AK-POLY-BAC description, usages, side effects, indications, overdosage, supplying and lots more!

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AK-POLY-BAC

DIRECT RX


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DESCRIPTION SECTION

AK-POLY-BAC

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:

AK-POLY-BAC

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 SECTION

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 & USAGE SECTION

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 SECTION

This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.

WARNINGS SECTION

Ophthalmic ointments may retard corneal healing.

PRECAUTIONS SECTION

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 & ADMINISTRATION SECTION

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

HOW SUPPLIED SECTION

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. 11/08

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 (1/8oz.)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AK-POLY-BAC

AK-POLY-BAC

AK-POLY-BAC OINTMENT

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:61919-989(NDC:17478-238)
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BACITRACIN ZINC BACITRACIN 500 g
Polymyxin B Sulfate POLYMYXIN B 10000 g

Inactive Ingredients

Ingredient Name Strength
Mineral Oil
petrolatum

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61919-989-35 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064028 2014-01-01


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