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Maxitrol Indications, Dosage, Storage, Stability - Neomycin; Polymyxin B and Dexamethasone

Maxitrol Indications, Dosage, Storage, Stability - Neomycin; Polymyxin B and Dexamethasone

INDICATIONS

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/ Enterobacterspecies, Neisseria species, and Pseudomonas aeruginosa.

This product does not provide adequate coverage against: Serratia marcescens and Streptococci, including Streptococcus pneumoniae.

DOSAGE AND ADMINISTRATION

One to two drops topically in the conjunctival sac(s). In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily.

Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS.

HOW SUPPLIED

Sterile ophthalmic suspension in 5 mL plastic DROP-TAINER® dispenser (NDC 61314-630-06).

Storage: Store at 8°- 27° C ( 46°- 80° F).

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