FML-S

Generic name: fluorometholone and sulfacetamide sodium
Dosage form: Ophthalmic Suspension
Drug class:Ophthalmic steroids with anti-infectives

Medically reviewed by Drugs.com. Last updated on Jan 24, 2022.

Sterile

FML-S Description

FML-S® ophthalmic suspension is a topical anti-inflammatory/anti-infective product for ophthalmic use.

Chemical Names:

Fluorometholone:

9-Fluoro-11β,17-dihydroxy-6α–methylpregna-1,4-diene-3,20-dione.

Sulfacetamide sodium:

N-Sulfanilyacetamide monosodium salt monohydrate.

Structural Formulas:

Contains: Actives: fluorometholone 0.1%; and sulfacetamide sodium 10%. Preservative: benzalkonium chloride 0.006%. Inactives: edetate disodium; polysorbate 80; polyvinyl alcohol (1.4%); povidone; purified water; sodium chloride; sodium phosphate dibasic; sodium phosphate, monobasic; sodium thiosulfate; and hydrochloric acid and/or sodium hydroxide to adjust the pH to 7.0 to 7.5.

FML-S - Clinical Pharmacology

Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. Since corticosteroids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.

Corticosteroids are capable of producing a rise in intraocular pressure. In clinical studies of documented steroid-responders, fluorometholone demonstrated a significantly longer average time to produce a rise in intraocular pressure than dexamethasone phosphate; however, in a small percentage of individuals, a significant rise in intraocular pressure occurred within one week. The ultimate magnitude of the rise was equivalent for both drugs.

The anti-infective component in FML-S® ophthalmic suspension is included to provide action against specific organisms susceptible to it. Sulfacetamide sodium is active in vitro against susceptible strains...