Posaconazole (3 brand names, 5 dosage forms, 3 routes)
Available dosage forms: TABLET, DELAYED RELEASE, SOLUTION, SUSPENSION, FOR SUSPENSION, DELAYED RELEASE, INJECTION.
Routes of administration: ORAL, INTRAVENOUS, SOLUTION.
Brand Names
- NOXAFIL
- NOXAFIL POWDERMIX KIT
- POSACONAZOLE
Adverse Reactions
The following serious and otherwise important adverse reactions are discussed in detail in another section of the labeling: • Arrhythmias and QT Prolongation [see Warnings and Precautions (5.2)] • Electrolyte Disturbances [see Warnings and Precautions (5.3)] • Pseudoaldosteronism [see Warnings and Precautions (5.4)] • Hepatic Toxicity [see Warnings and Precautions (5.5)]
Drug Interactions
Table 15 and Table 17 include drugs with clinically important drug interactions when administered concomitantly with posaconazole and instructions for preventing or managing them. These recommendations are based on either drug interaction studies or predicted interactions due to the expected magnitude of interaction and potential for serious adverse reactions or loss of efficacy [see Clinical Pharmacology (12.3)]. The following information was derived from data with Noxafil® (posaconazole) oral suspension or another posaconazole tablet formulation unless otherwise noted. All clinically important drug interactions with Noxafil® (posaconazole) oral suspension, except for those that affect the absorption of posaconazole (via gastric pH and motility), are considered relevant to clinically important drug interactions with posaconazole injection [Clinical Pharmacology (12.3)]. Consult the labeling of concomitantly used drugs to obtain further information about interactions with posaconazole.
Mechanism of Action
Posaconazole is an azole antifungal agent [see Clinical Pharmacology (12.4)].
Overdosage
There is no experience with overdosage of posaconazole injection. During the clinical trials, some patients received Noxafil® (posaconazole) oral suspension up to 1,600 mg/day with no adverse reactions noted that were different from the lower doses. In addition, accidental overdose was noted in one patient who took 1200 mg twice daily Noxafil® (posaconazole) oral suspension for 3 days. No related adverse reactions were noted by the investigator. Posaconazole is not removed by hemodialysis.