Neomycin and Polymyxin B Sulfates and Bacitracin Zinc
Generic: NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC
Basic Information
Manufacturer
Bausch & Lomb Incorporated
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
f3231f1c-665e-4efa-baa1-83bf296b2f8f
Indications & Usage
INDICATIONS AND USAGE Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria.
Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.
Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.
Warnings
WARNINGS NOT FOR INJECTION INTO THE EYE Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment should never be directly introduced into the anterior chamber of the eye.
Ophthalmic ointments may retard corneal wound healing.
Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization.
A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known.
The manifestations of sensitization to topical antibiotics are usually itching, reddening, and edema of the conjunctiva and eyelid.
A sensitization reaction may manifest simply as a failure to heal.
During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed.
Symptoms usually subside quickly on withdrawing the medication.
Application of products containing these ingredients should be avoided for the patient thereafter ( see PRECAUTIONS: General ).
Ophthalmic ointments may retard corneal wound healing.
Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization.
A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known.
The manifestations of sensitization to topical antibiotics are usually itching, reddening, and edema of the conjunctiva and eyelid.
A sensitization reaction may manifest simply as a failure to heal.
During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed.
Symptoms usually subside quickly on withdrawing the medication.
Application of products containing these ingredients should be avoided for the patient thereafter ( see PRECAUTIONS: General ).
Adverse Reactions
ADVERSE REACTIONS Adverse reactions have occurred with the anti-infective components of neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment.
The exact incidence is not known.
Reactions occurring most often are allergic sensitization reactions including itching, swelling, and conjunctival erythema ( see WARNINGS ).
More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.
Local irritation on instillation has also been reported.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
The exact incidence is not known.
Reactions occurring most often are allergic sensitization reactions including itching, swelling, and conjunctival erythema ( see WARNINGS ).
More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.
Local irritation on instillation has also been reported.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .