非达霉素(Dificid)的功效与作用

Fidaxomicin (Dificid) was developed by Astellas of Japan and was approved by the US FDA on May 27, 2011.

The efficacy and role of fidaxomicin (Dificid)

Fidaxomicin (Dificid) is a fermentation product obtained from the actinomycete Dactylosporangiumaurantiacum. It is a macrolide antibacterial drug that inhibits RNA synthesis by binding to RNA polymerase.

It has a bactericidal effect on Clostridium difficile in vitro and shows a post-bacterial effect of 6-10 hours.

Indications of fidaxomicin (Dificid)

1. Indications

It is used to treat Clostridium difficile-associated diarrhea (CDAD) in adults and children 6 months and older.

2. Applicable groups

Adults and children from 6 months to 18 years old. It is only used for confirmed or highly suspected infections caused by Clostridium difficile.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of fidaxomicin and other antibacterial drugs, fidaxomicin should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile.

The pictures come from public channels (such as the official website of the FDA, the official website of the original drug manufacturer, etc.) and are for reference only.

Usage and dosage of fidaxomicin (Dificid)

1. Adult standard dose

200mg each time, twice a day, for 10 consecutive days.

2. Medication time

Fidaxomicin is not affected by food and can be taken with food or on an empty stomach according to the patient's habits.

Precautions for fidaxomicin (Dificid)

1. Acute allergic reactions (angioedema, dyspnea, itching and rash) have been reported. If a severe allergic reaction occurs, fidaxomicin should be discontinued

2. Since fidaxomicin has very little systemic absorption, DIFICID is not expected to be effective in treating other types of infections, and fidaxomicin should only be used to treat Clostridium difficile-associated diarrhea.

3. Only use fidaxomicin for infections proven or strongly suspected to be caused by Clostridium difficile.

Adverse reactions/side effects of fidaxomicin (Dificid)

1. The most common adverse reactions (incidence rate ≥2%) in adults include: nausea, vomiting, abdominal pain, gastrointestinal bleeding, anemia and neutropenia.

2. The most common adverse reactions (incidence ≥5%) when using fidaxomicin in pediatric patients include: fever, abdominal pain, vomiting, diarrhea, constipation, elevated transaminases and rash.

Fidaxomicin (Dificid) Medication for Special Populations

1. Pregnant women

There is limited data on the use of fidaxomicin, but animal experiments have not found any obvious harm to the fetus. It should be used after weighing the pros and cons.

2. Breastfeeding women

You also need to be careful when taking the drug. It is not yet clear whether fidaxomicin will enter the breast milk.

3. Elderly patients

No dose adjustment is required. The study found that the plasma concentration of the elderly group was slightly higher than that of young patients, which was not clinically significant.

4. People with renal or hepatic insufficiency

There is no need to adjust the dosage, because the drug is almost not metabolized by the kidneys or liver.