Prednisolone/Sulfacetamide Ophthalmic

DEA Class; Rx

Common Brand Names; Blephamide, Blephamide S.O.P.

Indicated for steroid-responsive inflammatory ocular inflammation conditions (e.g., uveitis, bacterial conjunctivitis, corneal abrasion) for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.

Hypersensitivity to sulfa; active glaucoma, herpes, vaccinia, varicella, and other viral diseases of cornea or conjunctiva, mycobacterial infection of eye, fungal diseases of ocular structures, hypersensitivity to any ingredients

• Cataract
• Dizziness
• Eye discharge
• Eyelid edema
• Eyelid erythema
• Eye irritation
• Eye pain
• Eye pruritus
• Hypersensitivity including rash, skin pruritus, urticaria, ocular hyperemia, and visual disturbance (blurry vision)

Use for short term only because of steroid concerns

Watch for hypersensitivity to sulfas and steroid side effects (superinfection, glaucoma, etc)

Blood dyscrasias including aplastic anemia, agranulocytosis, and others reported with sulfonamides regardless of route

Stevens-Johnson syndrome, toxic epidermal necrolysis and other reactions reported with sulfonamides regardless of route

Fatal hepatic necrosis reported with sulfonamides regardless of route

Steroids may mask infections or enhance existing ocular infections

Prolonged use of steroids may result in injury to the optic nerve, glaucoma, defects in visual acuity with prolonged use; steroid use may delay healing after cataract surgery; perforation may occur with topical steroids in diseases that thin the cornea or sclera

Prolonged use of corticosteroids may result in posterior subcapsular cataract formation and may increase intraocular pressure in susceptible individuals, resulting in ocular hypertension/glaucoma with damage to the optic nerve

Pregnancy Category: C

Lactation: Not known whether topical application is excreted into milk; use caution

12 drops/day per affected eye of the suspension or solution (dispense no more than 20 ml without re-evaluation); 1/2 inch ointment per affected eye up to six times daily (dispense no more than 8 grams without re-evaluation).

12 drops/day per affected eye of the suspension or solution (dispense no more than 20 ml without re-evaluation); 1/2 inch ointment per affected eye up to six times daily (dispense no more than 8 grams without re-evaluation).

12 drops/day per affected eye of the suspension or solution (dispense no more than 20 ml without re-evaluation); 1/2 inch ointment per affected eye up to six times daily (dispense no more than 8 grams without re-evaluation).

6 years or older: 12 drops/day per affected eye of the suspension or solution (dispense no more than 20 ml without re-evaluation); 1/2 inch ointment per affected eye up to six times daily (dispense no more than 8 grams without re-evaluation).
Younger than 6 years: Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.