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 Forms
0.1% suspension, 5 mL fill in an 8 mL bottle.
Mechanism of Action
Corticosteroid; 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 & Lactation
Pregnancy: 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 Use
Safety and effectiveness in pediatric patients not established; no age threshold stated.