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:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

INN (International Name):

AMIKACIN SULFATE

Composition:

AMIKACIN 250 mg in 1 mL

Administration route:

INTRAMUSCULAR

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-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 post-operative infections (including post-vascular 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 USP are not indicated in uncomplicated initial episodes of urin

Product summary:

Amikacin Sulfate Injection USP is supplied as a clear colorless to light straw colored 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 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE EVENTS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088  or www.fda.gov/medwatch. Manufactured by: Emcure Pharmaceuticals Ltd., Sanand, Ahmedabad – 382110, India. Manufactured for: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Revised: 03/2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMIKACIN SULFATE- AMIKACIN SULFATE INJECTION, SOLUTION
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
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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.
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 a