Neo-Fradin

You should not take this medicine if you are allergic to neomycin or similar antibiotics such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).

You should not take neomycin if you have ulcerative colitis, Crohn's disease, a blockage in your intestines, or other inflammatory bowel disease.

To make sure you can safely take neomycin, tell your doctor if you have any of these other conditions:

• kidney disease;
• myasthenia gravis; or
• Parkinson's disease.

FDA pregnancy category D. Do not use neomycin if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether neomycin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using neomycin.

If you are being treated for hepatic coma, avoid eating foods that are high in protein. Follow your doctor's instructions about any other restrictions on food, beverages, or activity.

The most common adverse reactions to oral neomycin 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 ( see BOXED WARNINGS AND PRECAUTIONS section).

Read the entire FDA prescribing information for Neo-Fradin (Neomycin Sulfate)

Neomycin is an antibiotic that fights bacteria in the body.

Neomycin is used to reduce the risk of infection during surgery of your intestines. Neomycin is also used to reduce the symptoms of hepatic coma.

Neomycin may also be used for purposes not listed in this medication guide.

You should not take this medicine if you are allergic to neomycin or similar antibiotics such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).

You should not take neomycin if you have ulcerative colitis, Crohn's disease, a blockage in your intestines, or other inflammatory bowel disease.

To make sure you can safely take neomycin, tell your doctor if you have any of these other conditions:

• kidney disease;

• myasthenia gravis; or

• Parkinson's disease.

FDA pregnancy category D. Do not use neomycin if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether neomycin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using neomycin.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Any loss of hearing
• clumsiness
• diarrhea
• difficulty in breathing
• dizziness
• drowsiness
• greatly decreased frequency of urination or amount of urine
• increased amount of gas
• increased thirst
• light-colored, frothy, fatty-appearing stools
• ringing or buzzing or a feeling of fullness in the ears
• skin rash
• unsteadiness
• weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Irritation or soreness of the mouth or rectal area
• nausea or vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Neomycin Sulfate Oral Solution and other antibacterial drugs, Neomycin Sulfate Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

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.

Neuromuscular blockage and respiratory paralysis have been reported following the oral use of neomycin. The possibility of the occurrence of neuro-muscular blockage and respiratory paralysis should be considered if neomycin is administered, especially to patients receiving anesthetics, neuro-muscular blocking agents such as tubocurarine, succinylcholine, decamethonium, or in patients receiving massive transfusions of citrate anticoagulated blood. If blockage occurs, calcium salts may reverse these phenomena but mechanical respiratory assistance may be necessary.

Concurrent and/or sequential systemic, oral, or topical use of other aminoglycosides including paromomycin and other potentially nephrotoxic and/or neurotoxic drugs such as bacitracin, cisplatin, vancomycin, amphotericin B, polymyxin B, colistin, and viomycin should be avoided because the toxicity may be additive.

Other factors which increase the risk of toxicity are advanced age and dehydration.

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, diuretics may enhance neomycin toxicity by altering the antibiotic concentration in serum and tissue.

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:

1. Withdraw protein from diet. Avoid use of diuretic agents.

2. Give supportive therapy including blood products, as indicated.

3. Give Neo-Fradin Oral Solution in doses of four to twelve grams of neomycin sulfate per day 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.

4. If less potentially toxic drugs cannot be used for chronic hepatic insufficiency, neomycin sulfate in doses of up to four grams daily may be necessary. The risks for the development of neomycin induced toxicity progressively increase when the 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 (see PRECAUTIONS). 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.

There are no data on the excretion of neomycin into human milk. Other aminoglycosides are excreted into human milk. The manufacturer recommends that due to the potential for adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Neomycin was excreted into cow milk after intramuscular injection.