AZACTAM- aztreonam injection, 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 in 50 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AZACTAM (aztreonam injection) 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 , including

Product summary:

AZACTAM® (aztreonam injection) in GALAXY plastic container (PL 2040) is supplied as a frozen, 50 mL single-dose intravenous solution as follows: Store at or below –20°C (–4°F) [see Directions for Use of AZACTAM (aztreonam injection) in GALAXY Plastic Container (PL 2040) ].

Authorization status:

New Drug Application

Summary of Product characteristics

AZACTAM- AZTREONAM INJECTION, SOLUTION
E.R. SQUIBB & SONS, L.L.C.
----------
AZACTAM
(AZTREONAM INJECTION)
IN GALAXY PLASTIC CONTAINER (PL 2040)
FOR INTRAVENOUS USE
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 injection) 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 in the GALAXY plastic container (PL 2040) is a frozen,
iso-osmotic, sterile, sodium-free,
nonpyrogenic intravenous solution. Each 50 mL of solution contains 1
g, or 2 g aztreonam with
approximately 1.7 g, or 700 mg Dextrose Hydrous, USP added to adjust
osmolality, and approximately
780 mg, or 1.6 g of arginine added for pH adjustment, respectively.
Thawed solutions have a pH in the
range of 4.5 to 7.5. The solution is for intravenous administration
following thawing at room
temperature or under refrigeration.
This GALAXY container is fabricated from a specially designed
multilayer plastic (PL 2040).
Solutions are in contact with the polyethylene layer of this container
and can leach out certain chemical
components of the plastic in very small amounts within the expirati