국가: 남아프리카
언어: 영어
출처: South African Health Products Regulatory Authority (SAHPRA)
Bm_squib
AZACTAM 1g INJECTION SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): AZACTAM 1g INJECTION COMPOSITION Aztreonam is chemically designated as (Z)-2-[[[(2-amino-4-thiazolyl)-[[(2S,3S) -2-methyl-4-oxo-1-sulfo-3-azetidinyl] carbamoyl]methylene]-amino]oxy]-2-methylpropionic acid. AZACTAM is sodium free and contains approximately 780 mg 1-arginine per gram of aztreonam. PHARMACOLOGICAL CLASSIFICATION Category A20.1. Antibiotic and antibiotic combinations. PHARMACOLOGICAL ACTION Aztreonam is a synthetic monocyclic beta-lactam antibiotic (monobactam) with bactericidal activity against a wide spectrum of gram-negative aerobic pathogens. The monobactams, which were originally derived from a bacterium, Chromobacterium violaceum, have a novel single nuclear ring structure. Pharmacokinetics in Adults: Single 30 minute intravenous infusions of 0,5, 1, and 2 gram doses AZACTAM in healthy volunteers produced serum levels of 54, 90 and 204 mcg/mL respectively, immediately after administration. Single 3 minute intravenous infusions of the same doses resulted in peak serum levels of 58, 125 and 242 mcg/mL at 5 minutes following completion of infusion of the drug. Serum levels of aztreonam 8 hours after start of 3 or 30 minute infusions were 1, 3 and 6 mcg/mL respectively. After intramuscular administration, maximum serum aztreonam concentrations occur at about one hour. After identical single intravenous or intramuscular doses of AZACTAM, either 0,5 or 1 gram, the serum concentrations of aztreonam are comparable at 1 hour (1,5 hours from start of intravenous infusions) with similar slopes of serum concentrations thereafter. After single 0,5, 1 and 2 gram intravenous doses of AZACTAM (30 minute infusion) average urine concentrations of aztreonam were approximately 1100, 3500 and 6600 mcg/mL respectively wit 전체 문서 읽기