Chibroxin (Norfloxacin)

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Chibroxin is one brand name of the medicine also known by its generic name Norfloxacin. This page displays only reviews left by users of Chibroxin. Click here to see all reviews left for all forms of Norfloxacin. You can also choose other review combinations.
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More about Norfloxacin

What is/are Norfloxacin?

Norfloxacin is a synthetic chemotherapeutic antibacterial agent occasionally used to treat common as well as complicated urinary tract infections. It is sold under various brand names with the most common being Noroxin. In form of ophthalmic solutions it is known as Chibroxin. Norfloxacin is a first generation synthetic fluoroquinolone (quinolone) developed by Kyorin Seiyaku K.K. (Kyorin).

The licensed uses for norfloxacin are quite limited as norfloxacin is to be considered a drug of last resort when all other antibiotics have failed. There are currently only three approved uses in the adult population (one of which is restricted) and the other ineffective due to bacterial resistance. Chibroxin(ophthalmic) is approved for use in children older than one year of age.

Norfloxacin interacts with a number of other drugs, as well as a number of herbal and natural supplements. Such interactions increase the risk of anticoagulation and the formation of non-absorbable complexes, as well as increasing the risk of toxicity. Norfloxacin is associated with a number of serious and life threatening adverse reactions as well as spontaneous tendon ruptures and irreversible peripheral neuropathy. Such reactions may manifest long after therapy had been completed and in severe cases may result in lifelong disabilities. Hepatoxicity resulting in fatalities has also been reported with the use of norfloxacin.

Medical uses

n the adult population Oral and I.V. Norfloxacin is limited to the treatment of proven bacterial infections. The initial approval by the U.S. Food and Drug Administration (FDA) in 1986 encompassed the following indications:

  •     Uncomplicated urinary tract infections (including cystitis)
  •     Complicated urinary tract infections (restricted use)
  •     Uncomplicated urethral and cervical gonorrhea (however this indication is no longer considered to be effective by some experts due to bacterial resistance)
  •     Prostatitis due to Escherichia coli.
  •     Syphilis treatment: Norfloxacin has not been shown to be effective in the treatment of syphilis. Antimicrobial agents used in high doses for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis.
  • Though the fluoroquinolones are sometimes used to treat typhoid and paratyphoid fever, it should be noted here that norfloxacin had more clinical failures than the other fluoroquinolones (417 participants, 5 trials).

In ophthalmology, Norfloxacin licensed use is limited to the treatment of conjunctival infections caused by susceptible bacteria Norfloxacin has been restricted in the Republic of Ireland due to the risks of C. difficile super infections and permanent nerve as well as tendon injuries. It licensed use in acute and chronic complicated kidney infections has been withdrawn as a result.

The European Medicines Agency, also in 2008, had recommended restricting the use of oral norfloxacin to treat urinary infections. CHMP had concluded that the marketing authorizations for norfloxacin, when used in the treatment of acute or chronic complicated pyelonephritis, should be withdrawn because the benefits do not outweigh their risks in this indication. CHMP stated that doctors should not prescribe oral norfloxacin for complicated pyelonephritis and should consider switching patients already taking oral norfloxacin for this type of infection to an alternative antibiotic. Note: Norfloxacin may be licensed for other uses, or restricted, by the various regulatory agencies worldwide.

Adverse effects

Serious adverse events occur more commonly with fluoroquinolones than with any other antibiotic drug classes. Joint and tendon problems, as seen with all drugs within this class, have been associated with norfloxacin since 1983In 1989 Jeandel et al. comments on arthritis being induced by norfloxacin.] And in 1995 Terry el reports upon arthalgia being induced by norfloxacin. Within the cases of tendinopathy reported to the FDA from 1987 to 1997, more reports of ruptures and tendonitis were associated with norfloxacin, than any other fluoroquinolone in use at that time.

Hypersensitivity reactions such as erythema multiforme, TEN (toxic epidermal necrolysis),] Sweet syndrome (acute neutrophilic dermatosis), fixed drug eruptions(FDE), systemic contact dermatitis, acantholytic bullous eruptions] as well as pustular eruptions have been associated with norfloxacin since its introduction.

