Drugplain

Neomycin Polymyxin B Sulfates and Dexamethasone 1 mg/mL

Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone · SUSPENSION/ DROPS · Bausch & Lomb Incorporated

No Recall History
Plain English

Neomycin Polymyxin B Sulfates and Dexamethasone is a suspension/ drops containing neomycin sulfate, polymyxin b sulfate and dexamethasone at 1 mg/mL, taken ophthalmic. Manufactured by Bausch & Lomb Incorporated.

Key Facts

Brand Name
Neomycin Polymyxin B Sulfates and Dexamethasone
Generic Name
Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone
NDC Code (Product)
24208-830
Manufacturer
Bausch & Lomb Incorporated
Strength
1 mg/mL
Dosage Form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Marketing Status
Application #
ANDA064135
Drug Class
Corticosteroid [EPC]
Marketing Start
09/13/1995

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

abdominal discomfort1 reports
abscess1 reports
calciphylaxis1 reports
chronic kidney disease1 reports
cough1 reports
deep vein thrombosis1 reports
drug dispensing error1 reports
drug effect decreased1 reports
eye disorder1 reports
eyelid margin crusting1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & 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 infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids 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 streptoco…

Dosage & Administration

DOSAGE AND ADMINISTRATION One to two drops 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 above.

Warnings

WARNINGS 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 a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. Acute purulent or parasitic infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication. Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. 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 b…

Contraindications

CONTRAINDICATIONS Neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Adverse Reactions

ADVERSE REACTIONS Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available. Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. The reactions due to the corticosteroid component are: elevation of IOP with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing. Corticosteroid-containing preparations have also been reported to cause perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, and conjunctival hyperemia have occasionally been reported following use of steroids. Additional adverse reactions identified from post marketing use include ulcerative keratitis, headache, and Stevens-Johnson syndrome. The following additional adverse reactions have been reported with dexamethasone use: Cushing’s syndrome and adrenal suppression may occur after use of dexamethasone in excess of the listed dosing instructi…

Frequently Asked Questions

What is Neomycin Polymyxin B Sulfates and Dexamethasone used for?

Neomycin Polymyxin B Sulfates and Dexamethasone contains Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone. It is a suspension/ drops taken ophthalmic. Consult your doctor for specific uses.

Is Neomycin Polymyxin B Sulfates and Dexamethasone a controlled substance?

Neomycin Polymyxin B Sulfates and Dexamethasone is not classified as a controlled substance by the DEA.

What is the generic name for Neomycin Polymyxin B Sulfates and Dexamethasone?

The generic name for Neomycin Polymyxin B Sulfates and Dexamethasone is Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone. There are 7 other brand versions of Neomycin sulfate, Polymyxin B Sulfate and Dexamethasone.

What is the NDC code for Neomycin Polymyxin B Sulfates and Dexamethasone 1 mg/mL?

The NDC (National Drug Code) for Neomycin Polymyxin B Sulfates and Dexamethasone 1 mg/mL is 24208-830, listed by Bausch & Lomb Incorporated.

Product NDC

24208-830

Package NDC

24208-830-60

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)