1 to 2 drops into the affected eye BID beginning the day after surgery, continuing through the first 2 postoperative weeks
Ocular pain clears by day 4 and anterior chamber cells by day 8.
Contraindications
Most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella.
Mycobacterial infection of the eye.
Fungal diseases of ocular structures.
Available Forms
1% suspension (loteprednol etabonate 10 mg/mL), 2.8 mL in a 5 mL bottle
Mechanism of Action
Corticosteroid: binds and activates the glucocorticoid receptor and is thought to inhibit prostaglandin production through several independent mechanisms, suppressing the edema, fibrin deposition, capillary dilation, leukocyte migration, fibroblast proliferation, and collagen deposition of postoperative inflammation, and probably delaying healing. Lipid soluble and structurally engineered from prednisolone-related compounds for predictable breakdown to the inactive carboxylic acid metabolites PJ-90 and PJ-91; after 14 days of unilateral BID dosing in healthy subjects, plasma concentrations stayed below the 1 ng/mL limit of quantitation.
Warnings & Precautions
IOP elevation and glaucoma: Prolonged corticosteroid use may produce glaucoma with optic nerve damage and defects in visual acuity and visual fields; use with caution in the presence of glaucoma and monitor IOP if the product is used 10 days or longer.
Posterior subcapsular cataract: Corticosteroid use may produce it.
Delayed healing after cataract surgery: Steroids may delay healing and increase the incidence of bleb formation.
Corneal or scleral perforation: In diseases causing thinning of the cornea or sclera, perforations have occurred with topical steroids.
Prescription renewal: The initial prescription and renewal only after examination with magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. This label sets no day count for the gate.
Secondary ocular infection: Prolonged use may suppress host response and increase the hazard of secondary ocular infection; in acute purulent conditions of the eye steroids may mask infection or enhance existing infection.
Viral infection exacerbation: Ocular steroids may prolong the course and worsen the severity of many ocular viral infections including herpes simplex; a history of herpes simplex requires great caution.
Fungal keratitis: Fungal corneal infection is particularly prone to develop coincidentally with long-term local steroid use; consider fungal invasion in any persistent corneal ulceration where a steroid has been used or is in use, and culture when appropriate.
Soft contact lenses: Remove lenses before instillation; the benzalkonium chloride 0.01% preservative may be absorbed by soft lenses, which may be reinserted 15 minutes after administration.
Common Side Effects
Ocular, 1% each: Eye pain and posterior capsular opacification, the two most common reactions in the clinical trials; the label notes both may have been consequences of the surgical procedure.
Corticosteroid class effects: Elevated IOP with infrequent optic nerve damage and visual acuity and field defects, posterior subcapsular cataract formation, delayed wound healing, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where the cornea or sclera is thinned.
Overall tolerability: In the two registration trials, adverse events were reported more frequently on vehicle than on drug.
Pregnancy & Lactation
Pregnancy: Not absorbed systemically after topical ophthalmic administration, so maternal use is not expected to result in fetal exposure. This label carries no animal teratogenicity data.
Lactation: Not absorbed systemically by the mother after topical ophthalmic administration, so breastfeeding is not expected to expose the child.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.