Neomycin (oral)
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]
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Black Box Warning
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WARNINGS
See full prescribing information for complete Boxed Warning.
*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 their use. 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 NORMAL RENAL FUNCTION WHEN TREATED WITH HIGHER DOSES OF NEOMYCIN AND/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.
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Overview
Neomycin (oral) is an aminoglycoside that is FDA approved for the treatment of hepatic Coma and suppression of intestinal bacteria. There is a Black Box Warning for this drug as shown here. Common adverse reactions include nausea, vomiting, diarrhea, nephrotoxicity, ototoxicity and neuromuscular blockage.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
- To reduce the development of drug-resistant bacteria and maintain the effectiveness of neomycin sulfate tablets and other antibacterial drugs, neomycin sulfate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Suppression of Intestinal Bacteria
- Neomycin sulfate tablets are indicated as adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel, e.g., preoperative preparation of the bowel. It is given concomitantly with erythromycin enteric-coated base.
Hepatic Coma (Portal-Systemic Encephalopathy)
- Neomycin sulfate has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia-forming bacteria in the intestinal tract. The subsequent reduction in blood ammonia has resulted in neurologic improvement.
Dosage
- To minimize the risk of toxicity, use the lowest possible dose and the shortest possible treatment period to control the condition. Treatment for periods longer than two weeks is not recommended.
Hepatic Coma
- For use as an adjunct in the management of hepatic coma, the recommended dose is 4 to 12 grams per day given in the following regimen:
- Withdraw protein from diet. Avoid use of diuretic agents.
- Give supportive therapy, including blood products, as indicated.
- Give neomycin sulfate tablets in doses of 4 to 12 grams of neomycin sulfate per day (eight to 24 tablets) in divided doses. Treatment should be continued over a period of five to six days, during which time protein should be returned incrementally to the diet.
- If less potentially toxic drugs cannot be used for chronic hepatic insufficiency, neomycin in doses of up to four grams daily (eight tablets per day) may be necessary. The risk for the development of neomycin-induced toxicity progressively increases when treatment must be extended to preserve the life of a patient with hepatic encephalopathy who has failed to fully respond. Frequent periodic monitoring of these patients to ascertain the presence of drug toxicity is mandatory. Also, neomycin serum concentrations should be monitored to avoid potentially toxic levels. The benefits to the patient should be weighed against the risks of nephrotoxicity, permanent ototoxicity and neuromuscular blockade following the accumulation of neomycin in the tissues.
Preoperative Prophylaxis for Elective Colorectal Surgery
- Listed below is an example of a recommended bowel preparation regimen. A proposed surgery time of 8:00 a.m. has been used.
- Pre-op Day 3: Minimum residue or clear liquid diet. Bisacodyl, 1 tablet orally at 6:00 p.m.
- Pre-op Day 2: Minimum residue or clear liquid diet. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., 2:00 p.m., and 6:00 p.m. Enema at 7:00 p.m. and 8:00 p.m.
- Pre-op Day 1: Clear liquid diet. Supplemental (IV) fluids as needed. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., and 2:00 p.m. Neomycin sulfate (1 g) and erythromycin base (1 g) orally at 1:00 p.m., 2:00 p.m. and 11:00 p.m. No enema.
- Day of Operation: Patient evacuates rectum at 6:30 a.m. for scheduled operation at 8:00 a.m.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Neomycin (oral) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Neomycin (oral) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Neomycin (oral) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Neomycin (oral) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Neomycin (oral) in pediatric patients.
Contraindications
- Neomycin sulfate oral preparations are contraindicated in the presence of intestinal obstruction and in individuals with a history of hypersensitivity to the drug.
- Patients with a history of hypersensitivity or serious toxic reaction to other aminoglycosides may have a cross-sensitivity to neomycin.
- Neomycin sulfate oral preparations are contraindicated in patients with inflammatory or ulcerative gastrointestinal disease because of the potential for enhanced gastrointestinal absorption of neomycin.
Warnings
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WARNINGS
See full prescribing information for complete Boxed Warning.
*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 their use. 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 NORMAL RENAL FUNCTION WHEN TREATED WITH HIGHER DOSES OF NEOMYCIN AND/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.
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- Additional manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions.
- The risk of hearing loss continues after drug withdrawal.
- Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycoside antibiotics cross the placenta and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Although serious side effects to fetus or newborn have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. Animal reproduction studies of neomycin have not been conducted. If neomycin is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Adverse Reactions
Clinical Trials Experience
- The most common adverse reactions to oral neomycin sulfate are nausea, vomiting and diarrhea. The “Malabsorption Syndrome” characterized by increased fecal fat, decreased serum carotene and fall in xylose absorption has been reported with prolonged therapy. Nephrotoxicity, ototoxicity and neuromuscular blockage have been reported
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Neomycin (oral) in the drug label.
Drug Interactions
- Caution should be taken in concurrent or serial use of other neurotoxic and/or nephrotoxic drugs because of possible enhancement of the nephrotoxicity and/or ototoxicity of neomycin.
- Caution should also be taken in concurrent or serial use of other amino-glycosides and polymyxins because they may enhance neomycin’s nephrotoxicity and/or ototoxicity and potentiate neomycin sulfate’s neuromuscular blocking effects.
- Oral neomycin inhibits the gastrointestinal absorption of penicillin V, oral vitamin B-12, methotrexate and 5-fluorouracil. The gastrointestinal absorption of digoxin also appears to be inhibited. Therefore, digoxin serum levels should be monitored.
Oral neomycin sulfate may enhance the effect of coumarin in anticoagulants by decreasing vitamin K availability.
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Neomycin (oral) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Neomycin (oral) during labor and delivery.
Nursing Mothers
- It is not known whether neomycin is excreted in human milk, but it has been shown to be excreted in cow milk following a single intramuscular injection. Other aminoglycosides have been shown to be excreted in human milk. Because of the potential for serious adverse reactions from the aminoglycosides in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
- The safety and efficacy of oral neomycin sulfate in patients less than 18 years of age have not been established. If treatment of a patient less than 18 years of age is necessary, neomycin should be used with caution and the period of treatment should not exceed two weeks because of absorption from the gastrointestinal tract.
Geriatic Use
There is no FDA guidance on the use of Neomycin (oral) with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Neomycin (oral) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Neomycin (oral) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Neomycin (oral) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Neomycin (oral) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Neomycin (oral) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Neomycin (oral) in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
Monitoring
There is limited information regarding Monitoring of Neomycin (oral) in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Neomycin (oral) in the drug label.
Overdosage
- Because of low absorption, it is unlikely that acute overdosage would occur with oral neomycin sulfate. However, prolonged administration could result in sufficient systemic drug levels to produce neurotoxicity, ototoxicity and/or nephrotoxicity.
- Hemodialysis will remove neomycin sulfate from the blood.
Pharmacology
Mechanism of Action
There is limited information regarding Neomycin (oral) Mechanism of Action in the drug label.
Structure
- Neomycin sulfate tablets USP, for oral administration, contain neomycin which is an antibiotic obtained from the metabolic products of the actinomycete Streptomyces fradiae. Structurally, neomycin sulfate may be represented as follows:
- Chemically, it is O-2,6-diamino-2,6-dideoxy-α-D-glucopyranosyl-(1→3)-O-β-D-ribofuranosyl-(1→5)-O-[2,6-diamino-2,6-dideoxy-α-D-glucopyranosyl-(1→4)]-2-deoxy-D-streptamine. Neomycin B is identical except that the α-D-glucopyranosyl residue in the neobiosamine moiety is β-L-idopyranosyl. Each tablet contains 500 mg neomycin sulfate (equivalent to 350 mg neomycin base).
- Inactive Ingredients: calcium stearate, povidone, and sodium starch glycolate.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Neomycin (oral) in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Neomycin (oral) in the drug label.
Nonclinical Toxicology
- No long-term animal studies have been performed with neomycin sulfate to evaluate carcinogenic or mutagenic potential or impairment of fertility.
Clinical Studies
There is limited information regarding Clinical Studies of Neomycin (oral) in the drug label.
How Supplied
- Neomycin sulfate tablets USP, 500 mg (equivalent to 350 mg of neomycin base per tablet) are available as round, off-white, unscored tablets, debossed “93” and “1177”, in bottles of 100 tablets.
Storage
- Store at 20° to 25°C (68° to 77°F)
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
- Patients should be counseled that antibacterial drugs including neomycin sulfate tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When neomycin sulfate tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by neomycin sulfate tablets or other antibacterial drugs in the future.
- Before administering the drug, patients or members of their families should be informed of possible toxic effects on the eighth nerve. The possibility of acute toxicity increases in premature infants and neonates.
Precautions with Alcohol
- Alcohol-Neomycin (oral) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- NEOMYCIN SULFATE®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ "neomycin sulfate tablet".
- ↑ "http://www.ismp.org". External link in
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