Ophthalmic Safety Alert – intracameral cefuroxime
1 May 2018
There are a range of cefuroxime preparations currently in use for the prevention of endophthalmitis in intraocular surgery. There are two licensed versions, Aprokam (Thea Pharmaceuticals) and Ximaract (from Bausch & Lomb), both available as a 50mg powder and diluent solution for injection. Also used are unlicensed prefilled syringes, of which some are compliant with the British Pharmacopoeia monograph for cefuroxime for intracameral use and fall within a strict range of acceptable osmolarity, and preparations diluted in theatre from 250mg intravenous vials. Inadvertent dilution errors are more likely with some unlicensed products which may result in patient harm including inflammation and retinal toxicity1.
Some of the unlicensed preparations have recently amended their Summary of Product Characteristics (SmPCs) to include a ‘Special Warning and Precaution for Use’ wording that advises against intracameral use of cefuroxime as follows:
Intracameral use and eye disorders:
Cefuroxime is not formulated for intracameral use. Individual cases and clusters of serious ocular adverse reactions have been reported following unapproved intracameral use of cefuroxime sodium compounded from vials approved for intravenous/intramuscular administration. These reactions included macular oedema, retinal oedema, retinal detachment, retinal toxicity, visual impairment, visual acuity reduced, vision blurred, corneal opacity and corneal oedema.
The College recommends that for those using a non licensed product, users should check the SmPCs and avoid use of any product which specifically cautions against intraocular use.
Reference:
- OCULAR TOXICITY AFTER INADVERTENT INTRACAMERAL INJECTION OF HIGH DOSE OF CEFUROXIME DURING CATARACT SURGERY: A CASE SERIESKamal-Salah, Radua, MD, PhD; Osoba, Olayinka, MB, BS, FRCS; Doyle, Edward, FRCOpth
Retinal Cases and Brief Reports: March 15, 2017