Maxitrol Recall
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Questions & Answers
Side Effects & Adverse Reactions
NOT FOR INJECTION. Do not touch tube tip to any surface, as this may contaminate the contents. Prolonged use may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients.
Products containing neomycin sulfate may cause cutaneous sensitization.
Employment of steroid medication in the treatment of herpes simplex requires great caution.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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 (R1=H, R2=CH2NH2)
Neomycin C (R1=CH2NH2, R2=H)
The chemical structure for the active ingredient Polymyxin B Sulfate is:
The chemical structure for the active ingredient Dexamethasone is:
C22H29FO5
MW = 392.47
Established Name: Dexamethasone
Chemical Name: Pregna-1, 4-diene-3, 20-dione,9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β, 16α)-.
Each gram 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: white petrolatum, anhydrous liquid lanolin.
Sources