NEOMYCIN SULFATE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Teva Pharmaceuticals USA, Inc.

INN (Διεθνής Όνομα):

NEOMYCIN SULFATE

Σύνθεση:

NEOMYCIN 500 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 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 ). Neomycin sulfate has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia-forming bacteria in the intestinal tract. The subsequent r

Περίληψη προϊόντος:

Neomycin sulfate tablets USP, 500 mg (equivalent to 350 mg of neomycin base per tablet) are available as round, off-white, unscored tablets, debossed “93” and “1177”, in bottles of 100 tablets (NDC 0093-1177-01). 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. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. I 10/2022

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

NEOMYCIN SULFATE- NEOMYCIN SULFATE TABLET
TEVA PHARMACEUTICALS USA, INC.
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NEOMYCIN SULFATE TABLETS, USP
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.
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 PHEN