Dexamethasone / neomycin / polymyxin B

Steroid-responsive inflammatory conditions of conjunctiva, cornea or anterior globe where corticosteroid treatment is indicated and bacterial infection or its risk exists. Examples include chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns or foreign-body penetration; treatment follows ophthalmic diagnosis, not self-treatment of any irritation.

Labels identify activity against selected common ocular bacteria, including S. aureus, E. coli, H. influenzae, Klebsiella/Enterobacter, Neisseria and P. aeruginosa. Coverage is inadequate for Serratia marcescens and streptococci, including S. pneumoniae. This is not universal conjunctivitis coverage or treatment for fungal/viral eye infection.

Suspension initial prescription≤20 mL; ointment≤8 g. Initial prescribing and renewal beyond these quantities require physician examination with magnification/slit lamp and fluorescein when appropriate. Suspension nonresponse after 2 days requires reevaluation; both patient instructions advise stopping and consulting for persistent pain/inflammation beyond 48 hours or worsening. These are review thresholds, not fixed maximum treatment durations.

Use only the prescribed ophthalmic vehicle, avoid contaminated tips and sharing. Not for injection, including subconjunctival/anterior-chamber administration. Follow exact package handling instructions; no unsupported schedule for another manufacturer, an ear route or conversion between drops and ointment.

Epithelial herpes-simplex keratitis, vaccinia, varicella and other specified viral corneal/conjunctival disease; mycobacterial eye infection; fungal ocular disease; known/suspected ingredient hypersensitivity. Suspension additionally explicitly contraindicates hypersensitivity to other corticosteroids. Do not describe a steroid warning as treatment authorization for an excluded infection.

Neither selected Maxitrol label has a boxed warning. Significant ocular and systemic steroid risks remain in Warnings/Adverse reactions; lack of a box does not imply unrestricted use.

Allergic sensitization, raised IOP/glaucoma, cataract, delayed healing, keratitis/ulceration and secondary infection are reported; postmarketing headache, ulcerative keratitis and Stevens–Johnson syndrome are listed. Excess use may suppress adrenal function. Labels provide no validated acute overdose protocol or incidence denominator: excess dosing, accidental ingestion or serious symptoms require professional/Poison Control review, not a home detoxification algorithm.

Current labels report adrenal suppression/Cushing syndrome after excess dexamethasone dosing in predisposed patients, including patients taking CYP3A4 inhibitors. This supports careful medication review and avoidance of excess use, not an invented numerical dose-reduction algorithm or claim that every topical dose causes systemic toxicity.

These selected labels contain no comprehensive formal interaction table or validated spacing rule for every eye medicine. Review other ophthalmic products and allergies with the eye clinician/pharmacist; no automatic transfer of systemic neomycin renal/neuromuscular dosing warnings into an unverified topical interaction regimen.

Suspension safety/effectiveness below 2 years unestablished. Selected ointment states pediatric safety/effectiveness unestablished without a numerical lower age; do not apply the suspension age statement to ointment. No overall elderly/adult safety/effectiveness difference observed, but monitor individual ocular risk and treatment response.

Human pregnancy studies are inadequate; ocular dexamethasone animal findings and prolonged/repeated corticosteroid exposure risks warrant maternal-benefit/fetal-risk review. Infants after substantial maternal corticosteroid doses require observation for adrenal suppression. Whether topical administration yields detectable milk steroid levels is unknown; use caution during nursing. No absolute pregnancy-safe assertion or fixed milk-discard period.

Selected ophthalmic labels provide no numerical renal/hepatic adjustment or dialysis regimen. This is a source limitation, not proof that systemic steroid effects cannot occur; assess exposure, interacting drugs and clinical need with the prescriber.

Corticosteroid suppression of inflammation can delay healing and reduce host defense; an antibacterial component is included when that risk is clinically relevant. The combined vehicle supports delivery of the selected ingredients, but cannot prevent resistant-organism or fungal infection. Selected labels describe product activity, not universal bactericidal coverage.

These labels do not provide quantitative ocular/systemic bioavailability, serum half-life, renal clearance or therapeutic concentrations for the fixed combination. Steroid potency depends on structure, concentration and release from the vehicle. No numerical PK value borrowed from systemic dexamethasone or another formulation.

Review viral/fungal history, corneal/scleral thinning, glaucoma, surgery, aminoglycoside allergy and interacting drugs. Use slit-lamp/fluorescein examination when indicated for initial/renewal prescribing. Monitor IOP at ≥10 days and frequently in glaucoma; consider fungal infection in persistent ulcers and reassess nonresponse promptly. No universal laboratory timetable invented.

Do not touch dispenser tip to eyelids or surfaces, share bottles/tubes or use an injection/ear route. Keep tightly closed. Vision may blur temporarily: wait until vision is adequate before driving or operating machinery. Stop/contact clinician for pain/inflammation persisting beyond 48 hours, worsening or allergy; seek urgent assessment for serious visual change/systemic allergy.

Selected package

Harrow Maxitrol 5 mL in 8 mL white dispenser with pink cap; NDC 82667-100-05.

Per mL actives

Neomycin sulfate equivalent to 3.5 mg neomycin; polymyxin B sulfate 10,000 units; dexamethasone 0.1%.

Vehicle

Sterile suspension, benzalkonium chloride 0.004% preservative. Prescription ophthalmic use.

Suspension

Above strengths per mL; do not infer ointment gram-to-drop equivalence.

Ointment

Per gram: neomycin equivalent 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Lanolin/petrolatum with methylparaben 0.05% and propylparaben 0.01%.

Selected ointment package

Sandoz 3.5 g aluminum tube; NDC 66758-070-38. Other manufacturers/combinations need separate verification.

Selected suspension upright 8–27°C; selected ointment 2–25°C. Both selected labels permit use after opening until printed expiration; do not invent a universal 28-day discard rule. Close tightly, prevent tip contamination and keep away from children. Follow the exact current package.