| Drug Name |
Fidaxomicin |
| Drug ID |
BADD_D00896 |
| Description |
Fidaxomicin is a novel macrolide antibiotic used in the treatment of diarrhea caused by _Clostridioides_ (formerly _Clostridium_) _difficile_ in adult and pediatric patients over the age of 6 months.[L11575] Fidaxomicin is a naturally-occurring 18-member macrocycle derived from fermentation.[A190501] Because fidaxomicin contains an 18-membered lactone ring in its structure, it is referred to as a macrocyclic lactone antibiotic drug.[A190492] The antibacterial activity of fidaxomicin is distinct from macrolides and rifamycins, as the bactericidal activity is time-dependent, and not concentration-dependent.[A190492] Fidaxomicin was the first macrocyclic lactone antibiotic with activity against _C. difficile_,[A190486] and it displays a narrow spectrum of activity against gram-positive anaerobes.[A7445] It mediates its potent bactericidal action on the bacteria by inhibiting the bacterial RNA synthase, thereby disrupting bacterial transcription.[A190486] The minimum inhibitory concentration (MIC90) for fidaxomicin is four times less than that of [vancomycin], which was the primary drug of choice for _C. difficile_ infection before the approval of fidaxomicin.[A190492] Unlike vancomycin, however, fidaxomicin has a negligible effect on normal colonic microflora.[A190516]
The FDA initially approved fidaxomicin in May 2011 for the treatment of _C. difficile_-associated diarrhea in adult patients over the age of 18.[A190492] Later that year in December, the drug was also approved by the European Medicine Agency.[A190492] In June 2012, fidaxomicin was also granted approval by Health Canada.[A190486] The approved indication of fidaxomicin was expanded by the FDA in January 2020 to include pediatric patients over the age of 6 months in the treatment population.[L11575] |
| Indications and Usage |
Fidaxomicin is indicated for the treatment of _Clostridioides_ (formerly _Clostridium_) _difficile_-associated diarrhea in adult and pediatric patients 6 months of age and older.[L11575]
Fidaxomicin should only be used in patients with proven or strongly suspected _C. difficile_ infection to reduce the risk of development of drug-resistant bacteria and maximize the therapeutic effectiveness of fidaxomicin and other antimicrobial agents.[L11575] |
| Marketing Status |
approved |
| ATC Code |
A07AA12 |
| DrugBank ID |
DB08874
|
| KEGG ID |
D09394
|
| MeSH ID |
D000077732
|
| PubChem ID |
151383
|
| TTD Drug ID |
D06LNW
|
| NDC Product Code |
52015-080; 65727-027; 62227-003; 52015-700; 55500-0007 |
| UNII |
Z5N076G8YQ
|
| Synonyms |
Fidaxomicin | Lipiarmycin A3 | Lipiarmycin | Tiacumicin B | PAR 101 | PAR101 | PAR-101 | Dificid | Lipiarmycin B4 | Tiacumicin C | Lipiarmycin B | Lipiarmycin A4 | Lipiarmycin B3 |
