NEOMYCIN SULFATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

XGen Pharmaceuticals DJB, Inc.

INN (International Name):

NEOMYCIN SULFATE

Composition:

NEOMYCIN SULFATE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Neomycin Sulfate Tablets, USP 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) . Neomycin sulfate has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia-forming bacteria in the intestinal

Product summary:

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 39822-0310-5 as Unit Dose blister packages of 100 tablets (10 strips of 10 tablets each). Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Dispense in tight containers as defined in the USP/NF. Manufactured in Canada. Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814 Revised: March 2023 NST-PI-04 2000015347

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NEOMYCIN SULFATE- NEOMYCIN SULFATE TABLET
XGEN PHARMACEUTICALS DJB, 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, 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.
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 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 antico