NEOMYCIN SULFATE tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Hi-Tech Pharmacal Co. Inc.

INN (nume internaţional):

NEOMYCIN SULFATE

Compoziție:

NEOMYCIN SULFATE 500 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of neomycin sulfate tablets and other antibacterial drugs, neomycin sulfate tablets 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 epidimiology 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, eg, 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 hepatic com

Rezumat produs:

Neomycin Sulfate Tablets, USP, 500 mg (equivalent to 350 mg of neomycin base per tablet) are available as round, off-white, unscored tablets, debossed "500" and "PT".  Supplied as: NDC 50383-565-10 for 100 tablets/bottle. Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]. Manufactured for: X-Gen Pharmaceuticals, Inc. Big Flats, NY 14814 Distributed by: Hi-Tech Pharmacal Co. Inc. Amityville, NY 11701 Revised October, 2009 REV. 565:02 10/09

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

NEOMYCIN SULFATE- NEOMYCIN SULFATE TABLET
HI-TECH PHARMACAL CO. INC.
----------
NEOMYCIN SULFATE
TABLETS, USP 500 MG
(EQUIVALENT TO 350 MG OF NEOMYCIN BASE PER TABLET)
RX ONLY
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF NEOMYCIN
SULFATE TABLETS AND OTHER ANTIBACTERIAL DRUGS, NEOMYCIN SULFATE
TABLETS SHOULD BE USED ONLY TO TREAT
OR PREVENT INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE
CAUSED BY BACTERIA.
BOXED WARNING
_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
TOXOCITY 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
bl