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Neomycin: Drug information

Neomycin: Drug information
(For additional information see "Neomycin: Patient drug information" and see "Neomycin: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Toxicity:

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 blockade:

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 therapy:

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.

Pharmacologic Category
  • Ammonium Detoxicant;
  • Antibiotic, Aminoglycoside
Dosing: Adult
Small intestinal bacterial overgrowth, methanogen overgrowth

Small intestinal bacterial overgrowth, methanogen overgrowth (off-label use): Oral: 500 mg twice daily, in combination with rifaximin, for 14 days (Ref).

Surgical prophylaxis, colorectal

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 (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

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.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Neomycin: Pediatric drug information")

Note: Dosage expressed in terms of neomycin sulfate.

Cholangitis, prophylaxis of recurrent episodes after Kasai portoenterostomy

Cholangitis, prophylaxis of 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 two small randomized trials and a small case series (Ref).

Enteric bacteria eradication

Enteric bacteria eradication (including gut flora): Limited data available: Note: Use of neomycin for the treatment of enteric infection has been replaced by other agents (Ref).

Infants, Children, and Adolescents: Oral: 50 to 100 mg/kg/day in divided doses every 6 to 8 hours; maximum daily dose: 12 g/day (Ref); duration of treatment should not exceed 2 weeks due to GI absorption, which may result in systemic toxicities (Ref).

Hepatic encephalopathy

Hepatic encephalopathy: Limited data available: Infants, Children, and Adolescents: Oral: 50 to 100 mg/kg/day in divided doses every 6 hours for a maximum of 7 days (Ref); maximum daily dose: 12 g/day (Ref).

Surgical prophylaxis, colorectal

Surgical prophylaxis, colorectal: 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 as part of an appropriate combination regimen, with or without mechanical bowel preparation (consult institutional protocol); maximum dose: 1,000 mg/dose (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

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. Dialyzable.

Dosing: Hepatic Impairment: Pediatric

There are no dosing adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions are derived from product labeling unless otherwise specified.

Frequency not defined: Gastrointestinal: Diarrhea, nausea, vomiting

Postmarketing:

Dermatologic: Contact dermatitis (systemic contact dermatitis) (Carnicle 2020)

Gastrointestinal: Clostridioides difficile colitis (Bolton 1979), malabsorption syndrome (with prolonged therapy)

Nervous system: Neurotoxicity

Neuromuscular & skeletal: State of neuromuscular blockade

Otic: Ototoxicity (including auditory ototoxicity and vestibular ototoxicity) (Ward 1978)

Renal: Nephrotoxicity

Respiratory: Respiratory paralysis

Contraindications

Hypersensitivity to the neomycin or any component of the formulation; intestinal obstruction; patients with inflammatory or ulcerative GI disease.

Warnings/Precautions

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.

Special populations:

• Patients with genomic variants in MT-RNR1: Carriers of certain variants in the MT-RNR1 gene (eg, m.1555A>G) may be at increased risk for aminoglycoside-induced ototoxicity, including potentially significant hearing loss that may be irreversible, even when serum levels are within the normal range.

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.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral, as sulfate:

Generic: 500 mg

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (Neomycin Sulfate Oral)

500 mg (per each): $1.49 - $1.98

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Pediatric

Oral: Administer without regard to meals; for surgical prophylaxis, administer at prescribed dosing times.

Use: Labeled Indications

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).

Use: Off-Label: Adult

Small intestinal bacterial overgrowth, methanogen overgrowth

Metabolism/Transport Effects

None known.

Drug Interactions

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. Aminoglycosides may enhance the nephrotoxic 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

Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination

Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination

Foscarnet: May enhance the nephrotoxic effect of Aminoglycosides. Risk X: Avoid combination

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). 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

Pregnancy Considerations

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.

Breastfeeding Considerations

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).

Monitoring Parameters

Serum creatinine/BUN at baseline and periodically during chronic therapy; audiometry in symptomatic patients

Mechanism of Action

Interferes with bacterial protein synthesis by binding to 30S ribosomal subunits

Pharmacokinetics (Adult Data Unless Noted)

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)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Neomas bowers;
  • (AU) Australia: Neosulf;
  • (BE) Belgium: Neomycine diamant;
  • (CH) Switzerland: Neomycin drossapharm;
  • (CL) Chile: Neomicina;
  • (CN) China: Neomycin;
  • (DE) Germany: Neomycin;
  • (EG) Egypt: Neomycin;
  • (ES) Spain: Neomicina salvat;
  • (FI) Finland: Neomycin;
  • (FR) France: Neomycine diamant;
  • (GB) United Kingdom: Mycifradin | Neomycin | Nivemycin;
  • (GR) Greece: Neomycin sulphate | Nivemycin;
  • (HK) Hong Kong: Mycifradin | Neoate;
  • (HU) Hungary: Mycerine;
  • (ID) Indonesia: Neobiotic;
  • (IE) Ireland: Mycifradin | Neomycin | Nivemycin;
  • (IL) Israel: Neomycin;
  • (IT) Italy: Neomicina;
  • (JP) Japan: Dexmy | Fradio;
  • (LT) Lithuania: Neomycin;
  • (LV) Latvia: Neomycin;
  • (MX) Mexico: Neomicina pisa | Neomixen;
  • (NL) Netherlands: Neomycinum;
  • (NO) Norway: Neomycin amdipharm | Nivemycin;
  • (NZ) New Zealand: Neosulf;
  • (PH) Philippines: Mycifradin;
  • (PK) Pakistan: Neomycin;
  • (PL) Poland: Neomycinum;
  • (PT) Portugal: Neomicina;
  • (RU) Russian Federation: Neomycin;
  • (SE) Sweden: Neomycin Cortec | Neomycin Upjohn;
  • (SI) Slovenia: Mycifradin;
  • (TH) Thailand: Myneocin | Neobemed | Neomycin;
  • (TN) Tunisia: Neomycine diamant;
  • (TW) Taiwan: Neomycin;
  • (ZA) South Africa: Mycifradin
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