Label: BACITRACIN ZINC AND POLYMYXIN B SULFATE- bacitracin zinc and polymyxin b sulfate ointment

  • NDC Code(s): 0168-0273-38
  • Packager: E. FOUGERA & CO., A division of Nycomed US Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 05/09

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  • SPL UNCLASSIFIED SECTION

    STERILE

    Rx only

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  • DESCRIPTION

    Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP, is a sterile antimicrobial ointment for ophthalmic use. Each gram contains: bacitracin zinc equivalent to 500 bacitracin units, polymyxin B sulfate equivalent to 10,000 polymyxin B units, mineral oil, and white petrolatum.

    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:

    Structural Formula

    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:

    Structural Formula
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  • CLINICAL PHARMACOLOGY

    A wide range of antibacterial action is provided by the overlapping spectra of bacitracin and polymyxin B sulfate.

    Bacitracin is bactericidal for a variety of gram-positive and gram-negative organisms. It interferes with bacterial cell wall synthesis by inhibition of the regeneration of phospholipid receptors involved in peptidoglycan synthesis.

    Polymyxin B is bactericidal for a variety of gram-negative organisms. It increases the permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane.

    Microbiology: Bacitracin zinc and polymyxin B sulfate together are considered active against the following microorganisms: Staphylococcus aureus, streptococci including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. The product does not provide adequate coverage against Serratia marcescens.

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  • INDICATIONS AND USAGE

    Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.

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  • CONTRAINDICATIONS

    Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment is contraindicated in individuals who have shown hypersensitivity to any of its components.

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  • WARNINGS

    NOT FOR INJECTION INTO THE EYE. Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment should never be directly introduced into the anterior chamber of the eye. Ophthalmic ointments may retard corneal wound healing.

    Topical antibiotics may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known. The manifestations of sensitization to topical antibiotics are usually itching, reddening, and edema of the conjunctiva and eyelid. A sensitization reaction may manifest simply, as a failure to heal. During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication. Application of products containing these ingredients should be avoided for the patient thereafter (see PRECAUTIONS: General).

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  • PRECAUTIONS

    General: As with other antibiotic preparations, prolonged use of Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment may result in overgrowth of nonsusceptible organisms including fungi. If superinfection occurs, appropriate measures should be initiated.

    Bacterial resistance to Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment may also develop. If purulent discharge, inflammation, or pain become aggravated, the patient should discontinue use of the medication and consult a physician.

    There have been reports of bacterial keratitis associated with the use of topical ophthalmic products in multiple-dose containers which have been inadvertently contaminated by patients, most of whom has a concurrent corneal disease or a disruption of the ocular epithelial surface (see PRECAUTIONS: Information for Patients).

    Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.

    Information for Patients: Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, eyelid, fingers, or any other surface. The use of this product by more than one person may spread infection.

    Patients should also be instructed that ocular products, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated products (see PRECAUTIONS: General).

    If the condition persists or gets worse, or if a rash or other allergic reaction develops, the patient should be advised to stop use and consult a physician. Do not use this product if you are allergic to any of the listed ingredients.

    Keep tightly closed when not in use. Keep out of reach of children.

    Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate or bacitracin. Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown. No adverse effects on male or female fertility, litter size, or survival were observed in rabbits given bacitracin zinc 100 gm/ton of diet.

    Pregnancy:Teratogenic effects -Pregnancy Category C. Animal reproduction studies have not been conducted with polymyxin B sulfate or bacitracin. It is also not known whether Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment should be given to a pregnant woman only if clearly needed.

    Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment is administered to a nursing woman.

    Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

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  • ADVERSE REACTIONS

    Adverse reactions have occurred with the anti-infective components of Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment. The exact incidence is not known. Reactions occurring most often are allergic sensitization reactions including itching, swelling, and conjunctival erythema (see WARNINGS). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.

    Local irritation on instillation has also been reported.

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  • DOSAGE AND ADMINISTRATION

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

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  • HOW SUPPLIED

    Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP, is supplied as follows:

                                    NDC 0168-0273-38                                3.5 gram tubes

    Store between 15° and 25°C (59° and 77°F).

    E. FOUGERA & CO.

    A division of Nycomed US Inc.
    MELVILLE, NEW YORK 11747

    I273A
    R10/07

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  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 3.5g CONTAINER LABEL

    NDC 0168-0273-38

    FOUGERA®

    BACITRACIN ZINC

    AND POLYMYXIN B

    SULFATE OPHTHALMIC

    OINTMENT, USP

    STERILE Rx only

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

    NET WT. 3.5 g (1/8 Oz)

    Container Label
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  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 3.5 g CARTON

    NDC 0168-0273-38

    Rx only

    FOUGERA®

    BACITRACIN ZINC AND

    POLYMYXIN B SULFATE OPHTHALMIC

    OINTMENT, USP

    STERILE

    Each gram contains: bacitracin zinc Equivalent to 500 bacitracin units, polymyxin B sulfate equivalent to 10,000 polymyxin B units, mineral oil, and white petrolatum.

    NET WT. 3.5 g (1/8 Oz)

    Carton Label
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  • INGREDIENTS AND APPEARANCE
    BACITRACIN ZINC AND POLYMYXIN B SULFATE 
    bacitracin zinc and polymyxin b sulfate ointment
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0168-0273
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Bacitracin Zinc (bacitracin) Bacitracin Zinc 500   in 1 g
    polymyxin B sulfate (polymyxin B) polymyxin B sulfate 10000   in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    petrolatum  
    mineral oil  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0168-0273-38 3.5 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA065022 08/28/2008
    Labeler - E. FOUGERA & CO., A division of Nycomed US Inc. (043838424)
    Registrant - Nycomed US Inc. (043838424)
    Establishment
    Name Address ID/FEI Business Operations
    Nycomed US Inc. 174491316 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Nycomed US Inc. 043838424 ANALYSIS
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