INDICATIONS AND USAGE
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.
IMPORTANT SAFETY INFORMATION
Contraindicated in acute superficial herpes simplex keratitis, vaccinia, varicella, and most other viral
diseases of the 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
WARNINGS AND PRECAUTIONS
Topical Ophthalmic Use Only: Not for injection.
Intraocular Pressure Increase: Prolonged use may result in glaucoma, damage to the optic
nerve, and defects in visual acuity and visual field. It is advisable that the intraocular pressure be checked
Cataracts: Use of corticosteroids may result in cataract formation.
Delayed Healing: 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
Viral Infections: Use in the treatment of herpes simplex infection requires great caution.
Bacterial Infections: Use of corticosteroids may suppress the host response and thus aid in
the establishment of secondary ocular infections. Acute purulent infections of the eye may be masked or
exacerbated by the presence of steroid medication.
Fungal Infections: 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.
Contamination: Do not touch dropper tip to any surface as this may contaminate the suspension.
Contact Lens Wear: Contact lenses should be removed during instillation of FLAREX but may be
reinserted after 15 minutes.
Temporarily Blurred Vision: Vision may be temporarily blurred following dosing with FLAREX.
Care should be exercised in operating machinery or driving a motor vehicle.
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 postmarketing use
of FLAREX in clinical practice. Because reactions are reported voluntarily from a population of unknown size,
estimates of frequency cannot be made. The reaction, 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,
Please see the Full Prescribing