- LOTEMAX® ointment is a corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery.1
IMPORTANT RISK 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. 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 pain, redness, itching or inflammation becomes aggravated, the patient should
be advised to consult a physician. If signs and symptoms fail to improve after 2 days, the patient should be reevaluated. Fungal culture should be taken
- Patients should not wear contact lenses during their course of therapy with LOTEMAX ointment. LOTEMAX should not be used in children following ocular surgery as it may interfere with amblyopia treatment. 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.
- You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.