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Noroxin (Norfloxacin) - Summary

 
 



BOX WARNING

WARNING:

Fluoroquinolones, including NOROXIN, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (see WARNINGS).

 

NOROXIN SUMMARY

NOROXIN (Norfloxacin) is a synthetic, broad-spectrum antibacterial agent for oral administration.

NOROXIN is indicated for the treatment of adults with the following infections caused by susceptible strains of the designated microorganisms:

URINARY TRACT INFECTIONS:

Uncomplicated urinary tract infections (including cystitis) due to Enterococcus faecalis, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus epidermidis, Staphylococcus saprophyticus, Citrobacter freundii **, Enterobacter aerogenes **, Enterobacter cloacae **, Proteus vulgaris **, Staphylococcus aureus **, or Streptococcus agalactiae **.

Complicated urinary tract infections due to Enterococcus faecalis, Escherichia coli, Klebsiella pneumoniae, Pro-teus mirabilis, Pseudomonas aeruginosa, or Serratia marcescens **.

Sexually transmitted diseases (see WARNINGS):

Uncomplicated urethral and cervical gonorrhea due to Neisseria gonorrhoeae.

PROSTATITIS:

Prostatitis due to Escherichia coli.

(See DOSAGE AND ADMINISTRATION for appropriate dosing instructions.)

Penicillinase production should have no effect on norfloxacin activity.

Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to norfloxacin. Therapy with norfloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be given. Repeat culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agents but also on the possible emergence of bacterial resistance.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of NOROXIN and other antibacterial drugs, NOROXIN 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.


** Efficacy for this organism in this organ system was studied in fewer than 10 infections.


See all Noroxin indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Noroxin (Norfloxacin)

Norfloxacin therapy for hepatopulmonary syndrome: a pilot randomized controlled trial. [2010.12]
BACKGROUND & AIMS: The hepatopulmonary syndrome occurs in up to one-third of patients with cirrhosis. Animal models of this disease suggest that endotoxemia might cause nitric oxide-mediated vascular dilatation that can be inhibited by the antibiotic norfloxacin. We sought to test this hypothesis in humans... CONCLUSIONS: Recruitment difficulties and variability of the primary outcome measure suggest the need for a multicenter clinical research network for future therapeutic trials in this disease. There was no major effect of norfloxacin on gas exchange in patients with hepatopulmonary syndrome. Copyright (c) 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.

Norfloxacin Therapy for Hepatopulmonary Syndrome: A Pilot Randomized Controlled Trial. [2010.08.31]
BACKGROUND AND AIMS: The hepatopulmonary syndrome occurs in up to one third of patients with cirrhosis. Animal models of this disease suggest that endotoxemia may cause nitric oxide-mediated vascular dilatation which can be inhibited by the antibiotic norfloxacin. We sought to test this hypothesis in humans... CONCLUSIONS: Recruitment difficulties and variability of the primary outcome measure suggest the need for a multi-center clinical research network for future therapeutic trials in this disease. There was no major effect of norfloxacin on gas-exchange in patients with hepatopulmonary syndrome. Copyright (c) 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.

Norfloxacin modulates the inflammatory response and directly affects neutrophils in patients with decompensated cirrhosis. [2009.11]
BACKGROUND & AIMS: Patients with cirrhosis undergoing selective intestinal decontamination with norfloxacin show a reduction in serum cytokine levels, probably because of a combined effect of norfloxacin on bowel flora and neutrophils... CONCLUSIONS: Norfloxacin but not trimethoprim/sulfamethoxazole modulates inflammatory response and directly affects neutrophils in patients with cirrhosis.

Norfloxacin treatment for clinically significant portal hypertension: results of a randomised double-blind placebo-controlled crossover trial. [2009.03]
BACKGROUND: While selective intestinal decontamination (SID) can alter the hyperdynamic circulatory state of cirrhosis, the impact of SID on portal pressure remains unclear especially in the setting of clinically significant portal hypertension. Aims: To examine the impact of SID with norfloxacin on portal pressure in subjects with clinically significant portal hypertension and explore the potential mechanisms by which norfloxacin exerts its haemodynamic effects... CONCLUSIONS: Norfloxacin is not superior to placebo in reducing HVPG in subjects with clinically significant portal hypertension. Furthermore, norfloxacin does not appear to modulate the l-Arg transporter mechanism in this patient population. Although plasma UII correlates positively with HVPG, UII does not appear to have a direct role in modulating HVPG.

