Approved June 23, 2008

DIFLUPREDNATE
(FDA Category 1P)

DUREZOL(TM) (Sirion Therap) is a topical corticosteroid that is structurally similar to other corticosteroids that inhibit the inflammatory response to a variety of agents that may delay or slow healing. The mechanism of action of ocular corticosteroids is not well understood

DOSING INFORMATION: Beginning 24 hours after ocular surgery, instill one drop of difluprednate ophthalmic emulsion into the conjunctival sac of the affected eye(s) 4 times daily and continue for 2 weeks. Decrease to one drop into the affected eye(s) twice daily for one week and then taper based on patient response.

PHARMACOKINETICS: Systemic absorption of difluprednate after ocular instillation is limited. Difluprednate undergoes deacetylation in vivo to 6-alpha, 9-difluoroprednisolone 17-butyrate (DFB), which is the active metabolite of difluprednate.

CAUTIONS: Fungal disease of ocular structures, mycobacterial infection of the eye, and active viral diseases of the cornea and conjunctiva (e.g., epithelial herpes simplex keratitis, vaccinia, varicella) are contraindicated. Elevated intraocular pressure (IOP), which may result in optic nerve damage and visual acuity and field defects, has been associated with ophthalmic steroid use. Use caution in patients with glaucoma and IOP; furthermore, these patients should be regularly monitored. Adverse events reported with the use of difluprednate are ophthalmically related.

FDA APPROVED INDICATIONS: Difluprednate is a potent topical corticosteroid emulsion indicated for the treatment of inflammation and pain associated with ocular surgery.