Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, Sterile

AK-POLY-BAC by

Drug Labeling and Warnings

AK-POLY-BAC by is a Prescription medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

AK-POLY-BAC- bacitracin zinc and polymyxin b sulfate ointment 
A-S Medication Solutions

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Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, Sterile

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:

Structural Formula

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:

Structural Formula

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:

Product: 50090-0447

STORAGE:

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Akorn
Manufactured By: Akorn, Inc.
Lake Forest, IL 60045
AKP00N
Rev. 06/16

Bacitracin Zinc and Polymyxin B Sulfate

Label Image
AK-POLY-BAC 
bacitracin zinc and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 50090-0447(NDC: 17478-238)
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
Mineral Oil (UNII: T5L8T28FGP)  
Petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50090-0447-01 in 1 CARTON06/29/201604/30/2018
13.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06402805/08/200604/30/2018
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-0447)

Revised: 1/2020
Document Id: 359befb1-93ff-47c5-93f9-4ef228f98529
Set id: 9d7a5fb6-ad90-43e2-9734-d165ab19da73
Version: 12
Effective Time: 20200117
 
A-S Medication Solutions