Classes
DEA Class; Rx
Common Brand Names; Dificid
- Macrolides
Description
Oral macrolide antibiotic with minimal systemic absorption
Used for Clostridium difficile-associated diarrhea (CDAD) in adults and pediatric patients 6 months and older
May provide improved sustained response for CDAD
Indications
Indicated for treatment of Clostridioides difficile-associated diarrhea (CDAD)
To reduce the development of drug-resistant bacteria and maintain the effectiveness, use only to treat infections that are proven or strongly suspected to be caused by C difficile
Contraindications
Hypersensitivity
Adverse Effects
- Nausea (11%)
- Pyrexia (13.3%)
- Vomiting (7%)
- Abdominal pain (6%)
- Gastrointestinal hemorrhage (4%)
- Anemia (2%)
- Neutropenia (2%)
- Gastrointestinal disorders: Abdominal distension, abdominal tenderness, dyspepsia, dysphagia, flatulence, intestinal obstruction, megacolon
- Investigations: Increased blood alkaline phosphatase, decreased blood bicarbonate, increased hepatic enzymes, decreased platelet count
- Metabolism and nutrition disorders: Hyperglycemia, metabolic acidosis
- Skin and subcutaneous tissue disorders: Drug eruption, pruritus, rash
Warnings
Only use for infection proven or strongly suspected to be caused by C difficile to avoid development of drug resistant bacteria; therapy not effective for treatment of other types of infections due to minimal systemic absorption of fidaxomicin
Acute hypersensitivity reactions, including dyspnea, rash, pruritus, and angioedema of the mouth, throat, and face reported; discontinue and treat appropriately if reaction occurs therapy should be instituted
Some patients with hypersensitivity reactions also reported a history of allergy to other macrolides
Use in the absence of proven or strongly suspected C difficile infection is unlikely to provide benefit to the patient and increases risk of developing drug-resistant bacteria
Pregnancy and Lactation
Limited available data in pregnant women are insufficient to inform any drug-associated risk for major birth defects; miscarriage or adverse maternal or fetal outcomes
There is no information on presence of fidaxomicin or its main metabolite, OP-1118, in human milk, the effects on breastfed infant, or on milk production
Maximum Dosage
400 mg/day PO.
400 mg/day PO.
400 mg/day PO.
weight 12.5 kg or more: 400 mg/day PO.
weight 9 to 12.4 kg: 320 mg/day PO.
weight 7 to 8 kg: 240 mg/day PO.
6 to 11 months weighing 9 to 12.4 kg: 320 mg/day PO.
6 to 11 months weighing 7 to 8 kg: 240 mg/day PO.
6 to 11 months weighing 4 to 6 kg: 160 mg/day PO.
1 to 5 months: Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Fidaxomicin
tablet
- 200mg