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Levofloxacin

 

Levofloxacin is a synthetic chemotherapeutic agent used to treat severe or life-threatening bacterial infections. It is sold under various brand names, such as Levaquin and Tavanic, the most common. In form of ophthalmic solutions it is known as Oftaquix, Quixin and Iquix. Levofloxacin belongs to the class of fluoroquinolone (or quinolone) antiinfectives.

Levofloxacin is a chiral fluorinated carboxyquinolone. Investigation of ofloxacin, an older drug that is the racemic mixture, found that the l form [the (–)-(S) enantiomer] is more active. This specific component is levofloxacin.

Levofloxacin interacts with a number of other drugs, as well as a number of herbal and natural supplements. Such interactions increase the risk of cardiotoxicity and arrhythmias, anticoagulation, the formation of non-absorbable complexes, as well as increasing the risk of toxicity.

Levofloxacin 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 life long disabilities. Hepatoxicity has also been reported with the use of levofloxacin.

Levofloxacin generic (generic - what is it?)

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Levofloxacin: Medications and Prescriptions

Generic name: levofloxacin
Product Brand Name: levofloxacin


Levofloxacin description

History
Levofloxacin is a fluoroquinolone antibiotic, marketed by Ortho-McNeil in the United States and Canada under various trade names.[7] Levaquin is also marketed worldwide for oral and IV use, as well as used in ophthalmic solutions. Daiichi Sankyo had granted an exclusive license to Sanofi-Aventis to make, use and sell pharmaceutical preparations containing levofloxacin in the UK and Mexico. [8] Other manufacturers include Novell Pharmaceutical Laboratories (Levores).

Levofloxacin was first patented in 1987 (Levofloxacin European patent – Daiichi Pharmaceutical Co., Ltd.) and was approved by the United States Food and Drug Administration on December 20, 1996 for use in the United States to treat severe and life-threatening bacterial infections. Within a significant number of medical publications and books levofloxacin is described as a second generation fluoroquinolone. Where as within a number of medical web sites it has been described as a third-generation fluoroquinolone.

Levofloxacin was considered to be same as Ofloxacin by the U.S. Food and Drug Administration (FDA), with the exception of the potency shown in vitro against mycobacteria. In vitro, it is, in general, twice as potent as ofloxacin, whereas d-ofloxacin is less active against rnycobacteria. Within the New Drug Application (NDA) for levofloxacin it was stated that:
“...pre- NDA discussions with the applicant suggested quite strongly that levofloxacin is conceptually identical to ofloxacin. For ofloxacin, the dominant active drug substance is its 1- isomer, which is levofloxacin. Conceptually, this premise should lead to microbiological labeling essentially identical to ofloxacin... the applicant provided various basic studies in support of levofloxacin that had been actually performed using ofloxacin instead of levofloxacin. Particularly, some of the studies on mechanisms of action and the related resistance mechanisms were recapitulated from ofloxacin data rather than being generated anew for levofloxacin....”
Levofloxacin has moderate activity against anaerobes, and is about twice as potent as ofloxacin against mycobacterium tuberculosis and other mycobacteria, including mycobacterium avium complex.

The current United States patent is held by Ortho-McNeil-Janssen. Ranked 19th in world sales in 2007, sales for Levaquin exceeded $1.4 billion.

Levofloxacin is marketed worldwide under a significant number of different brand names, making post-marketing surveillance difficult.

In addition, generic versions of levofloxacin had been available since 2004 and marketed as a generic drug under a variety of different brand names. However Daiichi Sankyo-Johnson and Johnson-Ortho McNeil filed numerous patent lawsuits to prevent such generic equivalents from being marketed, claiming that their patent did not expire until June 23, 2009.

