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 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 B1 and B2 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:
Each Gram Contains: ACTIVES: Bacitracin Zinc equal to 500 bacitracin units and Polymyxin B Sulfate equal to 10,000 polymyxin B units; INACTIVES: White Petrolatum and Mineral Oil.
CLINICAL PHARMACOLOGY:
Polymyxin B sulfate attacks gram-negative bacilli, including virtually all strains of Pseudomonas aeruginosa and Haemophilus influenzae species.
Bacitracin is active against most gram-positive bacilli and cocci including hemolytic streptococci.
INDlCATlONS 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.
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.
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.
