黴菌感染 Candidemia and other Candida infections: Treatment of candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in adults and pediatric patients ≥1 month of age Candidiasis, esophageal, refractory disease: Treatment of esophageal candidiasis in adults
#仿單變更2021
藥理
Antifungal Agent, Echinocandin
Noncompetitive inhibitor of 1,3-beta-D-glucan synthase resulting in reduced formation of 1,3-beta-D-glucan, an essential polysaccharide comprising 30% to 60% of Candida cell walls (absent in mammalian cells); decreased glucan content leads to osmotic instability and cellular lysis
藥動學
Distribution:
Protein binding: greater than 99% Metabolism:
1. No hepatic metabolism observed (not a substrate, inducer, or inhibitor of CYP450)
2. Anidulafungin undergoes slow chemical degradation at physiologic temperature and pH to a ring-opened peptide that lacks antifungal activity Excretion:
1. Feces (30%, 10% as unchanged drug); urine (<1%)
2. Elimination half- life: 26.5 hrs
3. Dialyzable: no (hemodialysis)
禁忌症
Hypersensitivity to anidulafungin, any component of the product, or other echinocandins
懷孕分類
C
哺乳分類
Excretion in breast milk unknown/use caution
副作用
Diarrhea, hypokalemia, elevated ALT
劑量和給藥方法
Candidemia:
1. Dosage: 200 mg on day 1, then 100 mg once daily
2. Total duration (including oral step-down therapy) is ≥14 days after first negative blood culture and continues until signs/symptoms of candidemia and neutropenia, if present, have resolved Intra-abdominal infection (eg, peritonitis, abdominal abscess):
1. Dosage: 200 mg on day 1, then 100 mg once daily
2. Total duration (including oral step-down therapy) is ≥14 days and continues until source control and clinical resolution
小兒調整劑量
腎功能調整劑量
No dosing adjustments are required for patients with any degree of renal insufficiency, including dialysis patients.
肝功能調整劑量
No dosing adjustments are required for patients with any degree of hepatic insufficiency.
安定性
1. Store unreconstituted vials between 2 and 8℃; Do not store under 0℃. <20210524>
2. Once reconstituted (with sterile water for injection only), store between 2 and 8 ℃ for up to 24 hour prior to further dilution into the infusion solution.