polycin

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.

May be applied every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

Polycin® Ophthalmic Ointment is contraindicated in individuals who have shown hypersensitivity to any of its components.

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).

Adverse reactions have occurred with the anti-infective components Bacitracin Zinc and Polymyxin B Sulfate 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 Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Teratorgenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with polymyxin B sulfate or bacitracin. It is also not known whether Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment should be given to a pregnant woman only if clearly needed.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment is administered to a nursing woman.

Safety and effectiveness in pediatric patients have not been established.

Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, is a sterile antimicrobial ointment for ophthalmic use. Each gram contains: bacitracin zinc equivalent to 500 bacitracin units, polymyxin B sulfate equivalent to 10,000 polymyxin B units, mineral oil, and white petrolatum. Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus subtilis var Tracy. It has a potency of not less than 40 bacitracin units per mg. The structural formula for bacitracin A is: Polymyxin B sulfate is the sulfate salt of polymyxin B 1 and B 2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are: Structural Formula Image 1 Structural Formula Image 2

Polycin® Ophthalmic Ointment is supplied in 3.5 g (1/8 oz) sterile tamper evident tubes with ophthalmic tip. NDC 66267-925-35 Box of 3.5 g Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Polycin® is a Registered Trademark of Perrigo Company Manufactured For Perrigo, Minneapolis, MN 55427 R1113 Ini1113 6U200 RC J1 Rev 12-13 A