Steroid-responsive ocular inflammation where bacterial infection or a risk of infection exists
About a 0.5 inch ribbon into the conjunctival sac up to 3 or 4 times daily; not more than 8 g before re-examination
Contraindications
Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva.
Mycobacterial infection of the eye.
Fungal disease of ocular structures.
Known or suspected hypersensitivity to a component, with hypersensitivity to the antibiotic component occurring at a higher rate than to the other components.
Available Forms
Neomycin 3.5 mg/g, polymyxin B sulfate 10,000 units/g, dexamethasone 0.1% ointment, 3.5 g aluminum tube.
Mechanism of Action
Corticosteroid plus two antibacterials: dexamethasone suppresses the inflammatory response and probably delays or slows healing, neomycin blocks bacterial protein synthesis at the 30S ribosomal subunit, and polymyxin B permeabilizes the gram-negative outer membrane. Pairing them covers the infection risk created when a corticosteroid inhibits host defense.
Warnings & Precautions
Neomycin sensitization: Cutaneous sensitization may occur, ranging from local effects to erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions; discontinue if hypersensitivity develops.
Aminoglycoside cross-sensitivity: Sensitization to the topical aminoglycoside may extend to other topical or systemic aminoglycosides.
Periocular contact allergy: In a German patch test series of periorbital dermatitis, allergic contact dermatitis was the leading cause (44.3% and 31.6% across two cohorts) and neomycin sulfate ranked among the five most relevant allergens at 8%.
Prolonged steroid use: Glaucoma with optic nerve damage, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation.
Host response suppression: Prolonged use increases the hazard of secondary ocular infection and the possibility of persistent fungal corneal infection after prolonged steroid dosing; suspect fungal infection in any persistent corneal ulceration.
Infection masking: In acute purulent or parasitic ocular infection, steroids may mask infection or enhance existing infection.
Herpes simplex exacerbation: Ocular steroids may prolong the course and worsen many viral eye infections; treatment of herpes simplex requires great caution and frequent slit lamp microscopy.
Corneal or scleral thinning: Perforation has occurred with topical steroids in diseases that thin these tissues.
IOP monitoring at 10 days: Routine monitoring is required with use of 10 days or longer, including in children and uncooperative patients; use with caution in glaucoma and check IOP frequently.
Post-cataract surgery healing: Steroid use after cataract surgery may delay healing and increase the incidence of bleb formation.
Common Side Effects
Hypersensitivity: Allergic sensitization is the reaction reported most often from the anti-infective components; exact incidence figures are not available.
Ocular, corticosteroid: IOP elevation with possible glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.
Ocular, secondary infection: Fungal keratitis is particularly prone to develop with long-term steroid application and secondary bacterial infection follows suppression of host response; keratitis, conjunctivitis, corneal ulcer, and conjunctival hyperemia have occasionally been reported with steroid use.
Ocular, postmarketing: Ulcerative keratitis.
Systemic: Headache and Stevens-Johnson syndrome identified in postmarketing use.
Pregnancy & Lactation
Pregnancy: Dexamethasone is teratogenic in mice and rabbits after topical ocular application at multiples of the therapeutic dose, with fetal resorption and cleft palate in mice and head, ear, limb, and palate defects in rabbits; no adequate human studies, prolonged or repeated corticoid use in pregnancy is associated with intrauterine growth retardation, and infants exposed to substantial maternal corticosteroid doses should be watched for hypoadrenalism.
Lactation: Systemically administered corticosteroids appear in human milk and could suppress growth or interfere with endogenous corticosteroid production; whether topical ocular dosing yields detectable milk levels is unknown, so use with caution.
Pediatric Use
Route restriction: Not for injection.
Coverage gap: No adequate coverage against Serratia marcescens or streptococci, including Streptococcus pneumoniae.
48-hour reassessment: Inflammation or pain that persists beyond 48 hours or worsens is reason to stop the product and reassess.
Transient blurred vision: Vision may be temporarily blurred after dosing, which matters for driving and machinery.
Safety and effectiveness in pediatric patients not established; this label sets no age threshold.