NITROFURANTOIN SUMMARY
Nitrofurantoin is an antibacterial agent specific for urinary tract infections.
Nitrofurantoin monohydrate/macrocrystals capsules is indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus.
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 nitrofurantoin monohydrate/macrocrystals capsules and other antibacterial drugs, nitrofurantoin monohydrate/macrocrystals capsules 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 nitrofurantoin monohydrate/macrocrystals capsules are predisposed to persistence or reappearance of bacteriuria. (See CLINICAL STUDIES). 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 nitrofurantoin monohydrate/macrocrystals Capsules, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin monohydrate/macrocrystals capsules, 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.
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NEWS HIGHLIGHTS
Published Studies Related to Nitrofurantoin
One week of nitrofurantoin before percutaneous nephrolithotomy significantly reduces upper tract infection and urosepsis: a prospective controlled study. [2011.01] CONCLUSIONS: Prophylaxis with NFT for a week before PNL is beneficial in the prevention of urosepsis and endotoxemia in patients with larger stones and HDN. NFT covers most of the urinary isolates and is preferred in areas of fluoroquinolone resistance. Copyright A(c) 2011 Elsevier Inc. All rights reserved.
One-day compared with 7-day nitrofurantoin for asymptomatic bacteriuria in pregnancy: a randomized controlled trial. [2009.02] OBJECTIVE: To evaluate whether a 1-day nitrofurantoin regimen is as effective as a 7-day regimen in eradicating asymptomatic bacteriuria during pregnancy... CONCLUSION: A 1-day regimen of nitrofurantoin is significantly less effective than a 7-day regimen. Women with asymptomatic bacteriuria in pregnancy should receive the standard 7-day regimen. CLINICAL TRIAL REGISTRATION: ISRCTN, isrctn.org, ISRCTN11966080 LEVEL OF EVIDENCE: I.
Short-course nitrofurantoin for the treatment of acute uncomplicated cystitis in women. [2007.11.12] BACKGROUND: There is a paucity of data on the efficacy of nitrofurantoin for the treatment of acute uncomplicated cystitis in regimens shorter than 7 days. Evidence-based use of this drug is increasingly important as trimethoprim-sulfamethoxazole resistance among uropathogens increases... CONCLUSION: A 5-day course of nitrofurantoin is equivalent clinically and microbiologically to a 3-day course of trimethoprim-sulfamethoxazole and should be considered an effective fluoroquinolone-sparing alternative for the treatment of acute cystitis in women.
Clinical Trials Related to Nitrofurantoin
Study Comparing Nitrofurantoin to Fosfomycin for Acute Urinary Tract Infection in Women [Recruiting]
Developed before the establishment of a structured process for drug assessment,
nitrofurantoin is now being prescribed frequently given the rise in multi-resistant
gram-negative pathogens. Doubts remain regarding fosfomycin's long-term clinical
effectiveness. A randomized, controlled trial is needed to explore the clinical
effectiveness and better define the side effect profiles of both nitrofurantoin and
fosfomycin. This multi-center open trial will randomize 600 non-pregnant women at three
international sites (200 each in Poland, Switzerland, and Israel) at increased risk for
carriage of resistant uropathogens and with suspicion of uncomplicated lower urinary tract
infection to receive either oral nitrofurantoin 100 mg three times daily for 5 days or a
single 3g dose of oral fosfomycin. Patients will be followed for clinical and bacteriologic
response at days 14 and 28 post therapy completion. The study hypothesis holds that
nitrofurantoin will be superior to fosfomycin in clinical efficacy at final follow-up.
Short Course Nitrofurantoin for Acute Cystitis [Completed]
The purpose of this research study is to determine what the cure rates are with a 5 day
course of nitrofurantoin versus the more standard 3 day course of
trimethoprim/sulfamethoxazone. The study will improve our knowledge of which antibiotic and
what length of therapy is best for treatment of UTI, taking into account the problem of
antibiotic resistance.
Procedures subjects will undergo once they have read and signed the consent are:
Questions about their medical and sexual history and current symptoms of UTI. They will be
asked to provide a urine sample and then randomly assigned to one of the two treatment
groups.
will be obtained at each visit. If they were assigned to the nitrofurantoin treatment
regimen, they will also be asked to collect a urine sample at home on the third day. If the
subject develops recurrent urinary symptoms or does not have resolution of symptoms after
completing the initial treatment course, they will be asked to return to the clinic and
provide another urine sample for analysis. They will then be treated with another standard
antibiotic at no cost to them and will be withdrawn from the study at that time.