On September 23, 2008, the FDA required the manufacturer to add an additional warning to the package inserts that stated that “Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving quinolone therapy, including Noroxin.”

As with other drugs in this class norfloxacin is also associated with severe and even fatal liver diseases. Acute liver failure or serious liver injury (Hepatitis), was reported in 1993. Hepatitis, jaundice, including cholestatic jaundice and elevated liver function tests have been reported during norfloxacin therapy. Severe reversible thrombopenia has occurred with norfloxacin. Norfloxacin-induced hepatitis,

Acute pancreatitis has also been linked to norfloxacin.[59] Which is but one of the many serious adverse effects that may occur as a result of norfloxacin therapy. Another such serious reaction is irreversible peripheral neuropathy. In a 1996 study it was noted that paraesthesia of the feet, legs, hands and arms occurred in 81% of the patients while 51% involved reports of hypoaesthesia and numbness. Of the thirty- seven reports found within this study, thirty one involved Norfloxacin. Twenty nine percent of these patients were reported to still be experiencing peripheral sensory disturbances after therapy had been discontinued.

Allergic nephropathy is also associated with norfloxacin as well other serious kidney problems Renal failure was first report in 1986,[63] and reports of neutropenia, thrombopenia, agranulocytosis, nephrotic syndrome,eosinophilia and acute interstitial nephritis all being associated with norfloxacin therapy. Additional serious adverse reactions include temporary as well as permanent loss of vision, QTc prolongation/torsades de pointes, severe central nervous system disorders (CNS) including seizures, drug induced psychosis and hallucinations, clostridium difficile associated disease (CDAD: Pseudomembranous colitis), as well as photosensitivity/phototoxicity reactions. Pseudotumor cerebri, commonly known as idiopathic intracranial hypertension (IIH), (also referred to as increased intracranial pressure), has been reported to occur as a serious adverse reaction to norfloxacin.

Children and the elderly are at a much greater risk of experiencing such adverse reactions. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Such reactions may manifest during, as well as long after fluoroquinolone therapy had been discontinued. Norfloxacin may also exacerbate the signs of myasthenia gravis and lead to life threatening weakness of the respiratory muscles.

Serious visual complications have also been reported to occur with ophthalmic fluoroquinolone therapy, which may also occur with norfloxacin eye drops, especially corneal perforation, but also evisceration and enucleation. This increased incidents of corneal perforation may be due to fluoroquinolones causing alterations in stromal collagen, leading to a reduction in tectonic strength.There have also been a number of reports over the years of norfloxacin deposits on the corneal causing serious vision problems following the use of eye drops.

Some groups refer to these adverse events as "fluoroquinolone toxicity". These groups of people claim to have suffered serious long term harm to their health from using fluoroquinolones. This has led to a class action lawsuit by people harmed by the use of fluoroquinolones as well as legal action by the consumer advocate group Public Citizen.[88] Partly as a result of the efforts of The State of Illinois and Public Citizen the FDA ordered a black box warnings on all fluoroquinolones advising consumers of the possible toxic effects of fluoroquinolones on tendons.

History of the black box warnings

Musculoskeletal disorders attributed to use of quinolone antibiotics were first reported in the medical literature in 1972, as an adverse reaction to nalidixic acid.[90] Rheumatic disease after use of a fluoroquinolone (norfloxacin) was first reported eleven years later. In a 1995 letter published in the New England Journal of Medicine, representatives of the U.S. Food and Drug Administration (FDA) stated that the agency would "update the labeling [package insert] for all marketed fluoroquinolones to include a warning about the possibility of tendon rupture."

By August 1996, the FDA had not taken action, and the consumer advocacy group Public Citizen filed a petition with the FDA prompting the agency to act.[93] Two months later, the FDA published an alert in the FDA Medical Bulletin and requested that fluoroquinolone package inserts be amended to include information on this risk.

