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Drug overview for NEOMYCIN SULFATE (neomycin sulfate):
Generic name: NEOMYCIN SULFATE (nee-oh-MY-sin)
Drug class: Oral Aminoglycosides
Therapeutic class: Anti-Infective Agents
Neomycin is an aminoglycoside antibiotic.
No enhanced Uses information available for this drug.
Generic name: NEOMYCIN SULFATE (nee-oh-MY-sin)
Drug class: Oral Aminoglycosides
Therapeutic class: Anti-Infective Agents
Neomycin is an aminoglycoside antibiotic.
No enhanced Uses information available for this drug.
DRUG IMAGES
- NEOMYCIN 500 MG TABLET
The following indications for NEOMYCIN SULFATE (neomycin sulfate) have been approved by the FDA:
Indications:
Hepatic coma
Hepatic encephalopathy
Preoperative bowel preparation
Professional Synonyms:
Portal systemic encephalopathy
Indications:
Hepatic coma
Hepatic encephalopathy
Preoperative bowel preparation
Professional Synonyms:
Portal systemic encephalopathy
The following dosing information is available for NEOMYCIN SULFATE (neomycin sulfate):
Potency of neomycin sulfate has been expressed both in terms of the base and the salt, but generally is expressed in terms of the sulfate.
To minimize the risk of toxicity, the lowest possible dosage and shortest duration of therapy that is effective should be used. A treatment duration longer than 2 weeks is not recommended. If treatment is prolonged, serum neomycin concentrations should be monitored to avoid potentially toxic concentrations and the benefits of the drug to the patient should be weighed against the risks of nephrotoxicity, permanent ototoxicity, and neuromuscular blockade.
Safety and efficacy of oral neomycin in children younger than 18 years of age+ have not been established. The manufacturers state that if use of neomycin is considered necessary in this age group, the drug should be used with caution and the duration of therapy should not exceed 3 weeks.
The American Academy of Pediatrics (AAP) states that neonates up to 1 month of age+ may receive oral neomycin in a dosage of 25 mg/kg every 6 hours and children older than 1 month of age+ may receive 100 mg/kg daily given in 4 equally divided doses.
Dosage of neomycin sulfate should be reduced or the drug discontinued in patients with renal impairment. Some clinicians recommend the neomycin doses be given every 6 hours in patients with glomerular filtration rates (GFRs) greater than 50 mL/minute, every 12-18 hours in those with GFRs 10-50 mL/minute, and every 18-24 hours in those with GFRs less than 10 mL/minute.
To minimize the risk of toxicity, the lowest possible dosage and shortest duration of therapy that is effective should be used. A treatment duration longer than 2 weeks is not recommended. If treatment is prolonged, serum neomycin concentrations should be monitored to avoid potentially toxic concentrations and the benefits of the drug to the patient should be weighed against the risks of nephrotoxicity, permanent ototoxicity, and neuromuscular blockade.
Safety and efficacy of oral neomycin in children younger than 18 years of age+ have not been established. The manufacturers state that if use of neomycin is considered necessary in this age group, the drug should be used with caution and the duration of therapy should not exceed 3 weeks.
The American Academy of Pediatrics (AAP) states that neonates up to 1 month of age+ may receive oral neomycin in a dosage of 25 mg/kg every 6 hours and children older than 1 month of age+ may receive 100 mg/kg daily given in 4 equally divided doses.
Dosage of neomycin sulfate should be reduced or the drug discontinued in patients with renal impairment. Some clinicians recommend the neomycin doses be given every 6 hours in patients with glomerular filtration rates (GFRs) greater than 50 mL/minute, every 12-18 hours in those with GFRs 10-50 mL/minute, and every 18-24 hours in those with GFRs less than 10 mL/minute.
Neomycin sulfate is administered orally.
No dosing information available.
DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
---|---|---|
NEOMYCIN 500 MG TABLET | Maintenance | Adults take 4 tablets (2,000 mg) by oral route 2 times per day |
The following drug interaction information is available for NEOMYCIN SULFATE (neomycin sulfate):
There are 2 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
Drug Interaction | Drug Names |
---|---|
Live Typhoid Vaccine/Antimicrobials SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: The antimicrobial may be active against the organism in the live-vaccine. Antimicrobial therapy may prevent the vaccine organism from replicating enough to trigger an immune response.(1) CLINICAL EFFECTS: Vaccination may be ineffective. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Do not give oral typhoid vaccine until 72 hours after the last dose of antimicrobial. If possible, to optimize vaccine effectiveness, do not start antibacterial drugs for 72 hours after the last dose of oral typhoid vaccine. A longer interval should be considered for long-acting antimicrobials, such as azithromycin.(3) DISCUSSION: Because antimicrobial therapy may prevent sufficient vaccine-organism replication to generate an immune response, the manufacturer of live-attenuated typhoid vaccine and the Centers for Disease Control (CDC) state that the vaccine should not be administered to patients receiving antimicrobial therapy.(1-3) |
VIVOTIF |
Selected Nephrotoxic Agents/Bacitracin SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Bacitracin may cause renal failure due to glomerular and tubular necrosis. Concurrent administration of other nephrotoxic agents may result in additive renal toxicity.(1-3) CLINICAL EFFECTS: Concurrent use of bacitracin with other potentially nephrotoxic agents may result in renal toxicity.(1-3) PREDISPOSING FACTORS: Dehydration and high-dose bacitracin may predispose to adverse renal effects.(1) PATIENT MANAGEMENT: Health Canada states that bacitracin is contraindicated in patients with renal impairment, including those taking other nephrotoxic drugs.(1) The Canadian and US manufacturers of bacitracin state that concomitant use of bacitracin with other potentially nephrotoxic agents should be avoided.(2,3) DISCUSSION: Renal impairment is a major toxicity of bacitracin. Cases of nephrotoxicity have been reported when bacitracin was used off-label.(1-3) |
BACITRACIN, BACITRACIN MICRONIZED, BACITRACIN ZINC |
There are 4 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
Drug Interaction | Drug Names |
---|---|
Misc Antibiotics/Neuromuscular Blocking Agents SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Aminoglycosides, bacitracin, clindamycin, lincomycin, and polymyxins may enhance the pharmacologic effects of neuromuscular blocking agents. CLINICAL EFFECTS: May see an increase in the pharmacologic effects of neuromuscular blocking agents, including prolonged respiratory depression and apnea. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: If it is necessary to administer these drugs concurrently, do so with extreme caution. Monitor neuromuscular function and adjust the dose of the neuromuscular blocking agent accordingly. DISCUSSION: Concomitant administration of aminoglycosides, bacitracin, clindamycin, lincomycin, and polymixins with neuromuscular blocking agents has been shown to produce synergism of the effects on skeletal muscles. Concurrent administration of these drugs has been associated with prolonged respiratory depression, respiratory paralysis, and fatal apnea. The interaction usually occurs when the antibiotic is given prior to or concurrently with the neuromuscular blocking drug, but it may also occur when given after administration. Any antibiotic dosage or route of administration may produce respiratory depression. |
ANECTINE, ATRACURIUM BESYLATE, BOTOX, BOTOX COSMETIC, CISATRACURIUM BESYLATE, DAXXIFY, DYSPORT, JEUVEAU, MYOBLOC, NIMBEX, QUELICIN, ROCURONIUM BROMIDE, SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE-NACL, VECURONIUM BROMIDE, VECURONIUM BROMIDE-WATER, XEOMIN |
Anesthetics/Aminoglycosides SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The neuromuscular blocking activity of aminoglycosides results from a decreased sensitivity at the postjunctional membrane and interfere with transmitter release.(1) These actions produce a synergistic effect with anesthetic agents that produce neuromuscular blockade.(2,3) Some anesthetics cause renal failure due to release of fluoride ion. Aminoglycosides cause nephrotoxicity when high doses are given.(4,5) CLINICAL EFFECTS: Increased neuromuscular blockade activity, profound sedation, respiratory depression, coma, and/or death. Circulatory collapse may also occur secondary to the neuromuscular blockade.(6-10) Decreased urinary output and increased BUN and serum creatinine may indicate renal impairment. PREDISPOSING FACTORS: Patients in respiratory distress, history of renal impairment and high doses of aminoglycosides and anesthetics. PATIENT MANAGEMENT: Monitor neuromuscular blockade with train-of-four stimulus. Monitor vital signs, and respiratory rate. Intravenous neostigmine (0.2 to 2.5 mg), calcium (1 G), and possibly sodium bicarbonate (dose not reported) may be beneficial in reversal of neuromuscular blockade and respiratory depression.(6-10) Supportive care and ventilation should be utilized until the neuromuscular blockade is resolved. Volume replacement may be necessary for circulatory collapse.(6-10) Monitor BUN, serum creatinine, and urinary output and adjust aminoglycoside and anesthetic doses according to renal function. DISCUSSION: Aminoglycosides including kanamycin(6,11), streptomycin(6,13), amikacin(13), gentamicin(7,13-15), neomycin, and tobramycin(13) have been documented to have neuromuscular blocking activity. There is no documentation with netilmicin and paromomycin, though it is assumed that they produce the same effects as the other members of this class. Neomycin has been shown to interact with cyclopropane(8,9), halothane(6), methoxyflurane(6), and nitrous oxide(6). Enflurane, ethylene, and isoflurane share similar properties to the previous inhalation anesthetics and would likely interact with neomycin. Kanamycin(6,11) and streptomycin (6,12) are known to interact with ether. Gentamicin has been reported to potentiate atracurium.(16) Therefore it is hypothesized that all aminoglycosides interact with the inhaled anesthetics. One study evaluating gentamicin and halothane in animals did not exhibit a decrease in muscle strength.(17) Aminoglycosides have been proven to be nephrotoxic at high doses. Anesthetics containing fluoride also produce renal dysfunction. Nephrotoxicity occurred more often when gentamicin or tobramycin were given with enflurane than when enflurane was given alone or in patients who received nitrous oxide and opioid anesthesia.(4) |
DESFLURANE, FORANE, ISOFLURANE, SUPRANE, TERRELL |
Sorafenib/Neomycin SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Sorafenib is partially glucuronidated in the liver, and its conjugates may be cleaved by bacterial glucuronidases, allowing it to be reabsorbed systemically. Neomycin may disrupt the intestinal flora and decrease the enterohepatic recycling of sorafenib.(1) CLINICAL EFFECTS: Neomycin may reduce the plasma concentrations of sorafenib and decrease its antitumor activity.(1,2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of sorafenib states that concomitant use of neomycin should be avoided.(2) DISCUSSION: In a study of healthy subjects, neomycin (1 gram three times daily for 5 days) decreased the area-under-curve (AUC) of single-dose sorafenib (400 mg) by 54%.(1,2) |
NEXAVAR, SORAFENIB |
Fecal Microbiota Spores/Antibiotics SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Fecal microbiota spores is a suspension of live bacterial spores, which may be compromised by concurrent use of antibiotics.(1) CLINICAL EFFECTS: Antibiotics may decrease the effectiveness of fecal microbiota spores.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Antibiotics should not be used concurrently with fecal microbiota spores. Antibacterial treatment should be completed for 2 to 4 days before initiating treatment with fecal microbiota spores.(1) DISCUSSION: Antibiotics may compromise the effectiveness of fecal microbiota spores. |
VOWST |
There are 3 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
Drug Interaction | Drug Names |
---|---|
Digoxin, Oral/Aminoglycosides, Oral SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Aminoglycosides appears to inhibit gastrointestinal absorption of digoxin but the precise mechanism is unknown. CLINICAL EFFECTS: Therapeutic effects of digoxin may be decreased. However, in a minority of patients (10%) gut flora inactivates digoxin. In these patients, due to an aminoglycoside-induced reduction in GI bacteria, serum digoxin concentrations may be increased. Symptoms of digoxin toxicity can include anorexia, nausea, vomiting, headache, fatigue, malaise, drowsiness, generalized muscle weakness, disorientation, hallucinations, visual disturbances, and arrhythmias. PREDISPOSING FACTORS: None Determined. PATIENT MANAGEMENT: If both drugs are administered, monitor serum digoxin levels when initiating, discontinuing or changing the dose of the aminoglycoside. Measure serum digoxin concentrations before initiating gentamicin. Reduce digoxin concentrations by decreasing dose by approximately 30-50% or by modifying the dosing frequency and continue monitoring. (3) DISCUSSION: Separating the administration times of digoxin and the aminoglycoside is not likely to prevent this interaction. Digoxin levels were found to be decreased when neomycin was taken 3 or 6 hours before digoxin. Additionally, serum digoxin concentrations may increase when the aminoglycoside is stopped. Concomitant administration of gentamicin and digoxin caused an increase in digoxin serum concentration of 129-212%. (3) |
DIGITEK, DIGOXIN, DIGOXIN MICRONIZED, LANOXIN |
Aminoglycosides/Loop Diuretics SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The coadministration of aminoglycosides and loop diuretics may result in additive or synergistic ototoxicity and/or nephrotoxicity. CLINICAL EFFECTS: The combination of an aminoglycoside and a loop diuretic may increase risk for serious nephrotoxicity or ototoxicity.(1,2) Vestibular or auditory ototoxicity may be permanent.(1,3) PREDISPOSING FACTORS: Preexisting renal impairment, extended duration of aminoglycoside therapy, greater than one aminoglycoside dose per day, rapid injection or high doses of loop diuretics, concomitant use of additional nephrotoxic agents such as iodinated contrast media or vancomycin, or sepsis appear to increase the risk for nephrotoxicity and ototoxicity.(1-6). Patients carrying certain variants in the MT-RNR1 gene (m.1555A>G, m.1095T>C, and m.1494C>T) are at increased risk of developing ototoxicity. An additional risk factor includes patients with a maternal relative known to have a clinically relevant MT-RNR1 variant. The risk of ototoxicity can occur at standard recommended doses of aminoglycosides.(7) PATIENT MANAGEMENT: Administer aminoglycoside dosage every 24 to > 48 hours based upon renal function and continue therapy for less than 4 to 7 days, whenever possible.(4,5) The recommended maximal infusion rate for high dose furosemide therapy is 4 mg/minute.(2) When concurrent therapy is necessary monitor renal, hearing, and vestibular function. Signs of vestibular dysfunction include loss of balance and/or the visual sensation that stationary objects are moving (oscillopsia). In hospitalized or bedbound patients these symptoms may not be noticed or may be ascribed to other etiologies.(3) DISCUSSION: Several studies and case reports have documented altered aminoglycoside levels, nephrotoxicity, and ototoxicity with concurrent therapy.(8-14) Otic aminoglycosides are included in this interaction because high aminoglycoside concentrations in the ear have been associated with an increased risk for hearing loss. |
BUMETANIDE, EDECRIN, ETHACRYNATE SODIUM, ETHACRYNIC ACID, FUROSCIX, FUROSEMIDE, FUROSEMIDE-0.9% NACL, LASIX, SOAANZ, TORSEMIDE |
Selected Nephrotoxic Agents/Cisplatin SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The nephrotoxic effects of aminoglycosides or non-steroidal anti-inflammatory drugs (NSAIDs) may be additive to those of cisplatin. CLINICAL EFFECTS: The concurrent administration of amikacin, gentamicin, tobramycin, or NSAIDs with cisplatin may result in additive nephrotoxic effects.(1,2,5,6) PREDISPOSING FACTORS: Pre-existing renal insufficiency, advanced age, dehydration may increase the risk of nephrotoxicity.(1,5,6) PATIENT MANAGEMENT: The US labeling for aminoglycosides and cisplatin states that the concurrent use of aminoglycosides and cisplatin should be avoided.(1,3,4,6) Inform patients that concurrent cisplatin and aminoglycosides or NSAIDs can cause nephrotoxicity and that renal function and electrolyte monitoring during treatment is necessary.(2) DISCUSSION: The US manufacturers of amikacin, gentamicin and tobramycin state that since the nephrotoxic effects of these medications may be additive, avoid concurrent or sequential use of other neurotoxic and/or nephrotoxic agents including cisplatin.(1,3,6) |
CISPLATIN, KEMOPLAT |
The following contraindication information is available for NEOMYCIN SULFATE (neomycin sulfate):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 4 contraindications.
Absolute contraindication.
Contraindication List |
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Crohn's disease |
Gastrointestinal obstruction |
Gastrointestinal ulcer |
Ulcerative colitis |
There are 6 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
Severe List |
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Auditory neurotoxicity |
Disorder of the vestibulocochlear nerve |
Hypovolemia |
Kidney disease with reduction in glomerular filtration rate (GFr) |
Myasthenia gravis |
Pregnancy |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
Moderate List |
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Parkinsonism |
The following adverse reaction information is available for NEOMYCIN SULFATE (neomycin sulfate):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 6 severe adverse reactions.
