Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc
Drug Details
- Generic Name
- Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc
- Brand Names
- Neomycin and Polymyxin B Sulfates and Bacitracin Zinc
- Application Number
- ANDA064064
- Sponsor
- Bausch & Lomb Incorporated
- NDC Codes
- 1
- Dosage Forms
- OINTMENT
- Routes
- OPHTHALMIC
- Active Ingredients
- BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Indications and 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.
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 ).