NEOMYCIN SULFATE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)

Verfügbar ab:

Major Pharmaceuticals

INN (Internationale Bezeichnung):

NEOMYCIN SULFATE

Zusammensetzung:

NEOMYCIN SULFATE 500 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

NEOMYCIN SULFATE- NEOMYCIN SULFATE TABLET
MAJOR PHARMACEUTICALS
----------
NEOMYCIN SULFATE TABLETS USP, 500 MG
1177
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Neomycin
Sulfate Tablets USP and other antibacterial drugs, Neomycin Sulfate
Tablets USP should be used only
to treat or prevent infections that are proven or strongly suspected
to be caused by bacteria.
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 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 b