neomycin sulfate, polymyxin b sulfate and gramicidin

FDA Drug Profile — NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN

Drug Details

Generic Name
neomycin sulfate, polymyxin b sulfate and gramicidin
Brand Names
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN
Application Number
ANDA064047
Sponsor
Bausch & Lomb Incorporated
NDC Codes
2
Dosage Forms
SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients
GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE

Indications and Usage

INDICATIONS AND USAGE Neomycin and polymyxin B sulfates and gramicidin ophthalmic solution 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. This product should never be directly introduced into the anterior chamber of the eye or injected subconjunctivally. 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. Applications of products containing these ingredients should be avoided for the patient thereafter (see PRECAUTIONS : Error! Hyperlink reference not valid. ).