Systemic absorption of neomycin occurs following oral administration, and toxic reactions may occur. Patients treated with neomycin should be under close clinical observation because of the potential toxicity associated with the use of neomycin. Neurotoxicity (including ototoxicity) and nephrotoxicity following the oral use of neomycin sulfate have been reported, even when used in recommended doses. The potential for nephrotoxicity, permanent bilateral auditory ototoxicity, and sometimes vestibular toxicity, is present in patients with healthy renal function when treated with higher doses of neomycin or for longer periods than recommended. Serial, vestibular and audiometric tests, as well as tests of renal function, should be performed (especially in high-risk patients). The risk of nephrotoxicity and ototoxicity is greater in patients with impaired renal function. Ototoxicity is often delayed in onset, and patients developing cochlear damage will not have symptoms during therapy to warn them of developing eighth nerve destruction, and total or partial deafness may occur long after neomycin has been discontinued.
Other factors which increase the risk of toxicity are advanced age and dehydration.
Neuromuscular blockage and respiratory paralysis have been reported following the oral use of neomycin. The possibility of the occurrence of neuromuscular blockage and respiratory paralysis should be considered if neomycin is administered, especially to patients receiving anesthetics; neuromuscular-blocking agents such as tubocurarine, succinylcholine, decamethonium; or massive transfusions of citrate anticoagulated blood. If blockage occurs, calcium salts may reverse these phenomena, but mechanical respiratory assistance may be necessary.
Concurrent or sequential systemic, oral or topical use of other aminoglycosides, including paromomycin and other potentially nephrotoxic or neurotoxic drugs such as bacitracin, cisplatin, vancomycin, amphotericin B, polymyxin B, colistin and viomycin, should be avoided because the toxicity may be additive.
The concurrent use of neomycin with potent diuretics such as ethacrynic acid or furosemide should be avoided, since certain diuretics by themselves may cause ototoxicity. In addition, when administered intravenously (IV), diuretics may enhance neomycin toxicity by altering the antibiotic concentration in serum and tissue.
Small intestinal bacterial overgrowth, methanogen overgrowth (off-label use): Oral: 500 mg twice daily, in combination with rifaximin, for 14 days (Low 2010; Pimentel 2014).
Surgical prophylaxis, colorectal: Oral: 1 g at 1 PM, 2 PM, and 11 PM on the day preceding 8 AM surgery in combination with other appropriate agents and as an adjunct to mechanical cleansing of the intestine, followed by an appropriate IV antibiotic prophylaxis regimen (ASHP/IDSA/SIS/SHEA [Bratzler 2013]).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in manufacturer’s labeling; however, dosage reduction or discontinuation of therapy should be considered if a patient develops renal insufficiency. The risk of nephro- and/or ototoxicity is increased in patients with renal impairment.
There are no dosage adjustments provided in manufacturer’s labeling.
(For additional information see "Neomycin: Pediatric drug information")
Note: Dosage expressed in terms of neomycin sulfate.
Cholangitis, prophylaxis recurrent episodes after Kasai portoenterostomy: Limited data available: Infants and Children ≤3 years: Oral: 25 to 50 mg/kg/day in 4 divided doses 4 days per week; continue until 2 to 3 years of age. Dosing based on a prospective, randomized, comparative trial and a small case series of patients ≤2 years of age at time of therapy initiation who had an episode of cholangitis after a Kasai portoenterostomy (n=10). In the trial, two prophylactic regimens were compared (neomycin vs trimethoprim/sulfamethoxazole) against historic controls; the mean age at time of therapy initiation was 6.1 ± 3.6 months; both neomycin and trimethoprim/sulfamethoxazole decreased cholangitis incidence by ~60% and neomycin increased survival. In the case series, dosing was started at 25 mg/kg/day or 50 mg/kg/day for 5 days just prior to discharge then given 4 days per week (4 days on, 3 days off) (Bu 2003; Lien 2015; Mones 1994).
