Itching and injection begin easing about 2 hours after the first drop, improving through day 14.
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.
Known or suspected hypersensitivity to any ingredient of the preparation or to other corticosteroids.
Available Forms
Ophthalmic suspension, 0.2% (loteprednol etabonate 2 mg/mL), 5 mL in a 7.5 mL bottle, 10 mL in a 10 mL bottle
Mechanism of Action
Corticosteroid: induces lipocortins that inhibit phospholipase A2, cutting release of arachidonic acid and the prostaglandins and leukotrienes downstream of it, and suppressing edema, capillary dilation, leukocyte migration, fibroblast proliferation, and collagen deposition, while also probably delaying healing. Highly lipid soluble and lacking the position-20 ketone group present in other corticosteroids, it is built to undergo predictable conversion to inactive carboxylic acid metabolites; plasma levels of drug and primary metabolite stayed below 1 ng/mL after ocular dosing.
Warnings & Precautions
IOP elevation and glaucoma: Prolonged corticosteroid use may produce glaucoma with optic nerve damage and defects in visual acuity and visual fields; monitor IOP if used 10 days or longer, and use with caution in the presence of glaucoma.
Posterior subcapsular cataract: Prolonged corticosteroid use may produce it.
Secondary ocular infection: Prolonged use suppresses host response and increases the hazard of secondary infection; in acute purulent conditions 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 and culture in any persistent corneal ulceration where a steroid has been used or is in use.
Corneal or scleral perforation: In diseases causing thinning of the cornea or sclera, perforations have occurred with topical steroids.
Renewal beyond 14 days: Initial prescription and renewal past 14 days only after examination with magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining; re-evaluate if signs and symptoms fail to improve after 2 days.
Soft contact lenses: Do not wear a lens while the eye is red, and do not use this product for contact lens related irritation; when the eye is not red, wait at least 10 minutes after instillation before inserting lenses, since the benzalkonium chloride 0.01% preservative may be absorbed by soft lenses.
Common Side Effects
Ocular, 5% to 15%: Abnormal vision or blurring, burning on instillation, chemosis, discharge, dry eye, epiphora, foreign body sensation, itching, injection, photophobia. Frequencies are pooled across loteprednol etabonate 0.2% and 0.5% clinical studies, not the 0.2% product alone.
Ocular, under 5%: Conjunctivitis, corneal abnormalities, eyelid erythema, keratoconjunctivitis, ocular irritation, pain or discomfort, papillae, uveitis. Some of these events were similar to the underlying ocular disease being studied.
Intraocular pressure, 0.2% product: A clinically significant rise of 10 mmHg or more occurred in 1% (1/133) versus 1% (1/135) on placebo.
Intraocular pressure, pooled studies: In loteprednol etabonate studies of 28 days or longer, a rise of 10 mmHg or more occurred in 2% (15/901) versus 7% (11/164) on prednisolone acetate 1% and 0.5% (3/583) on placebo.
Systemic, under 15%: Headache, rhinitis, pharyngitis.
Pregnancy & Lactation
Pregnancy: No adequate and well controlled studies in pregnant women. Oral dosing in rabbits during organogenesis at 3 mg/kg/day (85 times the maximum daily clinical dose) was embryotoxic (delayed ossification) and teratogenic (meningocele, abnormal left common carotid artery, limb flexures) without maternal toxicity; NOEL 0.5 mg/kg/day. Oral rat dosing gave teratogenicity from 5 mg/kg/day and embryotoxicity at higher doses. Use only if the potential benefit justifies the potential fetal risk.
Lactation: Whether topical ophthalmic dosing yields detectable quantities in human milk is unknown. Systemic steroids appear in human milk and could suppress growth or interfere with endogenous corticosteroid production; use with caution in a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.