Posaconazole Dosage
Medically reviewed by Drugs.com. Last updated on Jul 4, 2024.
Applies to the following strengths: 40 mg/mL; 300 mg; 100 mg; 18 mg/mL
Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for Aspergillosis - Invasive
PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS:
IV:
- Loading dose: 300 mg IV twice a day on the first day
- Maintenance dose: 300 mg IV once a day thereafter
ORAL:
Delayed-Release Tablets:
- Loading dose: 300 mg orally twice a day on the first day
- Maintenance dose: 300 mg orally once a day, starting on the second day
Oral Suspension: 200 mg orally 3 times a day
Duration of Therapy:
- Loading dose: 1 day
- Maintenance dose: Should be based on recovery from immunosuppression or neutropenia
TREATMENT OF INVASIVE ASPERGILLOSIS:
IV:
- Loading dose: 300 mg IV twice a day on the first day
- Maintenance dose: 300 mg IV once a day, starting on the second day
ORAL:
Delayed-Release Tablets:
- Loading dose: 300 mg orally twice a day on the first day
- Maintenance dose: 300 mg orally once a day, starting on the second day
Duration of Therapy:
- Loading dose: 1 day
- Maintenance dose: 6 to 12 weeks (total)
Comments:
- Switching between the IV and delayed-release tablets is acceptable for the treatment of invasive aspergillosis; a loading dose is not needed when switching between formulations.
Uses:
- For the prophylaxis of invasive Aspergillus and Candida infections in high-risk, severely immunocompromised patients, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or patients with hematologic malignancies with prolonged neutropenia from chemotherapy
- For the treatment of invasive aspergillosis
Usual Adult Dose for Candidemia
PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS:
IV:
- Loading dose: 300 mg IV twice a day on the first day
- Maintenance dose: 300 mg IV once a day thereafter
ORAL:
Delayed-Release Tablets:
- Loading dose: 300 mg orally twice a day on the first day
- Maintenance dose: 300 mg orally once a day, starting on the second day
Oral Suspension: 200 mg orally 3 times a day
Duration of Therapy:
- Loading dose: 1 day
- Maintenance dose: Should be based on recovery from immunosuppression or neutropenia
TREATMENT OF INVASIVE ASPERGILLOSIS:
IV:
- Loading dose: 300 mg IV twice a day on the first day
- Maintenance dose: 300 mg IV once a day, starting on the second day
ORAL:
Delayed-Release Tablets:
- Loading dose: 300 mg orally twice a day on the first day
- Maintenance dose: 300 mg orally once a day, starting on the second day
Duration of Therapy:
- Loading dose: 1 day
- Maintenance dose: 6 to 12 weeks (total)
Comments:
- Switching between the IV and delayed-release tablets is acceptable for the treatment of invasive aspergillosis; a loading dose is not needed when switching between formulations.
Uses:
- For the prophylaxis of invasive Aspergillus and Candida infections in high-risk, severely immunocompromised patients, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or patients with hematologic malignancies with prolonged neutropenia from chemotherapy
- For the treatment of invasive aspergillosis
Usual Adult Dose for Oral Thrush
Oral Suspension:
Oropharyngeal candidiasis:
- Loading dose: 100 mg orally twice a day on the first day
- Maintenance dose: 100 mg orally once a day thereafter
- Duration of therapy:
- Loading dose: 1 day
- Maintenance dose: 13 days
Oropharyngeal candidiasis refractory to itraconazole and/or fluconazole: 400 mg orally twice a day
- Duration of therapy: Should be based on the severity of the patient's underlying disease and clinical response
Use: For the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole
Usual Pediatric Dose for Aspergillosis - Invasive
PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS:
IV:
2 to less than 18 years:
- Loading dose: 6 mg/kg IV twice a day on the first day
- Maximum dose: 300 mg/dose
- Maintenance dose: 6 mg/kg IV once a day thereafter
- Maximum dose: 300 mg/dose
ORAL:
Delayed-Release Tablets:
2 to less than 18 years, weighing greater than 40 kg:
- Loading dose: 300 mg orally twice a day on the first day
- Maintenance dose: 300 mg orally once a day, starting on the second day
Oral Suspension:
13 to less than 18 years: 200 mg orally 3 times a day
Powder for Delayed-Release Oral Suspension:
2 to less than 18 years, weighing 10 to 40 kg:
- Weight 10 to less than 12 kg:
- Loading dose: 90 mg orally twice a day on the first day
- Maintenance dose: 90 mg orally once a day thereafter
- Weight 12 to less than 17 kg:
- Loading dose: 120 mg orally twice a day on the first day
- Maintenance dose: 120 mg orally once a day thereafter
- Weight 17 to less than 21 kg:
- Loading dose: 150 mg orally twice a day on the first day
- Maintenance dose: 150 mg orally once a day thereafter
- Weight 21 to less than 26 kg:
- Loading dose: 180 mg orally twice a day on the first day
- Maintenance dose: 180 mg orally once a day thereafter
- Weight 26 to less than 36 kg:
- Loading dose: 210 mg orally twice a day on the first day
- Maintenance dose: 210 mg orally once a day thereafter
- Weight 36 to 40 kg:
- Loading dose: 240 mg orally twice a day on the first day
- Maintenance dose: 240 mg orally once a day thereafter
Duration of Therapy: Should be based on recovery from immunosuppression or neutropenia
TREATMENT OF INVASIVE ASPERGILLOSIS:
13 to less than 18 years (regardless of weight):
IV:
- Loading dose: 300 mg IV twice a day on the first day
- Maintenance dose: 300 mg IV once a day, starting on the second day
ORAL:
Delayed-Release Tablets:
- Loading dose: 300 mg orally twice a day on the first day
- Maintenance dose: 300 mg orally once a day, starting on the second day
Duration of Therapy:
- Loading dose: 1 day
- Maintenance dose: 6 to 12 weeks (total)
Comments:
- The powder for delayed-release oral suspension is not recommended for use in patients weighing greater than 40 kg as the recommended dosage cannot be achieved.
