DIFICID 200 MG ( FIDAXOMICIN )

What is Dificid?

Dificid is a macrolide antibiotic that works by killing sensitive bacteria.

Dificid is used to treat diarrhea caused by infection with Clostridium difficile.

Fidaxomicin works differently from other medicines because it passes into your stomach and intestines without being absorbed into your bloodstream.

Dificid is for use in adults and children at least 6 months old.

💊 Dosage & Administration

• Adults & Children ≥12.5 kg (able to swallow tablets):

  • 200 mg orally twice daily for 10 days

• Pediatric Patients (Oral Suspension):

  • 4 to <7 kg: 80 mg (2 mL) twice daily

  • 7 to <9 kg: 120 mg (3 mL) twice daily

  • 9 to <12.5 kg: 160 mg (4 mL) twice daily

  • ≥12.5 kg: 200 mg (5 mL) twice daily

• Administration: With or without food

⚙️ Mechanism of Action

Fidaxomicin inhibits bacterial RNA polymerase, thereby preventing transcription and subsequent bacterial replication. It exhibits a narrow spectrum of activity, targeting C. difficile while preserving the normal gut flora. This selective activity helps reduce the risk of recurrence.

🧪 Pharmacokinetics

• Absorption: Minimal systemic absorption; acts locally in the gastrointestinal tract

• Metabolism: Converted to an active metabolite, OP-1118

• Excretion: Approximately 92% excreted in feces; <1% in urine

• Half-life: Approximately 11.7 hours

⚠️ Side Effects

Common Adverse Reactions:

• Nausea

• Vomiting

• Abdominal pain

• Gastrointestinal hemorrhage

• Anemia

• Neutropenia

Pediatric Patients:

• Fever (13.3%)

• Abdominal pain (8.2%)

• Vomiting (7.1%)

• Diarrhea (7.1%)

• Constipation (5.1%)

• Increased aminotransferases (5.1%)

• Rash (5.1%)

🔬 Clinical Efficacy

In Phase III clinical trials, fidaxomicin demonstrated non-inferiority to vancomycin in achieving clinical cure for CDAD. Additionally, fidaxomicin was associated with a lower rate of recurrence compared to vancomycin.