NEOMYCIN SULFATE- neomycin sulfate tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Breckenridge Pharmaceutical, Inc.

Designació comuna internacional (DCI):

NEOMYCIN SULFATE

Composición:

NEOMYCIN 350 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Suppression of Intestinal Bacteria:   Neomycin Sulfate Tablets are indicated as adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel, e.g., preoperative preparation of the bowel. It is given concomitantly with erythromycin enteric-coated base (see DOSAGE AND ADMINISTRATION Section). Hepatic Coma (Portal-Systemic Encephalopathy):   Neomycin Sulfate has been shown to be effective adjunctive therapy in hepati

Resumen del producto:

Neomycin Sulfate Tablets USP, 500 mg (equivalent in activity to 350 mg of neomycin base per tablet) are available as round, off-white, unscored tablets, debossed "ZYNOVA" and "01", in bottles of 100 tablets (NDC-51991-738-01). Store at controlled room temperature between 20º and 25ºC (68º and 77ºF) (see USP). Dispense in tight containers as defined in the USP/NF. Address medical inquiries to Breckenridge Pharmaceutical: [phone]

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

NEOMYCIN SULFATE- NEOMYCIN SULFATE TABLET
BRECKENRIDGE PHARMACEUTICAL, INC.
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NEOMYCIN SULFATE TABLETS USP, 500 MG
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. NEUOROTOXICITY (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 BILATREAL 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 phe