Neomycin (Systemic)

Drug class: Antineoplastic Agents

Usage of Neomycin (Systemic)

Hepatic Encephalopathy

Management of hepatic encephalopathy. Used to inhibit ammonia-forming bacteria in the GI tract in patients with hepatic (portal-systemic) encephalopathy as an adjunct to protein restriction and supportive therapy. Subsequent reduction in blood ammonia may result in neurologic improvement.

Although efficacy of such adjunctive treatment is not clearly established, it has been suggested that nonabsorbable disaccharides (lactulose) are first-line treatment to reduce blood ammonia in adults with acute hepatic encephalopathy and anti-infectives (e.g., oral neomycin or metronidazole) are alternatives.

Perioperative Prophylaxis

Adjunct to mechanical cleansing of the large intestines for preoperative prophylaxis in patients undergoing colorectal surgery. Used in conjunction with oral erythromycin or oral metronidazole and with an appropriate diet and catharsis.

Preferred regimens for patients undergoing colorectal surgery are IV Cefoxitin or IV Cefotetan alone; IV Cefazolin and IV metronidazole; oral erythromycin and oral neomycin; or oral metronidazole and oral neomycin.

Hypercholesterolemia

Treatment of hypercholesterolemia† [off-label]. Therapeutic value may be due in part to reduction in GI absorption of cholesterol, resulting in enhanced elimination of cholesterol as Neutral sterols in the feces.

Not a first- or second-line agent; use only after all conventional treatments have been tried.

GI Infections

Not recommended for treatment of any GI infections† [off-label].

Relate drugs

How to use Neomycin (Systemic)

Administration

Oral Administration

Administer orally.

Dosage

Available as neomycin sulfate; dosage expressed in terms of the sulfate.

To minimize risk of toxicity, use lowest possible dosage and shortest duration of therapy. Closely monitor patients for aminoglycoside toxicity, especially when used for adjunctive treatment of chronic hepatic insufficiency.

Treatment duration >2 weeks is not recommended. Weigh risks of nephrotoxicity, permanent ototoxicity, and neuromuscular blockade against benefits of prolonged treatment. If treatment is prolonged, closely monitor serum neomycin concentrations and renal, auditory, and vestibular functions.

Individualize dosage taking into consideration the patient’s pretreatment body weight, renal status, and serum concentrations of the drug. Because of potential toxicity, fixed-dosage recommendations that are not based on patient weight or serum drug concentrations are not advised.

Pediatric Patients

General Pediatric Dosage Oral

Neonates ≤1 month of age† [off-label]: AAP recommends 25 mg/kg every 6 hours.

Infants and children >1 month of age† [off-label]: AAP recommends 100 mg/kg daily given in 4 equally divided doses.

Manufacturers state that if neomycin is considered necessary in children <18 years of age† [off-label], duration of therapy should not exceed 2 weeks . (See Pediatric Use under Cautions.)

Hepatic Encephalopathy Oral

Children†: 100 mg/kg daily given in 4 divided doses for ≤7 days.

Prior to initiation of neomycin, withdraw protein from the diet and avoid diuretics; incrementally return protein back to the diet during treatment. Monitor closely; give supportive therapy (including blood products) as indicated.

Adults

Hepatic Encephalopathy Oral

Hepatic coma: 4–12 g daily given in divided doses (e.g., 4 doses daily) for 5–6 days recommended by the manufacturers and others.

Chronic hepatic insufficiency when less toxic drugs cannot be used: Up to 4 g daily recommended by the manufacturers.

Some clinicians recommend 3–6 g daily for 1–2 weeks for acute encephalopathy and 1–2 g daily for chronic encephalopathy.

Prior to initiation of neomycin, withdraw protein from the diet and avoid diuretics; incrementally return protein back to the diet during treatment. Monitor closely; give supportive therapy (including blood products) as indicated.

Perioperative Prophylaxis Adjunct to Mechanical Cleansing in Patients Undergoing Colorectal Surgery Oral

For 8 a.m. surgery: Give 1 g neomycin sulfate and 1 g erythromycin base at 1 p.m., 2 p.m., and 11 p.m. on the day preceding surgery. Alternatively, give 2 g neomycin sulfate and 2 g metronidazole at 7 p.m. and 11 p.m. on the day preceding surgery.

Begin a minimum residue or clear liquid diet 1–3 days before colorectal surgery with appropriate catharsis.

Hypercholesterolemia† Oral

0.5–2 g daily. Do not use for long-term treatment.

