Flarex ® (fluorometholone acetate ophthalmic suspension) 0.1% Sterile

FLAREX® (fluorometholone acetate ophthalmic suspension) 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 C₂₄H₃₁FO₅ and a molecular weight of 418.5. Its chemical name is 9-fluoro-11^β, 17-dihydroxy-6^α-methylpregna-1, 4-diene-3, 20-dione 17-acetate. The chemical structure of Fluorometholone Acetate is presented below:

Each mL 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.

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 in susceptible individuals. In a small study, FLAREX (fluorometholone acetate ophthalmic suspension) demonstrated a significantly longer average time to produce a rise in intraocular pressure 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 intraocular pressure occurred within three days.

FLAREX (fluorometholone acetate ophthalmic suspension) 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.

FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. Use in the treatment of herpes simplex infection requires great caution. Prolonged use may result in glaucoma, damage to the optic nerve, defect in visual acuity and visual field, cataract formation and/or may aid in the establishment of secondary ocular infections from pathogens due to suppression of host response. Acute purulent infections of the eye may be masked or exacerbated by presence of steroid medication. Topical ophthalmic corticosteroids may slow corneal wound healing. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with chronic use of topical steroids. It is advisable that the intraocular pressure be checked frequently.

Glaucoma with optic nerve damage, visual acuity and field defects, cataract formation, secondary ocular infection following suppression of host response, and perforation of the globe may occur.

Postmarketing Experience: The following reaction has been identified during post-marketing use of FLAREX^® (fluorometholone acetate ophthalmic suspension) in clinical practice. Because reactions are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which has been chosen for inclusion due to either its seriousness, frequency of reporting, possible causal connection to FLAREX, or a combination of these factors, includes: dysgeusia.

Shake Well Before Using. One to two drops instilled into the conjunctival sac(s) four times daily. During the initial 24 to 48 hours the dosage may be safely increased to two drops every two hours. If no improvement after two weeks, consult physician. Care should be taken not to discontinue therapy prematurely.

FLAREX (fluorometholone acetate ophthalmic suspension) is supplied in white low density polyethylene (LDPE) bottles, with natural LDPE dispensing plugs and pink polypropylene closures. The product is supplied as 5mL in an 8 mL bottle.

5 mL: NDC 0065-0096-05

STORAGE: Store upright between 2°-25°C (36°-77°F). Protect from freezing.

Protect from freezing.

©2002, 2004, 2006, 2016 Novartis

Distributed by:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

Revised: October 2016

ALCON®

a Novartis company

9012837-0116

NDC 0065-0096-05

Alcon^®
a Novartis company

Flarex^®
(fluorometholone acetate ophthalmic suspension) 0.1%

5 mL    Sterile

Rx Only

STORAGE: Store upright between 2°-25°C (36°-77°F).

Protect from freezing.

©2004, 2006, 2016 Novartis

Each mL CONTAINS:
Active: fluorometholone acetate 0.1% (1 mg).
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.

DOSAGE AND ADMINISTRATION:
SHAKE WELL BEFORE USING.
One to two drops instilled into the conjunctival sac(s) four times daily. During the initial 24 to 48 hours, the dosage may be safely increased to two drops every two hours. If no improvement after two weeks, consult physician. Care should be taken not to discontinue therapy prematurely.

Alcon^®

ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
Country of Origin: Italy
A190374-0416

LOT:

EXP.:

NDC 0065-0096-05

Alcon^®

Flarex^®
(fluorometholone acetate ophthalmic suspension) 0.1%

Sterile     5 mL

Rx Only

STERILE

FOR OPHTHALMIC USE ONLY

Each mL contains:
Active: fluorometholone acetate 0.1% (1 mg).
Preservative: benzalkonium chloride 0.01%.
Inactive: sodium chloride, monobasic sodium phosphate, edetate disodium, hydroxyethyl cellulose, tyloxapol, hydrochloric acid and/or sodium hydroxide (to adjust pH), and purified water.

DOSAGE AND ADMINISTRATION: SHAKE WELL BEFORE USING.
One to two drops instilled into the conjunctival sac(s) four times daily. During the initial 24 to 48 hours, the dosage may be safely increased to two drops every two hours. If no improvement after two weeks, consult physician. Care should be taken not to discontinue therapy prematurely.

STORAGE: Store upright between 2°-25°C (36°-77°F). Protect From Freezing.

ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA
©2004, 2006, 2016 Novartis

LOT:

EXP.:

A190371-0416