AZTREONAM- aztreonam injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AZTREONAM (UNII: G2B4VE5GH8) (AZTREONAM - UNII:G2B4VE5GH8)

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

AZTREONAM

Composition:

AZTREONAM 1 g

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of aztreonam for injection, USP and other antibacterial drugs, aztreonam for injection 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. Aztreonam for Injection is indicated for the treatment of the following infections caused by susceptible Gram-negative microorganisms: Urinary Tract Infections (complicated and uncomplicated), including pyelonephritis and cystitis (initial and recurrent) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Enterobacter cloacae, Klebsiella oxytoca *, Citrobacter species*, and Serratia marcescens *. Lower Respiratory T

Product summary:

Store in original packages at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]; avoid excessive heat. The container closure is not made with natural rubber latex. The brand names mentioned in this document are the trademarks of their respective owners. Novaplus is a registered trademark of Vizient, Inc. Manufactured by: Fresenius Kabi Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451441B Revised: March 2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AZTREONAM - AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
FRESENIUS KABI USA, LLC
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AZTREONAM _FOR INJECTION, USP_
Rx only
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
aztreonam for injection and other antibacterial drugs, aztreonam for
injection should be
used only to treat or prevent infections that are proven or strongly
suspected to be
caused by bacteria.
DESCRIPTION
Aztreonam for Injection, USP contains the active ingredient aztreonam,
a monobactam.
It was originally isolated from _Chromobacterium violaceum_. It is a
synthetic bactericidal
antibiotic.
The monobactams, having a unique monocyclic beta-lactam nucleus, are
structurally
different from other beta-lactam antibiotics (e.g., penicillins,
cephalosporins,
cephamycins). The sulfonic acid substituent in the 1-position of the
ring activates the
beta-lactam moiety; an aminothiazolyl oxime side chain in the
3-position and a methyl
group in the 4-position confer the specific antibacterial spectrum and
beta-lactamase
stability.
Aztreonam is designated chemically as
(Z)-2-[[[(2-amino-4-thiazolyl)[[(2S,3S)-2-methyl-
4-oxo-1-sulfo-3-azetidinyl]
carbamoyl]methylene]amino]oxy]-2-methylpropionic acid.
Structural formula:
C
H
N O S M.W. 435.44
Aztreonam for injection is a sterile, nonpyrogenic, sodium-free
lyophilized, off-white to
slightly yellow solid containing approximately 780 mg arginine per
gram of aztreonam.
Following constitution, the product is for intramuscular or
intravenous use. Aqueous
solutions of the product have a pH in the range of 4.5 to 7.5.
Each 1 gram vial contains 1 gram aztreonam with approximately 780 mg
arginine.
Each 2 gram vial contains 2 grams aztreonam with approximately 1.56
grams arginine.
13
17
5
8 2
CLINICAL PHARMACOLOGY
Single 30-minute intravenous infusions of 500 mg, 1 g, and 2 g doses
of aztreonam for
injection in healthy subjects produced aztreonam peak serum levels of
54 mcg/mL, 90
mcg/mL, and 204 mcg/mL, respectively, immediately after
administration; at 8 hours,
ser