INDICATION

LOTEMAX^® GEL (loteprednol etabonate ophthalmic gel) 0.5% is indicated for the treatment of post-operative inflammation and pain following ocular surgery.

Important Safety Information

• LOTEMAX^® GEL is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
• Prolonged use of corticosteroids, including LOTEMAX, may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for 10 days or longer, IOP should be monitored.
• Use of corticosteroids may result in posterior subcapsular cataract formation.
• The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, and where appropriate, fluorescein staining.
• Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infection. In acute purulent conditions, steroids may mask infection or enhance existing infections.
• Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).
• 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. Fungal cultures should be taken when appropriate.
• Patients should not wear contact lenses during their course of therapy with LOTEMAX^® GEL.
• The most common adverse drug reactions reported in the clinical trials (2-5%) were anterior chamber inflammation, eye pain, and foreign body sensation.
• You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Prescribing Information for LOTEMAX^®GEL click here for Prescribing Information

LGX.0023.USA.20