Difluprednate Ophthalmic
Generic Name: difluprednate ophthalmic
Brand Names:
Difluprednate
11 DESCRIPTION Difluprednate ophthalmic emulsion 0.05% is a sterile, topical anti-inflammatory corticosteroid for topical ophthalmic use. The chemical name is 6α,9difluoro-11β,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 508.56 g/mol, and the empirical formula is C 27 H 34 F 2 O 7 .
Overview
11 DESCRIPTION Difluprednate ophthalmic emulsion 0.05% is a sterile, topical anti-inflammatory corticosteroid for topical ophthalmic use. The chemical name is 6α,9difluoro-11β,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 508.56 g/mol, and the empirical formula is C 27 H 34 F 2 O 7 .
Uses
1 INDICATIONS AND USAGE Difluprednate ophthalmic emulsion is a corticosteroid 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 is indicated for the treatment of inflammation and pain associated with ocular surgery. 1.2 Endogenous Anterior Uveitis Difluprednate ophthalmic emulsion is indicated for the treatment of endogenous anterior uveitis.
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.
Side Effects
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, conjunctiv...
Warnings
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. 4 CONTRAINDICATIONS 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.
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on difluprednate ophthalmic emulsion use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Systemic exposure to difluprednate ophthalmic emulsion following ocular administration is low [see Clinical Pharmacology ( 12.3 )]. Consequently, the systemic exposure of a pregnant woman to difluprednate is expected to be minimal following topical ocular administration.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Difluprednate ophthalmic emulsion 0.05% is a sterile, aqueous topical ophthalmic emulsion supplied in a white, LDPE bottle with a nozzle and a pink cap in the following sizes: 5 mL in a 5 mL bottle NDC 46708-750-05 Storage and Handling Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Tempe...
Frequently Asked Questions
What is Difluprednate Ophthalmic used for?▼
1 INDICATIONS AND USAGE Difluprednate ophthalmic emulsion is a corticosteroid 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 is indicated for the treatment of inflammation and pain associated with ocular surgery. 1.2 Endogenous Anterior Uveitis Difluprednate ophthalmic emulsion is indicated for the treatment of endogenous anterior uveitis.
What are the side effects of Difluprednate Ophthalmic?▼
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, conjunctiv...
Can I take Difluprednate Ophthalmic during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data on difluprednate ophthalmic emulsion use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Systemic exposure to difluprednate ophthalmic emulsion following ocular administration is low [see Clinical Pharmacology ( 12.3 )]. Consequently, the systemic exposure of a pregnant woman to difluprednate is expected to be minimal following topical ocular administration.
What are the important warnings for Difluprednate Ophthalmic?▼
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. 4 CONTRAINDICATIONS 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.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.