nitrofurantoin monohyd macro 100 mg oral capsule v

Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. In considering the use of nitrofurantoin capsules (macrocrystals), 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.Ĭlostridium difficile-associated diarrhea:Ĭlostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including nitrofurantoin, and may range in severity from mild diarrhea to fatal colitis. If persistence or reappearance of bacteriuria occurs after treatment with nitrofurantoin capsules (macrocrystals), other therapeutic agents with broader tissue distribution should be selected. Urine specimens for culture and susceptibility testing should be obtained before and after completion of therapy. Consequently, many patients who are treated with nitrofurantoin capsules (macrocrystals) are predisposed to persistence or reappearance of bacteriuria.

Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. Nitrofurantoin capsules (macrocrystals) are 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. NOTE: Some strains of Enterobacter species and Klebsiella species are resistant to nitrofurantoin.įor specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see. However, the efficacy of nitrofurantoin in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled trials.Ĭoagulase-negative staphylococci (including StaphylococcusĮpidermidis and Staphylococcus saprophyticus)

NOTE: While nitrofurantoin has excellent activity against Enterococcus faecalis, the majority of Enterococcus faecium isolates are not susceptible to nitrofurantoin.Īt 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. Nitrofurantoin has been shown to be active against most strains of the following bacteria both in vitro and in clinical infections (see Indications and Usage):Īerobic and facultative Gram-positive microorganisms:Īerobic and facultative Gram-negative microorganisms: Cross-resistance with antibiotics and sulfonamides has not been observed, and transferable resistance is, at most, a very rare phenomenon. Development of resistance to nitrofurantoin has not been a significant problem since its introduction in 1953.

Nitrofurantoin monohyd macro 100 mg oral capsule v