黴菌感染
In adults and pediatric patients ≥4 months of age:
1. Treatment of esophageal candidiasis, invasive candidemia, acute disseminated candidiasis, and Candida peritonitis and abscesses<20220413>
2. Prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation
In pediatric patients ≤4 months of age:
Treatment of candidemia, acute disseminated candidiasis without meningoencephalitis and/or ocular dissemination<20220413>
#仿單變更2022

Antifungal Agent, Echinocandin
Concentration-dependent inhibition 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

Distribution:
1. Distributes into lung, liver, and spleen; minimally to CNS and eyes
2. Protein binding: (Neonates) 96.7%; (Adults) >99% to albumin
Metabolism:
Hepatic to M-1, catechol form by arylsulfatase; further metabolized to M-2, methoxy form by catechol-O-methyltransferase; hydroxylation to M-5 by CYP3A
Excretion:
Primarily feces (71%); urine (<1%, unchanged)

prior hypersensitivity to micafungin or to any component of the product

C

C

Headache, skin rash, nausea, vomiting, diarrhea, rash, pruritus, facial swelling, vasodilatation, infusion-related reaction, injection site phlebitis or thrombophlebitis <20220413>

Esophageal candidiasis:
150 mg/day, for intravenous use only, infuse over 1 hour
Prophylaxis of candidiasis in hematopoietic stem cell transplantation:
50 mg/day IV over 1hr
Invasive candidemia, acute disseminated candidiasis, and Candida peritonitis and abscesses<20220413>:
100 mg /day IV over 1hr; Flush line with NS prior to administration

In pediatric patients ≤4 months of age:
4 mg/kg once daily<20220413>
In pediatric patients ≥4 months of age:

Indication	≤30kg	>30kg
Invasive candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses	2 mg/kg once daily<20220413> (Maximum 100mg/day)
Esophageal candidiasis	3 mg/kg once daily<20220413>	2.5 mg/kg once daily<20220413> (Maximum 150 mg/day)
Prophylaxis of candidiasis in hematopoietic stem cell transplantation	1 mg/kg once daily<20220413> (Maximum 50 mg/day)

1. Altered kidney function: No dosage adjustment necessary
2. Intermittent Hemodialysis, Peritoneal dialysis: Poorly dialyzed: No supplemental dose or dosage adjustment necessary
3. CRRT, PIRRT: No dosage adjustment necessary

No dosage adjustment necessary

1. Add 5 mL of 0.9% sodium chloride injection (without bacteriostatic agent) to 50 mg vial. Dextrose 5% injection can also be used for reconstitution and dilution.
2. Store reconstituted product still in original vial for up to 24 hrs at 25℃.<20220413>