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ALERT: U.S. Boxed Warning
The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling or www.fda.gov.
Pronunciation
(nee oh MYE sin)
Generic Available (U.S.)
Yes
Index Terms
Brand Names: U.S.
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Orally to prepare GI tract for surgery; treatment of diarrhea caused by E. coli; adjunct in the treatment of hepatic encephalopathy
Pregnancy Risk Factor
D
Pregnancy Considerations
Aminoglycosides cross the placenta; however, neomycin has limited maternal absorption. Therefore the portion of an orally administered maternal dose available to cross the placenta is very low. Teratogenic effects have not been observed following maternal use of neomycin. Because of several reports of total irreversible bilateral congenital deafness in children whose mothers received another aminoglycoside (streptomycin) during pregnancy, the manufacturer classifies neomycin as pregnancy category D.
Lactation
Excretion in breast milk unknown/not recommended
Breast-Feeding Considerations
It is not known if neomycin is excreted into breast milk; however, limited oral absorption by both the mother and infant would minimize exposure to the nursing infant. Nondose-related effects could include modification of bowel flora. Breast-feeding is not recommended by the manufacturer.
Contraindications
Hypersensitivity to neomycin or any component of the formulation, or other aminoglycosides; intestinal obstruction, inflammatory or ulcerative gastrointestinal disease
Warnings/Precautions
Boxed warnings:
• Nephrotoxicity: See “Concerns related to adverse effects” below.
• Neuromuscular blockade and respiratory paralysis: See “Concerns related to adverse effects” below.
• Neurotoxicity: See “Concerns related to adverse effects” below.
Concerns related to adverse effects:
• Nephrotoxicity: [U.S. Boxed Warning]: May cause nephrotoxicity; usual risk factors include pre-existing 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: [U.S. Boxed Warning]: May cause neuromuscular blockade and respiratory paralysis; especially when given soon after anesthesia or muscle relaxants.
• Neurotoxicity: [U.S. Boxed Warning]: May cause neurotoxicity; usual risk factors include pre-existing renal impairment, concomitant neuro-/nephrotoxic medications, advanced age and dehydration. Ototoxicity is proportional to the amount of drug given and the duration of treatment. Tinnitus or vertigo may be indications of vestibular injury and impending bilateral irreversible damage. Discontinue treatment if signs of ototoxicity occur.
• 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 pre-existing vertigo, tinnitus, or hearing loss.
• Neuromuscular disorders: Use with caution in patients with neuromuscular disorders, including myasthenia gravis.
• Renal impairment: Use with caution in patients with pre-existing renal insufficiency; dosage modification required.
Other warnings/precautions:
• Parenteral administration: More toxic than other aminoglycosides when given parenterally; do not administer parenterally.
• Peritoneal lavage: Do not use as peritoneal lavage due to significant systemic adsorption of the drug.
Adverse Reactions
>10%: Gastrointestinal: Nausea, diarrhea, vomiting, irritation or soreness of the mouth or rectal area
<1% (Limited to important or life-threatening): Dyspnea, eosinophilia, nephrotoxicity, neurotoxicity, ototoxicity (auditory), ototoxicity (vestibular)
Metabolism/Transport Effects
None known.
Drug Interactions
AbobotulinumtoxinA: Aminoglycosides may enhance the neuromuscular-blocking effect of AbobotulinumtoxinA. Risk C: Monitor therapy
Acarbose: Neomycin may enhance the adverse/toxic effect of Acarbose. Neomycin may enhance the therapeutic effect of Acarbose. Neomycin may decrease the metabolism of Acarbose. Risk C: Monitor therapy
Amphotericin B: May enhance the nephrotoxic effect of Aminoglycosides. Risk C: Monitor therapy
BCG: Antibiotics may diminish the therapeutic effect of BCG. Risk X: Avoid combination
Bisphosphonate Derivatives: Aminoglycosides may enhance the hypocalcemic effect of Bisphosphonate Derivatives. Risk C: Monitor therapy
Capreomycin: May enhance the neuromuscular-blocking effect of Aminoglycosides. Risk C: Monitor therapy
CARBOplatin: 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 (2nd Generation): May enhance the nephrotoxic effect of Aminoglycosides. Risk C: Monitor therapy
Cephalosporins (3rd Generation): May enhance the nephrotoxic effect of Aminoglycosides. Risk C: Monitor therapy
Cephalosporins (4th Generation): May enhance the nephrotoxic effect of Aminoglycosides. Risk C: Monitor therapy
CISplatin: May enhance the nephrotoxic effect of Aminoglycosides. Risk C: Monitor therapy
