DESCRIPTION

Bacitracin zinc and polymyxin B sulfate ophthalmic ointment, USP is a sterile antimicrobial ointment formulated for ophthalmic use.

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 subtilisvar Tracy. It has a potency of not less than 40 bacitracin units/mg. The structural formula for bacitracin A is:

Polymyxin B sulfate is the sulfate salt of polymyxin B 1and 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/mg, calculated on an anhydrous basis. The structural formulae are:

Each gram contains: Actives:bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units; Inactives:mineral oil and white petrolatum.

CLINICAL PHARMACOLOGY

Polymyxin B sulfate attacks gram-negative bacilli, including virtually all strains of Pseudomonas aeruginosaand Haemophilus influenzaespecies.

Bacitracin is active against most gram-positive bacilli and cocci including hemolytic streptococci.

INDICATIONS AND USAGE

For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate.

CONTRAINDICATIONS

This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.

WARNINGS

Ophthalmic ointments may retard corneal healing.

PRECAUTIONS

As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs.

ADVERSE REACTIONS

To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION

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

FOR OPHTHALMIC USE ONLY

HOW SUPPLIED

Bacitracin zinc and polymyxin B sulfate ophthalmic ointment, USP is available in tubes with an ophthalmic tip applicator in the following size:

NDC 68788-7599-3 - 3.5 g tube

PRINCIPAL DISPLAY PANEL

NDC 68788-7599-3

Bacitracin Zinc
and Polymyxin B
Sulfate
Ophthalmic
Ointment, USP
(Sterile)

FOR OPHTHALMIC
USE ONLY

Rx onlyNet Wt. 3.5 g
(1/8 oz)

BAUSCH + LOMB

Relabeled By: Preferred Pharmaceuticals Inc.