Fidaxomicin

Fidaxomicin in Kenya

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.

Drug Label Information | Brands:

Brands of Fidaxomicin in Kenya

NB: Fidaxomicin is not available in Kenya ,and its not approved by PPB in Kenya

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

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.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥ 2 %) are nausea, vomiting, abdominal pain, gastrointestinal hemorrhage, anemia, and neutropenia.

USE IN SPECIFIC POPULATIONS

Pediatrics: The safety and effectiveness of Fidaxomicin has not been studied in patients <18 years of age.

DOSAGE FORMS AND STRENGTHS

Film-coated tablets: 200 mg