(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.
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
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.
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
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,
Neomycin B is identical except that the
-α-D-glucopyranosyl residue in the neobiosamine moiety is
The molecular weight of Neomycin is 614.67. The structural formula
is represented below:
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.