Fidaxomicin is an antibacterial drug.

DIFICID is a macrolide antibacterial indicated in adult and pediatric patients 6 months of age and older for the treatment of C. difficile-associated diarrhea. To reduce the development of drug-resistant bacteria and maintain the effectiveness of DIFICID and other antibacterial drugs, DIFICID should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile.

• DIFICID is administered orally with or without food.
• Adults

o One 200 mg tablet orally twice daily for 10 days.

• Pediatrics (6 Months to Less than 18 Years of Age)
• Tablets

o Pediatric patients weighing at least 12.5 kg and able to swallow tablets:
o One 200 mg tablet orally twice daily for 10 days. 

• Oral Suspension 

o Pediatric patients weighing at least 4 kg: Weight-based dosing of the oral suspension twice daily for 10 days using an oral dosing syringe, a as specified in Table 1 in the full prescribing information.

See package insert for complete information.

The most common adverse reactions in adults (incidence ≥2%) are nausea, vomiting, abdominal pain, gastrointestinal hemorrhage, anemia, and neutropenia. The most common adverse reactions in pediatric patients (incidence ≥5%) treated with DIFICID are pyrexia, abdominal pain, vomiting, diarrhea, constipation, increased aminotransferases, and rash.

DIFICID is contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in DIFICID.

• Acute hypersensitivity reactions (angioedema, dyspnea, pruritus, and rash) have been reported. If a severe hypersensitivity reaction occurs, discontinue DIFICID.
• DIFICID is not expected to be effective for the treatment of other types of infections due to minimal systemic absorption of fidaxomicin. DIFICID should only be used for the treatment of C. difficile-associated diarrhea.
• Development of drug-resistant bacteria: Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile.