Fidaxomicin

Fidaxomicin is a prescription medication used for the treatment of Clostridioides difficile-Associated Diarrhea.

Adult and pediatric dosage

Tablet

• 200mg

Oral granules for suspension

• 200mg/5mL (40mg/mL) after reconstitution

Clostridioides difficile-Associated Diarrhea

Adult dosage

• 200 mg orally twice daily for 10 days

Pediatric dosage

• Children below 6 months: Safety and efficacy not established
• Children 6 months or older

Tablets

• Children weighing above 12.5 kg: 200 mg orally twice daily for 10 days

Oral suspension

• Weight base dose for 10 days
• Children weighing between 4 to 6 kg: 80 mg orally twice daily
• Children weighing between 7 to 8  kg: 120 mg orally twice daily
• Children weighing between 9 to 12 kg: 160 mg orally twice daily
• Children weighing above 12.5 kg: 200 mg orally twice daily

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Fidaxomicin include:

• nausea,
• vomiting,
• stomach pain,
• bloating,
• gas,
• mild rash, and
• itching

Serious side effects of Fidaxomicin include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• fever,
• chills,
• body aches,
• flu symptoms,
• sores in the mouth and throat,
• pale skin,
• lightheadedness,
• shortness of breath,
• rapid heart rate,
• trouble concentrating,
• black, bloody, or tarry stools,
• coughing up blood, and
• vomit that looks like coffee grounds.

Rare side effects of Fidaxomicin include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Fidaxomicin has no noted severe interactions with any other drugs.
• Fidaxomicin has no noted serious interactions with any other drugs.
• Fidaxomicin has no noted moderate interactions with any other drugs.
• Fidaxomicin has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Fidaxomicin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Fidaxomicin?”

Cautions

• Only use for infection proven or strongly suspected to be caused by C difficile to avoid the development of drug-resistant bacteria; therapy not effective for the treatment of other types of infections due to minimal systemic absorption of fidaxomicin
• Acute hypersensitivity reactions, including dyspnea, rash, pruritus, and angioedema of the mouth, throat, and face reported; discontinue and treat appropriately if a reaction occurs therapy should be instituted
• Some patients with hypersensitivity reactions also reported a history of allergy to other macrolides
• Use in the absence of proven or strongly suspected C difficile infection is unlikely to provide benefit to the patient and increases the risk of developing drug-resistant bacteria
• Drug interaction overview
  • Not dependent on CYP450 enzymes for metabolism
  • Fidaxomicin and its main metabolite, OP-1118, are P-gp substrates, but not significantly affected by P-gp inhibitors
  • Based on the results of studies coadministered with cyclosporine, fidaxomicin may be co-administered with P-gp inhibitors and no dose adjustment is recommended

Pregnancy and Lactation

• Limited available data in pregnant women are insufficient to inform any drug-associated risk for major birth defects; miscarriage or adverse maternal or fetal outcomes.
• Lactation
  • There is no information on the presence of fidaxomicin or its main metabolite, OP-1118, in human milk, the effects on the breastfed infant, or milk production; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from therapy or the underlying maternal condition