AMIKACIN SULFATE injection, solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

amikacin sulfate (UNII: N6M33094FD) (amikacin - UNII:84319SGC3C)

Saadav alates:

Sagent Pharmaceuticals

INN (Rahvusvaheline Nimetus):

amikacin sulfate

Koostis:

Amikacin 250 mg in 1 mL

Manustamisviis:

INTRAVENOUS

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Amikacin Sulfate Injection, USP 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, USP 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 post-vascular surgery). Clinical studies have shown amikacin also to be effective in serious complicated and recurrent urinary tract infections due to those organisms. Aminoglycosides, including Amikacin Sulfate Injection, USP are not indicated in uncomplicated initial episodes of uri

Toote kokkuvõte:

Amikacin Sulfate Injection, USP is supplied as follows: 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. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] *Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. Brands listed are the trademarks of their respective owners. SAGENT® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in Spain ©2022 Sagent Pharmaceuticals, Inc. Revised: September 2022 SAGENT Pharmaceuticals®

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

AMIKACIN SULFATE- AMIKACIN SULFATE INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
----------
AMIKACIN SULFATE INJECTION, USP
(FOR INTRAMUSCULAR OR INTRAVENOUS USE)
SAGENT
Rx only
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
the amikacin and other antibacterial drugs, amikacin 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 O