AMIKACIN SULFATE injection solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

AMIKACIN SULFATE (UNII: N6M33094FD) (AMIKACIN - UNII:84319SGC3C)

Dostopno od:

Teva Parenteral Medicines, Inc.

INN (mednarodno ime):

AMIKACIN SULFATE

Sestava:

AMIKACIN 500 mg in 2 mL

Tip zastaranja:

PRESCRIPTION DRUG

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

AMIKACIN SULFATE- AMIKACIN SULFATE INJECTION, SOLUTION
TEVA PARENTERAL MEDICINES, INC.
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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