The study population is women ages 18-45 with acute symptoms of a UTI without a history of
UTI in the past 6 weeks.
Nitrofurantoin and Urinary Tract Infections (UTIs) [Recruiting]
Urinary tract infection (UTI) is the most common complication after surgery for prolapse or
urinary incontinence. UTIs are painful and have the potential to turn into kidney
infections. We are asking women who self-catheterize after surgery to try either an
antibiotic or a placebo pill so we can see if we can prevent UTIs without causing side
effects.
This study will not require any additional visits or blood draws. You will be asked to
answer some questions, keep a brief diary of your experience, and immediately report any
symptoms of a UTI to your doctor.
Efficacy and Safety of Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infections in Adults [Completed]
The study aims to investigate bacteriological efficacy of a nitrofurantoin formulation given
twice daily for seven days in the treatment of adult patients with microbiologically
confirmed uncomplicated urinary tract infection.
Additional study objectives are to evaluate clinical efficacy as well as safety and
tolerability of the nitrofurantoin formulation.
Bioequivalence Study of Nitrofurantoin 100 mg Capsules Under Fed Conditions [Completed]
An open label, randomised, two-treatment, four-period, two-sequence, single-dose,
crossover, fully replicated bioavailability study on Nitrofurantoin formulations comparing
Nitrofurantoin 100 mg capsules of Ranbaxy Laboratories with Macrobid 100 mg capsules in
healthy, adult, human subjects under fed conditions
Reports of Suspected Nitrofurantoin Side Effects
Nausea (22),
Vomiting (16),
Urinary Tract Infection (14),
Glaucoma (11),
Pierre Robin Syndrome (11),
Pyrexia (11),
Cleft Palate (11),
Malaise (11),
Developmental Delay (11),
Craniosynostosis (11), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 3 ratings/reviews, Nitrofurantoin has an overall score of 6.67. The effectiveness score is 8 and the side effect score is 6.67. The scores are on ten point scale: 10 - best, 1 - worst.
| Nitrofurantoin review by 29 year old female patient | | Rating |
Overall rating: | | |
Effectiveness: | | Highly Effective |
Side effects: | | No Side Effects | | Treatment Info |
Condition / reason: | | UTI prevention |
Dosage & duration: | | 100 mg taken twice per day for the period of 3 months |
Other conditions: | | hay fever, psioriasis, eczema, allopecia areata |
Other drugs taken: | | none | | Reported Results |
Benefits: | | This preventative course stopped the chronic UTIs that the patient had experienced. |
Side effects: | | On a few occasions, mild nausea immediately after taking the drug. |
Comments: | | Twice daily, and then stepped down to once daily after a new doctor recommended that the patient only use one per day for prevention, due to slim size (110 pounds). |
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| Nitrofurantoin review by 58 year old female patient | | Rating |
Overall rating: | | |
Effectiveness: | | Considerably Effective |
Side effects: | | Severe Side Effects | | Treatment Info |
Condition / reason: | | UTI |
Dosage & duration: | | 100 mg taken b.i.d. for the period of 5 days |
Other conditions: | | none |
Other drugs taken: | | none | | Reported Results |
Benefits: | | Treated a UTI bactrim did not |
Side effects: | | End of 3rd day: extreme dizziness, with sense of room spinning wildly; deep-seated nausea but no vomiting; 4th day more serious than 3rd; uncertain if finishing the course (to the 5th day) is wise, or even possible, with full time work |
Comments: | | Treatment includes the option to get a refill: would seek alternative to Cipro, which was very harsh on gastro-intestinal system, Bactrim, which apparently was not effective in treating an ongoing problem...and this, which is causing some big problems |
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| Nitrofurantoin review by 58 year old female patient | | Rating |
Overall rating: | | |
Effectiveness: | | Considerably Effective |
Side effects: | | Severe Side Effects | | Treatment Info |
Condition / reason: | | UTI |
Dosage & duration: | | 100 mg taken b.i.d. for the period of 5 days |
Other conditions: | | none |
Other drugs taken: | | none | | Reported Results |
Benefits: | | Treated a UTI bactrim did not |
Side effects: | | End of 3rd day: extreme dizziness, with sense of room spinning wildly; deep-seated nausea but no vomiting; 4th day more serious than 3rd; uncertain if finishing the course (to the 5th day) is wise, or even possible, with full time work |
Comments: | | Treatment includes the option to get a refill: would seek alternative to Cipro, which was very harsh on gastro-intestinal system, Bactrim, which apparently was not effective in treating an ongoing problem...and this, which is causing some big problems |
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Page last updated: 2011-12-09
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