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The FLAREX® difference—broad indication and refined molecule

FLAREX is indicated for use in the treatment of steroid-responsive inflammatory conditions of the1:

  • Palpebral conjunctiva
  • Bulbar conjunctiva
  • Cornea
  • Anterior segment of the eye

Some conditions that are associated with ocular surface inflammation include2-8:

  • Dry eye disease
  • Allergic conjunctivitis
  • Superficial punctate keratitis
  • Episcleritis
  • Scleritis
  • Recovery from corneal and ocular surface surgeries
    • LASIK/PRK
    • Pterygium
    • Collagen cross-linking
    •  Corneal transplants/DSAEK/DMEK

Refined for improved efficacy3,9,10

FLAREX is a steroid ester and the only acetate derivative of fluorometholone. There is no generic equivalent of FLAREX.1,11,12

The addition of an acetate group improves the penetration and efficacy of the steroid3,9,10

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

CONTRAINDICATIONS

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 preparation.

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 frequently.

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 topical steroids.

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.

ADVERSE REACTIONS

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, includes dysgeusia.

Please see the Full Prescribing Information.

References: 1. FLAREX [package insert]. Fort Worth, TX: Alcon Laboratories, Inc; 2017. 2. Abelson MB, Smith L. A stepwise approach to acute dry eye. Rev Ophthalmol. https://www.reviewofophthalmology.com/article/a-stepwise-approach-to-acute-dry-eye. Accessed July 23, 2019. 3. Sendrowski DP, Jaanus SD, Semes LP, et al. Anti-inflammatory drugs. In: Bartlett JD, Jaanus SD, eds. Clinical Ocular Pharmacology. 5th ed. St Louis, MO: Butterworth-Heinemann; 2008:221-244. 4. Murrill CA, Stanfield DL, VanBrocklin MD. Postoperative care of the cataract patient. In: Bartlett JD, Jaanus SD, eds. Clinical Ocular Pharmacology. 5th ed. St Louis, MO: Butterworth-Heinemann; 2008:601-615. 5. Badalà F, Fioretto M, Macrì A. Effect of topical 0.1% indomethacin solution versus 0.1% fluorometholon acetate on ocular surface and pain control following laser subepithelial keratomileusis (LASEK). Cornea. 2004;23(6):550-553. 6. Steinert RF, McColgin AZ, Garg S. Laser in situ keratomileusis (LASIK). American Academy of Ophthalmology. https://www.aao.org/munnerlyn-laser-surgery-center/laser-in-situ-keratomileusis-lasik-3. Accessed July 23, 2019. 7. Ozgurhan EB, Kara N, Bozkurt E, et al. Effect of fluorometholone/tetrahydrozoline fixed combination on conjunctival autograft morphology after primary pterygium excision. Biomed Res Int. 2013;2013:481843. 8. Ibach M. Go thin for the win: a review of endothelial keratoplasty. Rev Optom. https://www.reviewofoptometry.com/article/go-thin-for-the-win-a-review-of-endothelial-keratoplasty. Accessed July 23, 2019. 9. Leibowitz HM, Hyndiuk RA, Lindsey C, et al. Fluorometholone acetate: clinical evaluation in the treatment of external ocular inflammation. Ann Ophthalmol. 1984;16(12):1110-1115. 10. Shah P, Westwell AD. The role of fluorine in medicinal chemistry. J Enzyme Inhib Med Chem. 2007;22(5):527-540. 11. US Department of Health and Human Services, Food and Drug Administration. Approved drug products with therapeutic equivalence evaluations. (Orange Book). 38th ed. Washington, DC: US Department of Health and Human Services, Food and Drug Administration; 2018. 12. National Center for Biotechnology Information, PubChem. Fluorometholone acetate. https://pubchem.ncbi.nlm.nih.gov/compound/fluorometholone-acetate. Accessed July 23, 2019.

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

CONTRAINDICATIONS

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 preparation.

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 frequently.

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 topical steroids.

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.

ADVERSE REACTIONS

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, includes dysgeusia.

Please see the Full Prescribing Information.