DUREZOL

5 WARNINGS AND PRECAUTIONS • 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 DUREZOL is used for 10 days or longer, IOP should be monitored. ( 5.1 ) • Cataracts: Use of corticosteroids may result in posterior subcapsular cataract formation. ( 5.2 ) • Delayed Healing: The use of corticosteroids after cataract surgery may delay healing and increase the incidence of bleb formation. ( 5.3 ) • Corneal and Scleral Melting: In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. ( 5.4 ) • Bacterial Infections: Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, corticosteroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be reevaluated. ( 5.5 ) • Viral Infections: Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). ( 5.6 ) • Fungal Infections: Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid application. Fungus invasion must be considered in any persistent corneal ulceration where a corticosteroid has been used or is in use. ( 5.7 ) 5.1 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. Corticosteroids should be used with caution in the presence of glaucoma. If DUREZOL is used for 10 days or longer, IOP should be routinely monitored. 5.2 Cataracts The use of corticosteroids may result in posterior subcapsular cataract formation. 5.3 Delayed Healing The use of corticosteroids 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 beyond 28 days should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and where appropriate, fluorescein staining. 5.4 Corneal and Scleral Melting Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation of the globe. 5.5 Bacterial Infections Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, corticosteroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be reevaluated. 5.6 Viral Infections Use of ocular corticosteroids 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; frequent slit lamp microscopy is recommended. 5.7 Fungal Infections Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid application. Fungus invasion must be considered in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal culture should be taken when appropriate. 5.8 Topical Ophthalmic Use DUREZOL is not indicated for intraocular administration. 5.9 Risk of Contamination Do not allow the dropper tip to touch the eye, eyelids, or any surface, as this may contaminate the ophthalmic emulsion. 5.10 Contact Lens Wear The anti-microbial preservative in DUREZOL may be absorbed by soft contact lenses. DUREZOL should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of DUREZOL. Contact lenses may be reinserted after 10 minutes following administration of DUREZOL.

6 ADVERSE REACTIONS The following serious reactions are found elsewhere in the labeling: • Intraocular Pressure (IOP) Increase [see Warnings and Precautions ( 5.1 )] • Cataracts [see Warnings and Precautions ( 5.2 )] • Delayed Healing [see Warnings and Precautions ( 5.3 )] • Corneal and Scleral Melting [see Warnings and Precautions ( 5.4 )] • Bacterial Infections [see Warnings and Precautions ( 5.5 )] • Viral Infections [see Warnings and Precautions ( 5.6 )] • Fungal Infections [see Warnings and Precautions ( 5.7 )] For treatment of inflammation and pain associated with ocular surgery, most common adverse reactions (incidence 5% to 15%) are corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis. For treatment of endogenous anterior uveitis, most common adverse reactions (incidence 5% to 10%) are blurred vision, eye irritation, eye pain, headache, increased IOP, iritis, limbal and conjunctival hyperemia, punctate keratitis, and uveitis. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Ocular Surgery Ocular adverse reactions occurring in 5% to 15% of subjects in clinical studies with DUREZOL, included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis. Other ocular adverse reactions occurring in 1% to 5% of subjects, included reduced visual acuity, punctate keratitis, eye inflammation, and iritis. Ocular adverse reactions occurring in less than 1% of subjects, included application-site discomfort or irritation, corneal pigmentation and striae, episcleritis, eye pruritus, eyelid irritation and crusting, foreign body sensation, increased lacrimation, macular edema, sclera hyperemia, and uveitis. Most of these reactions may have been the consequence of the surgical procedure. 6.2 Endogenous Anterior Uveitis A total of 200 subjects participated in the clinical trials for endogenous anterior uveitis, of which 106 were exposed to DUREZOL. The most common adverse reactions of those exposed to DUREZOL occurring in 5% to 10% of subjects included blurred vision, eye irritation, eye pain, headache, increased IOP, iritis, limbal and conjunctival hyperemia, punctate keratitis, and uveitis. Adverse reactions occurring in 2% to 5% of subjects included anterior chamber flare, corneal edema, dry eye, iridocyclitis, photophobia, and reduced visual acuity.