Polycin® Ointment

Bacitracin / Polymyxin B · ophthalmic ointment

Antibiotic

Approved uses

Superficial bacterial infection of the external eye and adnexa: conjunctivitis, keratitis, keratoconjunctivitis, blepharitis, blepharoconjunctivitis

Apply every 3 or 4 hours for 7 to 10 days, depending on severity of the infection

FDA label, Indications and Usage and Dosage and Administration. Susceptibility data: Freidlin J, Acharya N, Lietman TM, Cevallos V, Whitcher JP, Margolis TP. Spectrum of eye disease caused by methicillin-resistant Staphylococcus aureus. Am J Ophthalmol. 2007;144(2):313-315 (cross-sectional single-center laboratory series, not a treatment trial).

Contraindications

Hypersensitivity to any component of the product.

Available Forms

Ophthalmic ointment, 3.5 g (1/8 oz) sterile tamper evident tube with ophthalmic tip, bacitracin zinc 500 units per gram, polymyxin B sulfate 10,000 units per gram

Mechanism of Action

Bacitracin interferes with bacterial cell wall synthesis by inhibiting regeneration of the phospholipid receptors involved in peptidoglycan synthesis, and is bactericidal for a variety of gram-positive and gram-negative organisms. Polymyxin B is bactericidal for a variety of gram-negative organisms, increasing bacterial cell membrane permeability by interacting with the membrane phospholipids; the two spectra overlap to give a wide range of antibacterial action.

Warnings & Precautions

Route restriction: Not for injection into the eye, and never to be introduced directly into the anterior chamber.
Corneal wound healing: Ophthalmic ointments may retard corneal wound healing.
Cutaneous sensitization: Topical antibiotics may sensitize, primarily as skin rash, at an incidence that is not known; ocular manifestations are usually itching, reddening, and edema of the conjunctiva and eyelid.
Failure to heal: A sensitization reaction may present simply as failure to heal, so examine periodically during long-term use and discontinue if such signs appear, after which products containing these ingredients should be avoided.
Aminoglycoside cross-reactions: Allergic cross-reactions may preclude later use of kanamycin, paromomycin, streptomycin, and possibly gentamicin.
Superinfection and resistance: Prolonged use may allow overgrowth of nonsusceptible organisms including fungi, and bacterial resistance may develop.
Container contamination: Bacterial keratitis has been reported after inadvertent patient contamination of multiple-dose topical ophthalmic containers, most of those patients having concurrent corneal disease or a disrupted ocular epithelial surface.

Common Side Effects

Ocular, most frequent: Allergic sensitization reactions including itching, swelling, and conjunctival erythema; exact incidence not known.
Local irritation: Reported on instillation.
Systemic, rare: More serious hypersensitivity reactions including anaphylaxis.

Pregnancy & Lactation

Pregnancy: Category C; animal reproduction studies have not been conducted with either component and fetal harm potential is unknown, so give only if clearly needed.

Lactation: Excretion in human milk is unknown, so caution is warranted in a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.