Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2023 Publisher: Bristol-Myers Squibb Pharmaceuticals Unlimited Company, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, Dublin, D15 T867
Pharmacotherapeutic group: Anti-infectives for systemic use
ATC code: J01DF01
Aztreonam is a monocyclic beta-lactam antibiotic with potent bactericidal activity against a wide spectrum of Gram-negative aerobic pathogens.
Unlike the majority of beta-lactam antibiotics, it is not an inducer in vitro of beta-lactamase activity. Aztreonam is usually active in vitro against those resistant aerobic organisms whose beta-lactamases hydrolyse other antibiotics.
Single 30-minute i.v. infusions of 0.5 g, 1.0 g and 2.0 g in healthy volunteers produced peak serum levels of 54, 90 and 204 mg/L, and single 3-minute i.v. injections of the same doses produced peak levels of 58, 125 and 242 mg/L. Peak levels of aztreonam are achieved at about one hour after i.m. administration. After identical single i.m. or i.v. doses, the serum concentrations are comparable at 1 hour (1.5 hours from the start of i.v. infusion), with similar slopes of serum concentrations thereafter.
The serum half-life of aztreonam averaged 1.7 hours in subjects with normal renal function, independent of the dose and route. In healthy subjects 60-70% of a single i.m. or i.v. dose was recovered in the urine by 8 hours, and urinary excretion was essentially complete by 12 hours.
Aztreonam was well tolerated in a comprehensive series of preclinical toxicity and safety studies.
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