloramphenicol (multi-dose eye drops no more than 0.5% and 10ml pack size; eye ointment no more than 1% and 4g pack size) which can be sold or supplied directly to patients remains unchanged, where it can only be given to adults and children over 2 years old. The P form is licensed only for the treatment of bacterial conjunctivitis.