Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
AMIKACIN SULFATE (UNII: N6M33094FD) (AMIKACIN - UNII:84319SGC3C)
Teva Parenteral Medicines, Inc.
AMIKACIN SULFATE
AMIKACIN 500 mg in 2 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
AMIKACIN SULFATE- AMIKACIN SULFATE INJECTION, SOLUTION TEVA PARENTERAL MEDICINES, INC. ---------- AMIKACIN SULFATE INJECTION USP 9032 9040 RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of amikacin sulfate injection USP and other antibacterial drugs, amikacin sulfate injection USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. WARNINGS PATIENTS TREATED WITH PARENTERAL AMINOGLYCOSIDES SHOULD BE UNDER CLOSE CLINICAL OBSERVATION BECAUSE OF THE POTENTIAL OTOTOXICITY AND NEPHROTOXICITY ASSOCIATED WITH THEIR USE. SAFETY FOR TREATMENT PERIODS WHICH ARE LONGER THAN 14 DAYS HAS NOT BEEN ESTABLISHED. NEUROTOXICITY, MANIFESTED AS VESTIBULAR AND PERMANENT BILATERAL AUDITORY OTOTOXICITY, CAN OCCUR IN PATIENTS WITH PREEXISTING RENAL DAMAGE AND IN PATIENTS WITH NORMAL RENAL FUNCTION TREATED AT HIGHER DOSES AND/OR FOR PERIODS LONGER THAN THOSE RECOMMENDED. THE RISK OF AMINOGLYCOSIDE-INDUCED OTOTOXICITY IS GREATER IN PATIENTS WITH RENAL DAMAGE. HIGH FREQUENCY DEAFNESS USUALLY OCCURS FIRST AND CAN BE DETECTED ONLY BY AUDIOMETRIC TESTING. VERTIGO MAY OCCUR AND MAY BE EVIDENCE OF VESTIBULAR INJURY. OTHER MANIFESTATIONS OF NEUROTOXICITY MAY INCLUDE NUMBNESS, SKIN TINGLING, MUSCLE TWITCHING AND CONVULSIONS. THE RISK OF HEARING LOSS DUE TO AMINOGLYCOSIDES INCREASES WITH THE DEGREE OF EXPOSURE TO EITHER HIGH PEAK OR HIGH TROUGH SERUM CONCENTRATIONS. PATIENTS DEVELOPING COCHLEAR DAMAGE MAY NOT HAVE SYMPTOMS DURING THERAPY TO WARN THEM OF DEVELOPING EIGHTH-NERVE TOXICITY, AND TOTAL OR PARTIAL IRREVERSIBLE BILATERAL DEAFNESS MAY OCCUR AFTER THE DRUG HAS BEEN DISCONTINUED. AMINOGLYCOSIDE-INDUCED OTOTOXICITY IS USUALLY IRREVERSIBLE. AMINOGLYCOSIDES ARE POTENTIALLY NEPHROTOXIC. THE RISK OF NEPHROTOXICITY IS GREATER IN PATIENTS WITH IMPAIRED RENAL FUNCTION AND IN THOSE WHO RECEIVE HIGH DOSES OR PROLONGED THERAPY. NEUROMUSCULAR BLOCKADE AND RESPIRATORY PARALYSIS HAVE BEEN REPORTED FOLLOWING PARENTERAL INJECTION, TOPICAL INSTILLATION Прочитать полный документ