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moxifloxacin : ウィキペディア英語版
moxifloxacin

Moxifloxacin is a fourth-generation synthetic fluoroquinolone antibacterial agent developed by Bayer AG (initially called BAY 12-8039). It is marketed worldwide (as the hydrochloride) under the brand names Avelox, Avalox, and Avelon for oral treatment. In most countries, the drug is also available in parenteral form for intravenous infusion. Moxifloxacin is also sold in an ophthalmic solution (eye drops) under the brand names Vigamox, and Moxeza for the treatment of conjunctivitis (pink eye). Its antibacterial spectrum includes enteric Gram-(−) rods (''Escherichia coli'', ''Proteus'' species, ''Klebsiella'' species), ''Haemophilus influenzae'', atypical bacteria (''Mycoplasma'', ''Chlamydia'', ''Legionella''), and ''Streptococcus pneumoniae'', and anaerobic bacteria. It differs from earlier antibacterials of the fluoroquinolone class such as levofloxacin and ciprofloxacin in having greater activity against Gram-positive bacteria and anaerobes. Because of its potent activity against the common respiratory pathogen ''Streptococcus pneumoniae'', it is considered a "respiratory quinolone."
A United States patent application was submitted on 30 June 1989, for Avelox (moxifloxacin hydrochloride).〔(【引用サイトリンク】title=Avelox Patent Family )〕 In 1999 Avelox was approved by the U.S. Food and Drug Administration (FDA) for use in the United States.〔(【引用サイトリンク】url=http://www.drugpatentwatch.com/premium/preview/NDA/index.php?021085 )
In the United States, moxifloxacin is licensed for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, community acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and complicated intra-abdominal infections. In the European Union, it is licensed for acute bacterial exacerbations of chronic bronchitis, non-severe community-acquired pneumonia, and acute bacterial sinusitis. Based on its investigation into reports of rare but severe cases of liver toxicity and skin reactions, the European Medicines Agency recommended in 2008 that the use of the oral (but not the IV) form of moxifloxacin be restricted to infections in which other antibacterial agents cannot be used or have failed. In the US, the marketing approval does not contain these restrictions, though the label contains prominent warnings against skin reactions.
Avelox (moxifloxacin) was launched in the United States in 1999 and is marketed in more than 80 countries worldwide. In the United States, Avelox is marketed by Bayer's partner Merck.
In 2011, the FDA added two box warnings for this drug in reference to spontaneous tendon ruptures and the fact that moxifloxacin may cause worsening of myasthenia gravis symptoms, including muscle weakness and life-threatening breathing problems.〔http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021085s047,021277s041lbl.pdf〕
==Medical uses==
Moxifloxacin is used to treat a number of infections, including: respiratory tract infections, cellulitis, anthrax, intraabdominal infections, endocarditis, meningitis, and tuberculosis.〔(【引用サイトリンク】url=http://www.drugs.com/monograph/avelox.html )
The initial approval by the FDA (December 1999)〔http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21085ltr.pdf〕 encompassed these indications:
*Acute exacerbations of chronic bronchitis
*Acute bacterial sinusitis
*Community acquired pneumonia
Additional indications were approved by the FDA are:
*April 2001: Uncomplicated skin and skin structure infections〔http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-085S010_Avelox_Approv.pdf.〕
*May 2004: Community acquired pneumonia caused by multidrug resistant ''Streptococcus pneumoniae''〔^ http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21085se1-022,21277se1-017ltr.pdf.〕
*June 2005: Complicated skin and skin structure infections〔http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021085s026,021277s022ltr.pdf.〕
*November 2005: Complicated intra-abdominal infections〔^ http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021085s027,029,021277s024,025ltr.pdf.〕
The European Union requires that moxifloxacin only be prescribed when other antibiotics that have been initially recommended for treatment cannot be used or have failed.
No uses within the pediatric population for oral and intravenous moxifloxacin have been approved. A significant number of drugs found within this class, including moxifloxacin, are not licensed by the FDA for use in children due to the risk of permanent injury to the musculoskeletal system.〔(【引用サイトリンク】 SYNOPSIS )
In ophthalmology, moxifloxacin is approved for the treatment of conjunctival infections caused by susceptible bacteria.

抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
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