Flarex®
Fluorometholone 0.1% · ophthalmic suspension
Steroid
Approved uses
Steroid-responsive inflammation of the conjunctiva, cornea, and anterior segment
1 to 2 drops QID; may be increased to 2 drops every 2 hours during the initial 24 to 48 hours
Contraindications
- Acute superficial herpes simplex keratitis, vaccinia, varicella and most other viral diseases of the cornea and conjunctiva.
- Mycobacterial ocular infection.
- Fungal diseases.
- Acute purulent untreated infections.
- Known hypersensitivity to any component of the preparation.
Available Forms0.1% suspension, 5 mL fill in an 8 mL bottle.
Mechanism of ActionCorticosteroid; suppresses the inflammatory response to inciting agents of mechanical, chemical, or immunologic nature. Raises IOP in susceptible individuals; this label advances no receptor-level mechanism for the anti-inflammatory effect.
Warnings & Precautions
- Route restriction: Topical ophthalmic use only; not for injection.
- Prolonged use: May produce glaucoma, optic nerve damage, defects in visual acuity and visual field, and cataract formation, and may aid establishment of secondary ocular infection through suppression of host response.
- Steroid IOP response: In a small study the average time to a pressure rise was significantly longer than with dexamethasone phosphate, but the ultimate magnitude of the rise was equivalent and a small percentage rose significantly within three days; check IOP frequently.
- Herpes simplex infection: Treatment requires great caution.
- Acute purulent infection: May be masked or exacerbated by the presence of steroid.
- Corneal wound healing: May be slowed by topical ophthalmic corticosteroids.
- Corneal or scleral thinning: Perforation has occurred with chronic topical steroid use in diseases that thin these tissues.
- Fungal keratitis: Particularly prone to develop with long-term local steroid application; consider fungal invasion in any persistent corneal ulceration where a steroid has been or is in use.
- Soft contact lenses: Benzalkonium chloride 0.01% may be absorbed; remove lenses to instill and reinsert 15 minutes later.
- Transient blurred vision: Follows dosing; relevant to driving and operating machinery.
Common Side Effects
- Ocular: Glaucoma with optic nerve damage, visual acuity and visual field defects, cataract formation, secondary ocular infection following suppression of host response, and perforation of the globe; the label assigns no frequencies.
- Systemic: Dysgeusia, identified in postmarketing use; frequency cannot be estimated from spontaneous reports.
Pregnancy & LactationPregnancy: Embryocidal and teratogenic in rabbits at low multiples of the human ocular dose, with dose-related fetal loss, cleft palate, deformed rib cage, anomalous limbs, encephalocele, craniorachischisis, and spina bifida after ocular dosing on gestation days 6 to 18; no adequate human studies; use only if benefit justifies fetal risk.
Lactation: Systemically administered corticosteroids appear in human milk and could suppress growth or interfere with endogenous corticosteroid production; whether topical ocular dosing yields detectable milk levels is unknown; use with caution.
Pediatric UseSafety and effectiveness in pediatric patients not established; no age threshold stated.