Adult Dosing
Invasive fungal infection prophylaxis
- Delayed-Release Tablets: 300 mg (three 100 mg delayed-release tablets) PO x bid on Day 1
- Maintenance dose: then 300 mg PO qd, starting on the second day
- Oral suspension: 200 mg (5 mL) PO tid
Note:
- Duration of therapy is based on recovery from neutropenia or immunosuppression
Oropharyngeal candidiasis
- Start 100 (2.5 mL) mg PO bid x 1 day
- Maintenance dose:100 mg PO qd x 13 days
Oropharyngeal candidiasis, refractory
- Start 400 (10 mL) mg PO bid
- Duration of therapy is based on disease severity and patient response
Note:
- Give with full meal or liquid nutritional supplement or acidic carbonated beverage (e.g. ginger ale) in patients who cannot eat a full meal
- The delayed-release tablet and oral suspension should not be used interchangeably due to the differences in the dosing of each formulation
Pediatric Dosing
- Safety and effectiveness in pediatric patients <13 yrs of age have not been established
Invasive fungal infection prophylaxis
- Delayed-Release Tablets: 300 mg (three 100 mg delayed-release tablets) PO x bid on Day 1
- Maintenance dose: then 300 mg PO qd, starting on the second day
- Oral suspension: 200 mg (5 mL) PO tid
Note:
- Duration of therapy is based on recovery from neutropenia or immunosuppression
Oropharyngeal candidiasis
- Start 100 mg PO bid x 1 day
- Maintenance dose 100 mg PO qd x 13 days
Oropharyngeal candidiasis, refractory
- Start 400 mg PO bid
- Duration of therapy is based on disease severity and patient response
Note:
- Give with full meal or liquid nutritional supplement or acidic carbonated beverage (e.g. ginger ale) in patients who cannot eat a full meal
[Outline]
Delayed-Release Tablets and Oral Suspension
- Prophylaxis of invasive Aspergillus and Candida infections in immunocompromised patients
13 yrs of age, who are at high risk of developing these infections due to being severely immunocompromised (eg, hematopoietic stem cell transplant recipients with GVHD, hematologic malignancies with prolonged neutropenia from chemotherapy)
Oral Suspension
- Treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole
Renal Dose Adjustment (Based on CrCl)
- Mild to moderate renal impairment: No dose adjustments
- Severe renal impairment (<20 mL/min): Monitor for breakthrough invasive fungal infections, dose adjustments not defined
Hepatic Dose Adjustment
- Mild to severe hepatic impairment: No dose adjustments
See Supplemental Patient Information
- Co-administration of posaconazole with tacrolimus or cyclosporine increases the whole blood trough concentrations of these calcineurin inhibitors; monitor the tacrolimus or cyclosporine whole blood trough concentrations frequently during and at cessation of therapy and consider appropriate dose adjustments of these calcineurin inhibitors
- QT prolongation and torsades de pointes have been associated with posaconazole
- Mild to moderate elevations in ALT, AST, alkaline phosphatase, total bilirubin, and/or symptoms of clinical hepatitis may occur in patients treated with posaconazole; this can be reversed on discontinuation of therapy. Monitor patients who develop abnormal LFTs during therapy for development of more severe hepatic injury
- Co-administration of posaconazole with midazolam increases the plasma concentrations of midazolam by 5 fold, which could potentiate hypnotic and sedative effects
Cautions: Use cautiously in
- Severe renal impairment
- Hepatic impairment
- Bradycardia
- Cardiomyopathy
- Risk factors for QT prolongation
- Severe diarrhea
- Severe vomiting
- Electrolyte abnormalities
- Proarrhythmic conditions
Supplemental Patient Information
- Advise patients to take each dose during or within 20 minutes following a full meal or liquid nutritional supplement
- Advise patients to inform their physician if they develop severe diarrhea or vomiting
- Advise patients to report to their physicians as soon as they develop itching, if their eyes or skin turn yellow, if they feel more tired than usual, or if they have flu-like symptoms
Pregnancy Category:C
Breastfeeding: Safety unknown. As per the manufacture's data, posaconazole is excreted in breastmilk of lactating rats. Manufacturer recommends discontinuation of nursing or discontinuation of therapy, by analyzing risk and benefit ratio in nursing mothers
-demethylase and accumulation of methylated sterol precursors