Norfloxacin vs ceftriaxone in the prophylaxis of infections in patients with advanced cirrhosis and hemorrhage. [2006.10]
BACKGROUND & AIMS: Oral norfloxacin is the standard of therapy in the prophylaxis of bacterial infections in cirrhotic patients with gastrointestinal hemorrhage. However, during the last years, the epidemiology of bacterial infections in cirrhosis has changed, with a higher incidence of infections caused by quinolone-resistant bacteria. This randomized controlled trial was aimed to compare oral norfloxacin vs intravenous ceftriaxone in the prophylaxis of bacterial infection in cirrhotic patients with gastrointestinal bleeding... CONCLUSIONS: Intravenous ceftriaxone is more effective than oral norfloxacin in the prophylaxis of bacterial infections in patients with advanced cirrhosis and hemorrhage.

more studies >>

Clinical Trials Related to Noroxin (Norfloxacin)

Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis [Completed]
Advanced liver disease and low ascitic fluid protein concentration have been identified as risk factors for spontaneous bacterial peritonitis in cirrhosis. Moreover, renal impairment and hyponatremia increase mortality rate of this infection. Aims: To investigate if oral administration of norfloxacin prevents the first episode of SBP, hepatorenal syndrome and improves survival in cirrhotic patients with ascites and low protein concentration in ascitic fluid (<15 g/L) and at least one of the following inclusion criteria: functional renal failure (serum creatinine ≥ 1,2 mg/dl or BUN ≥ 25 mg/dl), hyponatremia (serum sodium ≤ 130 mEq/L) or advanced liver disease (Child ≥ 9 points with serum bilirubin ≥ 3 mg/dl). Methods: Prospective, multicenter, randomized, double-blind placebo controlled trial comparing oral norfloxacin (400 mg/d; n=35) with placebo (n=35).

A Pilot Study of Norfloxacin for Hepatopulmonary Syndrome [Recruiting]
The hepatopulmonary syndrome (HPS)and pre-HPS is a disease seen in patients with chronic liver disease, whereby patients develop dilations in the blood vessels of the lungs, resulting in low oxygen levels and shortness of breath.

In this study, each HPS and pre-HPS subject will be treated with a commonly used antibiotic called "norfloxacin" (approved for use in the treatment of gonorrhea, prostatitis and urinary tract infections) for a 4-week period. In order to ensure that any observed improvement was indeed due to norfloxacin, each subject will also be treated with a separate 4-week course of an identical placebo. There will also be a 4 week wash-out period (no study medication/placebo) between the 2 courses of treatment.

The primary aim of the study will be to measure improvements in oxygen levels while on norfloxacin, although a number of secondary parameters will also be followed.

Norfloxacin Versus Ciprofloxacin for Spontaneous Bacterial Peritonitis (SBP) Prevention [Recruiting]

- For the prevention of spontaneous bacterial peritonitis (SBP) in patients with liver

cirrhosis, norfloxacin 400mg per day is a standard regimen.

- Ciprofloxacin 750 mg per week is also known to be effective for prevention of SBP. In

addition, ciprofloxacin once weekly administration is more convenient and less costly.

- Therefore ciprofloxacin once weekly could be more useful if the the efficacy is

comparable to norfloxacin once daily.

- This study aims to prove ciprofloxacin once weekly administration is as effective as

norfloxacin once daily administration for the prevention of SBP in cirrhotic patients with ascites.

Comparison in the Treatment of Acute Cystitis Using Cephalosporin and Norfloxacin (CECI) [Not yet recruiting]

more trials >>

Reports of Suspected Noroxin (Norfloxacin) Side Effects

Overdose (7)Rhabdomyolysis (6)Tendonitis (6)Drug Interaction (5)Renal Failure Acute (4)Drug Eruption (3)Polymyalgia Rheumatica (3)Tendon Pain (3)Hepatitis Acute (3)Musculoskeletal Pain (3)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 3 ratings/reviews, Noroxin has an overall score of 7. The effectiveness score is 10 and the side effect score is 7.33. The scores are on ten point scale: 10 - best, 1 - worst.
 

Noroxin review by 54 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   urinary tract infection
Dosage & duration:   400 MG taken 2x daily for the period of 3 days
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   elimination of all symptoms related to the urinary tract infection including frequency of urination, pain upon urination, and urgency of urination
Side effects:   none were experienced
Comments:   Took one tablet in the morning and one in the evening. As it had to be taken on an empty stomach I took the tablet about 1 hour before breakfast, and one hour before dinner. Instructions were to avoid dairy products 6 hours before and 2 hours after taking this medication, but I found this to be too restrictive, and so I did not adhere to this recommendation.

 

Noroxin review by 63 year old male patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   Prostatitis
Dosage & duration:   400 mg twice daily taken daily for the period of 28 days
Other conditions:   Hypertension
Other drugs taken:   Perindopril
  
Reported Results
Benefits:   The bacterial infection in the prostate was quickly controlled, immediately .
Side effects:   After taking Norfloxacin, I developed severe peripheral neuropathy. This has lasted for 18 months, and still remains. The peripheral neuropathy is now treated with Lyrica
Comments:   The Norfloxacin treatment was given whilst I was an in-patient at hospital, and continued after returning home

 

Noroxin review by 63 year old male patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   Prostatitis
Dosage & duration:   400 mg twice daily taken daily for the period of 28 days
Other conditions:   Hypertension
Other drugs taken:   Perindopril
  
Reported Results
Benefits:   The bacterial infection in the prostate was quickly controlled, immediately .
Side effects:   After taking Norfloxacin, I developed severe peripheral neuropathy. This has lasted for 18 months, and still remains. The peripheral neuropathy is now treated with Lyrica
Comments:   The Norfloxacin treatment was given whilst I was an in-patient at hospital, and continued after returning home

See all Noroxin reviews / ratings >>

Page last updated: 2011-12-09

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