bacitracin zinc and polymyxin b sulfates

FDA Drug Profile — polycin

Drug Details

Generic Name
bacitracin zinc and polymyxin b sulfates
Brand Names
polycin
Application Number
ANDA065022
Sponsor
NuCare Pharmaceuticals,Inc.
NDC Codes
1
Dosage Forms
OINTMENT
Routes
OPHTHALMIC
Active Ingredients
BACITRACIN ZINC, POLYMYXIN B SULFATE

Indications and Usage

INDICATIONS AND USAGE: Polycin® 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. Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment should never be directly introduced into the anterior chamber of the eye. Ophthalmic ointments may retard corneal wound healing. Topical antibiotics 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 ).