Enteric bacteria eradication (including gut flora)/infection: Limited data available: Note: Use of neomycin for the treatment of enteric infection has been replaced by other agents; most contemporary use is for eradication of intestinal flora (Red Book [AAP 2015]). Infants, Children, and Adolescents: Oral: 50 to 100 mg/kg/day divided every 6 to 8 hours; maximum daily dose: 12 g/day (Bradley 2017; Marks 1973; Red Book [AAP 2015]); duration of treatment should not exceed 2 weeks due to GI absorption which may result in systemic toxicities
Hepatic encephalopathy: Limited data available: Infants, Children, and Adolescents: Oral: 50 to 100 mg/kg/day divided every 6 hours for a maximum of 7 days with or without lactulose (Debray 2006; Lovejoy 1975); maximum daily dose: 12 g/day
Preoperative intestinal antisepsis: Limited data available: Infants, Children, and Adolescents: Oral: 15 mg/kg/dose for 3 doses administered over 10 hours (eg, at 1 PM, 2 PM, and 11 PM) the day before surgery; maximum dose: 1,000 mg/dose (Bratzler 2013; Breckler 2010; Debo Adeyemi 1986; Feng 2015; Feng 2015a; Gal 2007; Pennington 2014; Rangel 2015); used in combination with other oral antimicrobial (eg, erythromycin or metronidazole) and with/or without adjunct to mechanical cleansing of the intestine (Feng 2015; Feng 2015a)
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
All patients: Dialyzable; there are no specific dosing adjustments provided in the manufacturer's labeling; however, based on experience with aminoglycosides in pediatric patients, renal impairment increases the risk for toxicity and consideration should be given to reducing the dose or discontinuing therapy.
There are no dosing adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral, as sulfate:
Generic: 500 mg
Yes
Oral: Administer without regard to meals; for preoperative intestinal antisepsis, administer at prescribed dosing times.
Surgical prophylaxis, colorectal: Adjunctive therapy given as part of an appropriate combination regimen for the suppression of the normal bacterial bowel flora (eg, preoperative bowel preparation).
Small intestinal bacterial overgrowth, methanogen overgrowth
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Central nervous system: Sore mouth
Gastrointestinal: Anorectal pain, diarrhea, mouth irritation, nausea, rectal irritation, vomiting
<1%, postmarketing, and/or case reports: Auditory ototoxicity, dyspnea, eosinophilia, nephrotoxicity, neurotoxicity, vestibular ototoxicity
Hypersensitivity to the neomycin or any component of the formulation; intestinal obstruction; patients with inflammatory or ulcerative GI disease.
Concerns related to adverse effects:
• Hypersensitivity: Cross-sensitivity to other aminoglycosides may occur.
• Malabsorption: Small amounts of neomycin are absorbed through intact intestinal mucosa; increases in fecal bile acid excretion and reduction of intestinal lactase activity may occur. Oral doses of >12 g/day produce malabsorption of fats, nitrogen, cholesterol, carotene, glucose, xylose, lactose, sodium, calcium, cyanocobalamin and iron.
• Nephrotoxicity: [US Boxed Warning]: May cause nephrotoxicity; usual risk factors include preexisting renal impairment, concomitant nephrotoxic medications, advanced age and dehydration. Discontinue treatment if signs of nephrotoxicity occur; renal damage is usually reversible.
• Neuromuscular blockade and respiratory paralysis: [US Boxed Warning]: May cause neuromuscular blockade and respiratory paralysis; especially when given soon after anesthesia or muscle relaxants.
• Neurotoxicity: [US Boxed Warning]: May cause neurotoxicity; symptoms also include numbness, skin tingling, muscle twitching and seizures. Usual risk factors include preexisting renal impairment and concomitant neuro-/nephrotoxic medications. Discontinue treatment if signs of ototoxicity occur; risk of hearing loss continues after drug withdrawal.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Hearing impairment: Use with caution in patients with preexisting vertigo, tinnitus, or hearing loss.
