FML-S SUMMARY
FML-S®
(fluorometholone and sulfacetamide sodium ophthalmic suspension, USP) 0.1%/10%
FML-S® ophthalmic suspension is a topical anti-inflammatory/anti-infective product for ophthalmic use.
FML-S® ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe, where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The anti-infective drug in this product, sulfacetamide, is active against the following common bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.
This product does not provide adequate coverage against Neisseria species and Serratia marcescens. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.
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