Neomycin Sulfate

DRUG DESCRIPTION

WARNINGS

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 highrisk 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 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 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.

Neomycin Sulfate Tablets, USP, for oral administration, contain neomycin which is an antibiotic obtained from the metabolic products of the actinomycete Streptomyces fradiae. It has the following molecular formula: C23H46N6O . 2? H2SO4 with a molecular weight of 614.67.

Chemically, it is O-2,6-diamino-2,6-dideoxy-a -D- glucopyranosyl(13)-O-b-D- ribofuranosyl-(15) O-[2,6-diamino-2,6-dideoxy-a-D-glucopyranosyl-(14)]-2-deoxy-D-streptamine. Neomycin B is identical except that the a- D- glucopyranosyl residue in the neobiosamine moiety is b-L-idopyranosyl.

Inactive Ingredients: Calcium Stearate, Povidone.

What are the possible side effects of neomycin (Mycifradin, Neo-Fradin, Neo-Tab)?

If you experience any of the following serious side effects, stop taking neomycin and seek emergency medical attention:

  • an allergic reaction (shortness of breath; closing of the throat; hives; swelling of the lips, face, or tongue; rash; or fainting);
  • little or no urine;
  • decreased hearing, ringing in the ears, or a feeling of fullness in the ears;
  • dizziness, clumsiness, or unsteadiness;
  • numbness, skin tingling, muscle twitching, or seizures; or
  • severe...

Read All Potential Side Effects and See Pictures of Neomycin Sulfate


Neomycin Sulfate Patient Information Including Side Effects

Brand Names: Mycifradin, Neo-Fradin, Neo-Tab

Generic Name: neomycin (Pronunciation: nee oh MY sin)

  • What is neomycin (Neomycin Sulfate)?
  • What are the possible side effects of neomycin (Neomycin Sulfate)?
  • What is the most important information I should know about neomycin (Neomycin Sulfate)?
  • What should I discuss with my healthcare provider before taking neomycin (Neomycin Sulfate)?
  • How should I take neomycin (Neomycin Sulfate)?
  • What happens if I miss a dose (Neomycin Sulfate)?
  • What happens if I overdose (Neomycin Sulfate)?
  • What should I avoid while taking neomycin (Neomycin Sulfate)?
  • What other drugs will affect neomycin (Neomycin Sulfate)?
  • Where can I get more information?

What is neomycin (Neomycin Sulfate)?

Neomycin is an antibiotic.

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

Neomycin may also be used for purposes other than those listed here.

What are the possible side effects of neomycin (Neomycin Sulfate)?

If you experience any of the following serious side effects, stop taking neomycin and seek emergency medical attention:

  • an allergic reaction (shortness of breath; closing of the throat; hives; swelling of the lips, face, or tongue; rash; or fainting);
  • little or no urine;
  • decreased hearing, ringing in the ears, or a feeling of fullness in the ears;
  • dizziness, clumsiness, or unsteadiness;
  • numbness, skin tingling, muscle twitching, or seizures; or
  • severe watery diarrhea and abdominal cramps.

Other, less serious side effects may be more likely to occur. Continue to take neomycin and talk to your doctor if you experience

  • nausea or vomiting; or
  • diarrhea.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about neomycin (Neomycin Sulfate)?

Neomycin may cause damage to the kidneys and/or nerves. Kidney function and drug levels in the blood may be monitored with blood tests during treatment. Tell your doctor if you experience decreased urination, hearing loss, ringing in the ears, feeling of fullness in the ears, dizziness, numbness, skin tingling, muscle twitching, or seizures which may be signs of kidney or nerve damage.

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