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FDA Label for Ak-poly-bac

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. DESCRIPTION:
    3. CLINICAL PHARMACOLOGY:
    4. INDICATIONS AND USAGE:
    5. CONTRAINDICATIONS:
    6. WARNINGS:
    7. PRECAUTIONS:
    8. DOSAGE AND ADMINISTRATION:
    9. HOW SUPPLIED:
    10. STORAGE:
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ak-poly-bac Product Label

The following document was submitted to the FDA by the labeler of this product Akorn. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



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].

Akorn
Manufactured By: Akorn, Inc.
Lake Forest, IL 60045
AKP00N
Rev. 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)

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


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