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Drug Catalog - Product Detail

FLUOROMETHOLONE OPHTHALMIC SUSPENSION 0.1 % 10ML

NDC Mfr Size Str Form
60758-0880-10 GREENSTONE 10 0.1% SUSPENSION
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Description
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 f luorometholone Structural Formula
How Supplied
HOW SUPPLIED 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 Storage: 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
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Shake well before using. Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased to one application every four hours. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see PRECAUTIONS ). The dosing of fluorometholone ophthalmic suspension 0.1% may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.