Blephamide®
sulfacetamide 10% / prednisolone sodium phosphate 0.23% · ophthalmic suspension
Antibiotic/Steroid
Approved uses
Corticosteroid-responsive ocular inflammation where bacterial infection or the risk of it is present
Two drops in the affected eye(s) every four hours; no more than 20 mL initially
The antibiotic covers the infection risk the steroid would otherwise let run
Contraindications
This product is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis, vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. It is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation, to other sulfonamides, or to other corticosteroids.
Available FormsSulfacetamide sodium 10% and prednisolone sodium phosphate 0.23% ophthalmic solution; no more than 20 mL should be prescribed initially.
Mechanism of ActionSulfacetamide sodium inhibits bacterial folic acid synthesis, crucial for bacterial growth. Prednisolone acetate is a corticosteroid, reducing inflammation by suppressing leukocyte migration and capillary permeability.
Warnings & Precautions
- Not for injection into the eye.
- Prolonged corticosteroid use may cause ocular hypertension and glaucoma with optic nerve damage and visual field loss, and may cause posterior subcapsular cataract.
- Prolonged use may suppress the host response and increase the risk of secondary ocular infection, including fungal infection of the cornea.
- Steroids may prolong and worsen viral infection of the cornea, including herpes simplex.
- Sensitivity to topically applied sulfonamides may occur, and fatalities have followed severe reactions to sulfonamides.
Common Side Effects
Reactions occurring most often from the antibacterial ingredient are allergic sensitizations, and sulfacetamide sodium may cause local irritation. Reactions due to the corticosteroid component, in decreasing order of frequency, are elevation of intraocular pressure with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.
Pregnancy & LactationPregnancy: Prednisolone has been shown to be teratogenic in rabbits, hamsters and mice; there are no adequate and well-controlled studies in pregnant women.
Lactation: Systemically administered corticosteroids appear in human milk; it is not known whether topical ocular use produces detectable amounts.
Pediatric Use≥6 years