Fidaxomicin: Difference between revisions

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==History==
==History==


Dificid brand of fidaxomicin was approved for Optimer Pharms by the [[Food and Drug Administration]] in the [[United States]] with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/ New Drug Application] (NDA) in 2011.<ref>{{FDA-Drug_Details|201699}}</ref>
Dificid brand of fidaxomicin was approved for Optimer Pharms by the [[Food and Drug Administration]] in the [[United States of America]] with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/ New Drug Application] (NDA) in 2011.<ref>{{FDA-Drug_Details|201699}}</ref>


==Usage==
==Usage==

Latest revision as of 13:18, 2 February 2023

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Main Article
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In infectious disease, fidaxomicin is an macrocyclide antibiotic. It may be used to treat diarrhea caused by clostridium difficile infection as well as Pseudomembranous enterocolitis.

History

Dificid brand of fidaxomicin was approved for Optimer Pharms by the Food and Drug Administration in the United States of America with a New Drug Application (NDA) in 2011.[1]

Usage

In a randomized controlled trial, the relative risk ratio of fidaxomicin, as compared to vancomycin, for recurrence of clostridium difficile infection was 0.6 and the relative risk reduction was 40.0%. In populations similar to those in this study which had a rate of risk as measured by the recurrence of C. difficile infection of 25% without treatment, the number needed to treat is 10. [2]

A second, unpublished randomized controlled trial found benefit on rate of recurrence.[3]

Pharmacology

Administration

Distribution

Metabolism

Excretion

Toxicity

Drug toxicity includes

External links

The most up-to-date information about Fidaxomicin and other drugs can be found at the following sites.


References

  1. Anonymous. Drugs@FDA for FDA Application No. 201699. U S Food and Drug Administration
  2. Louie TJ, Miller MA, Mullane KM, Weiss K, Lentnek A, Golan Y et al. (2011). "Fidaxomicin versus vancomycin for Clostridium difficile infection.". N Engl J Med 364 (5): 422-31. DOI:10.1056/NEJMoa0910812. PMID 21288078. Research Blogging.
  3. Template:Err (2011 [last update]). PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) - Study Results - ClinicalTrials.gov. clinicaltrials.gov. Retrieved on August 8, 2011.