• Neuromuscular disorders: Use with caution in patients with neuromuscular disorders, including myasthenia gravis and Parkinson disease.
• Renal impairment: Use with caution in patients with preexisting renal insufficiency; dosage modification required.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.
Other warnings/precautions:
• Parenteral administration: More toxic than other aminoglycosides when given parenterally; do not administer parenterally.
• Surgical irrigation: Do not use as surgical irrigation due to significant systemic absorption of the drug.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acarbose: Neomycin (Systemic) may enhance the adverse/toxic effect of Acarbose. Neomycin (Systemic) may decrease the metabolism of Acarbose. Risk C: Monitor therapy
Aminoglycosides: May enhance the nephrotoxic effect of other Aminoglycosides. Aminoglycosides may enhance the neurotoxic effect of other Aminoglycosides. Risk X: Avoid combination
Amphotericin B: May enhance the nephrotoxic effect of Aminoglycosides. Amphotericin B may enhance the neurotoxic effect of Aminoglycosides. Risk C: Monitor therapy
Ataluren: May enhance the adverse/toxic effect of Aminoglycosides. Specifically, an increased risk of nephrotoxicity may occur with the concomitant use of ataluren and aminoglycosides. Risk X: Avoid combination
Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification
Bacitracin (Systemic): Neomycin (Systemic) may enhance the nephrotoxic effect of Bacitracin (Systemic). Risk X: Avoid combination
Bisphosphonate Derivatives: Aminoglycosides may enhance the hypocalcemic effect of Bisphosphonate Derivatives. Risk C: Monitor therapy
Botulinum Toxin-Containing Products: Aminoglycosides may enhance the neuromuscular-blocking effect of Botulinum Toxin-Containing Products. Risk C: Monitor therapy
Capreomycin: May enhance the neuromuscular-blocking effect of Aminoglycosides. Risk C: Monitor therapy
CARBOplatin: May enhance the nephrotoxic effect of Aminoglycosides. Aminoglycosides may enhance the ototoxic effect of CARBOplatin. Especially with higher doses of carboplatin. Risk C: Monitor therapy
Cardiac Glycosides: Aminoglycosides may decrease the serum concentration of Cardiac Glycosides. This effect has only been demonstrated with oral aminoglycoside administration. Risk C: Monitor therapy
Cephalosporins: May enhance the nephrotoxic effect of Aminoglycosides. Cephalosporins may decrease the serum concentration of Aminoglycosides. Risk C: Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination
CISplatin: May enhance the nephrotoxic effect of Aminoglycosides. CISplatin may enhance the neurotoxic effect of Aminoglycosides. Risk X: Avoid combination
Colistimethate: Aminoglycosides may enhance the nephrotoxic effect of Colistimethate. Aminoglycosides may enhance the neuromuscular-blocking effect of Colistimethate. Management: Avoid coadministration of colistimethate and aminoglycosides whenever possible due to the risk of nephrotoxicity and neuromuscular blockade. If coadministration cannot be avoided, monitor renal and neuromuscular function. Risk D: Consider therapy modification
Cyclizine: May enhance the ototoxic effect of Aminoglycosides. Risk C: Monitor therapy
CycloSPORINE (Systemic): Aminoglycosides may enhance the nephrotoxic effect of CycloSPORINE (Systemic). Risk C: Monitor therapy
Distigmine: Aminoglycosides may diminish the therapeutic effect of Distigmine. Risk C: Monitor therapy
Foscarnet: May enhance the nephrotoxic effect of Aminoglycosides. Risk X: Avoid combination
Immune Checkpoint Inhibitors: Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors. Risk C: Monitor therapy
Loop Diuretics: May enhance the adverse/toxic effect of Aminoglycosides. Specifically, nephrotoxicity and ototoxicity. Risk C: Monitor therapy
Mannitol (Systemic): May enhance the nephrotoxic effect of Aminoglycosides. Risk X: Avoid combination
Mecamylamine: Aminoglycosides may enhance the neuromuscular-blocking effect of Mecamylamine. Risk X: Avoid combination
