Difluprednate

Difluprednate ophthalmic emulsion is a topical corticosteroid that is indicated for: The treatment of inflammation and pain associated with ocular surgery ( 1.1 ) The treatment of endogenous anterior uveitis ( 1.2 )

1.1Ocular Surgery

Difluprednate ophthalmic emulsion 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery.

1.2Endogenous Anterior Uveitis

Difluprednate ophthalmic emulsion is also indicated for the treatment of endogenous anterior uveitis.

The use of difluprednate ophthalmic emulsion, as with other ophthalmic corticosteroids, is contraindicated in most active 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 disease of ocular structures. Difluprednate ophthalmic emulsion, as with other ophthalmic corticosteroids, is contraindicated in most active 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.

( 4 )

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. ( 5.1 ) Cataracts-Use of corticosteroids may result in posterior subcapsular cataract formation. ( 5.2 ) Delayed healing-The use of steroids 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. ( 5.3 ) Bacterial infections-Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections.