Comment
Author: Admin | 2025-04-28
Facultative Gram-positive microorganisms: Staphylococcus aureus Enterococci (e.g. Enterococcus faecalis) Aerobic and facultative Gram-negative microorganisms: Escherichia coli NOTE: While nitrofurantoin has excellent activity against Enterococcus faecalis, the majority of Enterococcus faecium isolates are not susceptible to nitrofurantoin. At least 90 percent of the following microorganisms exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for nitrofurantoin. However, the efficacy of nitrofurantoin in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled trials. Aerobic and facultative Gram-positive microorganisms: Coagulase-negative staphylococci (including Staphylococcus epidermidis and Staphylococcus saprophyticus) Streptococcus agalactiae Group D streptococci Viridans group streptococci Aerobic and facultative Gram-negative microorganisms: Citrobacter amalonaticus Citrobacter diversus Citrobacter freundii Klebsiella oxytoca Klebsiella ozaenae NOTE: Some strains of Enterobacter species and Klebsiella species are resistant to nitrofurantoin. Susceptibility Testing: For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC. Indications and Usage for Macrodantin Macrodantin is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Macrodantin and other antibacterial drugs, Macrodantin 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. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Macrodantin are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. If persistence or reappearance of bacteriuria occurs after treatment with Macrodantin, other therapeutic agents with broader tissue distribution should be selected. In considering the use of Macrodantin, lower eradication rates should be balanced against the increased potential for systemic toxicity and for the development of antimicrobial resistance when agents with broader tissue distribution are utilized. Contraindications Anuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per
Add Comment