MAXITROL

INDICATIONS AND USAGE For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa . This product does not provide adequate coverage against: Serratia marcescens and Streptococci , including Streptococcus pneumoniae .

DOSAGE AND ADMINISTRATION Apply a small amount into the conjunctival sac(s) up to three or four times daily. How to Apply MAXITROL ® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment): 1. Tilt your head back. 2. Place a finger on your cheek just under your eye and gently pull down until a "V" pocket is formed between your eyeball and your lower lid. 3. Place a small amount (about 1⁄2 inch) of MAXITROL (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) in the "V" pocket. Do not let the tip of the tube touch your eye. 4. Look downward before closing your eye. Not more than 8 g should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

CONTRAINDICATIONS MAXITROL ® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) is contraindicated in epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. MAXITROL (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) is also contraindicated in individuals with known or suspected hypersensitivity to a component of the medication. (Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.)

ADVERSE REACTIONS Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available. Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. The reactions due to the steroid component are: elevation of IOP with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing. Secondary Infection: The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Keratitis, conjunctivitis, corneal ulcers, and conjunctival hyperemia have occasionally been reported following use of steroids. Secondary bacterial ocular infection following suppression of host responses also occurs. Additional adverse reactions identified from post marketing use include ulcerative keratitis, headache, and Stevens-Johnson syndrome. The following additional adverse reactions have been reported with dexamethasone use: Cushing’s syndrome and adrenal suppression may occur after use of dexamethasone in excess of the listed dosing instructions in predisposed patients, including children and patients treated with CYP3A4 inhibitors.

DESCRIPTION MAXITROL ® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) is a multiple dose anti-infective steroid combination in sterile ointment form for topical application. The chemical structure for the active ingredient Neomycin Sulfate is: Neomycin B (R 1 =H, R 2 =CH 2 NH 2 ) Neomycin C (R 1 =CH 2 NH 2 , R 2 =H) The chemical structure for the active ingredient Polymyxin B Sulfate is: The chemical structure for the active ingredient dexamethasone is: C 22 H 29 FO 5 Molecular Weight = 392.47 g/mol Established name: dexamethasone Chemical name: pregna-1, 4-diene-3, 20-dione,9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β, 16α)-. Each gram of MAXITROL ® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) contains: Active: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Preservatives: methylparaben 0.05%, propylparaben 0.01%. Inactives: anhydrous liquid lanolin and white petrolatum. The chemical structure for the active ingredient Neomycin Sulfate The chemical structure for the active ingredient Polymyxin B Sulfate polymyxin-text The chemical structure for the active ingredient Dexamethasone

HOW SUPPLIED MAXITROL ® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) is supplied as a STERILE ointment in an aluminum tube with a white polyethylene tip and white polyethylene cap as follows: 3.5 g in an aluminum tube NDC 66758-070-38 Storage : Store at 2°C to 25°C (36°F to 77°F). After opening, MAXITROL (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) can be used until the expiration date on the tube. Manufactured by SA Alcon-Couvreur NV Puurs, Belgium for Sandoz Inc., Princeton, NJ 08540 Revised: December 2023 9101235 US