In 2005, the Illinois Attorney General filed a petition with the FDA seeking black box warnings and "Dear Doctor" letters emphasizing the risk of tendon rupture; the FDA responded that it had not yet been able to reach a decision on the matter. In 2006, Public Citizen, supported by the Illinois Attorney General, renewed its demand of ten years prior for a black box warning. In January 2008, Public Citizen filed suit to compel the FDA to respond to their 2006 petition. On July 7, the FDA ordered the makers of systemic-use fluoroquinolones to add a boxed warning regarding tendon rupture, and to develop a Medication Guide for patients. The package inserts for Cipro (ciprofloxacin), Avelox (moxifloxacin), Proquin XR, Factive (gemifloxacin), Floxin (ofloxacin), Noroxin (norfloxacin) and Levaquin (levofloxacin) were amended on September 8, 2008 to include these new warnings. Bayer, which manufactures Cipro, Avelox and Proquin XR, issued a Dear Healthcare Professional letter on October 22 concerning these changes. Ortho-McNeil, the manufacturers of Levaquin, issued a similar letter in November. through the Health Care Notification Network, a registration-only website that distributes drug alerts to licensed healthcare professionals. To date no such letters have been issued by the manufacturers of Noroxin or other products containing norfloxacin.

Regulatory actions

There has been a significant number of regulatory actions taken as a result of such adverse reactions, which included published warnings, additional warnings and safety information added to the package inserts together with the request for the issuance of "Dear Doctor Letters" concerning the recent addition of Black Box Warnings in 2008. Although requested to do so by the FDA back in 2008, the manufacturers of Noroxin have not issued any "Dear Doctor Letters" regarding the tendon issues as of September 2009. Fifteen years ago, in 1994, the manufacturers had added minimal warnings concerning the association with norfloxacin and musculoskeletal tendinitis as well as spontaneous tendon ruptures. This change was approved by the FDA on July 1, 1994 and included minimal warnings regarding ruptures, as well as pseudomembranous colitis. The tendon warnings were once again revised in 1996 as the previous warnings concerning tendon issues were considered by the FDA to be inadequate.

In 2004 the FDA requested new warning labels to be added to all of the Fluoroquinolones, including norfloxacin, regarding Peripheral Neuropathy (irreversible nerve damage), Tendon Damage, Heart Problems (prolonged QT Interval / Torsades de pointes), Pseudomembranous colitis, Rhabdomyolysis (muscle wasting), Steven Johnson Syndrome, as well as concurrent usage of NSAIDs contributing to the severity of these reactions. The package insert was not changed to include any warnings regarding Steven Johnson Syndrome until September, 2008, four years later. In 1994 the product information for norfloxacin was amended in Japan (October 1994), to state that rhabdomyolysis may occur. A number of case reports concerning this had also been published as early as 1992. This has also been reported again within the literature in 1996. However the warnings concerning Rhabdomyolysis (muscle wasting) remain absent from the package inserts (as of September 2009) within the United States.

On September 23, 2008, the FDA required the manufacturer to add an additional warning to the package inserts that stated that “Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving quinolone therapy, including Noroxin.”

Mechanism of action

Norfloxacin is a broad-spectrum antibiotic that is active against both Gram-positive and Gram-negative bacteria. It functions by inhibiting DNA gyrase, a type II topoisomerase, and topoisomerase IV, enzymes necessary to separate bacterial DNA, thereby inhibiting cell division.

This mechanism can also affect mammalian cell replication. In particular, some congeners of this drug family (for example those that contain the C-8 fluorine), display high activity not only against bacterial topoisomerases, but also against eukaryotic topoisomerases and are toxic to cultured mammalian cells and in vivo tumor models. Although quinolones are highly toxic to mammalian cells in culture, its mechanism of cytotoxic action is not known. Quinolone induced DNA damage was first reported in 1986 (Hussy et al.).

Recent studies have demonstrated a correlation between mammalian cell cytotoxicity of the quinolones and the induction of micronuclei.[ As such some fluoroquinolones, including Norfloxacin, may cause injury to the chromosome of eukaryotic cells.

There continues to be considerable debate as to whether or not this DNA damage is to be considered one of the mechanisms of action concerning the severe adverse reactions experienced by some patients following fluoroquinolone therapy.

This article uses material from the Wikipedia article Norfloxacin, which is released under the Creative Commons Attribution-Share-Alike License 3.0.

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