- Medicines and Healthcare products Regulatory Agency
- 25 September 2014
- Therapeutic area:
- Infectious disease and Urology and nephrology
A short course (3 to 7 days) may be used with caution in certain patients with an eGFR of 30 to 44 ml/min/1.73m2
Article date: September 2014
Nitrofurantoin is an oral antibiotic for the treatment and prevention of urinary tract infections. The antibacterial efficacy in this infection depends on the renal secretion of nitrofurantoin into the urinary tract. In patients with renal impairment, renal secretion of nitrofurantoin is reduced. This may reduce the antibacterial efficacy, increase the risk of side effects (eg, nausea, vomiting, loss of appetite), and may result in treatment failures.
Nitrofurantoin was previously contraindicated in patients with a creatinine clearance of less than 60 ml/min. We have reviewed the evidence for this contraindication in the context of increasing antibiotic resistance of lower urinary tract pathogens to standard therapy (trimethoprim and amoxicillin). We also considered the risk of Clostridium difficile colitis associated with the widespread use of alternative broad-spectrum antibiotics (cephalosporins and flouroquinolones). We concluded that the existing contraindication is no longer supported and that the available evidence 1 2 justified a revised contraindication against use in patients with an eGFR of less than 45 ml/min/1.73m2.
We remind you that antibiotic treatment of asymptomatic bacteriuria is not advised except during pregnancy and other special circumstances.
Advice for healthcare professionals
- Nitrofurantoin is contraindicated in patients with an estimated glomerular filtration rate (eGFR) of less than 45 ml/min/1.73m2.
- Nitrofurantoin should not be used to treat sepsis syndrome secondary to urinary tract infection or suspected upper urinary tract infections
- A short course (3 to 7 days) may be used with caution in certain patients with an eGFR of 30 to 44 ml/min/1.73m2. Only prescribe to such patients to treat lower urinary tract infection with suspected or proven multidrug resistant pathogens when the benefits of nitrofurantoin are considered to outweigh the risks of side effects.
- Consider checking renal function when choosing to treat with nitrofurantoin, especially in the elderly.
- Closely monitor for signs of pulmonary, hepatic, neurological, haematological, and gastrointestinal side effects during treatment, as previously advised in the summary of product characteristics (see below).
- Consult official guidance on the appropriate use of antibiotics when prescribing nitrofurantoin.
Article citation: Drug Safety Update volume 8 issue 2, September 2014: A3
Published: 25 September 2014