Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)
Teva Pharmaceuticals USA, Inc.
NEOMYCIN SULFATE
NEOMYCIN 500 mg
ORAL
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
NEOMYCIN SULFATE- NEOMYCIN SULFATE TABLET TEVA PHARMACEUTICALS USA, INC. ---------- 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 Olvassa el a teljes dokumentumot