Colistimethate: Aminoglycosides may enhance the nephrotoxic effect of Colistimethate. Aminoglycosides may enhance the neuromuscular-blocking effect of Colistimethate. Risk D: Consider therapy modification
CycloSPORINE: Aminoglycosides may enhance the nephrotoxic effect of CycloSPORINE. Risk C: Monitor therapy
CycloSPORINE (Systemic): Aminoglycosides may enhance the nephrotoxic effect of CycloSPORINE (Systemic). Risk C: Monitor therapy
Gallium Nitrate: Aminoglycosides may enhance the nephrotoxic effect of Gallium Nitrate. Risk X: Avoid combination
Loop Diuretics: May enhance the adverse/toxic effect of Aminoglycosides. Specifically, nephrotoxicity and ototoxicity. Risk C: Monitor therapy
Neuromuscular-Blocking Agents: Aminoglycosides may enhance the respiratory depressant 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
OnabotulinumtoxinA: Aminoglycosides may enhance the neuromuscular-blocking effect of OnabotulinumtoxinA. Risk C: Monitor therapy
Penicillins: May decrease the serum concentration of Aminoglycosides. Primarily associated with extended spectrum penicillins, and patients with renal dysfunction. Exceptions: Amoxicillin; Ampicillin; Cloxacillin; Dicloxacillin; Nafcillin; Oxacillin; Penicillin G (Parenteral/Aqueous); Penicillin G Benzathine; Penicillin G Procaine; Penicillin V Potassium. Risk D: Consider therapy modification
RimabotulinumtoxinB: Aminoglycosides may enhance the neuromuscular-blocking effect of RimabotulinumtoxinB. Risk C: Monitor therapy
SORAfenib: Neomycin may decrease the serum concentration of SORAfenib. Risk C: Monitor therapy
Vancomycin: May enhance the nephrotoxic effect of Aminoglycosides. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Neomycin may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
Mechanism of Action
Interferes with bacterial protein synthesis by binding to 30S ribosomal subunits
Pharmacodynamics/Kinetics
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.
Vd: 0.36 L/kg
Protein binding: 0% to 30%
Metabolism: Slightly hepatic
Half-life elimination (age and renal function dependent): 3 hours
Time to peak, serum: Oral: 1-4 hours
Excretion: Feces (97% of oral dose as unchanged drug); urine (30% to 50% of absorbed drug as unchanged drug)
Dosage
Children: Oral:
Preoperative intestinal antisepsis: 90 mg/kg/day divided every 4 hours for 2 days; or 25 mg/kg at 1 PM, 2 PM, and 11 PM on the day preceding surgery as an adjunct to mechanical cleansing of the intestine and in combination with erythromycin base
Hepatic encephalopathy: 50-100 mg/kg/day in divided doses every 6-8 hours or 2.5-7 g/m2/day divided every 4-6 hours for 5-6 days not to exceed 12 g/day
Adults: Oral:
Preoperative intestinal antisepsis: 1 g each hour for 4 doses then 1 g every 4 hours for 5 doses; or 1 g at 1 PM, 2 PM, and 11 PM on day preceding surgery as an adjunct to mechanical cleansing of the bowel and oral erythromycin; or 6 g/day divided every 4 hours for 2-3 days
Hepatic encephalopathy: 500-2000 mg every 6-8 hours or 4-12 g/day divided every 4-6 hours for 5-6 days
Chronic hepatic insufficiency: 4 g/day for an indefinite period
Monitoring Parameters
Renal function tests, audiometry in symptomatic patients
Patient Education
Oral: Maintain adequate hydration unless instructed to restrict fluid intake. You may experience nausea, vomiting, constipation, or diarrhea. Report immediately any change in hearing; ringing or sense of fullness in ears; persistent diarrhea; changes in voiding patterns; or numbness, tingling, or pain in any extremity.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
None reported
Mental Health: Effects on Psychiatric Treatment
None reported
Nursing: Physical Assessment/Monitoring
Monitor for ototoxicity, nephrotoxicity, and neurotoxicity with oral use. Teach patient appropriate use. Minimal absorption across GI mucosa or skin surfaces; however, with ulceration, open, or burned surfaces (especially large surfaces), absorption is possible.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, oral, as sulfate:
Neo-Fradin™: 125 mg/5 mL (480 mL [DSC]) [contains benzoic acid; cherry flavor]
Tablet, oral, as sulfate: 500 mg
Pricing: U.S. (www.drugstore.com)
Tablets (Neomycin Sulfate)
500 mg (30): $39.99
References
Abramowicz M, “Antimicrobial Prophylaxis in Surgery,” Medical Letter on Drugs and Therapeutics, Handbook of Antimicrobial Therapy, 16th ed, New York, NY: Medical Letter, 2002.
Begg EJ and Barclay ML, “Aminoglycosides - 50 Years On,” Br J Clin Pharmacol, 1995, 39(6):597-603.
Edson RS and Terrell CL, “The Aminoglycosides,” Mayo Clin Proc, 1991, 66(11):1158-64.
Feigin RD and Cherry JD, Textbook of Pediatric Infectious Diseases, 4th ed, Philadelphia, PA: WB Saunders Co, 1997.
International Brand Names
Lexi-Comp.com
Last full review/revision March 2012
Content last modified March 2012
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