Microbiology: The anti-infective components in CORTISPORIN Ophthalmic Ointment are included to provide action against specific organisms susceptible to it. Neomycin sulfate and polymyxin B sulfate are active in vitro against susceptible strains of the following microorganisms: Staphylococcus aureus, streptococci including Streptococcus pneumoniae , Escherichia coli , Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa . The product does not provide adequate coverage against Serratia marcescens (see INDICATIONS ).
In an open-label HPA axis safety trial in subjects 3 months to 12 years of age with atopic dermatitis , DIPROLENE AF Cream % was applied twice daily for 2 to 3 weeks over a mean body surface area of 58% (range 35% to 95%). In 19 of 60 (32%) evaluable subjects, adrenal suppression was indicated by either a ≥ 5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol ≥ 18 mcg/dL and/or an increase of < 7 mcg/dL from the baseline cortisol. Out of the 19 subjects with HPA axis suppression, 4 subjects were tested 2 weeks after discontinuation of DIPROLENE AF Cream, and 3 of the 4 (75%) had complete recovery of HPA axis function. The proportion of subjects with adrenal suppression in this trial was progressively greater, the younger the age group.