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Neo-Fradin

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Neo-Fradin

Neo-Fradin
(neomycin sulfate) Oral Solution, USP

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.

Neo-Fradin

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.

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.

DRUG DESCRIPTION

NEO-FRADIN Oral Solution for oral administration contains neomycin which is an antibiotic obtained from the metabolic products of the actinomycete Streptomyces fradiae. The pH range is 5.0 to 7.5. NEO-FRADIN Oral Solution is a clear orange solution with a cherry flavor. Each 5 mL of NEO-FRADIN Oral Solution contains 125 mg of neomycin sulfate (equivalent to 87.5 mg of neomycin).

Inactive ingredients: benzoic acid, FD&C yellow no. 6, cherry flavor, glycerin, methylparaben, proplyparaben, sodium phosphate dibasic heptahydrate, sulfuric acid, diatomaceous earth, and purified water.

Sodium phosphate dibasic heptahydrate and sulfuric acid are used as pH adjusters.

The chemical name for Neomycin is: 0-2, 6-diamino-2, 6-dideoxy-α-Dlucopyranosyl-(1→3)- 0β-D-ribofuranosyl-(1→5)0-[2, 6-diamino-2, 6-dideoxyα-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-idopyranosly.

The molecular weight of Neomycin is 614.67. The structural formula is represented below:

Neo-Fradin (Neomycin sulfate) Structural Formula Illustration

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 watery diarrhea and abdominal cramps.

Other, less serious...

Read All Potential Side Effects and See Pictures of Neo-Fradin »

Last reviewed on RxList: 9/4/2012
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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