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  • CLASSES

    Urinary Antibiotics and/or Sulfonamides

    DEA CLASS

    Rx

    DESCRIPTION

    Urinary bladder irrigation to prevent infections due to indwelling catheters. For short-term use (up to 10 days).

    COMMON BRAND NAMES

    Neosporin GU

    HOW SUPPLIED

    Neomycin, Polymyxin B/Neosporin GU Intravesical Sol: 1mL, 40-200000U
    Neomycin, Polymyxin B/Neosporin GU Irrigation Sol: 1mL, 40-200000U

    DOSAGE & INDICATIONS

    For bacteriuria prophylaxis and bacteremia prophylaxis via continuous prophylactic irrigation of the intact urinary bladder in patients with indwelling catheters.
    Bladder irrigant dosage
    Adults

    Neomycin base 40 mg/day and polymyxin B 200,000 units/day as a continuous bladder irrigation. Administration rate is adjusted to patient's urine output.

    MAXIMUM DOSAGE

    Adults

    2 million units of polymyxin B/day (topical and systemic); maximum dose information is not available for Neosporin.

    Elderly

    2 million units of polymyxin B/day (topical and systemic); maximum dose information is not available for Neosporin.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    No dosage guidelines are available; it appears no dosage adjustment is needed.

    Renal Impairment

    No dosage guidelines are available; it appears no dosage adjustment is needed.

    ADMINISTRATION

     
    NOTE: This monograph discusses the use of the combination product neomycin; polymyxin B genitourinary (GU) irrigant solution for prophylaxis of infections associated with use of indwelling catheters. Clinicians may wish to consult the individual drug monographs for more information.
     
    NOTE: 57 mg of neomycin sulfate is equivalent to 40 mg of neomycin base and 200,000 units of polymyxin B sulfate is equivalent to 20 mg of polymyxin B base.

    Other Administration Route(s)

    Bladder Irrigation
    Follow strict aseptic techniques.
    Administer via a 3-way catheter or other catheter system permitting continuous irrigation of the urinary bladder. The inflow of the solution should not be interrupted for more than a few minutes.
    Dilute 1 ml of neomycin; polymyxin B irrigant (equivalent to 40 mg neomycin base and 200,000 units polymyxin B) in a 1000 ml container of sterile 0.9% Sodium Chloride (NS).
    Connect the container to the inflow lumen of the 3-way catheter. The outflow lumen should be connected, via a sterile disposable plastic tube, to a disposable plastic collection bag. Tape the inflow and outflow junction at the catheter to insure the junctional integrity of the system.
    Adjust the inflow rate to a slow drip to deliver 1 L/24 h (roughly 40 ml/h). If the patient's urine output exceeds 2 L/d, the manufacturer recommends that the inflow rate be adjusted to 2 L/24 h.
    The undiluted vials and prepared irrigation solution should be stored under refrigeration (2—8 degrees C or 36—46 degrees F). The irrigation solution should be used within 48 hours of preparation.

    STORAGE

    Neosporin GU:
    - Store between 36 to 46 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    NOTE: This monograph discusses the use of the combination product neomycin; polymyxin B genitourinary (GU) irrigant solution for prophylaxis of infections associated with the use of indwelling catheters. Clinicians may wish to consult the individual drug monographs for more information.
     
    Neomycin; polymyxin B GU irrigant is for use with three-way closed catheters or other catheter systems allowing continuous irrigation of the urinary bladder. Urine specimens should be collected during prophylactic care for urinalysis, culture, and susceptibility testing. If uropathogens are isolated, they should be identified and tested for susceptibility patterns. If indicated, systemic antimicrobial therapy should be instituted.
     
    Neomycin; polymyxin B GU irrigant should not be used for other types of irrigations including topical wound, burn, and granulating surfaces. Serum concentrations comparable to or higher than those achieved with oral and parenteral therapy have been reported when local therapy resulted in systemic absorption.

    Aminoglycoside hypersensitivity, neomycin hypersensitivity, polymyxin hypersensitivity

    Neomycin; polymyxin B GU irrigant is contraindicated in any patient with a known neomycin hypersensitivity, polymyxin hypersensitivity or sensitivity to any ingredient in the product. A history of aminoglycoside hypersensitivity or serious toxic reactions to aminoglycosides may also contraindicate use because of known cross-sensitivity to drugs in this class.

    Botulism, dehydration, geriatric, hearing impairment, myasthenia gravis, neuromuscular disease, parkinsonism, renal disease, renal impairment, respiratory insufficiency, surgery

    Significant systemic absorption should be rare if neomycin; polymyxin B GU irrigant is used for <= 10 days in a patient with an intact urinary bladder; however absorption of neomycin from the denuded bladder has been reported. Prophylactic bladder care with neomycin; polymyxin B GU irrigant should not be used when there is the possibility of systemic absorption. Irrigation should be avoided in patients with defects in the bladder mucosa or bladder wall (i.e., vesical rupture). The safety and effectiveness of neomycin; polymyxin B GU irrigant in patients with recent lower urinary tract surgery have not been established. Neomycin; polymyxin B GU irrigant should be used cautiously in patients with renal disease, renal impairment, dehydration, as well as geriatric patients. Patients with preexisting tinnitus, vertigo, or subclinical high-frequency hearing impairment should be closely monitored for signs of ototoxicity during therapy with neomycin. Aminoglycosides, due to their potential curare-like effect, may aggravate muscle weakness in patients with neuromuscular disease such as myasthenia gravis, infant botulism or parkinsonism. Polymyxin B can cause respiratory paralysis also as a result of neuromuscular blockade. Concurrent administration of polymyxin B with neuromuscular blockers during surgery should be avoided. If signs of hearing impairment, respiratory insufficiency, muscle weakness or nephrotoxicity occur, neomycin; polymyxin B GU irrigant should be discontinued.

