Amikacin Sulfate Injection USP

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Teva Parenteral Medicines, Inc.

administration_route:

INTRAMUSCULAR

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Amikacin sulfate injection is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli , species of indole-positive and indole-negative Proteus , Providencia species, Klebsiella-Enterobacter-Serratia species and Acinetobacter (Mima-Herellea ) species. Clinical studies have shown amikacin sulfate injection to be effective in bacterial septicemia (including neonatal sepsis); in serious infections of the respiratory tract, bones and joints, central nervous system (including meningitis) and skin and soft tissue; intra-abdominal infections (including peritonitis); and in burns and postoperative infections (including postvascular surgery). Clinical studies have shown amikacin also to be effective in serious complicated and recurrent urinary tract infections due to these organisms. Aminoglycosides, including amikacin sulfate injection, are not indicated in uncomplicated initial episodes of urinary tract infec

leaflet_short:

Amikacin Sulfate Injection USP is supplied as a colorless solution which requires no refrigeration. At times the solution may become a very pale yellow; this does not indicate a decrease in potency. Amikacin Sulfate Injection USP is supplied as follows: 0703-9032-03 500 mg per 2 mL 0703-9040-03 1 gram per 4 mL 2 mL and 4 mL vials are packaged in shelf packs of 10. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA. Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. E 10/2022

authorization_status:

Abbreviated New Drug Application

SPC

AMIKACIN SULFATE- AMIKACIN SULFATE INJECTION, SOLUTION
TEVA PARENTERAL MEDICINES, INC.
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AMIKACIN SULFATE INJECTION USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
amikacin sulfate injection and other antibacterial drugs, amikacin
sulfate injection 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 (AS IN ORTHOPEDIC