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neomycin sulfate, polymyxin b sulfate and dexamethasone
Overview
What is MAXITROL?
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 (R=H, R=CHNH)
Neomycin C (R=CHNH, R=H)
The chemical structure for the active ingredient Polymyxin B Sulfate is:
The chemical structure for the active ingredient Dexamethasone is:
C
H
FO
MW = 392.47
Established
n
ame:
Chemical
n
ame:
Each gram of MAXITROL* (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) contains:
Active:
Preservatives:
Inactives:
What does MAXITROL look like?
What are the available doses of MAXITROL?
Sorry No records found.
What should I talk to my health care provider before I take MAXITROL?
Sorry No records found
How should I use MAXITROL?
What interacts with MAXITROL?
Sorry No Records found
What are the warnings of MAXITROL?
Sorry No Records found
What are the precautions of MAXITROL?
Sorry No Records found
What are the side effects of MAXITROL?
Sorry No records found
What should I look out for while using MAXITROL?
NOT 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 the treatment of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.
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 acute purulent conditions or parasitic infections of the eye, steroids may mask infection or enhance existing infection.
In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids.
If this product is used for 10 days or longer, intraocular pressure (IOP) should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma. IOP should be checked frequently.
The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
Products containing neomycin sulfate may cause cutaneous sensitization. Sensitivity to topically administered aminoglycosides, such as neomycin, may occur in some patients. Severity of hypersensitivity reactions may vary from local effects to generalized reactions such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If hypersensitivity develops during use of the product, treatment should be discontinued. Cross-hypersensitivity to other aminoglycosides can occur, and the possibility that patients who become sensitized to topical neomycin may also be sensitive to other topical and/or systemic aminoglycosides should be considered.
What might happen if I take too much MAXITROL?
Sorry No Records found
How should I store and handle MAXITROL?
Store the vials in original cartons between 20° to 25°C (68° to 77°F). [See .] Retain in the original package to protect from light.MAXITROL (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 as follows: 3.5 g in an aluminum tube 0065-0631-36Storage© 2002, 2003, 2016, 2017 © NovartisDistributed by: Fort Worth, Texas 76134 USA*a trademark of NovartisAlcon a Novartis companyT2017-122December 2017MAXITROL (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 as follows: 3.5 g in an aluminum tube 0065-0631-36Storage© 2002, 2003, 2016, 2017 © NovartisDistributed by: Fort Worth, Texas 76134 USA*a trademark of NovartisAlcon a Novartis companyT2017-122December 2017MAXITROL (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 as follows: 3.5 g in an aluminum tube 0065-0631-36Storage© 2002, 2003, 2016, 2017 © NovartisDistributed by: Fort Worth, Texas 76134 USA*a trademark of NovartisAlcon a Novartis companyT2017-122December 2017MAXITROL (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 as follows: 3.5 g in an aluminum tube 0065-0631-36Storage© 2002, 2003, 2016, 2017 © NovartisDistributed by: Fort Worth, Texas 76134 USA*a trademark of NovartisAlcon a Novartis companyT2017-122December 2017MAXITROL (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 as follows: 3.5 g in an aluminum tube 0065-0631-36Storage© 2002, 2003, 2016, 2017 © NovartisDistributed by: Fort Worth, Texas 76134 USA*a trademark of NovartisAlcon a Novartis companyT2017-122December 2017MAXITROL (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 as follows: 3.5 g in an aluminum tube 0065-0631-36Storage© 2002, 2003, 2016, 2017 © NovartisDistributed by: Fort Worth, Texas 76134 USA*a trademark of NovartisAlcon a Novartis companyT2017-122December 2017MAXITROL (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 as follows: 3.5 g in an aluminum tube 0065-0631-36Storage© 2002, 2003, 2016, 2017 © NovartisDistributed by: Fort Worth, Texas 76134 USA*a trademark of NovartisAlcon a Novartis companyT2017-122December 2017
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
NOT 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 the treatment of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.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 acute purulent conditions or parasitic infections of the eye, steroids may mask infection or enhance existing infection.
In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids.
If this product is used for 10 days or longer, intraocular pressure (IOP) should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma. IOP should be checked frequently.
The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
Products containing neomycin sulfate may cause cutaneous sensitization. Sensitivity to topically administered aminoglycosides, such as neomycin, may occur in some patients. Severity of hypersensitivity reactions may vary from local effects to generalized reactions such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If hypersensitivity develops during use of the product, treatment should be discontinued. Cross-hypersensitivity to other aminoglycosides can occur, and the possibility that patients who become sensitized to topical neomycin may also be sensitive to other topical and/or systemic aminoglycosides should be considered.
Due to the potential for additive effects, caution and careful titration are warranted in patients receiving diltiazem concomitantly with any agents known to affect cardiac contractility and/or conduction (see ).
Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with diltiazem (see ).
As with all drugs, care should be exercised when treating patients with multiple medications. Diltiazem is both a substrate and an inhibitor of the cytochrome P450 3A4 enzyme system. Other drugs that are specific substrates, inhibitors, or inducers of this enzyme system may have a significant impact on the efficacy and side effect profile of diltiazem. Patients taking other drugs that are substrates of CYP450 3A4, especially patients with renal and/or hepatic impairment, may require dosage adjustment when starting or stopping concomitantly administered diltiazem in order to maintain optimum therapeutic blood levels.
Anesthetics:
Beta-Blockers:
Administration of diltiazem concomitantly with propranolol in five normal volunteers resulted in increased propranolol levels in all subjects, and bioavailability of propranolol was increased approximately 50%. , propranolol appears to be displaced from its binding sites by diltiazem. If combination therapy is initiated or withdrawn in conjunction with propranolol, an adjustment in the propranolol dose may be warranted (see ).
Buspirone:
Carbamazepine:
Cimetidine:
Clonidine:
Cyclosporine:
Ivabradine:
Quinidine:
Rifampin:
Statins:
In a healthy volunteer cross-over study (N = 10), coadministration of a single 20 mg dose of simvastatin at the end of a 14 day regimen with 120 mg BID diltiazem SR resulted in a 5-fold increase in mean simvastatin AUC versus simvastatin alone. Subjects with increased average steady-state exposures of diltiazem showed a greater fold increase in simvastatin exposure. Computer-based simulations showed that at a daily dose of 480 mg of diltiazem, an 8- to 9-fold mean increase in simvastatin AUC can be expected. If coadministration of simvastatin with diltiazem is required, limit the daily doses of simvastatin to 10 mg and diltiazem to 240 mg.
In a ten-subject randomized, open label, 4-way crossover study, coadministration of diltiazem (120 mg BID diltiazem SR for 2 weeks) with a single 20 mg dose of lovastatin resulted in 3- to 4-fold increase in mean lovastatin AUC and C versus lovastatin alone. In the same study, there was no significant change in 20 mg single dose pravastatin AUC and C during diltiazem coadministration. Diltiazem plasma levels were not significantly affected by lovastatin or pravastatin.
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 physician only after examination of the patient with the aid of magnification, such as a slit lamp biomicroscopy and, where appropriate, fluorescein staining.
The possibility of persistent fungal infections of the cornea should be considered after prolonged steroid dosing. Fungal infection should be suspected in patients with persistent corneal ulceration.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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