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  • CLASSES

    Ophthalmological Anti-infectives
    Topical Polypeptide Anti-infectives, Plain or in Combination

    DEA CLASS

    Rx, OTC

    DESCRIPTION

    Bacitracin; Polymyxin B is available in ophthalmic and topical forms. Polymyxin B is primarily active against gram-negative, aerobic bacteria, while bacitracin is effective against gram-positive bacteria.

    COMMON BRAND NAMES

    AK-Poly Bac, Double Antibiotic, Polycin, Polycin-B, Polysporin, Polytracin

    HOW SUPPLIED

    AK-Poly Bac/Bacitracin Zinc, Polymyxin B Sulfate/Bacitracin, Polymyxin B/Polycin/Polycin-B/Polysporin/Polytracin Ophthalmic Ointment: 1g, 500-10000U
    Bacitracin Zinc, Polymyxin B Sulfate/Bacitracin, Polymyxin B/Double Antibiotic/Polysporin Topical Ointment: 500-10000U
    Polysporin Topical Pwd: 1g, 500-10000U

    DOSAGE & INDICATIONS

    For the treatment of superficial ophthalmic infection caused by susceptible bacteria (e.g., bacterial conjunctivitis, keratitis, keratoconjunctivitis, blepharitis, and blepharoconjunctivitis).
    Ophthalmic dosage (ophthalmic ointment)
    Adults

    Apply a thin strip of ointment to the affected eye(s) every 3 to 4 hours for 7 to 10 days, depending upon the severity of the infection.

    For the prevention of skin and skin structure infections, including wound management of skin abrasion and minor burn wound infection.
    Topical dosage
    Adults

    Apply as a thin film (amount equal to the surface area of the fingertip) or a light dusting of powder to the affected area 1 to 3 times daily. Continue for full course of treatment; therapy should be limited to 7 days.

    Children and Adolescents

    Apply as a thin film (amount equal to the surface area of the fingertip) or a light dusting of powder to the affected area 1 to 3 times daily. Continue for full course of treatment; therapy should be limited to 7 days.

    MAXIMUM DOSAGE

    Adults

    8 applications/day for up to 10 days for ophthalmic ointment; 3 applications/day for up to 7 days topically.

    Elderly

    8 applications/day for up to 10 days for ophthalmic ointment; 3 applications/day for up to 7 days topically.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    No dosage adjustment needed.

    Renal Impairment

    No dosage adjustment needed.

    ADMINISTRATION

    Topical Administration

    Clean affected area of any debris prior to treatment.
    Apply sparingly in a thin film to the affected area.
    Do not cover with an occlusive dressing. A light gauze dressing may be used if required.
    To avoid risk of infection, use one tube per individual patient.

    Cream/Ointment/Lotion Formulations

    Do not apply topical ointment to eyes or ears.

    Ophthalmic Administration

    For topical ophthalmic administration only.
    Inspect product prior to use. Do not use if cap and neck-ring are not intact.
    Instruct patient on proper instillation of eye ointment.
    Do not touch applicator tip to the eye, eyelid, fingers, or other surface.
    Apply directly into the conjunctival sac. In blepharitis all scales and crusts should be carefully removed and the ointment then spread uniformly over the lid margins.
    Instruct patient to avoid wearing contact lenses during treatment.
    To avoid risk of infection, use one tube per individual patient.

    STORAGE

    AK-Poly Bac:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Double Antibiotic :
    - Store between 59 to 77 degrees F
    Polycin:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Polycin-B :
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Polysporin:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Polytracin:
    - Store at controlled room temperature (between 68 and 77 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    NOTE: This monograph discusses the use of bacitracin and polymyxin B in combination for infectious conditions of the eyes and skin. Clinicians may wish to consult the individual monographs for more information about specific contraindications and precautions of each agent.

