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:

Cardinal Health

INN (International Name):

aztreonam

Composition:

aztreonam 1 g

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

AZACTAM- AZTREONAM INJECTION, POWDER, FOR SOLUTION
CARDINAL HEALTH
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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 4 35.4 4
AZACTAM is a sterile, nonpyrogenic, sodium-free, white powder
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 AZACTAM 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, and 242 mcg/mL at 5 minutes following
completion of injection.
Serum concentrations of aztreonam in healthy