Blephamide® Ointment

sulfacetamide 10% / prednisolone 0.2% · ophthalmic ointment

Antibiotic/Steroid

Approved uses

Steroid-responsive ocular inflammation with superficial bacterial infection or a risk of it

Approximately 1/2 inch ribbon in the conjunctival sac three or four times daily and once or twice at night; not more than 8 g initially

Chronic anterior uveitis, and corneal injury from chemical, radiation, or thermal burns or foreign body penetration

Approximately 1/2 inch ribbon in the conjunctival sac three or four times daily and once or twice at night; not more than 8 g initially

Contraindications

Most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella; mycobacterial infection of the eye; fungal diseases of ocular structures.
Known or suspected hypersensitivity to any ingredient of the preparation, to other sulfonamides, or to other corticosteroids; hypersensitivity to the antimicrobial component occurs at a higher rate than for the other components.

Available Forms

Ophthalmic ointment, 10%/0.2% (sulfacetamide sodium 10%, prednisolone acetate 0.2%), 3.5 g tube

Mechanism of Action

Sulfacetamide is bacteriostatic, competing with p-aminobenzoic acid to restrict the folic acid synthesis susceptible bacteria need for growth; prednisolone acetate suppresses the inflammatory response and probably delays or slows healing. The anti-infective is present because corticosteroids may inhibit the body's defense mechanism against infection, so the pairing is aimed at settings where the risk of superficial infection is high or dangerous numbers of bacteria are expected.

Warnings & Precautions

Topical ophthalmic use only: Not for injection into the eye.
IOP elevation and glaucoma: Prolonged corticosteroid use may produce ocular hypertension or glaucoma with optic nerve damage and defects in visual acuity and visual fields; check IOP routinely if used 10 days or longer, even though it may be difficult in children and uncooperative patients, and use with caution in the presence of glaucoma.
Posterior subcapsular cataract: Prolonged corticosteroid use may produce it.
Delayed healing: Steroids after cataract surgery may delay healing and increase the incidence of filtering blebs; ophthalmic ointments may also retard corneal healing.
Secondary or masked infection: Prolonged use may suppress host response and increase the hazard of secondary ocular infection; in acute purulent conditions corticosteroids may mask infection or enhance existing infection.
Viral infection exacerbation: Ocular corticosteroids may prolong the course and worsen the severity of many ocular viral infections including herpes simplex; herpes simplex treatment requires great caution.
Corneal or scleral perforation: In diseases causing thinning of the cornea or sclera, perforation has occurred with topical corticosteroids.
Severe sulfonamide reactions: Fatalities have occurred, although rarely, from Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias; sensitization may recur when a sulfonamide is readministered by any route, so discontinue at the first sign of hypersensitivity or other serious reaction.
Corticosteroid cross-sensitivity: Cross-sensitivity among corticosteroids has been demonstrated.
Acute anterior uveitis: May occur in susceptible individuals, primarily Blacks.

Common Side Effects

Corticosteroid component: In the label's stated decreasing order of frequency, IOP elevation with possible glaucoma and infrequent optic nerve damage, posterior subcapsular cataract, and delayed wound healing; also acute anterior uveitis, globe perforation, and occasional mydriasis, loss of accommodation, and ptosis. No incidence figures exist, since the label states no denominator of treated patients is available.
Antibacterial component: Allergic sensitization is the reaction occurring most often; sulfacetamide sodium may cause local irritation.
Severe sulfonamide reactions: Rare fatalities from Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias.
Secondary infection: Fungal and viral corneal infection is particularly prone to develop coincidentally with long-term corticosteroid application; secondary bacterial infection also follows suppression of host responses.
Systemic hypercorticoidism: Rare after topical corticosteroid use; systemic effects are otherwise extremely uncommon.

Pregnancy & Lactation

Pregnancy: Category C. No adequate well-controlled studies in pregnant women dosed with corticosteroids, and no animal reproduction studies with sulfacetamide sodium. Prednisolone is teratogenic in rabbits, hamsters, and mice, and ocular application of dexamethasone, hydrocortisone and prednisolone to both eyes of pregnant mice five times daily on gestation days 10 through 13 significantly increased cleft palate in the fetuses. Systemic sulfonamides given in the third trimester may precipitate kernicterus in infants. Use only if the potential benefit justifies the potential fetal risk.

Sulfonamide resistance: A significant percentage of staphylococcal isolates are completely resistant to sulfonamides; p-aminobenzoic acid present in purulent exudate competes with sulfonamides and further reduces their effectiveness.

Mustard gas and Sjögren keratitis: Topical steroids are not effective in mustard gas keratitis and Sjögren's keratoconjunctivitis.

Severe dry eye: Use with caution.

Lactation: Whether topical administration produces detectable quantities in human milk is unknown. Systemically administered corticosteroids appear in human milk and could suppress growth or interfere with endogenous corticosteroid production, and systemically administered sulfonamides can produce kernicterus in infants of lactating women; decide whether to discontinue nursing or the drug.

Pediatric Use

Safety and effectiveness in children below age 6 have not been established.