Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
aztreonam (UNII: G2B4VE5GH8) (aztreonam - UNII:G2B4VE5GH8)
Cardinal Health
aztreonam
aztreonam 1 g
PRESCRIPTION DRUG
New Drug Application
AZACTAM- AZTREONAM INJECTION, POWDER, FOR SOLUTION CARDINAL HEALTH ---------- 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 Preberite celoten dokument