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IMPORTANT PRODUCT RISK INFORMATION ABOUT LOTEMAX GEL

Intraocular pressure (IOP) increase—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.
Cataracts—Use of corticosteroids may result in posterior subcapsular cataract formation.
Bacterial infections—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.
Viral infections—Use of 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 exacerbate the severity of many viral infections of the eye (including herpes simplex).
Fungal infections—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.

IMPORTANT PRODUCT RISK INFORMATION

ZYLET 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 the ocular structures. ZYLET is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
NOT FOR INJECTION INTO THE EYE
Prolonged use of ZYLET is associated with several warnings and precautions, including glaucoma with optic nerve damage, defects in visual acuity, cataract formation, secondary ocular infections, exacerbation or prolongation of viral ocular infections (including herpes simplex), delay in wound healing and increase in bleb formation
If this product is used for 10 days or longer, intraocular pressure should be monitored. 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. Fungal infections of the cornea may develop with prolonged use of corticosteroids.
As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Cross-sensitivity to other aminoglycoside antibiotics may occur.
In a 42- day safety study comparing ZYLET to placebo, the incidence of ocular adverse events reported in greater than 10% of subjects included injection (approximately 20%) and superficial punctate keratitis (approximately 15%). Increased intraocular pressure was reported in 10% (ZYLET) and 4% (placebo) of subjects. The incidence of clinically significant increases in intraocular pressure ≥ 10 mm Hg from baseline was reported in 3.6% (4/112) of subjects receiving ZYLET and 0% (0/56) among subjects receiving placebo. Nine percent (9%) of ZYLET subjects reported burning and stinging upon instillation.
Please see complete information regarding CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS in the accompanying ZYLET full prescribing information by clicking the link below

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.

See full prescribing information

IMPORTANT PRODUCT RISK INFORMATION

ALREX 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 the ocular structures. ALREX 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 ALREX is associated with several warnings and precautions, including glaucoma with optic nerve damage, defects in visual acuity, cataract formation, secondary ocular infections, exacerbation or prolongation of viral ocular infections (including herpes simplex), delay in wound healing and increase in bleb formation.
If this product is used for 10 days or longer, intraocular pressure should be monitored. 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. Fungal infections of the cornea may develop with prolonged use of corticosteroids.
Ocular adverse reactions occurring in 5-15% of patients treated with loteprednol etabonate ophthalmic suspension (0.2% - 0.5%) in clinical studies included abnormal vision/blurring, burning on instillation, chemosis, discharge, dry eyes, epiphora, foreign body sensation, itching, injection, and photophobia.
Please see complete information regarding CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS in the accompanying ALREX full prescribing information by clicking the link below

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.

See full prescribing information

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 when appropriate.
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 www.fda.gov/medwatch,or call 1-800-FDA-1088.

See full prescribing information

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