Posaconazole delayed-release tablets (adult prophylaxis) - selected U.S. labeling
- Product / population
- Adults receiving fungal prophylaxis with whole oral 100 mg delayed-release posaconazole tablets. The selected generic label is prophylaxis-only; oral suspension, PowderMix and IV formulations are excluded.
- Renal measure
- eGFR mL/min/1.73 m2 for exposure-monitoring caution, not a reduced-dose algorithm.
Labeled basic dosing
For prophylaxis of invasive Aspergillus/Candida infections in severely immunocompromised adults: 300 mg orally twice on day 1, then 300 mg once daily from day 2. Duration follows recovery from neutropenia or immunosuppression. Swallow tablets whole.
Renal information and dialysis
The label keeps the same dosing in renal impairment. At eGFR below 20 mL/min/1.73 m2, monitor especially closely for breakthrough fungal infection because exposure is variable. Hemodialysis does not remove posaconazole.
Selected warnings and limits
Do not substitute liquid formulations. Review CYP3A4 interactions, tacrolimus/cyclosporine exposure, QT/electrolyte risks and liver tests.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5f795eca-7a03-4c91-9a0e-c1235791b665