AZTREONAM aztreonam injection, powder, lyophilized, for solution
Fresenius Kabi USA, LLC
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, monobactam. It was originally isolated from Chromobacterium violaceum It is synthetic bactericidal antibiotic.
The monobactams, having 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 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.
C13 H17 N5 O8 S2 MW 435.44
Aztreonam for injection is 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 pH in the range of 4.5 to 7.5.
Each 500 mg contains 500 mg aztreonam with approximately 390 mg arginine.
Each gram vial contains gram aztreonam with approximately 780 mg arginine.
Each gram vial contains grams aztreonam with approximately 1.56 grams arginine.
Microbiology
Mechanism of Action
Aztreonam is bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Aztreonam has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of Gram-negative and Gram-positive bacteria.
INDICATIONS AND USAGE:
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 info. 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.
DOSAGE AND ADMINISTRATION:
Dosage in Adult Patients
Aztreonam for injection may be administered intravenously or by intramuscular injection. Dosage and route of administration should be determined by susceptibility of the causative organisms, severity and site of infection, and the condition of the patient.
Table 4: Aztreonam for Injection Dosage Guidelines for Adults*
Type of Infection
Dose
Frequency (hours)
Urinary tract infections
500 mg or g
8 or 12
Moderately severe systemic infections
1 or g
8 or 12
Severe systemic or life-threatening infections
2 g
6 or 8
* Maximum recommended dose is g per day.
Because of the serious nature of infections due to Pseudomonas aeruginosa dosage of g every six or eight hours is recommended, at least upon initiation of therapy, in systemic infections caused by this organism.
The intravenous route is recommended for patients requiring single doses greater than g or those with bacterial septicemia, localized parenchymal abscess (e.g., intra-abdominal abscess), peritonitis or other severe systemic or life-threatening infections.
The duration of therapy depends on the severity of infection. Generally, aztreonam for injection should be continued for at least 48 hours after the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. Persistent infections may require treatment for several weeks. Doses smaller than those indicated should not be used.
Renal Impairment in Adult Patients
Prolonged serum levels of aztreonam may occur in patients with transient or persistent renal insufficiency. Therefore, the dosage of aztreonam for injection should be halved in patients with estimated creatinine clearances between 10 and 30 mL/min/1.73 m2 after an initial loading dose of or g.
When only the serum creatinine concentration is available, the following formula (based on sex, weight, and age of the patient) may be used to approximate the creatinine clearance (Clcr). The serum creatinine should represent steady state of renal function.
Males: Clcr weight (kg) (140 age)
72 serum creatinine (mg/dL)
Females: 0.85 above value
In patients with severe renal failure (creatinine clearance less than 10 mL/min/1.73 m2), such as those supported by hemodialysis, the usual dose of 500 mg, g or g should be given initially. The maintenance dose should be one-fourth of the usual initial dose given at the usual fixed interval of 6, or 12 hours. For serious or life-threatening infections, in addition to the maintenance doses, one-eighth of the initial dose should be given after each hemodialysis session.
HOW SUPPLIED:
Aztreonam for Injection, USP
Product No.
NDC No.
Strength
PRX400120
63323-401-24
1 per vial
20 mL single dose vial, supplied in packages of ten.
PRX400220
63323-402-24
2 per vial
30 mL single dose vial, supplied in packages of ten.
Storage
Store in original packages at 20? to 25?C (68? to 77?F) [see USP Controlled Room Temperature]; avoid excessive heat.This container closure is not made with natural rubber latex.
