CDC Updates Guidance on Ophthalmia Neonatorum Prophylaxis

The CDC has updated its recommendations to physicians for prophylaxis against ophthalmia neonatorum, or neonatal conjunctivitis, in light of the current shortage of erythromycin ophthalmic ointment (0.5%), which is the only product available in the United States that is FDA-approved for this indication.

The agency said Sept. 4 that azithromycin ophthalmic solution (1%), which is marketed by Inspire Pharmaceuticals as AzaSite, is an acceptable substitute if erythromycin ophthalmic ointment (0.5%) is not available.

However, CDC officials cautioned that there are no clinical data on the efficacy of azithromycin ophthalmic solution (1%) for the prophylaxis of ophthalmia neonatorum, and the recommendation for this off-label use was made on the basis of available data on pharmacology and gonococcal microbiologic sensitivity.

The CDC said the recommended dose of azithromycin ophthalmic solution (1%) is one or two drops in the conjunctival sac of each eye, taking care to not touch the infant with the applicator tip.

"Because this is a solution rather than an ointment, it is important to assure that drops are placed properly," the CDC said. "Consider a two-person administration approach -- one (person) to hold the eyelids open and the other to administer the medication."

Prophylaxis is recommended whether the infant is delivered vaginally or by cesarean section, the agency said.

If neither azithromycin ophthalmic solution (1%) nor erythromycin ophthalmic ointment (0.5%) is available, the CDC advised that gentamicin ophthalmic ointment (0.3%) and tobramycin ophthalmic ointment (0.3%) are acceptable alternatives. Both products are marketed under various brand names and also are available as generic products.

If none of the aforementioned products is available, ciprofloxacin ophthalmic ointment (0.3%), marketed as Ciloxan by Alcon Laboratories, can be used, but CDC officials said this product is a less suitable alternative because of possible gonococcal antimicrobial resistance. The agency also noted that povidone iodine is not recommended for this indication.

According to the CDC, efficacy data are not available for any of the suggested alternate regimens, so physicians should be alert to the possibility of failure of prophylaxis and are encouraged to follow the American Academy of Pediatrics' recommendation that infants be seen for their first postnatal office visit within 48 to 72 hours after being discharged from the hospital. At that time, infants treated with any of these prophylactic alternatives should be examined closely for ophthalmia neonatorum.

Furthermore, the CDC said all infants who present with ophthalmia neonatorum should be tested for gonorrhea, and reports of prophylaxis failure should be sent to local health departments and to the CDC.

According to information on the FDA Web site, the shortage of erythromycin ophthalmic ointment (0.5%) was caused by a change in manufacturers, and the agency is working with drug makers to increase the supply of this product.

FDA officials said that although erythromycin ophthalmic ointment (0.5%) also is approved for the treatment of superficial conjunctival or corneal infections caused by organisms susceptible to erythromycin, physicians are asked to consider alternative drugs for this indication during the shortage to maximize availability of the product for ophthalmia neonatorum prophylaxis.