Table 6b. Product Labeling Dose and Administration

Intravenous
Oral
> 40 kg
< 40 kg
Loading Dose
2 doses of 6 mg/kg
Q 12 hrs x 24 hrs
2 doses of 400 mg Q 12 hrs x 24 hrs
2 doses of 200 mg Q 12 hrs x 24 hrs
Maintenance Dosea,b,c
Serious
Candida Infectionsd
3 mg/kg Q 12 hrs 200 mg Q 12 hrs 100 mg Q 12 hrs

Aspergillosis,
Scedosporium and
Fusarium, other moulds

4 mg/kg Q 12 hrs 200 mg Q 12 hrs 100 mg Q 12 hrs

aInitial oral maintenance dose of 200 mg Q 12 hrs is recommended rather than 300 mg Q 12 hrs for considerations of hepatic safety
bProvision is made for dose increase if inadequate response; 300 mg PO BID (if < 40 kg: 150 mg PO BID); if not tolerating therapy IV dose may be decreased to 3 mg/kg IV Q 12 hrs
cMaintenance dose may need to be decreased by 50% for patients with mild-to-moderate hepatic impairment (Child-Pugh class A or B), not enough data to recommend in patients with severe hepatic impairment (Child-Pugh class C)
dNot a FDA-approved indication

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