非达霉素(Dificid)的用法用量:用药指南,剂量调整,特殊人群用药

Fidaxomicin (Dificid) was approved by the US FDA in May 2011 for the treatment of Clostridium difficile infection (CDI).

Usage and dosage of fidaxomicin (Dificid)

1. Common dosage for Clostridium difficile infection in adults

Take 200 mg orally twice a day for 10 days.

2. Common dosage for Clostridium difficile infection in children

Children weighing at least 12.5 kg: 200 mg orally, twice daily.

Fidaxomicin (Dificid) dose adjustment

1. Renal function adjustment dose

No dose adjustment is required.

2. Liver function adjustment dose

There is no relevant data yet.

3. Medication for dialysis patients

There is currently no relevant data.

Fidaxomicin (Dificid) storage requirements

Tablets: Store original bottle at 20°C-25°C (68°F-77°F), allow brief exposure to 15°C-30°C (59°F-86°F).

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.

Use of fidaxomicin (Dificid) in special populations

1. Pregnancy period

Existing data are insufficient to provide information on whether there is a risk of major birth defects, miscarriage or adverse maternal and fetal outcomes when pregnant women use this drug.

No evidence of harm to the fetus was found when fidaxomicin was administered intravenously to rats and rabbits during organogenesis at doses that resulted in exposures to fidaxomicin and its major metabolite OP-1118 that were 65 times or more the exposure reported for humans at recommended doses.

2. Lactation

It is not known whether fidaxomicin or its major metabolite (OP-1118) is excreted into human milk, affects breastfed infants, or affects breast milk.

The developmental and health benefits of breastfeeding should be considered, as well as the mother's clinical need for fidaxomicin and the potential adverse effects of this drug or underlying maternal disease on the breastfed infant.

3. Pediatric medication

The safety and effectiveness in patients under 18 years of age have not been established. Designated as an orphan drug by the FDA for the treatment of pediatric patients with †CDI.

In a Phase 2a clinical trial of pediatric patients ≥6 months of age† with Clostridium difficile -associated diarrhea, the drug's safety profile was similar to that reported in adults.

4. Geriatric use

There is generally no difference in effectiveness or safety observed in older adults aged ≥65 years compared with younger adults.

Plasma concentrations of fidaxomicin and its major metabolite (OP-1118) were higher in patients ≥65 years of age than in younger adults, but remained within the nanograms per milliliter (ng/mL) range. Not considered clinically important; no dose adjustment recommended.

5. Hepatic insufficiency

The impact of hepatic insufficiency on pharmacokinetics has not been formally studied, but since fidaxomicin and its major metabolite (OP-1118) do not appear to undergo significant hepatic metabolism, their elimination is not expected to be substantially affected.

6. Renal insufficiency

In clinical trials in patients with mild, moderate, or severe renal insufficiency (based on creatinine clearance Clcr) who received fidaxomicin (200 mg orally twice daily for 10 days), plasma concentrations of fidaxomicin and its major metabolite (OP-1118) did not change with the severity of renal insufficiency. No dosage adjustment is recommended.