Fidaxomicin: A Novel Macrocyclic Antibiotic for the Treatment of Clostridium difficile Infection

Tonya Crawford, Pharm.D; Emily Huesgen, Pharm.D; Larry Danziger, Pharm.D

Disclosures

Am J Health Syst Pharm. 2012;69(11):933-943. 

In This Article

Dosage and Administration

The dosage of fidaxomicin oral tablets in FDA-approved labeling,[50] based on clinical efficacy trials,[46,48,49] is 200 mg orally twice daily for 10 days. An oral suspension is in Phase II development. Fidaxomicin has not been studied in patients with hepatic or renal dysfunction. However, since absorption of the drug and its metabolite is negligible, it is unlikely that dosage adjustments would be required in patients with hepatic or renal dysfunction.[50]

Studies investigating the pharmacokinetic effects of high-fat meals on the Cmax and AUC of fidaxomicin have found a decrease in Cmax of 21.5% and 33.4% for fidaxomicin and OP-1118, respectively, while the AUC remained unchanged.[49] Because the change in C max was not considered clinically significant, fidaxomicin can be administered with or without food.

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