fidaxomicin (fi-dax-oh-mye-sin) Dificid

 Indications

Treatment of diarrhea associated with Clostridium difficile.

Action

Bactericial action mostly against clostridia; inhibits RNA

synthesis. Acts locally in the GI tract to eliminate Clostridium

difficile. Therapeutic Effects: Elimination

of diarrhea caused by Clostridium difficile.

Pharmacokinetics

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.

TIME/ACTION PROFILE

ROUTE ONSET PEAK DURATION

PO unknown unknown unknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity.

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.

Interactions

Drug-Drug: No significant interactions noted.

Route/Dosage

PO (Adults 18 yr): 200 mg twice daily for 10 days.

Availability

Tablets: 200 mg.