Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, Sterile
SPL UNCLASSIFIED SECTION
Rx only
DESCRIPTION:
Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment is a sterile antimicrobial ointment 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: Bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units, white petrolatum and mineral oil.
CLINICAL PHARMACOLOGY:
Polymyxin B attacks gram-negative bacilli, including virtually all strains of Pseudomonas aeruginosa and H influenzae species.
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.
DOSAGE AND ADMINISTRATION:
Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.
HOW SUPPLIED:
Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment USP, sterile, each gram contains bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units, in a tube of 3.5 g (1/8 oz) with ophthalmic tip.
NDC 17478-238-35
STORAGE:
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
AkornManufactured By: Akorn, Inc.Lake Forest, IL 60045AKP00NRev. 06/16
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel Text for Container Label:
NDC 17478-238-35 Akorn
AK-POLY-BAC™
brand of Bacitracin Zinc and Polymyxin B Sulfate
Ophthalmic Ointment USP
For Ophthalmic Use Only. Sterile
Rx only Net Wt 3.5 g (1/8 oz)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel Text for Carton Label:
NDC 17478-238-35
AK-POLY-BAC™
brand of Bacitracin Zinc and Polymyxin B Sulfate
Ophthalmic Ointment, USP
Net Wt 3.5 g (1/8 oz.) Sterile Rx only Akorn Logo