Label: MAXITROL- neomycin sulfate, polymyxin b sulfate and dexamethasone ointment
- NDC Code(s): 66758-070-38
- Packager: Sandoz Inc
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 29, 2023
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SPL UNCLASSIFIED SECTIONMAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) Sterile
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DESCRIPTIONMAXITROL® (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 ...
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CLINICAL PHARMACOLOGYCorticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body's defense mechanism against infection ...
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INDICATIONS AND USAGEFor 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 ...
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CONTRAINDICATIONSMAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) is contraindicated in epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many ...
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WARNINGSNOT FOR INJECTION. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of steroid medication in ...
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PRECAUTIONSGeneral - The initial prescription and renewal of the medication order beyond 8 g of MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) should be made by a ...
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ADVERSE REACTIONSAdverse 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 ...
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DOSAGE AND ADMINISTRATIONApply 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 ...
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HOW SUPPLIEDMAXITROL® (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 ...
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PRINCIPAL DISPLAY PANELNDC 66758-070-38 - Maxitrol® (neomycin and polymyxin B - sulfates and dexamethasone - ophthalmic ointment) Sterile 3.5 g Net Wt. Rx Only - SANDOZ
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INGREDIENTS AND APPEARANCEProduct Information