البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
fluorometholone (UNII: SV0CSG527L) (fluorometholone - UNII:SV0CSG527L), sulfacetamide sodium (UNII: 4NRT660KJQ) (sulfacetamide - UNII:4965G3J0F5)
Allergan, Inc.
fluorometholone and sulfacetamide sodium
SUSPENSION
1.0 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
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: Esche
FML-S® (fluorometholone and sulfacetamide sodium ophthalmic suspension, USP) 0.1%/10% is supplied sterile in opaque white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows: Note: Store at 15°C - 30°C (59° -86°F). Protect from freezing and light. SHAKE WELL BEFORE USING. Do not use suspension if it is dark brown. Rx Only Rev February 2005 © 2005 Allergan, Inc. ® marks owned by Allergan, Inc. 7767X 71745US10P
FML-S- FLUOROMETHOLONE AND SULFACETAMIDE SODIUM SUSPENSION ALLERGAN, INC. ---------- FML-S (FLUOROMETHOLONE AND SULFACETAMIDE SODIUM OPHTHALMIC SUSPENSION, USP) 0.1%/10% Sterile 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. ® 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 اقرأ الوثيقة كاملة