Dosing and uses of Durezol (difluprednate ophthalmic)
Adult dosage forms and strengths
ophthalmic solution
- 0.05%
Ocular Inflammation & Pain
Initate 24 hours postop: Instill 1 gtt in conjunctival sac of affected eye(s) q6hr for 2 weeks, then q12hr for1 week, then taper and discontinue
Uveitis
Indicated for treatment of endogenous anterior uveiti
Instill 1 ftt into conjunctival sac to affected eye(s) q6hr for 14 days and then taper dose downward as clinically indicated
Pediatric dosage forms and strengths
Safety and efficacy not established
Durezol (difluprednate ophthalmic) adverse (side) effects
Frequency not defined
Increased IOp
Anterior chamber inflammation
Corneal edema
Conjunctival edema
Blepharitis
Cataract
Optic nerve damage
Abnormal healing (after surgery)
Local irritation
Punctate keratitis
Hyperemia
Punctate keratitis
Decreased visual acuity
Eye pain
Photophobia
Postmarketing Reports
Elevated intraocular pressure
Posterior subcapsular cataract formation
Secondary ocular infection
Perforation of the globe
Warnings
Contraindications
Most active viral diseases of 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
Cautions
Use caution in glaucoma, prolonged use may increase IOP (monitor)
May increase risk of cataracts
The use of steroids after cataract surgery may delay healing and increase incidence of bleb formation; perforations, associated with thinning of cornea or sclera, may occur; initial prescription and renewal of medication order beyond 28 days should be made by a physician only after examination of patient with aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining
Employment of corticosteroid medication in treatment of patients with history of herpes simplex requires great caution; use of ocular steroids may prolong course and may exacerbate severity of many viral infections of the eye (including herpes simplex)
Prolonged use of corticosteroids may suppress host response and thus increase hazard of secondary ocular infections; in acute purulent conditions, steroids may mask infection or enhance existing infection; if signs and symptoms fail to improve after 2 days, patient should be re-evaluated
Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application; fungus invasion must be considered in any persistent corneal ulceration where steroid has been used or is in use
Not for intraocular administration
Pregnancy and lactation
Pregnancy category: C
Lactation: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in milk. Use caution.
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Durezol (difluprednate ophthalmic)
Mechanism of action
Antiinflammatory corticosteroid; inhibits inflammatory response including capillary dilation, edema, leukocyte migration, and scar formation
Absorption
Absorption: Negligible absorption
Metabolism: Undergoes deacetylation to active metabolite
