Products
Fidaxomicin was approved in the U.S. and EU in 2011 and in many countries in 2014 in film-coated tablet form (Dificlir).
Structure and properties
Fidaxomicin (C52H74Cl2O18, Mr = 1058.0 g/mol) is a complex macrocycline obtained by fermentation from the actinomycete ssp. It is practically insoluble in water.
Effects
Fidaxomicin (ATC A07AA12) has bactericidal properties against . It is effective locally in the intestine and is poorly absorbed into the organism. The effects are due to inhibition of bacterial RNA synthesis by inhibition of RNA polymerases.
Indications
For the treatment of -associated diarrhea (CDAD).
Dosage
According to the SmPC. The usual dose is 200 mg twice daily for 10 days. The tablets can be taken independently of meals.
Contraindications
- Hypersensitivity
For complete precautions, see the drug label.
Interactions
Fidaxomicin and its metabolite OP-1118 are substrates of P-glycoprotein. With concomitant use of a P-gp inhibitor, plasma concentrations of fidaxomicin may increase slightly and efficacy may be slightly reduced.
Adverse effects
Among the most common possible adverse effects vomiting, nausea, and constipation.