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DOSAGE
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Mild Bacterial Infection: 1-2 gtts QID to 6/day
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Severe Bacterial Infection: 1-2 gtts q1hr, then taper to discontinuation as the inflammation subsides
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GENERIC
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neomycin 0.35%, polymyxin B + dexamethasone 0.1%
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SIZE
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2.5mL, 5mL
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INDICATIONS
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For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitis 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.
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MECHANISM OF ACTION
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aminoglycoside, cationic detergent, corticosteroid: Aminoglycosides inhibit bacterial protein synthesis. Polymyxins bind to bacterial cell membrane increasing permeability. Corticosteroids inhibit arachidonic acid release
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MICROBIOLOGY
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Active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa.
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This product does not provide adequate coverage against: Serratia marcescens and streptococci, including Streptococcus pneumoniae.
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CONTRAINDICATIONS & WARNINGS
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MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
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MAXITROL is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
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PEDIATRIC USE
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Safety and effectiveness in pediatric patients below the age of 2 years have not been established.
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PREGNANCY
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Category C Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose. In the mouse, corticosteroids produce fetal resorptions and a specific abnormality, cleft palate. In the rabbit, corticosteroids have produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, palate, etc. There are no adequate or well-controlled studies in pregnant women. However, prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation. MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.
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NOTE
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Hypersensitivity to neomycin is common but it is not considered a classical sulfonamide sensitivity. Glaucoma risk with extended use.
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Other Generic name: Neo Poly Dex (B&L) , Falcon (Alcon) , B&L , AK-Trol, Dexacidin, Dexasporin
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