Fidaxomicin: Difference between revisions

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'''| [[Fidaxomicin labels and packages|Labels and Packages]]'''
'''| [[Fidaxomicin labels and packages|Labels and Packages]]'''


==Mechanism==
==Mechanism of Action==
It works by inhibiting the bacterial enzyme [[RNA polymerase]], resulting in the death of ''Clostridium difficile''.<ref>{{cite journal |doi=10.1016/j.mib.2011.07.030 |title=New target for inhibition of bacterial RNA polymerase: 'switch region' |year=2011 |last1=Srivastava |first1=Aashish |last2=Talaue |first2=Meliza |last3=Liu |first3=Shuang |last4=Degen |first4=David |last5=Ebright |first5=Richard Y |last6=Sineva |first6=Elena |last7=Chakraborty |first7=Anirban |last8=Druzhinin |first8=Sergey Y |last9=Chatterjee |first9=Sujoy |journal=Current Opinion in Microbiology |volume=14 |issue=5 |pages=532–43 |pmid=21862392 |pmc=3196380}}</ref> It is active against [[gram positive]] bacteria especially [[clostridia]].  The minimal inhibitory concentration (MIC) range for ''C. difficile'' (ATCC 700057) is 0.03–0.25(μg/mL).<ref name=PrescribingInfo/>
It works by inhibiting the bacterial enzyme [[RNA polymerase]], resulting in the death of ''Clostridium difficile''.<ref>{{cite journal |doi=10.1016/j.mib.2011.07.030 |title=New target for inhibition of bacterial RNA polymerase: 'switch region' |year=2011 |last1=Srivastava |first1=Aashish |last2=Talaue |first2=Meliza |last3=Liu |first3=Shuang |last4=Degen |first4=David |last5=Ebright |first5=Richard Y |last6=Sineva |first6=Elena |last7=Chakraborty |first7=Anirban |last8=Druzhinin |first8=Sergey Y |last9=Chatterjee |first9=Sujoy |journal=Current Opinion in Microbiology |volume=14 |issue=5 |pages=532–43 |pmid=21862392 |pmc=3196380}}</ref> It is active against [[gram positive]] bacteria especially [[clostridia]].  The minimal inhibitory concentration (MIC) range for ''C. difficile'' (ATCC 700057) is 0.03–0.25(μg/mL).<ref name=PrescribingInfo/>



Revision as of 04:43, 9 January 2014

Fidaxomicin
DIFICID ® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

Overview

Fidaxomicin (trade names Dificid, Dificlir, and previously OPT-80 and PAR-101) is the first in a new class of narrow spectrum macrocyclic antibiotic drugs.[1] It is a fermentation product obtained from the actinomycete Dactylosporangium aurantiacum subspecies hamdenesis.[2][3] Fidaxomicin is non-systemic, meaning it is minimally absorbed into the bloodstream, it is bactericidal, and it has demonstrated selective eradication of pathogenic Clostridium difficile with minimal disruption to the multiple species of bacteria that make up the normal, healthy intestinal flora. The maintenance of normal physiological conditions in the colon can reduce the probability of Clostridium difficile infection recurrence.[4] [5]

It is marketed by Cubist Pharmaceuticals after acquisition of its the originating company Optimer Pharmaceuticals. The target use is for treatment of Clostridium difficile infection. Fidaxomicin is available in a 200 mg tablet that is administered every 12 hours for a recommended duration of 10 days. Total duration of therapy should be determined by the patient's clinical status.

Category

Other

US Brand Names

DIFICID®

FDA Package Insert

Description | Clinical Pharmacology | Microbiology | Indications and Usage | Contraindications | Warnings and Precautions | Adverse Reactions | Drug Interactions | Overdosage | Clinical Studies | Dosage and Administration | How Supplied | Labels and Packages

Mechanism of Action

It works by inhibiting the bacterial enzyme RNA polymerase, resulting in the death of Clostridium difficile.[6] It is active against gram positive bacteria especially clostridia. The minimal inhibitory concentration (MIC) range for C. difficile (ATCC 700057) is 0.03–0.25(μg/mL).[2]

References

  1. Revill, P.; Serradell, N.; Bolós, J. (2006). "Tiacumicin B". Drugs of the Future. 31 (6): 494. doi:10.1358/dof.2006.031.06.1000709.
  2. 2.0 2.1 "Dificid, Full Prescribing Information" (PDF). Optimer Pharmaceuticals. 2013.
  3. "Fidaxomicin". Drugs in R&D. 10: 37. 2012. doi:10.2165/11537730-000000000-00000.
  4. Louie, T. J.; Emery, J.; Krulicki, W.; Byrne, B.; Mah, M. (2008). "OPT-80 Eliminates Clostridium difficile and is Sparing of Bacteroides Species during Treatment of C. Difficile Infection". Antimicrobial Agents and Chemotherapy. 53 (1): 261–3. doi:10.1128/AAC.01443-07. PMC 2612159. PMID 18955523.
  5. Johnson, Stuart (2009). "Recurrent Clostridium difficile infection: A review of risk factors, treatments, and outcomes". Journal of Infection. 58 (6): 403–10. doi:10.1016/j.jinf.2009.03.010. PMID 19394704.
  6. Srivastava, Aashish; Talaue, Meliza; Liu, Shuang; Degen, David; Ebright, Richard Y; Sineva, Elena; Chakraborty, Anirban; Druzhinin, Sergey Y; Chatterjee, Sujoy (2011). "New target for inhibition of bacterial RNA polymerase: 'switch region'". Current Opinion in Microbiology. 14 (5): 532–43. doi:10.1016/j.mib.2011.07.030. PMC 3196380. PMID 21862392.