LOTEMAX® Ointment is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.
Important Safety Information
LOTEMAX® Ointment, as with other ophthalmic corticosteroids, 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 may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If this product is used for 10 days or longer, IOP should be monitored.
Use of corticosteroids may result in posterior subcapsular cataract formation and may delay healing and increase the incidence of bleb formation after cataract surgery. 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 beyond 14 days should be made by a physician only after examination of the patient with the aid of magnification.
Corticosteroids may increase the hazard of secondary ocular infections. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated. Fungal culture should be taken when appropriate.
Patients should not wear contact lenses during their course of therapy with LOTEMAX® Ointment. Do not touch the eyelid or surrounding areas with the tip of the tube. The cap should remain on the tube when not in use. LOTEMAX® is not indicated for intraocular administration.
The most common ocular adverse event, reported in approximately 25% of subjects in clinical studies, is anterior chamber inflammation. Other common adverse events, with an incidence of 4-5%, are conjunctival hyperemia, corneal edema, and eye pain. Many of these events may have been the consequence of the surgical procedure.