API FidaxoMicin CAS 873857-62-6 Raw Power With USP/EP Grade 99% High Quality Choice

Fidaxomicin More Info

Fidaxomicin is a macrocyclic lactone antibiotic, specifically an 18-membered macrolide, naturally derived from the fermentation of the actinomycete Dactylosporangium aurantiacum subsp. hamdenensis, with the CAS Registry Number 873857-62-6. It is also known by several synonyms, including lipiarmycin A3, tiacumicin B, clostomicin B1, and difimicin, reflecting its independent discovery by multiple research groups. Chemically, it is characterized by a complex macrocyclic structure containing chlorine atoms and multiple sugar moieties, with a molecular weight of 1058.04. It is the first member of a novel class of macrocyclic antibiotics developed for treating Clostridioides difficile infections.

The mechanism of action of fidaxomicin is distinct from that of traditional macrolide antibiotics. While macrolides typically inhibit protein synthesis, fidaxomicin exerts its potent bactericidal activity by specifically inhibiting bacterial RNA polymerase. It binds to the DNA template-RNA polymerase complex, blocking the initiation of RNA synthesis at the transcription phase. This unique target site, particularly its interaction with the sigma subunit of the enzyme, is thought to contribute to its narrow spectrum of activity, as this mechanism is not shared by all bacterial species. Its activity is time-dependent, and it demonstrates potent killing specifically against Gram-positive anaerobes, with a minimum inhibitory concentration significantly lower than that of vancomycin for C. difficile.

The primary and approved clinical application of fidaxomicin is the treatment of diarrhea associated with Clostridioides difficile infection in both adults and pediatric patients aged six months and older. A critical advantage of fidaxomicin is its narrow spectrum, which allows it to target C. difficile effectively while causing minimal disruption to the protective, normal colonic microflora, a key factor in preventing infection recurrence. It is indicated specifically for this infection and does not treat infections elsewhere in the body or those caused by viruses. Its efficacy has been demonstrated in clinical studies, including in pediatric populations, where it is associated with low rates of treatment failure.

Fidaxomicin is administered orally, as it acts locally within the gastrointestinal tract. It is available as 200 mg film-coated tablets and as granules for oral suspension, which when reconstituted with water, yields a 40 mg/mL berry-flavored liquid for patients who cannot swallow tablets. The standard dosage for both adults and children weighing at least 12.5 kg is 200 mg twice daily for 10 days. Pediatric dosing is weight-based for those between 4 and 12.5 kg. It can be taken with or without food; while a high-fat meal may slightly reduce the peak concentration of the drug and its metabolite, this is not clinically significant due to its local action.

The pharmacokinetic profile of fidaxomicin is notable for its minimal systemic absorption following oral administration. It is primarily confined to the gastrointestinal tract, where it is transformed via hydrolysis to its main and pharmacologically active metabolite. This metabolism is not mediated by cytochrome P450 enzymes. The drug and its metabolites are almost exclusively eliminated in the feces, with over 92% of a dose recovered there, and less than 1% excreted in the urine. Its safety profile is favorable, with the most common side effects being gastrointestinal, such as nausea, vomiting, and abdominal pain. Serious adverse events, including hypersensitivity reactions and gastrointestinal hemorrhage, are rare. Its safety during pregnancy and breastfeeding is not fully established, and it should be used only if the potential benefit justifies the risk.

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