Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
FLUOROMETHOLONE (UNII: SV0CSG527L) (FLUOROMETHOLONE - UNII:SV0CSG527L)
Allergan, Inc.
OPHTHALMIC
PRESCRIPTION DRUG
FML FORTE ® suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. FML FORTE ® suspension is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. FML FORTE ® suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
FML FORTE ® (fluorometholone ophthalmic suspension, USP) 0.25% is supplied sterile in opaque white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle NDC 11980-228-05 10 mL in 15 mL bottle NDC 11980-228-10 Storage: Store at 2°-25°C (36°-77°F); protect from freezing. Store in an upright position. Revised: 12/2023 Distributed by: AbbVie Inc. North Chicago, IL 60064 © 2023 AbbVie. All rights reserved. FML FORTE and its design are trademarks of Allergan, Inc., an AbbVie company. V2.0USPI228
New Drug Application
FML FORTE- FLUOROMETHOLONE SUSPENSION/ DROPS ALLERGAN, INC. ---------- FML FORTE (FLUOROMETHOLONE OPHTHALMIC SUSPENSION, USP) 0.25% STERILE RX ONLY DESCRIPTION FML FORTE (fluorometholone ophthalmic suspension, USP) 0.25% is a sterile, topical anti-inflammatory agent for ophthalmic use. CHEMICAL NAME Fluorometholone: 9-Fluoro-11ß, 17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione STRUCTURAL FORMULA CONTAINS ACTIVE: fluorometholone 0.25%. PRESERVATIVE: benzalkonium chloride 0.005%. INACTIVES: edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; sodium phosphate, monobasic; and sodium hydroxide to adjust pH. FML FORTE suspension is formulated with a pH from 6.2 to 7.5. CLINICAL PHARMACOLOGY Corticosteroids inhibit the inflammatory response to a variety of inciting agents and 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. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by ® ® ® 2 phospholipase A . 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 equivalen Կարդացեք ամբողջական փաստաթուղթը