Trade Names:FML-S- Ophthalmic Suspension 0.1% fluorometholone and 10% sodium sulfacetamide
Depresses formation, release, and activity of endogenous mediators of inflammation as well as modifying body's immune response.Sulfacetamide
Competitively antagonizes PABA, an essential component of folic acid synthesis.
Treatment of 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. Use of corticosteroids in combination with an anti-infective agent 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.
Epithelial herpes simplex keratitis (dendritic keratitis) and vaccinia; varicella, mycobacterial infection, and fungal diseases of the ocular structure; hypersensitivity to any component of this product.
Topical Instill 1 gtt into the conjunctival sac 4 times daily, taking care not to discontinue therapy prematurely.
None well documented.
None well documented.
Local irritation; elevation in IOP with possible development of glaucoma; optic nerve damage; posterior subscapular cataract formation; delayed wound healing.
Agranulocytosis; aplastic anemia and other blood dyscrasias.
Fulminant hepatic necrosis.
Allergic sensitization; Stevens-Johnson syndrome; toxic epidermal necrolysis; secondary infections (including fungal).
Category C .
Undetermined; however, systemic hydrocortisone is excreted in breast milk.
Safety and efficacy not established.
Deaths associated with sulfonamide administration have been reported rarely from hypersensitivity reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Early indications of serious blood disorders include sore throat, fever, pallor, purpura, or jaundice.
Use corticosteroid with caution in patients with a history of herpes simplex.
Long-term use of topical corticosteroids may cause corneal and scleral thinning, possibly leading to perforation.
Prolonged use may result in glaucoma with damage to the optic nerve, defects in visual acuity, fields of vision, and in posterior subcapsular cataract formation.
Prolonged use may result in bacterial or fungal overgrowth of nonsusceptible microorganisms.
May occur irrespective of the route of administration.
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