More Frequent | Less Frequent |
---|---|
None. | None. |
Rare/Very Rare |
---|
Allergic dermatitis Malabsorption states Nephrotoxicity Neuromuscular blockade Ototoxicity Skin rash |
There are 6 less severe adverse reactions.
More Frequent | Less Frequent |
---|---|
Diarrhea Mouth irritation Nausea Rectal irritation Rectal pain Vomiting |
None. |
Rare/Very Rare |
---|
None. |
The following precautions are available for NEOMYCIN SULFATE (neomycin sulfate):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
None |
Severe Precaution
None |
Management or Monitoring Precaution
None |
No enhanced Pregnancy information available for this drug.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for NEOMYCIN SULFATE (neomycin sulfate):
WARNING: This medication can rarely cause serious kidney problems and nerve damage, resulting in permanent hearing loss (including deafness or decreased hearing) and balance problems. These serious side effects may occur even in people without kidney problems and taking usual doses. Hearing problems may occur long after neomycin has been stopped.
The risk is increased if you are older, already have kidney disease, or if you have a severe loss of body water (dehydration). Your risk is also increased if you receive high doses, or with longer use of this medication. Careful monitoring by your doctor (which may include hearing, kidney, and urine tests) will reduce the risk of these side effects.
Avoid other medications that may increase your risk for these serious side effects if taken together with neomycin (See also Drug Interactions section). Tell your doctor right away if you notice any signs of these serious side effects, including: ringing/roaring sounds in the ears, hearing loss, dizziness, or an unusual decrease in the amount of your urine. Severe muscle and breathing problems may also rarely occur.
WARNING: This medication can rarely cause serious kidney problems and nerve damage, resulting in permanent hearing loss (including deafness or decreased hearing) and balance problems. These serious side effects may occur even in people without kidney problems and taking usual doses. Hearing problems may occur long after neomycin has been stopped.
The risk is increased if you are older, already have kidney disease, or if you have a severe loss of body water (dehydration). Your risk is also increased if you receive high doses, or with longer use of this medication. Careful monitoring by your doctor (which may include hearing, kidney, and urine tests) will reduce the risk of these side effects.
Avoid other medications that may increase your risk for these serious side effects if taken together with neomycin (See also Drug Interactions section). Tell your doctor right away if you notice any signs of these serious side effects, including: ringing/roaring sounds in the ears, hearing loss, dizziness, or an unusual decrease in the amount of your urine. Severe muscle and breathing problems may also rarely occur.
The following icd codes are available for NEOMYCIN SULFATE (neomycin sulfate)'s list of indications:
Hepatic coma | |
B15.0 | Hepatitis A with hepatic coma |
B16.0 | Acute hepatitis B with delta-agent with hepatic coma |
B16.2 | Acute hepatitis B without delta-agent with hepatic coma |
B17.11 | Acute hepatitis C with hepatic coma |
B19.0 | Unspecified viral hepatitis with hepatic coma |
B19.11 | Unspecified viral hepatitis B with hepatic coma |
B19.21 | Unspecified viral hepatitis C with hepatic coma |
K70.41 | Alcoholic hepatic failure with coma |
K71.11 | Toxic liver disease with hepatic necrosis, with coma |
K72.01 | Acute and subacute hepatic failure with coma |
K72.11 | Chronic hepatic failure with coma |
K72.91 | Hepatic failure, unspecified with coma |
K76.82 | Hepatic encephalopathy |
Hepatic encephalopathy | |
B15.0 | Hepatitis A with hepatic coma |
B16.0 | Acute hepatitis B with delta-agent with hepatic coma |
B16.2 | Acute hepatitis B without delta-agent with hepatic coma |
B17.11 | Acute hepatitis C with hepatic coma |
B19.0 | Unspecified viral hepatitis with hepatic coma |
B19.11 | Unspecified viral hepatitis B with hepatic coma |
B19.21 | Unspecified viral hepatitis C with hepatic coma |
K70.41 | Alcoholic hepatic failure with coma |
K71.11 | Toxic liver disease with hepatic necrosis, with coma |
K72.01 | Acute and subacute hepatic failure with coma |
K72.11 | Chronic hepatic failure with coma |
K72.90 | Hepatic failure, unspecified without coma |
K72.91 | Hepatic failure, unspecified with coma |
K76.82 | Hepatic encephalopathy |
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