    Polymyxin hypersensitivity

    Bacitracin and polymyxin B products are contraindicated in patients who are allergic to any of the components including those patients with polymyxin hypersensitivity. Monitor patients for the development of hypersensitivity reactions and discontinue treatment if symptoms are observed (see Adverse Reactions).

    Fungal infection, herpes infection, mycobacterial infection, tuberculosis, varicella, viral infection

    Bacitracin and polymyxin B products are approved for the treatment and prevention of infections caused by susceptible bacteria and should not be used in patients with viral infection, fungal infection, or mycobacterial infection. Avoid use of the ophthalmic preparations for fungal infections of ocular structures, viral infections of the cornea and conjunctiva (including herpes infection [dendritic keratitis], vaccinia, varicella), and for mycobacterial infections of the eye. In addition, the topical ointment is not recommended for use in patients with cutaneous tuberculosis. According to the manufacturer, prolonged use of bacitracin and polymyxin B products may result in secondary infections from non-susceptible organisms; therefore, it is recommended not to use the topical ointment longer than 7 days nor the ophthalmic preparations longer than 10 days.

    Renal failure, renal impairment

    Systemic exposure to bacitracin may be increased in patients with damaged epithelium, renal impairment, or renal failure. As a result, these patients are at an increased risk of developing side effects such as bacitracin-induced nephrotoxicity. Consider the possibility of increased systemic exposure prior to administering bacitracin and polymyxin B products to patients with damaged skin or preexisting renal disease.

    Geriatric

    Geriatric patients are more likely to have damaged skin and preexisting renal impairment placing them at risk of developing side effects from systemically absorbed bacitracin. Monitor elderly patients closely while on bacitracin and polymyxin B products.

    Children, infants, neonates

    Patients with immature skin, including children < 2 years of age, infants, and neonates, may be at increased risk of side effects from systemically absorbed bacitracin. Avoid use of bacitracin and polymyxin B products in children < 2 years of age.

    Diarrhea, pseudomembranous colitis

    While rare with topical use, almost all antibacterial agents have been associated with pseudomembranous colitis (antibiotic-associated colitis) which may range in severity from mild to life-threatening. In the colon, overgrowth of Clostridia may exist when normal flora is altered subsequent to antibacterial administration. The toxin produced by Clostridium difficile is a primary cause of pseudomembranous colitis. Consideration should be given to the diagnosis of pseudomembranous colitis in patients presenting with diarrhea following antibacterial administration. Following diagnosis of pseudomembranous colitis, therapeutic measures should be instituted. In milder cases, the colitis may respond to discontinuation of the offending agent. In moderate to severe cases, fluids and electrolytes, protein supplementation, and treatment with an antibacterial effective against Clostridium difficile may be warranted. Products inhibiting peristalsis are contraindicated in this clinical situation.

    Contact lenses

    Patients should avoid wearing contact lenses while being treated with bacitracin; polymyxin B ophthalmic preparations for an ocular infection.

    Ophthalmic administration

    Only apply bacitracin and polymyxin B topical ointment to the skin; avoid ophthalmic administration of the topical ointment. The ophthalmic preparations should never be directly administered into the anterior chamber of the eye. Ophthalmic ointments may retard corneal wound healing.

    Pregnancy

    Bacitracin and polymyxin B products are classified as FDA pregnancy risk category C. The use of bacitracin and polymyxin B has not been studied in animals or pregnant women. Bacitracin and polymyxin B should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

    Breast-feeding

    It is not known whether bacitracin and polymyxin B products are excreted in human milk. Topical and ophthalmic use would result in minimal absorption. Oral ingestion by the nursing infant would also result in minimal absorption. To minimize the amount of drug that reaches the systemic circulation and breast milk, apply pressure over the tear duct by the corner of the eye for 1 minute after ophthalmic administration. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.

