Macrobid (Nitrofurantoin) - Summary

MACROBID SUMMARY

Macrobid^®
(nitrofurantoin monohydrate/macrocrystals)
Capsules

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.

See all indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Macrobid (Nitrofurantoin)

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.

Differential effects of chrysin on nitrofurantoin pharmacokinetics mediated by intestinal breast cancer resistance protein in rats and mice. [2009]
PURPOSE: The activities of breast cancer resistance protein (Bcrp/ABCG2) as well as P-glycoprotein (P-gp) and drug-metabolizing enzymes can be inhibited by several flavonoids or drugs in rats. However, the species, gender and regional differences of effects of flavonoids on Bcrp/ABCG2 in rats and mice remain unclear, although Bcrp, like P-gp, is also important in controlling drug absorption and disposition... CONCLUSIONS: These results suggest that chrysin-nitrofurantoin interactions occur in the small intestine in rats, but not in mice, possibly due to the higher levels of Bcrp expression in the small intestine in rats, compared with those in mice.

Nitrofurantoin: the return of an old friend in the wake of growing resistance. [2008.12]
OBJECTIVE: To re-evaluate the first- and second-line therapies for treating uncomplicated urinary tract infection (UTI), as although fluoroquinolones are commonly used for this purpose, its level of use is thought to be inappropriately excessive and will eventually have a detrimental impact; thus we hypothesise that nitrofurantoin might be the best choice for this indication, due to its low frequency of use and its high susceptibility rate in common UTI pathogens... CONCLUSIONS: We consider that nitrofurantoin is a good fluoroquinolone-sparing alternative to co-trimoxazole; this study shows that nitrofurantoin is bactericidal to a mean of 95% of E. coli UTIs. Nitrofurantoin also has a resistance rate of 2.3%, by contrast to the quinolones (ciprofloxacin and levofloxacin), with resistant rates of approximately 24%, and Co-trimoxazole, with a resistant rate of 29%. Nitrofurantoin is an acceptable treatment for uncomplicated UTIs and should now be considered the first-line treatment. A reconsideration of UTI treatment guidelines might now be appropriate.

N-(4-[2-(1,2,3,4-tetrahydro-6,7-dimethoxy-2-isoquinolinyl)ethyl]-phenyl)-9,10-dihydro-5-methoxy-9-oxo-4-acridine carboxamide (GF120918) as a chemical ATP-binding cassette transporter family G member 2 (Abcg2) knockout model to study nitrofurantoin transfer into milk. [2008.12]
Genetic knockout mice studies suggested ATP-binding cassette transporter family G member 2 (ABCG2)/Abcg2 translocates nitrofurantoin at the mammary-blood barrier, resulting in drug accumulation in milk. The purpose of this study was to establish the role of Abcg2 in nitrofurantoin accumulation in rat milk using N-(4-[2-(1,2,3,4-tetrahydro-6,7-dimethoxy-2-isoquinolinyl)ethyl]-phenyl)-9,10-dihydro-5-methoxy-9-oxo-4-acridine carboxamide (GF120918) as a "chemical knockout" equivalent...

more studies >>

Clinical Trials Related to Macrobid (Nitrofurantoin)

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.

Food Study of Nitrofurantoin Macrocrystals 100 mg Capsules and Macrodantin® 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 Macrodantin® 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.

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.

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.

more trials >>

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 28 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		uti
Dosage & duration:		100mg twice a day taken daily for the period of 11 months
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		got rid of uti
Side effects:		severe joint pain in arms, hands and shoulders. Ligament damage in arms. Numbness, tingling, weakness in arms. Malaise, fatigue, deep tissue itching, nausea, confusion, chest constriction, Interstitial Cystitis, breathing problems, racing heart with palpitations. After 11 months I stopped this drug found a natural cure for my uti's called d-mannose. It sounds too good to be true but it stopped my uti's cold. Please visit http://www.squidoo.com/d-mannose to read my personal experience. I'm not selling d-mannose or anything else, I just want to help prevent the kind og suffering I endured.
Comments:		for the treatment of prevention of chronic uti