Macrobid (Nitrofurantoin) - Summary

MACROBID SUMMARY

Nitrofurantoin is an antibacterial agent specific for urinary tract infections. The Macrobid ^® brand of nitrofurantoin is a hard gelatin capsule shell containing the equivalent of 100 mg of nitrofurantoin in the form of 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate.

Macrobid 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 Macrobid and other antibacterial drugs, Macrobid 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 Macrobid 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 Macrobid, other therapeutic agents with broader tissue distribution should be selected. In considering the use of Macrobid, 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 Macrobid (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.

Nitrofurantoin compares favorably to recommended agents as empirical treatment of uncomplicated urinary tract infections in a decision and cost analysis. [2011.06]
OBJECTIVE: To analyze the costs of nitrofurantoin use compared to those of other antibiotics recommended for treatment of uncomplicated urinary tract infection (UTI)... CONCLUSION: From a payer perspective, nitrofurantoin appears to be a reasonable alternative to TMP-SMX and fluoroquinolones for empirical treatment of uncomplicated UTIs, especially given the current prevalence of antibiotic resistance among community uropathogens. On the basis of efficacy, cost, and low impact on promoting antimicrobial resistance, clinicians should consider nitrofurantoin as a reasonable alternative to TMP-SMX and fluoroquinolones for first-line therapy for uncomplicated UTIs.

[Antimicrobial and clinical efficacy of nitrofurantoin in the treatment of acute lower urinary tract infections in adults]. [2010.10]
BACKGROUND AND PURPOSE: In the light of increasing resistance to antibiotics used for the treatment of acute urinary tract infections, nitrofurantoin currently experiences a renaissance. Nitrofurantoin shows good efficacy against most bacteria expected in urinary tract infection, and the development of resistance is low. A study on the antimicrobial and clinical efficacy of nitrofurantoin in the treatment of acute lower urinary tract infections was conducted in Mexico City, an area where resistance rates of uropathogens to trimethoprim/sulfamethoxazole (cotrimoxazole) are high... CONCLUSION: The results of the present study indicate good antimicrobial and clinical efficacy of nitrofurantoin in the treatment of acute uncomplicated urinary tract infections as well as acceptable tolerability in adults.

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Clinical Trials Related to Macrobid (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.

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 [Completed]
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.

Food Study of Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® 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 Macrobid® capsules following a single, oral 100 mg (1 x 100 mg) dose under fed conditions.

Fed Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan nitrofurantoin monohydrate/macrocrystals capsules to Procter & Gamble Macrobid® 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.

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Reports of Suspected Macrobid (Nitrofurantoin) Side Effects

Palpitations (19),  Burning Sensation (19),  Blood Pressure Increased (18),  Cystitis (18),  Weight Decreased (17),  Headache (17),  Loss of Consciousness (17),  Blood Count Abnormal (16),  Dizziness (16),  Ingrowing Nail (15), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Macrobid review by 42 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		bladder infecton
Dosage & duration:		250 mg. taken 4 times daily for the period of 10 days
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		Lessened frequency of urination and burning sensation
Side effects:		None
Comments:		Simply took the macrobid capsules as prescribed and did not notice any negative effects. Infection was eliminated according to subsequent urine cultures. The only possible side effect noted was stomach upset, if the medication is taken on a completely empty stomach. Discoloration of urine while taking the medication may also be observed.

Macrobid review by 48 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		bladder infection
Dosage & duration:		100 mg cap taken once for the period of one day
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		No treatment benefit, because the complete prescription was not used because of adverse side effects.
Side effects:		The side effects were horrible after one dose - severe dizziness - room spinning. Loss of balance. Severe nausea, vomiting.
Comments:		Supposed to take 1 tablet every 12 hours, if I remember correctly - did not take more than one dose because of horrid side effects.

Macrobid review by 58 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		uti
Dosage & duration:		100mcg (dosage frequency: 2 daily) for the period of 1 day
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		it did clear up my uti but not worth feeling like I did after taking this drug.
Side effects:		severe headache, chills, fever, I literally thought I was going to die. I took the drug as prescribed with food and after taking one pill became extremely sick. I would not recommend this drug and I flushed the rest of my prescription down the toilet!!
Comments:		the prescription was to take 1 pill 2x per day for 7 days.