Overview
11 DESCRIPTION Difluprednate ophthalmic emulsion 0.05% is a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. The chemical name is 6α, 9difluoro-11 β ,17,21-trihydroxypregna-1,4-diene-3,20-dione 21-acetate 17-butyrate (CAS number 23674-86-4). Difluprednate is represented by the following structural formula: Difluprednate has a molecular weight of 508.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 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.
Indications
- 1 INDICATIONS AND USAGE 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) 1.1 Ocular Surgery Difluprednate ophthalmic emulsion 0.05%, a topical corticosteroid, is indicated for the treatment of inflammation and pain associated with ocular surgery. 1.2 Endogenous Anterior Uveitis Difluprednate ophthalmic emulsion is also indicated for the treatment of endogenous anterior uveitis. 1.1 Ocular Surgery Difluprednate ophthalmic emulsion 0.
Common Doses
- Refer to label
Dosage
2 DOSAGE AND ADMINISTRATION For the treatment of inflammation and pain associated with ocular surgery instill one 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 postoperative period, followed by 2 times daily for a week and then a taper based on the response. (2.1) For the treatment of endogenous anterior uveitis instill one drop into the conjunctival sac of the affected eye 4 times daily for 14 days followed by tapering as clinically indicated. (2.2) 2.
Contraindications
- 4 CONTRAINDICATIONS 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),...
Side Effects
- 6 ADVERSE REACTIONS The following serious reactions are found elsewhere in the labeling: Elevated intraocular pressure [see Warnings and Precautions (5.1) ] Posterior subcapsular cataract formation [see Warnings and Precautions (5.2) ] Secondary ocular infection [see Warnings and Precautions (5.4) ] Perforation of the globe [see Warnings and Precautions (5.3) ] 6.1 Ocular Surgery Ocular adverse reactions occurring in 5-15% of subjects in clinical studies with difluprednate ophthalmic emulsion included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule...
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.