Prescribing Limits

Adults

Hepatic Encephalopathy Chronic Hepatic Encephalopathy Oral

Maximum: 4 g daily.

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time other than those for patients with hepatic encephalopathy.

Renal Impairment

Reduce dosage or discontinue drug in patients with renal impairment.

Some clinicians recommend that doses be given every 6 hours in those with GFR >50 mL/minute, every 12–18 hours in those with GFR 10–50 mL/minute, or every 18–24 hours in those with GFR <10 mL/minute.

Geriatric Patients

Select dosage with caution and closely monitor renal function because of age-related decreases in renal function.

Warnings

Contraindications

  • History of hypersensitivity or serious toxic reactions to neomycin or other aminoglycosides.
  • Intestinal obstruction.
  • Inflammatory or ulcerative GI disease; may enhance GI absorption of neomycin.

    • Warnings/Precautions

    Warnings

    Neurotoxicity and Ototoxicity

    Patients receiving aminoglycosides should be under close clinical observation because of possible ototoxicity.

    Vestibular and permanent bilateral auditory ototoxicity occurs most frequently in those with past or present history of renal impairment, those receiving other ototoxic drugs, and those who receive high dosages or prolonged treatment.

    Perform serial, vestibular, and audiometric tests, if feasible, in patients old enough to be tested, particularly in high-risk patients.

    Perform tests of the vestibulocochlearis nerve (eighth cranial nerve) function prior to and periodically during neomycin therapy.

    Numbness, skin tingling, muscle twitching, and convulsions also may be signs of neurotoxicity.

    Risk of hearing loss continues after drug withdrawal.

    Some aminoglycosides have caused fetal ototoxicity when administered to pregnant women. (See Pregnancy under Cautions.)

    Nephrotoxicity

    Patients receiving aminoglycosides should be under close clinical observation because of possible nephrotoxicity. Renal function should be assessed prior to therapy and daily, or more frequently, during therapy.

    Nephrotoxicity occurs most frequently in those with past or present history of renal impairment, those receiving other nephrotoxic drugs, and those who receive high dosage or prolonged treatment.

    Monitor urine for increased protein excretion, decreased specific gravity, and the presence of cells and casts. Obtain Clcr, Scr, and/or BUN at the onset of therapy and periodically during therapy.

    Decrease dosage or discontinue drug if renal insufficiency develops.

    Neuromuscular Blockade

    Neuromuscular blockade and respiratory paralysis reported following oral neomycin.

    Possibility of neuromuscular blockade should be considered, especially in patients receiving anesthetics or neuromuscular blocking agents (e.g., tubocurarine, succinylcholine, decamethonium) or in those receiving massive transfusions of citrate-anticoagulated blood.

    Calcium Salts may reverse neuromuscular blockade, but mechanical respiratory assistance may be necessary.

    Sensitivity Reactions

    Hypersensitivity

    Serious and occasionally fatal hypersensitivity reactions, including anaphylaxis, reported with aminoglycosides.

    Cross-sensitivity

    Cross-sensitivity occurs among the aminoglycosides.

    General Precautions

    Selection and Use of Anti-infectives

    To reduce development of drug-resistant bacteria and maintain effectiveness of neomycin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.

    When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing. In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.

    Topical Instillation

    Quickly and almost totally absorbed from body surfaces (except the urinary bladder) after local irrigation or intraoperative topical application in association with medical procedures; neurotoxicity, nephrotoxicity, neuromuscular blockade, or respiratory paralysis may occur, even with minute quantities of neomycin, regardless of renal function.

    Neuromuscular Disorders

    Use with caution in patients with neuromuscular disorders such as myasthenia gravis or parkinsonism; may aggravate muscle weakness because of potential curare-like effect on the neuromuscular junction.

    Superinfection

    Possible emergence and overgrowth of nonsusceptible bacteria or fungi. Institute appropriate therapy if superinfection occurs.

    Malabsorption Syndrome

    May produce a malabsorption syndrome for a variety of substances including fat, nitrogen, cholesterol, carotene, glucose, xylose, lactose, sodium, calcium, cyanocobalamin, and iron. Usually reversible and dose-related; occurs most frequently in prolonged therapy or at high dosage (i.e., 12 g daily).

    Specific Populations

    Pregnancy

    Category D.

    Possibility of fetal harm if administered to a pregnant woman. Complete, irreversible, bilateral congenital deafness reported when another aminoglycoside (i.e., streptomycin) was used during pregnancy.

