Cortisporin®
neomycin 0.35%, polymyxin B, bacitracin, hydrocortisone 1% · ophthalmic ointment
Antibiotic/Steroid
Approved uses
Steroid-responsive ocular inflammation with bacterial infection or a risk of it
Apply the ointment in the affected eye every 3 or 4 hours depending on severity; not more than 8 g initially
Chronic anterior uveitis or corneal injury from burns or foreign bodies, where bacterial infection or a risk of it also exists
Apply the ointment in the affected eye every 3 or 4 hours depending on severity; 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.
- Hypersensitivity to any component; hypersensitivity to the antibiotic component occurs at a higher rate than to the other components.
Available FormsOphthalmic ointment, per gram: neomycin sulfate equivalent to 3.5 mg neomycin base (0.35%), polymyxin B sulfate 10,000 units, bacitracin zinc 400 units, hydrocortisone acetate 10 mg (1%), 3.5 g (1/8 oz) tube
Mechanism of ActionNeomycin binds the bacterial 30S ribosomal subunit and polymyxin B disrupts the gram-negative outer membrane, while bacitracin blocks cell wall peptidoglycan synthesis; the combination covers Staphylococcus aureus, streptococci including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella and Enterobacter species, Neisseria species, and Pseudomonas aeruginosa, but not Serratia marcescens. Hydrocortisone acetate suppresses the inflammatory response and probably delays or slows healing, which is the reason an anti-infective is paired with it where dangerous numbers of bacteria are expected.
Warnings & Precautions
- Topical ophthalmic use only: Not for injection into the eye, and never to be introduced directly into the anterior chamber.
- Neomycin sensitization: Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization, and the label states a precise incidence is not known. Manifestations are itching, reddening, and edema of the conjunctiva and eyelid, and a sensitization reaction may present simply as failure to heal. Hypersensitivity to the antibiotic component occurs at a higher rate than to the other components. Examine periodically during long-term use, discontinue if these signs appear, and avoid products containing these ingredients thereafter; symptoms usually subside quickly on withdrawal.
- Aminoglycoside cross-reactions: Allergic cross-reactions may prevent future use of kanamycin, paromomycin, streptomycin, and possibly gentamicin.
- IOP elevation and glaucoma: Prolonged corticosteroid use may cause ocular hypertension or glaucoma with optic nerve damage and defects in visual acuity and fields of vision; monitor IOP routinely once use reaches 10 days, and use with caution where glaucoma is already present.
- Posterior subcapsular cataract: Prolonged corticosteroid use may produce it.
- Corneal and scleral thinning: Long-term topical corticosteroid use and various ocular diseases cause corneal and scleral thinning; use over already thin tissue may lead to perforation.
- Delayed healing: Ophthalmic ointments may retard corneal wound healing, and corticosteroid use after cataract surgery may delay healing and increase the incidence of filtering blebs.
- Secondary or masked infection: Prolonged use may suppress the host immune response and increase the hazard of secondary ocular infection, and acute purulent infections of the eye may be masked or enhanced by corticosteroid.
- Viral infection exacerbation: Ocular corticosteroids may prolong the course and exacerbate the severity of many viral eye infections including herpes simplex; treating herpes simplex with a steroid requires great caution and frequent slit lamp microscopy.
- Multi-dose container contamination: Bacterial keratitis has followed inadvertent contamination of multiple-dose topical ophthalmic containers, mostly in patients with concurrent corneal disease or a disrupted ocular epithelial surface.
- Failure to improve at two days: Re-evaluate rather than continue on assumption, and take fungal cultures where appropriate, since fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use.
Common Side Effects
- Anti-infective component: Allergic sensitization is the reaction occurring most often, presenting as itching, swelling, and conjunctival erythema; more serious hypersensitivity including anaphylaxis has been reported rarely. The label states the exact incidence is not known.
- Corticosteroid component: In the label's stated decreasing order of frequency, IOP elevation with possible development of glaucoma and infrequent optic nerve damage, then posterior subcapsular cataract, then delayed wound healing.
- Secondary infection: Fungal and viral corneal infection is particularly prone to develop alongside long-term corticosteroid use; suspect fungal invasion in any persistent corneal ulceration treated with a steroid.
- Local irritation: Reported on instillation.
Pregnancy & LactationPregnancy: Category C. Corticosteroids are teratogenic in rabbits applied topically at 0.5% on gestation days 6 to 18 and in mice applied topically at 15% on days 10 to 13. There are no adequate and well-controlled studies in pregnant women; use only if the potential benefit justifies the potential risk to the fetus.
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; decide whether to discontinue nursing or the drug.
Pediatric UseSafety and effectiveness in children have not been established.