FLULIX

A glucocorticoid employed, usually as eye drops, in the treatment of allergic and inflammatory conditions of the eye.

It has also been used topically in the treatment of various skin disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p732).

For the ophthalmic treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

Corticosteroids such as fluorometholone 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.

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Side effects may include acute anterior uveitis and perforation of the globe.

Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids.

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.

If these products are used for 10 days or longer, intraocular pressure (IOP) should be routinely monitored even though it may be difficult in children and uncooperative patients.

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.

One to two drops instilled into the conjunctival sac(s) four times daily.

During the initial 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.

Not more than one bottle should be prescribed initially, and the prescription should not be refilled without further evaluation.

(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. 5 mL: NDC 71776-100-05 STORAGE 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.

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.

Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose.

Fluorometholone was applied ocularly to rabbits daily on days 6-18 of gestation, and dose-related fetal loss and fetal abnormalities including cleft palate, deformed rib cage, anomalous limbs and neural abnormalities such as encephalocele, craniorachischisis, and spina bifida were observed.

There are no adequate and well controlled studies of fluorometholone in pregnant women, and it is not known whether fluorometholone can cause fetal harm when administered to a pregnant woman.

Fluorometholone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.

Because many drugs are excreted in human milk, caution should be exercised when FLAREX (fluorometholone acetate ophthalmic suspension) 0.1%, is administered to a nursing woman.

Safety and effectiveness in pediatric patients have not been established.

No overall differences in safety or effectiveness have been observed between elderly and younger patients.