Difluprednate is indicated for the treatment of inflammation and pain associated with ocular surgery. It is also indicated for the treatment of uveitis, ocular surface diseases, e.g. blepharitis & corneal inflammation.
Ophthalmic Steroid preparations
Corticosteroids inhibit the inflammatory response to a variety of inciting agents and may delay or slow healing. They inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Difluprednate is structurally similar to other corticosteroids.
For the treatment of inflammation and pain associated with ocular surgery: Instill 1 drop into the conjunctival sac of the affected eye 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period, followed by 2 times daily for a week and then a taper based on the response. For the treatment of endogenous anterior uveitis: Instill 1 drop into the conjunctival sac of the affected eye 4 times daily for 14 days followed by tapering as clinically indicated. For blepharitis: Instill 1 drop into the conjunctival sac of the affected eyes 2 times daily for 1 week & then once daily for 1 week. For pseudophakic cystoid macular edema: Instill 1 drop into the conjunctival sac of the affected eyes 2 times daily.
Specific drug interaction studies have not been conducted with Difluprednate 0.05% ophthalmic emulsion.
Difluprednate is contraindicated in most viral diseases of the cornea and conjunctiva, mycobacterial infection of the eye and fungal diseases of ocular structures.
Glaucoma with optic nerve damage, visual acuity & field defects, cataract formation, secondary ocular infection following suppression of host response, and perforation of the globe may occur.
Use in pregnancy: Use of difluprednate in pregnancy has not been evaluated. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Use in lactation: It is not known whether difluprednate passes into breast milk. Caution should be exercised when it is administered to a nursing mother.
Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.
Store at room temperature, protect from light and freezing. It is desirable that the contents should not be used more than 1 month after first opening of the bottle.
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