Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
FLUOROMETHOLONE (UNII: SV0CSG527L) (FLUOROMETHOLONE - UNII:SV0CSG527L)
REMEDYREPACK INC.
OPHTHALMIC
PRESCRIPTION DRUG
Fluorometholone ophthalmic suspension 0.1% is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. Fluorometholone ophthalmic suspension 0.1% 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. Fluorometholone ophthalmic suspension 0.1% is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
Fluorometholone ophthalmic suspension, USP 0.1% is supplied sterile in opaque white LDPE plastic bottles with white high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle NDC 60758-880-05 10 mL in 15 mL bottle NDC 60758-880-10 15 mL in 15 mL bottle NDC 60758-880-15 Store at 2°-25°C (36°-77°F); protect from freezing. Store in an upright position. Revised : 12/2018 For more information, call 1-800-678-1605 Distributed for: Allergan USA, Inc. Madison, NJ 07940 © 2018 Allergan. All rights reserved. All trademarks are the property of their respective owners. v1.0USPI880
New Drug Application Authorized Generic
FLUOROMETHOLONE- FLUOROMETHOLONE SOLUTION/ DROPS REMEDYREPACK INC. ---------- FLUOROMETHOLONE OPHTHALMIC SUSPENSION, USP 0.1% S TERILE DESCRIPTION Fluorometholone ophthalmic suspension, USP 0.1% is a sterile topical anti-inflammatory agent for ophthalmic use. CHEMICAL NAME Fluorometholone: 9-Fluoro-11β,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione. CONTAINS ACTIVE: fluorometholone 0.1%. PRESERVATIVE: benzalkonium chloride 0.004%. 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. Fluorometholone suspension is formulated with a pH from 6.2 to 7.5. It has an osmolality range of 290-350 mOsm/kg. STRUCTURAL FORMULA FLUOROMETHOLONE 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 2 phospholipids by 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 mag Belgenin tamamını okuyun