AMIKACIN SULFATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

AMIKACIN SULFATE

Composition:

AMIKACIN 250 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 species, Enterobacter species, Serratia species, and Acinetobacter species. To reduce the development of drug-resistant bacteria and maintain the effectiveness of 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 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. A history of hypersensitivity to amikacin is a contraindication for its use. A history of hypersensitivity or serious toxic react

Product summary:

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]. The container closure is not made with natural rubber latex. The brand names mentioned in this document are the trademarks of their respective owners. Manufactured for: Lake Zurich, IL 60047 www.fresenius-kabi.com/us Made in Austria 451298D Revised: March 2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMIKACIN SULFATE - AMIKACIN SULFATE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
----------
AMIKACIN SULFATE INJECTION, USP
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.
BOXED 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 pre-existing 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 and
abdominal irrigation or
in