Levofloxacin is a synthetic chemotherapeutic antibiotic of the fluoroquinolone drug class and is used to treat severe or life-threatening bacterial infections or bacterial infections which have failed to respond to other antibiotic classes. 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 is a chiral fluorinated carboxyquinolone. Investigation of ofloxacin, an older drug that is the racemic mixture, found that the l form 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.
History
Levofloxacin is a fluoroquinolone antibiotic, marketed by sanofi aventis under the tradename " TAVANIC ". 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 Mexicounder the trade name TAVANIC . Other manufacturers include Novell Pharmaceutical Laboratories (Levores).
Levaquin has proven to be a blockbuster drug for Johnson and Johnson / Ortho McNeil, generating billions of dollars in additional revenue. In 2007 alone, Levaquin accounted for 6.5% of Johnson and Johnson's total revenue, generating $1.6 billion, an 8% increase over the previous year. Ranking 37th within the top 200 prescribed drugs in the United States for 2007, and ranked 19th in world sales in 2007, total sales for Levaquin were in excess of 1.6 billion dollars. Levaquin was the most prescribed fluoroquinolone drug in the world for 2007.
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 is 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 mycobacteria.
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. Levaquin was the most prescribed fluoroquinolone drug in the world for 2007.
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. see Generic equivalents
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 Not generally recommended due to lack of superiority to placebo.
- 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
Note: Levofloxacin has shown moderate activity against anaerobes, and is about twice as potent as ofloxacin against mycobacterium tuberculosis and other mycobacteria, including mycobacterium avium complex.
Oral and I.V. Levaquin are not licensed by the FDA for use in children other than the exception (inhalational anthrax), due to the risk of reversible or irreversible injury to the musculoskeletal system. Although claimed 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). However, the fluoroquinolones are licensed to treat lower respiratory infections in children with cystic fibrosis in the UK.
Note: levofloxacin may be licensed for other uses, or restricted, by the various regulatory agencies worldwide.
Availability
Levofloxacin is available by prescription in tablet form (oral multiple strengths), injection (multiple strengths), solution (oral 250 mg/10ml) as well as used in prescription eye and ear drops.
Contraindications
As noted above, under licensed use, levofloxacin is now considered to be contraindicated for the treatment of certain sexually transmitted diseases by some experts due to bacterial resistance.
There is one contraindication now found within the 2008 package insert for Levaquin, namely that Levaquin is to be avoided in patients with a known hypersensitivity to levofloxacin or other quinolone drugs.
Due to growing prevalence of antibiotic resistance to the fluoroquinolones in Southeast Asia, the use of levofloxacin in patients that have been to Southeast Asia is increasingly being contraindicated.
Caution should be exercised in prescribing to patients with liver disease.
Levofloxacin is also considered to be contraindicated in patients with epilepsy or other seizure disorders.
Research indicates that the fluoroquinolones can rapidly cross the blood-placenta and blood-milk barrier, and are extensively distributed into the fetal tissues. Peak concentration in human breast milk is similar to levels attained in plasma. Breast-feeding mothers that take levofloxacin may expose their infants to severe adverse reactions and pregnant women are at risk of spontaneous abortions and birth defects. For this reason the prescribing of levofloxacin is contraindicated during pregnancy. Other flouroquinolones have also been reported as being present in the mother’s milk and are passed on to the nursing child.
Oral and I.V. Levofloxacin is not licensed for use in the pediatric population, except as noted above, due to the risk of serious, life-threatening and permanent injury to the pediatric patient. Within one study it was stated that the pediatric patient has a 3.8% chance of experiencing a serious musculoskeletal adverse event.
Adverse effects which have been associated with levofloxacin use in children include musculoskeletal disorders such as arthralgia, arthritis, tendonopathy, and gait abnormality The studies found within the new drug application (NDA) for levofloxacin showed an adverse drug reaction (ADR) rate in excess of 40%, as well as a number of reported fatalities. However, the two most recent pediatric studies involving the use of levofloxacin, indicates that the pediatric patient has a greater than 50% chance of experiencing one or more adverse reactions. Within the first pediatric study it is stated that “Of the 712 subjects evaluable for safety, 275 (52%) levofloxacin-treated subjects experienced one or more adverse event.... Serious adverse events were reported in 33 (6%) levofloxacin-treated subjects.... Two serious adverse events in levofloxacin-treated subjects resulted in fatal outcomes.” Within the second pediatric study it is stated that “Of the 204 subjects evaluable for safety, 122 experienced one or more adverse events.... Twelve subjects (6%) discontinued study drug due to an adverse event.... Seven subjects (3%) experienced 8 serious adverse events.” (circa 2007)
The current ban on the use of Oral and I.V. levofloxacin and other fluoroquinolones in the pediatric population has been supported by a number of clinical studies. The evidence presented at that 62 Meeting of the Anti-Infective Drugs Advisory Commi
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