Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
aztreonam (UNII: G2B4VE5GH8) (aztreonam - UNII:G2B4VE5GH8)
E.R. Squibb & Sons, L.L.C.
aztreonam
aztreonam 1 g
INTRAMUSCULAR
PRESCRIPTION DRUG
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 ,
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.
New Drug Application
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 Baca dokumen lengkapnya