Brands of Fidaxomicin in Kenya
NB: Fidaxomicin is not available in Kenyan market
Fidaxomicin Mechanism of Action:
Fidaxomicin is a fermentation product obtained from the Actinomycete Dactylosporangium aurantiacum. Fidaxomicin is bactericidal against C. difficile in vitro, inhibiting RNA synthesis by RNA polymerases, and demonstrates a post-antibiotic effect vs. C. difficile of 6-10 hrs.
INDICATIONS AND USAGE
Fidaxomicin is a macrolide antibacterial drug indicated in adults (≥18 years of age) for treatment of Clostridium difficile-associated diarrhea.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Fidaxomicin and other antibacterial drugs, Fidaxomicin should be used only to treat infections that are proven or strongly suspected to be caused by Clostridium difficile.
DOSAGE AND ADMINISTRATION
One 200 mg tablet orally twice daily for 10 days with or without food
USE IN SPECIFIC POPULATIONS
Pediatrics: The safety and effectiveness of Fidaxomicin has not been studied in patients <18 years of age.
CONTRAINDICATIONS
Fidaxomicin is contraindicated in patients who have known hypersensitivity to fidaxomicin ingredient in
WARNINGS AND PRECAUTIONS
Fidaxomicin should only be used for the treatment of C. difficile-associated diarrhea. Fidaxomicin is not effective for treatment of other types of infections due to minimal systemic absorption of fidaxomicin.
Acute hypersensitivity reactions (angioedema, dyspnea, pruritus, and rash) have been reported. In the event of a severe reaction, discontinue Fidaxomicin
Development of drug-resistant bacteria: Only use Fidaxomicin for infection proven or strongly suspected to be caused by C. difficile.
DRUG INTERACTIONS
Effect of P-gp inhibitors on fidaxomicin
Fidaxomicin is a substrate of P-gp. Co-administration of single doses of the P-gp inhibitor cyclosporine A and fidaxomicin in healthy volunteers, resulted in a 4- and 2-fold increase in fidaxomicin Cmax and AUC, respectively and in a 9.5 and 4-fold increase in Cmax and AUC, respectively, of the main active metabolite OP-1118. As the clinical relevance of this increase in exposure is unclear, co-administration of potent inhibitors of P-gp, such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone is not recommended (see sections 4.4 and 5.2).
Effect of fidaxomicin on P-gp substrates
Fidaxomicin may be a mild to moderate inhibitor of intestinal P-gp.
Fidaxomicin (200 mg twice daily) had a small but not clinically relevant effect on digoxin exposure. However, a larger effect on P-gp substrates with lower bioavailability more sensitive to intestinal P-gp inhibition such as dabigatran etexilat cannot be excluded.
Effect of fidaxomicin on other transporters
Fidaxomicin does not have a clinically significant effect on the exposure of rosuvastatin, a substrate for the transporters OATP2B1 and BCRP. Co-administration of 200 mg fidaxomicin twice daily with a single dose of 10 mg rosuvastatin to healthy subjects did not have a clinically significant effect on the AUCinf of rosuvastatin.
Paediatric population
Interaction studies have only been performed in adults.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥ 2 %) are nausea, vomiting, abdominal pain, gastrointestinal hemorrhage, anemia, and neutropenia.
Clinical | Pharmacokinetic data
Pregnancy Category: B (No risk in non-human studies)
Routes of Administration: Oral
Bioavailability: Minimal systemic absorption
Protein Binding: Not Available
Metabolosim: Not Available
Onset of Action: Not Available
Elimination Half life: 11.7 ± 4.80 hours
Excretion: Urine (
Legal Status | Dosage forms & Strengths
Prescription Category:
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Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
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References/ Citation:
Fidaxomicin