(see BOXED WARNINGS)
Additional manifestations of neurotoxicity may include
numbness, skin tingling, muscle twitching, and convulsions.
The risk of hearing loss continues after drug withdrawal.
Aminoglycosides can cause fetal harm when administered to a
Aminoglycoside antibiotics cross the placenta and there have
been several reports of total irreversible bilateral congenital deafness in
children whose mothers received streptomycin during pregnancy. Although serious
side effects to fetus or newborn have not been reported in the treatment of
pregnant women with other aminoglycosides, the potential for harm exists.
Animal reproduction studies of neomycin have not been conducted. If neomycin is
used during pregnancy, or if the patient becomes pregnant while taking this
drug, the patient should be apprised of the potential hazard to the fetus.
Prescribing Neomycin Sulfate Oral Solution in the absence of
a proven or strongly suspected bacterial infection or a prophylactic indication
is unlikely to provide benefit to the patient and increases the risk of the
development of drug-resistant bacteria.
As with other antibiotics, use of oral neomycin may result
in overgrowth of non-susceptible organisms, particularly fungi. If this occurs,
appropriate therapy should be instituted.
Neomycin is quickly and almost totally absorbed from body
surfaces (except the urinary bladder) after local irrigation and when applied
topically in association with surgical procedures. Delayed-onset, irreversible
deafness, renal failure, and death due to neuromuscular blockade (regardless of
the status of renal function) have been reported following irrigation of both small
and large surgical fields with minute quantities of neomycin.
Cross-allergenicity among aminoglycosides has been
Aminoglycosides should be used with caution in patients with
muscular disorders such as myasthenia gravis or parkinsonism since these drugs
may aggravate muscle weakness because of their potential curare-like effect on
the neuromuscular junction.
Small amounts of orally administered neomycin are absorbed
through intact intestinal mucosa.
There have been many reports in the literature of
nephrotoxicity and/or ototoxicity with the oral use of neomycin. If renal
insufficiency develops during oral therapy, consideration should be given to
reducing the drug dosage or discontinuing therapy.
An oral neomycin dose of 12 grams per day produces a
malabsorption syndrome for a variety of substances including fat, nitrogen,
cholesterol, carotene, glucose, xylose, lactose, sodium, calcium,
cyanocobalamin and iron.
Oral administered neomycin increases fecal bile acid
excretion and reduces intestinal lactase activity.
Patients with renal insufficiency may develop toxic neomycin
blood levels unless doses are properly regulated. If renal insufficiency
develops during treatment, the dosage should be reduced or the antibiotic
discontinued. To avoid nephrotoxicity and eighth nerve damage associated with
high doses and prolonged treatment, the following should be performed prior to
and periodically during therapy: urinalysis for increased excretion of protein,
decreased specific gravity, casts and cells; renal function tests such as serum
creatinine, BUN or creatinine clearance; tests of the vestibulocochlearis nerve
(eighth cranial nerve) function.
Serial, vestibular and audiometric tests should be performed
(especially in high risk patients). Since elderly patients may have reduced
renal function which may not be evident in the results of routine screening
tests such as BUN or serum creatinine, a creatinine clearance determination may
be more useful.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed with
neomycin to evaluate carcinogenic or mutagenic potential or impairment of
Pregnancy Category D
( see WARNINGS section)
It is not known whether neomycin is excreted in human milk
but it has been shown to be excreted in cow milk following a single
intramuscular injection. Other aminoglycosides have been shown to be excreted
in human milk. Because of the potential for serious adverse reactions from the
aminoglycosides in nursing infants, a decision should be made whether to
discontinue nursing or to discontinue the drug, taking into account the
importance of the drug to the mother.
The safety and efficacy of oral neomycin in patients less
than eighteen years of age have not been established. If treatment of a patient
less than eighteen years of age is necessary, neomycin should be used with
caution and the period of treatment should not exceed three weeks because of
the absorption from the gastrointestinal tract.