Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc and Hydrocortisone

Get an overview of NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC, AND HYDROCORTISONE (neomycin sulfate, polymyxin b sulfate, bacitracin zinc and hydrocortisone ointment), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone.

Drug Basics

Brand Name: Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone

Generic Name: NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC AND HYDROCORTISONE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: OPHTHALMIC

Dosage Form: OINTMENT

Data Current As Of: 2018-10-05

Rx Only

indications & usage:

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment is indicated 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 corticosteroid 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 (see CLINICAL PHARMACOLOGY: Microbiology ).

The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens: Staphylococcus aureus, streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa.

The product does not provide adequate coverage against Serratia marcescens.

contraindications:

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment is contraindicated in most viral diseases of the cornea and conjunctiva including: epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment is also contraindicated in individuals who have shown hypersensitivity to any of its components. Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.

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. The exact incidence is not known.

Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitization reactions including itching, swelling and conjunctival erythema (see WARNINGS ). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.

The reactions due to the corticosteroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

Secondary Infection: The development of the secondary infection has occurred after use of combinations containing corticosteroids and antimicrobials. Fungal and viral infections of the cornea are particularly prone to develop with long-term applications of a corticosteroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where corticosteroid treatment has been used (See WARNINGS ).

Local irritation on instillation has also been reported.

If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see PRECAUTIONS ).

dosage & administration:

Apply the ointment in the affected eye every 3 or 4 hours, depending on the severity of the condition.

Not more than 8 grams should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

how supplied:

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment, USP is supplied in a tube with ophthalmic applicator tip in the following size:

NDC 0404-7195-1          1/8 oz (3.5 g) tube

DO NOT USE IF BOTTOM RIDGE OF TUBE CAP IS EXPOSED.

FOR OPHTHALMIC USE ONLY.

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

KEEP OUT OF REACH OF CHILDREN

Distributed by (in US only):
HENRY SCHEIN INC.
135 DURYEA ROAD
MELVILLE, NY 11747 USA

BNP00N Rev. 08/14

Principal Display Panel Text for Container Label:

HENRY SCHEIN Logo

NDC 0404-7195-01

112-7195

NEOMYCIN AND POLYMYXIN B SULFATES,

BACITRACIN ZINC, AND HYDROCORTISONE

OPHTHALMIC OINTMENT, USP

STERILE OPHTHALMIC OINTMENT Rx only Net Wt. 3.5 g (1/8 oz.)

neo08 0000 05.jpg

Principal Display Panel Text for Carton Label:

HENRY SCHEIN Logo

NDC 0404-7195-01

112-7195

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC,

AND HYDROCORTISONE OPHTHALMIC OINTMENT, USP

Sterile Ophthalmic Ointment Rx only Net Wt. 3.5 g (1/8 oz.)

neo08 0000 06.jpg

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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