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  • CLASSES

    Ophthalmological Anti-infectives
    Ophthalmological Corticosteroid and Anti-infective Combinations
    Topical Aminoglycosides, Plain or in Combination
    Topical Polypeptide Anti-infectives, Plain or in Combination

    DEA CLASS

    OTC, Rx

    DESCRIPTION

    Neomycin; polymyxin B; bacitracin are available in topical and ophthalmic forms to treat infections of the eyes and skin. Neomycin and polymyxin B are primarily active against gram-negative, aerobic bacteria, while bacitracin is active against gram-positive bacteria.

    COMMON BRAND NAMES

    Neo-Polycin, Neocidin, Neosporin, Ocu-Spore-B, Polymycin, Triple Antibiotic

    HOW SUPPLIED

    Bacitracin, Neomycin, Polymyxin B/Neomycin, Polymyxin B, Bacitracin Zinc/Neosporin/Triple Antibiotic Topical Ointment: 1g, 3.5-5000-400U, 3.5-5000-500U, 400-3.5-5000U
    Neocidin/Neomycin, Polymyxin B, Bacitracin Zinc/Neo-Polycin/Neosporin/Ocu-Spore-B/Polymycin Ophthalmic Ointment: 1g, 3.5-10000-400U, 3.5-10000-400IU

    DOSAGE & INDICATIONS

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

    Apply a thin strip (approximately 1/2 inch) 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 for skin abrasion and minor burn wound infection.
    Topical dosage (topical skin ointment)
    Adults, Adolescents, and Children >= 2 years

    Apply a thin film (amount equal to the surface area of the fingertip) 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 for ophthalmic ointment; 3 applications/day for up to 7 days topically.

    Children

    >= 2 years: Safety and efficacy have not been established for ophthalmic ointment; 3 applications/day for up to 7 days topically.
    < 2 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    No dosage adjustment needed.

    Renal Impairment

    No dosage adjustment needed; use topically with caution in situations where systemic exposure may occur.

    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

    Generic:
    - Avoid excessive heat (above 104 degrees F)
    - Avoid excessive humidity
    - Store at room temperature (between 59 to 86 degrees F)
    Neocidin :
    - Store between 59 to 77 degrees F
    Neo-Polycin:
    - Store between 59 to 77 degrees F
    Neosporin:
    - Store at room temperature
    Ocu-Spore-B:
    - Store between 59 to 77 degrees F
    Polymycin:
    - Store between 59 to 77 degrees F
    Triple Antibiotic:
    - Store at room temperature

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    NOTE: This monograph discusses the use of neomycin; polymyxin B; bacitracin 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.

    Aminoglycoside hypersensitivity, neomycin hypersensitivity, polymyxin hypersensitivity

    Neomycin; polymyxin B; bacitracin products are contraindicated in patients who are allergic to any of the components including those patients with aminoglycoside hypersensitivity, neomycin hypersensitivity, or polymyxin hypersensitivity. Monitor patients for the development of hypersensitivity reactions and discontinue treatment if symptoms are observed. Long-term use of neomycin products may place patients at risk of developing neomycin hypersensitivity. Avoid further use of neomycin-containing products in those patients who develop this reaction.

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

    Neomycin; polymyxin B; bacitracin 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 neomycin; polymyxin B; bacitracin 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.

    Hearing impairment, renal failure, renal impairment

    Systemic exposure to bacitracin and neomycin 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 or neomycin-induced nephrotoxicity and neomycin-induced irreversible ototoxicity (hearing impairment). Consider the possibility of increased systemic exposure prior to administering topical neomycin; polymyxin B; bacitracin 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 and neomycin with topical product use. Monitor elderly patients closely while on neomycin; polymyxin B; bacitracin products. No particular precautions exist for the use of ophthalmic products in geriatric patients.

    Children, infants, neonates

    The safety and efficacy of neomycin; polymyxin B; bacitracin ophthalmic products have not been established in neonates, infants, children, or adolescents. Patients with immature skin, including children younger than 2 years of age, infants, and neonates, may be at increased risk of side effects from systemically absorbed bacitracin and neomycin when applied topically to the skin. Avoid use of these topical products in patients younger than 2 years of age.

    C. difficile-associated diarrhea, diarrhea, pseudomembranous colitis

    Consider pseudomembranous colitis in patients presenting with diarrhea after antibacterial use. Careful medical history is necessary as pseudomembranous colitis has been reported to occur over 2 months after the administration of antibacterial agents. Almost all antibacterial agents, including neomycin; polymyxin B; bacitracin, have been associated with pseudomembranous colitis or C. difficile-associated diarrhea (CDAD) which may range in severity from mild to life-threatening. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

    Contact lenses

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

    Ophthalmic administration

    Apply neomycin; polymyxin B; bacitracin topical ointment only 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

    Neomycin; polymyxin B; bacitracin products have not been studied in pregnant women and animal reproduction studies have not been conducted. It is not known if they can cause fetal harm when administered to a pregnant woman or if they can affect reproduction capacity. There is little information to demonstrate the possible effect of topically applied neomycin in pregnancy; however, neomycin present in maternal blood can cross the placenta. Neomycin; polymyxin B; bacitracin ophthalmic ointment should be used during pregnancy only if clearly needed. Neomycin; polymyxin B; bacitracin topical ointment is not recommended in pregnancy.

    Breast-feeding

    It is not known whether neomycin; polymyxin B; bacitracin products are excreted in human milk. Topical and ophthalmic use would 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. Oral ingestion by the nursing infant would also result in minimal absorption. 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
    hearing loss / Delayed / Incidence not known
    C. difficile-associated diarrhea / Delayed / Incidence not known

    Moderate

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

    Mild

    ocular pruritus / Rapid / 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

    Neomycin; polymyxin B; bacitracin products have not been studied in pregnant women and animal reproduction studies have not been conducted. It is not known if they can cause fetal harm when administered to a pregnant woman or if they can affect reproduction capacity. There is little information to demonstrate the possible effect of topically applied neomycin in pregnancy; however, neomycin present in maternal blood can cross the placenta. Neomycin; polymyxin B; bacitracin ophthalmic ointment should be used during pregnancy only if clearly needed. Neomycin; polymyxin B; bacitracin topical ointment is not recommended in pregnancy.

    It is not known whether neomycin; polymyxin B; bacitracin products are excreted in human milk. Topical and ophthalmic use would 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. Oral ingestion by the nursing infant would also result in minimal absorption. 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

    Neomycin: Neomycin is an aminoglycoside antibiotic with bactericidal activity against many gram-positive and gram-negative bacteria. In susceptible bacteria, neomycin prevents the formation of functional proteins. This is accomplished through active transport into the bacterial cell and subsequent irreversible binding to receptors present on the 30S ribosomal subunit. This binding interferes with the initiation complex between the messenger RNA (mRNA) and the subunit. As a result, abnormal, nonfunctional proteins are formed due to misreading of the bacterial DNA. Eventually, susceptible bacteria die because of the lack of functional proteins. Neomycin may also inhibit DNA polymerase.
    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: 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.

    PHARMACOKINETICS

    Neomycin; polymyxin B; bacitracin combination products are applied topically to the eyes or skin. If any systemic absorption occurs, bacitracin and neomycin are excreted renally.

    Topical Route

    Except when applied to large areas or for an extended period of time, systemic absorption of neomycin; polymyxin B; bacitracin is negligible. Polymyxin B has a high affinity for cell membranes so there is little systemic absorption even when applied to open wounds. Bacitracin and neomycin may be absorbed systemically if applied to damaged epithelium.