    Lactation

    IM neomycin is distributed into milk in cows; not known whether distributed into human milk. Discontinue nursing or the drug.

    Pediatric Use

    Safety and efficacy not established in children <18 years of age.

    If neomycin is considered necessary in children <18 years of age†, use with caution and do not treat for >2 weeks since GI absorption may occur.

    Risk of toxicity is increased in premature infants and neonates†.

    Geriatric Use

    Increased risk of toxicity; use with caution and closely monitor renal function.

    When assessing renal function in geriatric patients, Clcr may be more useful than BUN or Scr.

    Renal Impairment

    Patients with renal impairment are at higher risk of nephrotoxicity and ototoxicity.

    Patients with renal insufficiency may develop toxic blood concentrations unless doses are properly regulated.

    Common Adverse Effects

    Nausea, vomiting, diarrhea, abdominal cramps.

    What other drugs will affect Neomycin (Systemic)

    Neurotoxic, Ototoxic, or Nephrotoxic Drugs

    Concomitant or sequential use with other drugs that have neurotoxic, ototoxic, or nephrotoxic effects may result in additive toxicity and should be avoided, if possible.

    Because of the possibility of an increased risk of ototoxicity due to additive effects or altered serum and tissue aminoglycoside concentrations, do not use concurrently with potent diuretics.

    Specific Drugs

    Drug

    Interaction

    Comments

    Aminoglycosides

    Concurrent or serial use may enhance nephrotoxicity, ototoxicity, and/or potentiate neuromuscular blockade

    Avoid concurrent or sequential use, if possible

    Amphotericin B

    Possible increased incidence of nephrotoxicity and/or neurotoxicity

    Avoid concurrent or sequential use, if possible

    Anticoagulants, oral

    Neomycin may enhance warfarin effects by decreasing vitamin K availability

    Monitor prothrombin time; adjust warfarin dosage as required

    Anti-emetics (e.g., dimenhydrinate, meclizine)

    Anti-emetics that suppress nausea and vomiting of vestibular origin and vertigo may mask symptoms of vestibular ototoxicity

    Bacitracin

    Possible increased incidence of nephrotoxicity and/or neurotoxicity

    Avoid concurrent or sequential use, if possible

    β-Lactam antibiotics (cephalosporins, penicillins)

    Possible increased incidence of nephrotoxicity reported with some cephalosporins; cephalosporins may spuriously elevate creatinine concentrations

    Potential in vitro and in vivo inactivation of aminoglycosides

    Monitor serum aminoglycoside concentrations, especially when high penicillin doses are used or patient has renal impairment

    Cisplatin

    Possible increased incidence of nephrotoxicity and/or neurotoxicity

    Avoid concurrent or sequential use, if possible

    Colistimethate/Colistin

    Possible increased incidence of nephrotoxicity and/or neurotoxicity

    Avoid concurrent or sequential use, if possible

    Cyanocobalamin (vitamin B12)

    Neomycin inhibits GI absorption of oral vitamin B12

    Clinical importance unclear

    Digoxin

    Neomycin inhibits GI absorption of digoxin

    Monitor digoxin serum concentrations

    Diuretics (ethacrynic acid, furosemide)

    Possible increased risk of ototoxicity (diuretics themselves may cause ototoxicity) or increased risk of other aminoglycoside-related adverse effects (diuretics may alter aminoglycoside serum or tissue concentrations)

    5-Fluorouracil

    Neomycin inhibits GI absorption of 5-fluorouracil

    Clinical importance unclear

    Methotrexate

    Neomycin inhibits GI absorption of methotrexate

    Clinical importance unclear

    Neuromuscular blocking agents and general anesthetics (succinylcholine, tubocurarine, decamethonium)

    Possible potentiation of neuromuscular blockade and respiratory paralysis

    Use concomitantly with caution; observe closely for signs of respiratory depression

    NSAIAs

    Possible increased serum aminoglycoside concentrations reported with Indomethacin in premature neonates; may be related to indomethacin-induced decreases in urine output

    Closely monitor aminoglycoside concentrations and adjust dosage accordingly

    Penicillin V

    Neomycin inhibits GI absorption of penicillin V

    Clinical importance unclear

    Polymyxins

    Possible increased incidence of nephrotoxicity and/or neurotoxicity; possible potentiation of neuromuscular blockade

    Avoid concurrent or sequential use, if possible

    Vancomycin

    Possible increased incidence of nephrotoxicity and/or neurotoxicity

    Avoid concurrent or sequential use, if possible

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