Treatment of diarrhea associated with Clostridium difficile.
- Bactericial action mostly against clostridia; inhibits RNA synthesis.
- Acts locally in the GI tract to eliminate Clostridium difficile.
Elimination of diarrhea caused by Clostridium difficile.
Absorption: Minimal systemic absorption.
Distribution: Stays primarily in the GI tract.
Metabolism and Excretion: Mostly transformed via hydrolysis in the GI tract to OP-1118, its active metabolite. Eliminated mostly (>92%) in feces: <1% excreted in urine.
Half-life: Fidaxomicin– 11.7 hr; OP-1118– 11.2 hr.
Use Cautiously in:
- OB: Lactation: Use during pregnancy only if clearly needed, use cautiously during lactation;
- Pedi: Safe and effective use in children <18 yr has not been established.
Adverse Reactions/Side Effects
GI: GI HEMORRHAGE, nausea, abdominal pain
Hemat: anemia, neutropenia
Misc: HYPERSENSITIVITY REACTIONS
* CAPITALS indicate life-threatening.
Italics indicate most frequent.
No significant interactions noted.
PO: (Adults >18 yr): 200 mg twice daily for 10 days.
Tablets: 200 mg
- Monitor bowel function for diarrhea, abdominal cramping, fever, and bloody stools. May begin up to several weeks following cessation of antibiotic therapy.
- Monitor for signs and symptoms of hypersensitivity reactions (dyspnea, pruritus, rash, angioedema of mouth, throat, and face) periodically during therapy. Risk increases with a macrolide allergy.
Lab Test Considerations: May cause ↑ serum alkaline phosphatase, and hepatic enzymes.
- May cause ↓ serum bicarbonate, ↓ platelet count, anemia, and neutropenia.
- May cause hyperglycemia and metabolic acidosis.
- PO: Administer twice daily without regard to food.
- Instruct patient to take fidamoxicin as directed for the full course of therapy, even if feeling better. Skipping doses or not completing full course of therapy may decrease effectiveness of therapy and increase risk that bacteria will develop resistance and not be treatable in the future.
- Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Decrease in diarrhea caused by Clostridium difficile.