Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious reactions are found elsewhere in the labeling: • Intraocular Pressure ( IOP) Increase [see Warnings and Precautions ( 5.1 )] • Cataracts [see Warnings and Precautions ( 5.2 )] • Delayed Healing [see Warnings and Precautions ( 5.3 )] • Corneal and Scleral Melting [see Warnings and Precautions ( 5.4 )] • Bacterial Infections [see Warnings and Precautions ( 5.5 )] • Viral Infections [see Warnings and Precautions ( 5.6 )] • Fungal Infections [see Warnings and Precautions ( 5.7 )] For treatment of inflammation and pain associated with ocular surgery, most common adverse reactions (incidence 5% to 15%) are corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis.
For treatment of endogenous anterior uveitis, most common adverse reactions (incidence 5% to 10%) are blurred vision, eye irritation, eye pain, headache, increased IOP, iritis, limbal and conjunctival hyperemia, punctate keratitis, and uveitis.
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Ocular Surgery Ocular adverse reactions occurring in 5% to 15% of subjects in clinical studies with difluprednate ophthalmic emulsion included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, and blepharitis.
Other ocular adverse reactions occurring in 1% to 5% of subjects, included reduced visual acuity, punctate keratitis, eye inflammation, and iritis.
Ocular adverse reactions occurring in less than 1% of subjects, included application-site discomfort or irritation, corneal pigmentation and striae, episcleritis, eye pruritus, eyelid irritation and crusting, foreign body sensation, increased lacrimation, macular edema, sclera hyperemia, and uveitis.
Most of these reactions may have been the consequence of the surgical procedure.
6.2 Endogenous Anterior Uveitis A total of 200 subjects participated in the clinical trials for endogenous anterior uveitis, of which 106 were exposed to difluprednate ophthalmic emulsion.
The most common adverse reactions of those exposed to difluprednate ophthalmic emulsion occurring in 5% to 10% of subjects included blurred vision, eye irritation, eye pain, headache, increased IOP, iritis, limbal and conjunctival hyperemia, punctate keratitis, and uveitis.
Adverse reactions occurring in 2% to 5% of subjects included anterior chamber flare, corneal edema, dry eye, iridocyclitis, photophobia, and reduced visual acuity.
5 WARNINGS AND PRECAUTIONS • 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 difluprednate ophthalmic emulsion 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 corticosteroids after cataract surgery may delay healing and increase the incidence of bleb formation.
( 5.3 ) • Corneal and Scleral Melting: In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids.
Like all medications, Difluprednate Ophthalmic can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: