Vasocidin®
Sulfacetamide 10% /Prednisolone phosphate 0.23% · ophthalmic solution
Antibiotic/Steroid
Approved uses
Corticosteroid-responsive ocular inflammation with superficial bacterial infection or a high risk of it
Two drops in the eye(s) every 4 hours, not more than 20 mL initially, tapered by frequency in chronic disease
Chronic anterior uveitis, or corneal injury from chemical, radiation, or thermal burns or foreign body penetration, where superficial bacterial ocular infection or a risk of it exists
Two drops in the eye(s) every 4 hours, not more than 20 mL 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 disease of ocular structures.
- Known or suspected hypersensitivity to any ingredient of this preparation, to other sulfonamides, or to other corticosteroids; hypersensitivity to the antimicrobial component occurs at a higher rate than to the other components.
Available FormsSulfacetamide sodium 10% with prednisolone phosphate 0.23% solution, thimerosal 0.01% preserved, 5 mL fill in a 10 mL bottle, 10 mL fill in a 10 mL bottle
Mechanism of ActionCorticosteroid plus sulfonamide antibacterial: prednisolone phosphate suppresses the inflammatory response and probably delays or slows healing, while sulfacetamide is bacteriostatic against susceptible bacteria, competing with p-aminobenzoic acid to restrict the folic acid synthesis they need for growth. Because corticosteroids can inhibit host defenses against infection, the anti-infective is included where the risk of superficial ocular infection is high or dangerous numbers of bacteria are expected.
Warnings & Precautions
- Route restriction: Not for injection into the eye.
- Ocular hypertension and glaucoma: Prolonged corticosteroid use raises IOP with optic nerve damage and defects in visual acuity and fields; monitor IOP routinely if treatment runs 10 days or longer, and use with caution in existing glaucoma.
- Posterior subcapsular cataract: Prolonged corticosteroid use causes lens opacity.
- Corneal or scleral thinning: Perforation has occurred with topical corticosteroids in diseases that thin the cornea or sclera.
- Infection masking: Corticosteroids may mask or enhance an acute purulent infection, may prolong and worsen viral eye infection including herpes simplex, and suppress host response enough to invite secondary ocular infection; consider corneal fungal infection after prolonged dosing and culture when appropriate.
- Sulfonamide hypersensitivity: Rare fatalities from Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias; sensitization can recur when a sulfonamide is readministered by any route, so stop the drug at any sign of hypersensitivity.
- Thimerosal sensitivity: Contains thimerosal 0.01%; do not use in patients sensitive to thimerosal or any other mercury-containing ingredient.
- Sulfonamide resistance: A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.
- Wound healing after cataract surgery: Corticosteroids may delay healing and increase the incidence of filtering blebs.
- Acute anterior uveitis: Reported in susceptible individuals, primarily Black patients.
- Nonresponsive conditions: Topical corticosteroids are not effective in mustard gas keratitis or Sjögren's keratoconjunctivitis.
- Drug interactions: Incompatible with silver preparations; local anesthetics related to p-aminobenzoic acid, and the p-aminobenzoic acid present in purulent exudate, antagonize sulfonamide action.
Common Side Effects
- Ocular, corticosteroid component: IOP elevation with possible glaucoma and infrequent optic nerve damage, posterior subcapsular cataract, delayed wound healing, in decreasing order of frequency.
- Ocular, anti-infective component: Allergic sensitization is the reaction occurring most often; sulfacetamide sodium may also cause local irritation.
- Ocular, other corticosteroid effects: Globe perforation, and occasionally reported mydriasis, loss of accommodation, and ptosis.
- Secondary infection: Fungal and viral corneal infection is particularly prone to develop with long-term corticosteroid use, and secondary bacterial infection follows suppression of host response; suspect fungal invasion in any persistent corneal ulceration treated with a steroid.
- Systemic, rare: Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias, with rare fatalities; systemic hypercorticoidism is extremely uncommon.
Pregnancy & LactationPregnancy: Prednisolone is teratogenic in rabbits, hamsters, and mice, in mice at 1 to 10 times the human ocular dose; ocular application to pregnant mice five times daily on gestation days 10 through 13 significantly increased cleft palate in the fetuses. Sulfonamides given systemically in the third trimester may precipitate kernicterus in the infant, and there are no adequate well-controlled studies in pregnant women.
Lactation: Systemically administered corticosteroids appear in human milk and could suppress growth or endogenous corticosteroid production, and systemically administered sulfonamides can produce kernicterus in infants of lactating women; the choice is between discontinuing nursing and discontinuing the drug.
Pediatric UseSafety and effectiveness below age 6 not established.