Document

DailyMed Label: AK-POLY-BAC

Title
DailyMed Label: AK-POLY-BAC
Date
2020
Document type
DailyMed Prescription
Name
AK-POLY-BAC
Generic name
Bacitracin Zinc and Polymyxin B Sulfate
Manufacturer
Akorn
Product information
NDC: 17478-238
Product information
NDC: 17478-238
Product information
NDC: 17478-238
Product information
NDC: 17478-238
Product information
NDC: 17478-238
Product information
NDC: 17478-238
Product information
NDC: 17478-238
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 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: 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. Structural Formula Structural Formula
Indications
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate.
Dosage
Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.
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.
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
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.
Package label
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) Principal Display Panel Text for Container Label

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