Flarex (Fluorometholone Acetate)

FLAREX®

Alcon

Fluorometholone Acetate

Corticosteroid

Action And Clinical Pharmacology: Adrenocorticoids suppress the inflammatory response (edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, deposition of collagen and scar formation) to chemical, immunological or mechanical irritants. Adrenocorticoids may cause a rise in intraocular pressure in susceptible individuals. They are absorbed into aqueous humor, cornea, iris, choroid, ciliary body, and retina. Systemic absorption occurs but may be significant only at higher doses than recommended.

Indications And Clinical Uses: For use in the treatment of allergic and other steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.

Contra-Indications: In acute superficial herpes simplex keratitis, vaccinia, varicella, and most viral diseases of the cornea and conjunctiva; tuberculosis of the eye; fungal diseases of the eye, acute purulent untreated infections of the eye, which, like other diseases caused by microorganisms, may be masked or enhanced by the presence of the steroid; and in those persons who have a known hypersensitivity to any component of this preparation.

Manufacturers’ Warnings In Clinical States: Fluorometholone acetate ophthalmic suspension is not for injection.

Use of topical corticosteroid may cause increased intraocular pressure in certain individuals. It is necessary that the intraocular pressure be checked frequently and particularly in patients with a history of glaucoma or with a family history of glaucoma. Prolonged use may result in glaucoma, damage to the optic nerve, defects in visual acuity and visual field, posterior subcapsular 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 the presence of steroid medications. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with the chronic use of topical steroids.

If sensitivity or other untoward reactions occur, discontinue the medication.

Pregnancy: Animal reproduction studies have not been conducted with this product. However, it has been reported that studies with fluorometholone (alcohol) applied ocularly to pregnant rabbits at approximate human doses and above resulted in a significant dose-related increase in fetal abnormalities and in fetal loss. It is not known whether Flarex ophthalmic suspension can cause fetal harm when administered to a pregnant woman. It should be used in pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Precautions: Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application; fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use.

It is advisable to check intraocular pressure in some individuals (see Warnings). In diseases due to microorganisms, the infection may be masked, enhanced or activated by corticosteroids. Whenever there is a possibility of infection, supplemental therapy with suitable antibiotic agents should be considered.

Patients should be advised to inform their physicians of any prior use of corticosteroids.

Lactation: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when it is administered to a nursing woman.

Children: Safety and effectiveness in children have not been established.

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

Extended ophthalmic use of corticosteroid drugs may cause increased intraocular pressure in certain individuals and in those diseases causing thinning of the cornea, perforation has been known to occur.

Rarely, filtering blebs have been reported when topical steroids have been used following cataract surgery.

Occasionally, stinging or burning may occur.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Overdosage in the use of topical ophthalmic corticosteroids is a remote possibility. Discontinue medication when heavy or protracted use is suspected.

Dosage And Administration: 1 or 2 drops instilled into the conjunctival sac 2 to 4 times daily. During the initial 24 to 48 hours the dosage may be safely increased to 2 drops every 2 hours. Care should be taken not to discontinue therapy prematurely.

Special Instructions: Patients should be advised to shake well before using and to avoid contamination of the dropper tip.

Availability And Storage: Each 5 mL Drop-Tainer dispenser of sterile ophthalmic suspension contains: fluorometholone acetate 0.1%. Nonmedicinal ingredients: benzalkonium chloride 0.01% (as preservative), edetate disodium, hydrochloric acid and/or sodium hydroxide (to adjust pH), hydroxyethyl cellulose, monobasic sodium phosphate, purified water, sodium chloride and tyloxapol. Plastic Drop-Tainer dispensers of 5 mL. Protect from freezing. Store upright at room temperature.

FLAREX® Alcon Fluorometholone Acetate Corticosteroid

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