Get your patient on Bacitracin Zinc And Polymyxin B Sulfate - Bacitracin Zinc And Polymyxin B Sulfate ointment (Bacitracin Zinc And Polymyxin B Sulfate)

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Bacitracin Zinc And Polymyxin B Sulfate - Bacitracin Zinc And Polymyxin B Sulfate ointment prescribing information

Indications & Usage

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.

Dosage & Administration

DOSAGE AND ADMINISTRATION

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

FOR OPHTHALMIC USE ONLY

Contraindications

CONTRAINDICATIONS

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

Adverse Reactions

ADVERSE REACTIONS

To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Description

DESCRIPTION

Bacitracin zinc and polymyxin B sulfate ophthalmic ointment, USP is a sterile antimicrobial ointment formulated 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/mg. The structural formula for bacitracin A is:

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Polymyxin B sulfate is the sulfate salt of polymyxin B 1 and B 2 , 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/mg, calculated on an anhydrous basis. The structural formulae are:

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Each gram contains: Actives: bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units; Inactives: mineral oil and white petrolatum.

Pharmacology

CLINICAL PHARMACOLOGY

Polymyxin B sulfate attacks gram-negative bacilli, including virtually all strains of Pseudomonas aeruginosa and Haemophilus influenzae species.

Bacitracin is active against most gram-positive bacilli and cocci including hemolytic streptococci.

How Supplied/Storage & Handling

HOW SUPPLIED

Bacitracin zinc and polymyxin B sulfate ophthalmic ointment, USP is available in tubes with an ophthalmic tip applicator in the following size:

NDC 24208-555-55 - 3.5 g tube

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Storage:

Store between 15°C to 25°C (59°F to 77°F). KEEP TIGHTLY CLOSED.

KEEP OUT OF REACH OF CHILDREN.

Distributed by:
Bausch & Lomb Americas Inc.
Bridgewater, NJ 08807 USA

Manufactured by:
Bausch & Lomb Incorporated
Tampa, FL 33637 USA

© 2023 Bausch & Lomb Incorporated or its affiliates

Revised: January 2023

9130705 (Folded)
9130605 (Flat)

Data SourceWe receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available
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