Posaconazole
Dosing in kidney impairment
Dosage Modifications in Patients with Renal Impairment The recommended dosage of posaconazole delayed-release tablets is the same in patients with renal impairment compared to those with normal renal function.
Dosing in liver impairment
Hepatic Impairment No dosage adjustment is recommended for posaconazole delayed-release tablets in patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, or C, respectively) [see Clinical Pharmacology ]. However, a specific hepatic impairment study has not been conducted with the posaconazole delayed-release tablets.
Preparation and administration
Important Administration Instructions Non-substitutable Noxafil ® oral suspension is not substitutable with posaconazole delayed-release tablets due to the differences in the dosing of each formulation. Therefore, follow the specific dosage recommendations for each of the formulations [see Dosage and Administration (2.2 , 2.3) ].
Posaconazole delayed-release tablets Swallow tablets whole. Do not divide, crush, or chew. Administer with or without food [see Dosage and Administration and Clinical Pharmacology ] . For patients who cannot eat a full meal, posaconazole delayed-release tablets should be used instead of Noxafil ® oral suspension for the prophylaxis indication.
Posaconazole delayed-release tablets generally provide higher plasma drug exposures than Noxafil ® oral suspension under both fed and fasted conditions.
Administration Instructions for Posaconazole Delayed-Release Tablets Swallow the posaconazole delayed-release tablets whole. Do not divide, crush, or chew. Administer posaconazole delayed-release tablets orally with or without food [see Clinical Pharmacology ].