AZACTAM- aztreonam injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

aztreonam (UNII: G2B4VE5GH8) (aztreonam - UNII:G2B4VE5GH8)

Available from:

E.R. Squibb & Sons, L.L.C.

INN (International Name):

aztreonam

Composition:

aztreonam 1 g

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AZACTAM (aztreonam for injection, USP) and other antibacterial drugs, AZACTAM 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. AZACTAM 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 Tract Infections ,

Product summary:

AZACTAM® (aztreonam for injection, USP) Single-dose vials: Packages of 10 NDC 0003-2560-16 Packages of 10 NDC 0003-2570-16 Store in original package at 20°C to 25°C (68°F to 77°F) [see USP controlled room temperature]; avoid excessive heat.

Authorization status:

New Drug Application

Summary of Product characteristics

AZACTAM- AZTREONAM INJECTION, POWDER, FOR SOLUTION
E.R. SQUIBB & SONS, L.L.C.
----------
AZACTAM
(AZTREONAM FOR INJECTION, USP)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
AZACTAM and other antibacterial drugs, AZACTAM should be used only to
treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
DESCRIPTION
AZACTAM (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:
C
H
N O S MW 435.44
AZACTAM is a sterile, nonpyrogenic, sodium-free, white powder
containing 0.78 grams
arginine per 1 gram of aztreonam and 1.54 grams arginine per 2 grams
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 AZACTAM in
®
®
®
13
17
5
8 2
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, and 242 mcg/mL at 5 minutes following