Formulary
Fidaxomicin: Indications, Dosing, Side Effects and Interactions
Fidaxomicin is a macrocyclic antibacterial that is poorly absorbed from the gastro-intestinal tract, and, therefore, it should not be used to treat systemic...
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Fidaxomicin: Indications, Dosing, Side Effects and Interactions
Fidaxomicin is a macrocyclic antibacterial that is poorly absorbed from the gastro-intestinal tract, and, therefore, it should not be used to treat systemic...
Drug action
Fidaxomicin is a macrocyclic antibacterial that is poorly absorbed from the gastro-intestinal tract, and, therefore, it should not be used to treat systemic infections.
Indications and dose
**Clostridioides difficileinfection**
- **Adult** (By Mouth): Clostridioides difficile infection 200 mg every 12 hours for 10 days.
**Clostridioides difficileinfection [extended-pulsed dosing]**
- **Adult** (By Mouth Using Tablets): Clostridioides difficile infection [extended-pulsed dosing] Initially 200 mg every 12 hours on days 1-5, then 200 mg once daily on alternate days on days 7-25.
**Clostridioides difficile infection for fidaxomicin**
- **Neonate (body-weight up to 4 kg)** (By mouth): 40 mg every 12 hours for 10 days.
- **Neonate (body-weight 4-6 kg)** (By mouth): 80 mg every 12 hours for 10 days.
- **Child (body-weight up to 4 kg)** (By mouth): 40 mg every 12 hours for 10 days.
- **Child (body-weight 4-6 kg)** (By mouth): 80 mg every 12 hours for 10 days.
- **Child (body-weight 7-8 kg)** (By mouth): 120 mg every 12 hours for 10 days.
- **Child (body-weight 9-12.4 kg)** (By mouth): 160 mg every 12 hours for 10 days.
- **Child (body-weight 12.5 kg and above)** (By mouth): 200 mg every 12 hours for 10 days.
Side effects
Common or very common Constipation; nausea; vomiting Uncommon Abdominal distension; appetite decreased; dizziness; dry mouth; flatulence; headache; skin reactions; taste altered
Interactions
**Severe interactions:**
- 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.
**Other interactions (5):**
- 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 C max and AUC, respectively and in a...
- 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,...
- 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.
Pregnancy
Manufacturer advises avoid-no information available.
Breast feeding
Manufacturer advises avoid-no information available.
Hepatic impairment
Manufacturer advises caution in moderate to severe impairment-limited information available.
Renal impairment
Caution in severe impairment (limited information available). M
Medicinal forms
Tablet,Suspension
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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