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:

Hospira, Inc.

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 1, Citrobacter species1, and Serratia marcescens 1. Lower Respiratory Tract Infections , including pneumonia and bronchitis caused by Escherichia coli , Klebsiella pneumoniae , Pseudomonas aeruginosa , Haemophilus influenzae , Proteus mirabilis , Enterobacter species, and Serratia marcescens 1. Septicemia caused by Escherichia coli , Klebsiella pneumoniae , Pseudomonas aeruginosa , Proteus mirabilis 1, Serratia marcescens 1, and Enterobacter species. Skin and Skin-Structure Infections , including those associated with postoperative wounds, ulcers, and burns, caused by Escherichia coli , Proteus mirabilis , Serratia marcescens , Enterobacter species, Pseudomonas aeruginosa , Klebsiella pneumoniae , and Citrobacter species1. Intra-abdominal Infections , including peritonitis caused by Escherichia coli , Klebsiella species including K. pneumoniae , Enterobacter species including E. cloacae 1, Pseudomonas aeruginosa , Citrobacter species1 including C. freundii 1, and Serratia species1 including S. marcescens 1. Gynecologic Infections , including endometritis and pelvic cellulitis caused by Escherichia coli , Klebsiella pneumoniae 1, Enterobacter species1 including E. cloacae 1, and Proteus mirabilis 1. Aztreonam for Injection is indicated for adjunctive therapy to surgery in the management of infections caused by susceptible organisms, including abscesses, infections complicating hollow viscus perforations, cutaneous infections, and infections of serous surfaces. Aztreonam for Injection is effective against most of the commonly encountered Gram-negative aerobic pathogens seen in general surgery. Concurrent initial therapy with other antimicrobial agents and aztreonam for injection is recommended before the causative organism(s) is known in seriously ill patients who are also at risk of having an infection due to Gram-positive aerobic pathogens. If anaerobic organisms are also suspected as etiologic agents, therapy should be initiated using an anti-anaerobic agent concurrently with aztreonam for injection (see DOSAGE AND ADMINISTRATION ). Certain antibiotics (eg, cefoxitin, imipenem) may induce high levels of beta-lactamase in vitro in some Gram-negative aerobes such as Enterobacter and Pseudomonas species, resulting in antagonism to many beta-lactam antibiotics including aztreonam. These in vitro findings suggest that such beta-lactamase inducing antibiotics not be used concurrently with aztreonam. Following identification and susceptibility testing of the causative organism(s), appropriate antibiotic therapy should be continued. This preparation is contraindicated in patients with known hypersensitivity to aztreonam or any other component in the formulation.

Product summary:

Aztreonam for Injection, USP single-dose vials are supplied as follows: NDC 0409-0829-01 Carton containing 10 1 gram/vial NDC 0409-0829-11 Single-dose vial NDC 0409-0830-01 Carton containing 10 2 grams/vial NDC 0409-0830-11 Single-dose vial Store original package at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]; avoid excessive heat.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AZTREONAM- AZTREONAM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
HOSPIRA, INC.
----------
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 (eg, 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:
C13H17N5O8S2 MW 435.44
Aztreonam for Injection is a sterile, nonpyrogenic, sodium-free,
lyophilized, off-white to
slightly yellowish 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.
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,
serum levels were 1 mcg/mL, 3 mcg/mL, and 6 mcg/mL, respectively
(Figure 1). Single 3-
minute intravenous injections of the same doses resulted in serum
levels of 58 mcg/mL,
125 mcg/mL, an