Licensed uses:
The licensed uses for Oral and I.V. levofloxacin in the United States are as follows:

In the adult population Oral and I.V. levofloxacin is limited to the treatment of proven serious and life-threatening bacterial infections such as:

Urinary Tract Infections Added 12/17/1998
Community-acquired pneumonia Added 2/2/2000
Skin and Skin Structure Infections Added 9/8/2000
Nosocomial Pneumonia Added 10/30/2002
Chronic Bacterial Prostatitis Added 05/23/2003
Inhalational Anthrax (Post-Exposure)Added 11/24/2004
Acute Bacterial Sinusitis Added 8/4/2005 Revised 6/23/2006
Acute Bacterial Exacerbation of Chronic Bronchitis Added 6/23/2006
Acute Pyelonephritis Added 6/23/2006

Within the pediatric population Oral and I.V. levofloxacin is limited to:
Inhalational Anthrax (Post-Exposure) Added 5/5/2008
Prescribing Levaquin to treat an unapproved use (other than those listed above) within the pediatric, as well as the adult population, does take place rather frequently. Even though within the pediatric population Oral and I.V. levofloxacin is limited to the treatment of inhalational anthrax (post-exposure) as noted above.

Oral and I.V. Levaquin are not licensed by the FDA for use in children other than the exception (inhalational anthrax), noted above due to the risk of fatalities as well as permanent injury to the musculoskeletal system.[37] Although alleged to be effective, levofloxacin is not to be considered a first line agent for inhalational anthrax in the pediatric population due to severe adverse reactions involving the musculoskeletal system and other serious adverse reactions, including fatalities.

The CDC revoked its recommendation regarding the use of fluoroquinolones (ciprofloxacin) as a first line agent in treating anthrax (in part) due to the risk of adverse reactions documented within the Antimicrobial Postexposure Prophylaxis for Anthrax study (aka Cipro 60-day study).[43] However, the fluoroquinolones are licensed to treat lower respiratory infections in children with cystic fibrosis in the UK.

keywords: levofloxacin may be licensed for other uses, or restricted, by the various regulatory agencies worldwide.


Levofloxacin notes:

Levofloxacin is a powerful synthetic chemotherapeutic drug that is prescribed for treating severe or fatal bacterial infections. It is available in different trade names including Levaquin and Tavanic. The ophthalmic solution form of this drug is known as Quixin, Oftaquix and Iquix. This chemotherapeutic drug belongs to the class of fluoroquinolone (or quinolone) antiinfectives and is a chiral fluorinated carboxyquinolone. Levofloxacin is associated with several serious complications when used in combination with some types of drugs and herbal and natural supplements. These drug interactions are found to increase the risk for cardiotoxicity, arrhythmias, anticoagulation, the formation of non-absorbable complexes, along with the increase in the chance of toxicity.

Levofloxacin also cause several adverse reactions with some drug such as spontaneous tendon ruptures and irreversible peripheral neuropathy. Cases of life long disabilities are also found. Use of levofloxacin is also associated with hepatoxicity. It is also found that patients taking this drug can develop serious hypersensitivity or anaphylactic reactions that can be accompanied by cardiovascular collapse, hypotension, seizure, loss of consciousness, tingling, angioedema, facial edema, airway obstruction (example: bronchospasm), shortness of breath, acute respiratory distress, urticaria, dyspnea, itching, and acute skin diseases.

Some serious central nervous system effects like convulsions, toxic psychoses, insomnia, increased intracranial pressure, anxiety, restlessness, confusion, lightheadedness, hallucinations, nightmares, depression, paranoia and even severe disorders like cerebral arteriosclerosis and epilepsy are also found. It is also reported that the use of this drug can cause clostridium difficile related diarrhea. It also brings about musculoskeletal disorders, photosensitivity, jaundice, hepatitis, vasculitis, myalgia, arthralgia, etc. Sensorimotor axonal polyneuropathy is rare side effect of Levaquin. Due to all these fatal side effects, it is strictly advised that this drug should not be used by pregnant women, breast feeding mothers or those who are planning to become pregnant.


 

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