From the FDA Drug Label
Pediatric Use: Safety and effectiveness in children below the age of 2 months have not been established (see WARNINGS) The recommended age for Polytrim is 2 months and above, as safety and effectiveness in children below the age of 2 months have not been established 1.
From the Research
Polytrim (polymyxin B-trimethoprim) eye drops are approved for use in patients 2 months of age and older. This antibiotic combination medication should not be used in infants younger than 2 months due to limited safety data in this age group, as supported by studies such as 2, which demonstrated the efficacy and safety of polymyxin B-trimethoprim in children aged 1-18 years. When prescribing Polytrim for children, it's essential to maintain the standard dosing regimen of 1 drop in the affected eye(s) every 3 hours for 7-10 days, though the frequency may be reduced as the infection improves. The age restriction exists because trimethoprim may interfere with folic acid metabolism, which is particularly important in very young infants whose systems are still developing. Additionally, the preservatives in the solution may potentially cause more irritation in the delicate eyes of very young infants. For bacterial conjunctivitis in infants younger than 2 months, alternative antibiotic eye drops such as erythromycin ophthalmic ointment are typically recommended instead.
Some key points to consider when prescribing Polytrim for children include:
- The medication is effective against a wide range of bacterial pathogens, including Haemophilus influenzae and Streptococcus pneumoniae, as demonstrated in studies such as 3 and 2.
- The standard dosing regimen is 1 drop in the affected eye(s) every 3 hours for 7-10 days, though the frequency may be reduced as the infection improves.
- The age restriction for use in infants younger than 2 months is due to limited safety data in this age group.
- Alternative antibiotic eye drops, such as erythromycin ophthalmic ointment, are recommended for infants younger than 2 months with bacterial conjunctivitis.
It's also important to note that studies such as 4, 5, and 6 have demonstrated the efficacy and safety of trimethoprim-polymyxin B sulphate ophthalmic ointment in the treatment of bacterial conjunctivitis, although these studies may not be directly applicable to the use of Polytrim eye drops in children. However, the most recent and highest quality study, 2, provides the strongest evidence for the use of Polytrim in children aged 1-18 years.