Methotrexate: Neomycin (Systemic) may decrease the serum concentration of Methotrexate. Neomycin (Systemic) may increase the serum concentration of Methotrexate. Risk C: Monitor therapy
Methoxyflurane: Aminoglycosides may enhance the nephrotoxic effect of Methoxyflurane. Risk X: Avoid combination
Netilmicin (Ophthalmic): Aminoglycosides may enhance the nephrotoxic effect of Netilmicin (Ophthalmic). Risk X: Avoid combination
Neuromuscular-Blocking Agents: Aminoglycosides may enhance the therapeutic effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy
Nonsteroidal Anti-Inflammatory Agents: May decrease the excretion of Aminoglycosides. Data only in premature infants. Risk C: Monitor therapy
Oxatomide: May enhance the ototoxic effect of Aminoglycosides. Risk C: Monitor therapy
Penicillins: May decrease the serum concentration of Aminoglycosides. Primarily associated with extended spectrum penicillins, and patients with renal dysfunction. Risk C: Monitor therapy
Polymyxin B: May enhance the nephrotoxic effect of Aminoglycosides. Polymyxin B may enhance the neurotoxic effect of Aminoglycosides. Risk X: Avoid combination
Regorafenib: Neomycin (Systemic) may decrease serum concentrations of the active metabolite(s) of Regorafenib. Risk C: Monitor therapy
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification
SORAfenib: Neomycin (Systemic) may decrease the serum concentration of SORAfenib. Risk X: Avoid combination
Tacrolimus (Systemic): Aminoglycosides may enhance the nephrotoxic effect of Tacrolimus (Systemic). Risk C: Monitor therapy
Tenofovir Products: Aminoglycosides may increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Aminoglycosides. Risk C: Monitor therapy
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification
Vancomycin: May enhance the nephrotoxic effect of Aminoglycosides. Vancomycin may enhance the neurotoxic effect of Aminoglycosides. Management: Consider avoiding coadministration of aminoglycosides and vancomycin unless clinically indicated. If coadministered, monitor closely for signs of nephrotoxicity and neurotoxicity. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Neomycin (Systemic) may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
Animal reproduction studies have not been conducted. Aminoglycosides cross the placenta. Aminoglycosides may cause fetal harm if administered to a pregnant woman. There are several reports of total irreversible bilateral congenital deafness in children whose mothers received another aminoglycoside (streptomycin) during pregnancy. Although serious side effects to the fetus/infant have not been reported following maternal use of all aminoglycosides, a potential for harm exists. Large oral doses may cause malabsorption of some nutrients in the mother.
It is not known if neomycin is excreted into breast milk. Due to the potential for serious adverse reactions in the nursing infant, the manufacturer recommends a decision be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of treatment to the mother. As a class, aminoglycosides are expected to be poorly distributed into breast milk, limiting systemic exposure to a nursing infant. In general, modification of bowel flora may occur with any antibiotic exposure (Chung 2002).
Serum creatinine/BUN at baseline and periodically during chronic therapy; audiometry in symptomatic patients
Interferes with bacterial protein synthesis by binding to 30S ribosomal subunits
Absorption: Oral, percutaneous: Poor (3%)
Distribution: 97% of an orally administered dose remains in the GI tract. Absorbed neomycin distributes to tissues and concentrates in the renal cortex. With repeated doses, accumulation also occurs in the inner ear.
Protein binding: 0% to 30%
Time to peak serum concentration: 1 to 4 hours
Excretion: Feces (97% of oral dose as unchanged drug); urine (30% to 50% of absorbed drug as unchanged drug)
Tablets (Neomycin Sulfate Oral)
500 mg (per each): $1.36 - $1.98
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