Prescription Drug Information: BACITRACIN ZINC AND POLYMYXIN B SULFATE

BACITRACIN ZINC AND POLYMYXIN B SULFATE — bacitracin zinc and polymyxin b sulfate ointment
STAT RX USA LLC

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:

Structure Image 1
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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:

Structure Image 2
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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.

BACITRACIN ZINC AND POLYMYXIN B SULFATE 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].

Manufactured By: Akorn, Inc.
Lake Forest, IL 60045

AKP00N
Rev. 11/08

PACKAGE LABEL — AK — POLY-BAC OPHTHALMIC OINTMENT 3.5 GRAMS

Label Image
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BACITRACIN ZINC AND POLYMYXIN B SULFATE
bacitracin zinc and polymyxin b sulfate ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16590-989(NDC:17478-238)
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACITRACIN ZINC (BACITRACIN) BACITRACIN ZINC 500 [USP’U] in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B SULFATE 10000 [USP’U] in 1 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM
MINERAL OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16590-989-35 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 3.5 g in 1 TUBE This package is contained within the CARTON (16590-989-35)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064028 01/30/1995
Labeler — STAT RX USA LLC (786036330)
Establishment
Name Address ID/FEI Operations
STAT RX USA LLC 786036330 relabel, repack

Revised: 08/2011 STAT RX USA LLC

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