General

Pronunciation:
fi-dax-oh-mye-sin

Trade Name(s)

• Dificid

Ther. Class.
anti-infectives

Pharm. Class.
macrolides

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 Effect(s):

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

Contraindication/Precautions

Contraindicated in:

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

Use Cautiously in:

• OB:   Use only if potential maternal benefit justifies potential fetal risk;
• Lactation: Use while breast feeding only if potential maternal benefit justifies potential risk to infant;
• Pedi:   Safety and effectiveness not established.

Adverse Reactions/Side Effects

GI: GI HEMORRHAGE, nausea, abdominal pain

Hemat: anemia, neutropenia

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANGIOEDEMA)

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

None reported.

Route/Dosage

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

Availability

Tablets: 200 mg

Assessment

• Monitor bowel function for diarrhea, abdominal cramping, fever, and bloody stools. May begin up to several wk 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.

Potential Diagnoses

• Risk for infection (Indications) 
• Diarrhea (Indications) 

Implementation

• PO Administer twice daily, about 12 hr apart, without regard to food.

Patient/Family Teaching

• Instruct patient to take fidamoxicin 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.
• Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breast feeding.

Evaluation/Desired Outcomes

Decrease in diarrhea caused by Clostridium difficile.