Dificid

Fidaxomicin has been gradually launched in Europe, the United States and some countries, and has been gradually included in the standard treatment guidelines for Clostridium difficile infection. Foreign news has reported that fidaxomicin has shown in clinical trials that its recurrence rate is significantly lower than vancomycin, bringing new treatment options to patients with refractory and recurrent Clostridium difficile infection.

1. Drug name

1. Generic name: Fidaxomicin (Fidaxomicin)

2. Trade name: Dificid

2. Indications

It is used to treat Clostridium difficile-associated diarrhea (CDAD) in adults and children 6 months and older. Only suitable for infections confirmed or highly suspected to be caused by Clostridium difficile to reduce the development of drug-resistant bacteria.

3. Specifications and properties

Tablet: 200mg

4. Main ingredients

Active ingredient: Fidaxomicin sesquihydrate. Excipients include microcrystalline cellulose, citric acid, mixed berry essence, etc. (suspension) or magnesium stearate, polyvinyl alcohol, etc. (tablets).

5. Usage and Dosage

1. Adult : 200 mg tablet orally taken twice a day, for 10 days.

2. Children :

(1). Those ≥12.5kg and able to swallow tablets: 200mg tablets twice a day.

(2) For patients ≥4kg: use suspension according to body weight (for example, 80mg/time for 4-7kg, 120mg/time for 7-9kg).

3. How to take : Can be taken with food or on an empty stomach. If you miss a dose, you can make up for it if it is ≥ 12 hours before the next dose.

VI. Dose adjustment

1. Hematological toxicity : Suspend administration when hemoglobin <8g/dL or platelets <100,000/mcL, and reduce the dose to 100mg/time after recovery.

2. Hepatotoxicity : Permanent discontinuation when ALT/AST>5 times normal value or bilirubin>3 times.

7. Medication precautions

1. Monitoring requirements : Regularly test liver function, blood routine and electrolytes during treatment.

2. Allergic reaction : If dyspnea, angioedema, etc. occur, the drug must be discontinued immediately.

8. U200c medication for special groups

1. Pregnant women: : There is no sufficient data, and the pros and cons need to be weighed.

2. During lactation : Suspend breastfeeding or discontinue medication.

3. Children : The safety of children under 6 months of age has not been established.

4. U200c for the elderly: No need to adjust the dosage.

9. Adverse reactions

1. Common in adults: Nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal bleeding (4%).

2. Common symptoms in children: Fever (13%), abdominal pain (8%), and rash (5%).

10. Contraindications

It is prohibited for those allergic to fidaxomicin or excipients.

11. Drug interactions

1. Combination with cyclosporine may increase the plasma concentration of fidaxomicin, but there is no need to adjust the dose.

2. Avoid using it in combination with powerful P-glycoprotein inhibitors.

12. Storage method

Tablets: Store at room temperature 20-25°C.