    ADVERSE REACTIONS

    Severe

    anaphylactoid reactions / Rapid / Incidence not known

    Moderate

    edema / Delayed / Incidence not known
    erythema / Early / Incidence not known
    superinfection / Delayed / Incidence not known

    Mild

    ocular pruritus / Rapid / Incidence not known
    rash (unspecified) / Early / Incidence not known
    pruritus / Rapid / Incidence not known

    DRUG INTERACTIONS

    Amphotericin B cholesteryl sulfate complex (ABCD): (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, such as amphoteracin B; when possible, avoid concomitant administration. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, should not be given with other drugs that have a nephrotoxic potential.
    Amphotericin B lipid complex (ABLC): (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, such as amphoteracin B; when possible, avoid concomitant administration. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, should not be given with other drugs that have a nephrotoxic potential.
    Amphotericin B liposomal (LAmB): (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, such as amphoteracin B; when possible, avoid concomitant administration. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, should not be given with other drugs that have a nephrotoxic potential.
    Amphotericin B: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents, such as amphoteracin B; when possible, avoid concomitant administration. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, should not be given with other drugs that have a nephrotoxic potential.
    Bumetanide: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as loop diuretics. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
    Ethacrynic Acid: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as loop diuretics. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
    Furosemide: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as loop diuretics. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
    Loop diuretics: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as loop diuretics. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.
    Torsemide: (Minor) Additive nephrotoxicity may occur with concurrent use of systemic bacitracin and other nephrotoxic agents. When possible, avoid concomitant administration of systemic bacitracin and other nephrotoxic drugs such as loop diuretics. Topical administration of any preparation containing bacitracin, especially when applied to large surface areas, also should not be given with other drugs that have a nephrotoxic potential.

    PREGNANCY AND LACTATION

    Pregnancy

    Bacitracin and polymyxin B products are classified as FDA pregnancy risk category C. The use of bacitracin and polymyxin B has not been studied in animals or pregnant women. Bacitracin and polymyxin B should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

    It is not known whether bacitracin and polymyxin B products are excreted in human milk. Topical and ophthalmic use would result in minimal absorption. Oral ingestion by the nursing infant would also result in minimal absorption. To minimize the amount of drug that reaches the systemic circulation and breast milk, apply pressure over the tear duct by the corner of the eye for 1 minute after ophthalmic administration. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    •Bacitracin: Bacitracin is primarily bacteriostatic, but may have bactericidal activity depending upon the antibiotic concentration and the susceptibility of the bacteria. Bacitracin inhibits bacterial cell wall synthesis. This is achieved by preventing the final dephosphorylation step in the phospholipid carrier cycle, which interferes with the mucopeptide transfer to the growing cell wall. Bacitracin is active against many gram-positive and some gram-negative bacteria.
     
    •Polymyxin B: Polymyxin B binds to phospholipids on cell membranes of gram-negative bacteria. This binding destroys bacterial membranes with a surface detergent-like mechanism resulting in increased cell membrane permeability and loss of essential metabolites. Polymyxin B is bactericidal against most gram-negative bacilli; however, some Proteus and Serratia species may be resistant. Polymyxin B has no in vitro activity against gram-positive bacteria.
     
    Bacitracin and polymyxin B in combination are considered active against the following bacteria: Enterobacter sp., Escherichia coli, Haemophilus influenzae, Klebsiella sp., Neisseria sp., Pseudomonas aeruginosa, Staphylococcus aureus, and Streptococcus sp., including Streptococcus pneumoniae. The combination does not provide adequate coverage against Serratia marcescens.

    PHARMACOKINETICS

    Bacitracin; polymyxin B combination products are applied topically to the eyes or skin.

    Topical Route

    Except when applied to large areas or for an extended period of time, systemic absorption of bacitracin; polymyxin B is negligible after topical administration. Polymyxin B has a high affinity for cell membranes so there is little systemic absorption even when applied to open wounds. Bacitracin may be absorbed systemically if applied to denuded or damaged epithelium. Any systemically absorbed bacitracin or polymyxin B are primarily excreted by the kidneys.