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FDA Drug information

Bacitracin Zinc and Polymyxin B Sulfate

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


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.

Contraindications

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

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: 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: 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. bacitracinchemstructure polychemstructure

Dosage And 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

Indications And Usage

INDlCATlONS 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.

Warnings

WARNINGS Ophthalmic ointments may retard corneal healing.

Clinical 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.

Effective Time

20230206

Version

11

Spl Product Data Elements

Bacitracin Zinc and Polymyxin B Sulfate Bacitracin Zinc and Polymyxin B Sulfate BACITRACIN ZINC BACITRACIN POLYMYXIN B SULFATE POLYMYXIN B PETROLATUM MINERAL OIL

Application Number

ANDA064046

Brand Name

Bacitracin Zinc and Polymyxin B Sulfate

Generic Name

Bacitracin Zinc and Polymyxin B Sulfate

Product Ndc

50090-3274

Product Type

HUMAN PRESCRIPTION DRUG

Route

OPHTHALMIC

Package Label Principal Display Panel

Bacitracin Zinc and Polymyxin B Sulfate Label Image

Spl Unclassified Section

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.

How Supplied

HOW SUPPLIED Product: 50090-3274 NDC: 50090-3274-0 3.5 g in a TUBE / 1 in a CARTON

Storage And Handling

Storage Store between 15°-25°C (59°-77°F). KEEP TIGHTLY CLOSED. Keep out of reach of children Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA

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