Neomycin and Polymyxin B Sulfates and Dexamethasone

FDA Drug Profile — Neomycin and Polymyxin B Sulfates and Dexamethasone

Neomycin and Polymyxin B Sulfates and Dexamethasone is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand name including Neomycin and Polymyxin B Sulfates and Dexamethasone. Available dosage form: ointment.

Drug Details

Generic Name
Neomycin and Polymyxin B Sulfates and Dexamethasone
Brand Names
Neomycin and Polymyxin B Sulfates and Dexamethasone
Application Number
NDA050065
Sponsor
Sandoz Inc
NDC Codes
4
Dosage Forms
OINTMENT
Routes
OPHTHALMIC
Active Ingredients
NEOMYCIN SULFATE, POLYMYXIN B SULFATE, DEXAMETHASONE

Indications and Usage

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.