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Neomycin Sulfate

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Neomycin Sulfate

Neomycin Sulfate Tablets

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 . 2½ H2SO4 with a molecular weight of 614.67.

Chemically, it is O-2,6-diamino-2,6-dideoxy-a -D- glucopyranosyl(1®3)-O-b-D- ribofuranosyl-(1®5) O-[2,6-diamino-2,6-dideoxy-a-D-glucopyranosyl-(1®4)]-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 (Neo-Fradin, Neo-Tab)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • hearing problems, ringing in your ears, or a feeling of fullness in the ears;
  • spinning sensation, nausea, feeling like you might pass out;
  • loss of balance or coordination, trouble walking;
  • numbness or tingly feeling under your skin;
  • muscle twitching, seizure (convulsions);
  • urinating less than...

Read All Potential Side Effects and See Pictures of Neomycin Sulfate »

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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