• Treatment of diarrhea associated with Clostridioides difficile.

Contraindicated in:

• Hypersensitivity to fidaxomicin or macrolides (cross-sensitivity may occur).

Use Cautiously in:

• OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi: Children <6 mo (safety and effectiveness not established).

GI: nausea, abdominal pain, GI HEMORRHAGE.

Hemat: anemia, neutropenia.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANGIOEDEMA).

Drug-Drug:

• None reported.

• Granules for oral suspension (berry flavor): 40 mg/mL;
• Tablets: 200 mg;

• PO (Adults): 200 mg twice daily for 10 days.
• PO (Children ≥6 mo and ≥12.5 kg): Tablets: 200 mg twice daily for 10 days (if unable to swallow tablets, use granules for oral suspension).
• PO (Children ≥6 mo and 9–<12.5 kg): Granules for oral suspension: 160 mg twice daily for 10 days.
• PO (Children ≥6 mo and 7–<9 kg): Granules for oral suspension: 120 mg twice daily for 10 days.
• PO (Children ≥6 mo and 4–<7 kg): Granules for oral suspension: 80 mg twice daily for 10 days.

Dificid

• Bactericidal action mostly against clostridia; inhibits RNA synthesis.
• Acts locally in the GI tract to eliminate Clostridioides difficile.

• Elimination of diarrhea caused by Clostridioides difficile.

Therapeutic Classification: anti-infectives

Pharmacologic Classification: macrolides

Absorption: Minimal systemic absorption.

Distribution: Stays primarily in the GI tract.

Metabolism/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.

• Instruct patient to take fidaxomicin twice daily, 12 hr apart, 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 patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

fi-dax-oh-MYE-sin

NDC Code^*

• 52015- Merck Sharp and Dohme Corp.
  • 52015-080- Dificid
    • 52015-080-01- 1 BOTTLE in 1 CARTON (52015-080-01) > 20 TABLET, FILM COATED in 1 BOTTLE