البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
FLUOROMETHOLONE ACETATE (UNII: 9I50C3I3OK) (FLUOROMETHOLONE - UNII:SV0CSG527L)
Eyevance Pharmaceuticals
OPHTHALMIC
PRESCRIPTION DRUG
FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% is indicated for use in the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye. Contraindicated in acute superficial herpes simplex keratitis, vaccinia, varicella, and most other viral diseases of cornea and conjunctiva; mycobacterial infection of the eye; fungal diseases; acute purulent untreated infections, which like other diseases caused by microorganisms, may be masked or enhanced by the presence of the steroid; and in those persons who have known hypersensitivity to any component of this preparation.
FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% is supplied in white low density polyethylene (LDPE) bottles, with natural LDPE dispensing plugs and pink polypropylene closures. The product is supplied as 5 mL in an 8 mL bottle. Store upright between 2°C to 25°C (36°F to 77°F). After opening, FLAREX can be used until the expiration date on the bottle. Protect from freezing.
New Drug Application
FLAREX- FLUOROMETHOLONE ACETATE SUSPENSION/ DROPS EYEVANCE PHARMACEUTICALS ---------- FLAREX (FLUOROMETHOLONE ACETATE OPHTHALMIC SUSPENSION) 0.1% STERILE DESCRIPTION FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% is a corticosteroid prepared as a sterile topical ophthalmic suspension. The active ingredient, fluorometholone acetate, is a white to creamy white powder with an empirical formula of C H FO and a molecular weight of 418.5. Its chemical name is 9-fluoro-11β, 17- dihydroxy-6α-methylpregna-1, 4-diene-3, 20-dione 17-acetate. The chemical structure of Fluorometholone Acetate is presented below: EACH ML OF FLAREX (FLUOROMETHOLONE ACETATE OPHTHALMIC SUSPENSION) 0.1% CONTAINS: ACTIVE: fluorometholone acetate 1 mg (0.1%). PRESERVATIVE: benzalkonium chloride 0.01%. INACTIVES: sodium chloride, monobasic sodium phosphate, edetate disodium, hydroxyethyl cellulose, tyloxapol, hydrochloric acid and/or sodium hydroxide (to adjust pH), and purified water. The pH of the suspension is approximately 7.3, with an osmolality of approximately 300 mOsm/kg. CLINICAL PHARMACOLOGY Corticosteroids suppress the inflammatory response to inciting agents of mechanical, chemical or immunological nature. No generally accepted explanation of this steroid property has been advanced. Corticosteroids cause a rise in intraocular pressure (IOP) in susceptible individuals. In a small study, FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% demonstrated a significantly longer average time to produce a rise in IOP than did dexamethasone phosphate; however, the ultimate magnitude of the rise was equivalent for both drugs and in a small percentage of individuals a significant rise in IOP occurred within three days. ® ® 24 31 5 INDICATIONS AND USAGE FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% is indicated for use in the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye. CONTRAINDICATIONS Contraindicated in acute superfic اقرأ الوثيقة كاملة