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Home > Drugs > Ophthalmic anti-infectives > Ak-poly-bac > AK-POLY-BAC Prescribing Information
Ophthalmic anti-infectives
https://themeditary.com/pro/ak-poly-bac-prescribing-information-14667.html

AK-POLY-BAC Prescribing Information

Drug Detail:Ak-poly-bac (Bacitracin and polymyxin b ophthalmic [ bas-i-tray-sin-and-pol-ee-mix-in-b-off-thal-mik ])

Drug Class: Ophthalmic anti-infectives

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Rx only

AK-POLY-BAC 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.

AK-POLY-BAC - 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 AK-POLY-BAC

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.

AK-POLY-BAC Dosage and Administration

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

How is AK-POLY-BAC 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 and Handling

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

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

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

Principal Display Panel Text for Carton Label
AK-POLY-BAC
bacitracin zinc and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)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:17478-238-351 in 1 CARTON05/08/2006
13.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06402805/08/2006
Labeler - Akorn (117696770)
Registrant - Akorn Operating Company LLC (117693100)
Establishment
NameAddressID/FEIBusiness Operations
Akorn117696840MANUFACTURE(17478-238) , ANALYSIS(17478-238) , STERILIZE(17478-238) , PACK(17478-238) , LABEL(17478-238)

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