#Antibiotic eye drops over the counter professional#
With restrictions introduced on the use of some products in children younger than 2 years, concerns were raised by the Royal College of Ophthalmologists and other professional organisations regarding the applicability of these warnings and restrictions for very young children and the lack of suitable alternatives to chloramphenicol eye drops. The European guidance requires the addition of strong warnings not to give children aged 0 to 2 years products if an exposure greater than 1 milligram (mg) of boron a day is exceeded due to concerns around impaired fertility.
#Antibiotic eye drops over the counter update#
Marketing authorisation holders were asked to update their product information (Summary of Product Characteristics and Patient information Leaflet) in line with the 2017 guidance over a period of time and this occurred in the UK last year. In October 2017, warnings for boric acid (and borates) were introduced into the European Commission guideline for excipients in the labelling and package leaflet of medicines containing boron. Review of the interpretation of EU guidance on boric acid and borates as excipients Excipient guidance
some eye drops contain borax or boric acid, which are sources of boron – these ingredients are included as buffers to make sure the medicine is not too acidic or alkaline and is comfortable when administered to the eye.chloramphenicol eye drops are an important medicine for treating bacterial eye infections in children and have been used safely for many years.eye infections (conjunctivitis) are very common in babies and infants and it is important they are treated properly.the product information for affected chloramphenicol products is being updated to reflect the revised advice and remove restrictions for use in infants – in the meantime we ask healthcare professionals to reassure parents and carers that these products can be safely given to children aged 0 to 2 years as prescribedĪdvice for healthcare professionals to provide to parents and carers.advise parents and caregivers that chloramphenicol eye drops remain an important medicine for children when antibiotic eye treatment is indicated and that they have been used safely for many years – see Advice to provide to parents and carers below.a typical regimen of one drop, applied typically 3 to 4 times a day, to both eyes, would result in a daily exposure well below the safety limit for children aged 0 to 2 years (see notes on dosing schedule in section on Findings of review).our review has concluded that the benefits of chloramphenicol eye drops containing borax or boric acid outweigh the potential risks for children, including those aged 0 to 2 years.we have reviewed the available evidence and sought independent expert advice to understand whether there is a risk for children aged 0 to 2 years when using these products within the licensed indication, for what is likely to be a short period of time.some licences for chloramphenicol eye drop products containing borax or boric acid buffers were recently updated to restrict use in children younger than 2 years of age to reflect warnings on maximum daily limits for boron exposure.