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:

Lannett Company, Inc.

INN (International Name):

NEOMYCIN SULFATE

Composition:

NEOMYCIN 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 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 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 ). Hepatic Coma (Portal-Systemic Encephalopathy) Neomycin sulfate has been shown to be effective adjunctive therapy in hepatic coma by reduction o

Product summary:

Neomycin sulfate tablets USP, 500 mg (equivalent to 350 mg of neomycin base per tablet) are available as white to off-white, round, standard convex tablets debossed "LCI" on one side and "1210", on the other side and are supplied in: Bottles of 100 (NDC 0527-1210-01) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight containers as defined in the USP/NF. Distributed By: Lannett Company, Inc. Philadelphia, PA 19154 Rev. 10/17 CIB71710A

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NEOMYCIN SULFATE- NEOMYCIN SULFATE TABLET
LANNETT COMPANY, INC.
----------
NEOMYCIN SULFATE TABLETS USP, 500 MG
(EQUIVALENT TO 350 MG OF NEOMYCIN)
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.
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