    Children, infants, neonates

    The safety and effectiveness of neomycin; polymyxin B GU irrigant in neonates, infants, children, and adolescents have not been established.

    Pregnancy

    Neomycin; polymyxin B GU irrigant is classified in FDA pregnancy risk category D. Systemically-absorbed neomycin crosses the placenta and aminoglycosides are known to cause fetal nephrotoxicity and permanent ototoxicity in children whose mothers received them during pregnancy. Systemic absorption of neomycin could occur if the mother's bladder were not intact. If neomycin; polymyxin B GU irrigant is used during pregnancy, the patient should be informed of the potential hazard to the fetus.

    Breast-feeding

    Neomycin; polymyxin B is used as a genitourinary irrigation. If the mother's bladder is intact and irrigation does not exceed 10 days, the likelihood that the irrigant would be absorbed in significant quantities to adversely effect a nursing infant is remote. If systemic absorption by the mother did occur, there would be minimal oral absorption by the breast-feeding infant. 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, healthcare providers are encouraged to report the adverse effect to the FDA.

    ADVERSE REACTIONS

    Moderate

    superinfection / Delayed / Incidence not known
    candidiasis / Delayed / Incidence not known

    Mild

    pruritus / Rapid / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Neomycin; Polymyxin B products.

    PREGNANCY AND LACTATION

    Pregnancy

    Neomycin; polymyxin B GU irrigant is classified in FDA pregnancy risk category D. Systemically-absorbed neomycin crosses the placenta and aminoglycosides are known to cause fetal nephrotoxicity and permanent ototoxicity in children whose mothers received them during pregnancy. Systemic absorption of neomycin could occur if the mother's bladder were not intact. If neomycin; polymyxin B GU irrigant is used during pregnancy, the patient should be informed of the potential hazard to the fetus.

    Neomycin; polymyxin B is used as a genitourinary irrigation. If the mother's bladder is intact and irrigation does not exceed 10 days, the likelihood that the irrigant would be absorbed in significant quantities to adversely effect a nursing infant is remote. If systemic absorption by the mother did occur, there would be minimal oral absorption by the breast-feeding infant. 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, healthcare providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Mechanism of Action: Neomycin and polymyxin B are combined in a single irrigating solution to prevent bacteriuria and gram-negative rod septicemia associated with the use of indwelling catheters. The combined action of neomycin and polymyxin B is bactericidal.•Neomycin sulfate: Neomycin inhibits bacterial protein synthesis through irreversible binding to the 30 S ribosomal subunit of susceptible bacteria. Neomycin is actively transported into the bacterial cell where it binds to receptors present on the 30 S ribosomal subunit. This binding interferes with the initiation complex between the messenger RNA 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.•Polymyxin B sulfate: Polymyxin B binds to gram-negative bacterial cell membrane phospholipids. This binding destroys bacterial membranes with a surface detergent-like mechanism and increases the permeability of the cell membrane, which results in loss of metabolites essential to bacterial existence. Polymyxin B has no in vitro activity against gram-positive organisms or fungi. The in vivo activity of polymyxin B against Pseudomonas aeruginosa is decreased by the presence of divalent cations such as calcium, which is believed to interfere with the binding of the drug to the cell membrane.The following organisms are generally considered susceptible to neomycin; polymyxin B GU irrigant in-vitro: Enterobacter sp.; Escherichia coli; Haemophilus influenzae (beta-lactamase negative); Haemophilus influenzae (beta-lactamase positive); Klebsiella sp.; Neisseria sp.; Pseudomonas aeruginosa; Staphylococcus aureus (MSSA). Neomycin; Polymyxin B GU irrigant is not active in-vitro against Serratia marcescens and streptococci.

    PHARMACOKINETICS

    Neomycin; polymyxin B is administered via continuous bladder irrigation.

    Other Route(s)

    Bladder Irrigation
    Negligible systemic absorption of neomycin; polymyxin B GU irrigant occurs when administered to patients with intact bladders for <= 10 days. If systemic absorption should occur, significant neuro-, nephro- and ototoxicity may occur.
    Neomycin sulfate: A neomycin serum level of 0.1 mcg/ml has been observed with bladder irrigation, which is well below the limit associated with neomycin-induced toxicity.
    Polymyxin B sulfate: After prophylactic irrigation of the intact urinary bladder, polymyxin B is systemically absorbed in clinically insignificant quantities.