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, |
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