DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Nitrofurantoin (Nitrofurantoin) - Summary

 
 



NITROFURANTOIN SUMMARY

NITROFURANTOIN
(Monohydrate/Macrocrystals)
CAPSULES, 100 mg
(Twice-a-day Dosage)
Rx only

Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin monohydrate/macrocrystals is a hard gelatin-capsule containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate.

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.

Nitrofurantoin monohydrate/macrocrystals capsules are 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.

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 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, other therapeutic agents with broader tissue distribution should be selected. In considering the use of nitrofurantoin monohydrate/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.


See all Nitrofurantoin indications & dosage >>

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.

more studies >>

Clinical Trials Related to Nitrofurantoin

Food Study of Nitrofurantoin Macrocrystals 100 mg Capsules and MacrodantinŽ 100 mg [Completed]
The objective of this study was to evaluate the relative bioavailability of Mylan's nitrofurantoin macrocrystals 100 mg capsules to Procter & Gamble's MacrodantinŽ 100 mg capsules following a single, oral 100 mg (1 x 100 mg) dose in 28 healthy, adult, non-tobacco using volunteers under fed conditions.

Food Study of Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and MacrobidŽ Capsules 100 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's nitrofurantoin monohydrate/macrocrystals capsules to Procter & Gamble's MacrobidŽ capsules following a single, oral 100 mg (1 x 100 mg) dose under fed conditions.

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.

Does Post-Operative Prophylaxis With Macrobid Reduce the Incidence of Post-Operative Urinary Tract Infection in Patients Undergoing Placement of a Sub-Urethral Sling for the Treatment of Stress Urinary Incontinence [Recruiting]
This project will be a randomized, double blinded, placebo controlled clinical trial. The aim of the trial is to determine whether or not post-operative prophylaxis with macrobid will decrease the incidence of postoperative urinary tract infection in women receiving sub-urethral slings for the treatment of urinary incontinence.

Suppressive Therapy With Oral Antibiotics for Prevention of Postoperative Urinary Tract Infection (UTI) [Recruiting]
This is a study of patients undergoing gynecologic surgery who require post-operative catheterization to determine if prophylactic antibiotic treatment decreases the risk of post-operative urinary tract infection in these patients.

more trials >>

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 >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based 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).

 

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

 

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

See all Nitrofurantoin reviews / ratings >>

Page last updated: 2011-12-09

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014