|Manufacturer:||Bausch & Lomb Incorporated|
Revised April 2006Bausch & Lomb Incorporated, Tampa, Florida 33637U.S.
Patent No.5,747,061©Bausch & Lomb IncorporatedLotemax is a registered trademark of Bausch & Lomb Incorporated.9067501 (Folded)9067401 (Flat)
LOTEMAX is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.LOTEMAX is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with LOTEMAX experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%.
The incidence of patients with clinically significant increases in IOP (?10 mmHg) was 1% with LOTEMAX and 6% with prednisolone acetate 1%.LOTEMAX should not be used in patients who require a more potent corticosteroid for this indication.LOTEMAX is also indicated for the treatment of post-operative inflammation following ocular surgery.
LOTEMAX, 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.LOTEMAX is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation.
Steroids should be used with caution in the presence of glaucoma.Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections.
In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids.
In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.