- Switching between the IV and delayed-release tablets is acceptable for the treatment of invasive aspergillosis; a loading dose is not needed when switching between formulations.
Uses:
- For the prophylaxis of invasive Aspergillus and Candida infections in high-risk, severely immunocompromised patients, such as HSCT recipients with GVHD or patients with hematologic malignancies with prolonged neutropenia from chemotherapy
- For the treatment of invasive aspergillosis in pediatric patients at least 13 years of age
Usual Pediatric Dose for Candidemia
PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS:
IV:
2 to less than 18 years:
- Loading dose: 6 mg/kg IV twice a day on the first day
- Maximum dose: 300 mg/dose
- Maintenance dose: 6 mg/kg IV once a day thereafter
- Maximum dose: 300 mg/dose
ORAL:
Delayed-Release Tablets:
2 to less than 18 years, weighing greater than 40 kg:
- Loading dose: 300 mg orally twice a day on the first day
- Maintenance dose: 300 mg orally once a day, starting on the second day
Oral Suspension:
13 to less than 18 years: 200 mg orally 3 times a day
Powder for Delayed-Release Oral Suspension:
2 to less than 18 years, weighing 10 to 40 kg:
- Weight 10 to less than 12 kg:
- Loading dose: 90 mg orally twice a day on the first day
- Maintenance dose: 90 mg orally once a day thereafter
- Weight 12 to less than 17 kg:
- Loading dose: 120 mg orally twice a day on the first day
- Maintenance dose: 120 mg orally once a day thereafter
- Weight 17 to less than 21 kg:
- Loading dose: 150 mg orally twice a day on the first day
- Maintenance dose: 150 mg orally once a day thereafter
- Weight 21 to less than 26 kg:
- Loading dose: 180 mg orally twice a day on the first day
- Maintenance dose: 180 mg orally once a day thereafter
- Weight 26 to less than 36 kg:
- Loading dose: 210 mg orally twice a day on the first day
- Maintenance dose: 210 mg orally once a day thereafter
- Weight 36 to 40 kg:
- Loading dose: 240 mg orally twice a day on the first day
- Maintenance dose: 240 mg orally once a day thereafter
Duration of Therapy: Should be based on recovery from immunosuppression or neutropenia
TREATMENT OF INVASIVE ASPERGILLOSIS:
13 to less than 18 years (regardless of weight):
IV:
- Loading dose: 300 mg IV twice a day on the first day
- Maintenance dose: 300 mg IV once a day, starting on the second day
ORAL:
Delayed-Release Tablets:
- Loading dose: 300 mg orally twice a day on the first day
- Maintenance dose: 300 mg orally once a day, starting on the second day
Duration of Therapy:
- Loading dose: 1 day
- Maintenance dose: 6 to 12 weeks (total)
Comments:
- The powder for delayed-release oral suspension is not recommended for use in patients weighing greater than 40 kg as the recommended dosage cannot be achieved.
- Switching between the IV and delayed-release tablets is acceptable for the treatment of invasive aspergillosis; a loading dose is not needed when switching between formulations.
Uses:
- For the prophylaxis of invasive Aspergillus and Candida infections in high-risk, severely immunocompromised patients, such as HSCT recipients with GVHD or patients with hematologic malignancies with prolonged neutropenia from chemotherapy
- For the treatment of invasive aspergillosis in pediatric patients at least 13 years of age
Usual Pediatric Dose for Oral Thrush
Oral Suspension:
13 to less than 18 years:
Oropharyngeal candidiasis:
- Loading dose: 100 mg orally twice a day on the first day
- Maintenance dose: 100 mg orally once a day thereafter
- Duration of therapy:
- Loading dose: 1 day
- Maintenance dose: 13 days
Oropharyngeal candidiasis refractory to itraconazole and/or fluconazole: 400 mg orally twice a day
- Duration of therapy: Should be based on the severity of the patient's underlying disease and clinical response
Use: For the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole
Renal Dose Adjustments
IV:
- Moderate or severe renal dysfunction (estimated glomerular filtration rate [eGFR] less than 50 mL/min): The injection should be avoided unless benefit justifies risk.
Oral:
- Mild to severe renal dysfunction (eGFR up to 80 mL/min/1.73 m2): No adjustment recommended
Comments:
- IV: The IV vehicle, betadex sulfobutyl ether sodium (SBECD), is expected to accumulate in patients with moderate or severe renal dysfunction; serum creatinine levels should be monitored closely in these patients and if increases occur, switching to oral posaconazole therapy should be considered.
- Oral: Patients with severe renal dysfunction (eGFR less than 20 mL/min/1.73 m2) should be monitored closely for breakthrough fungal infections.
Liver Dose Adjustments
Mild to severe liver dysfunction (Child-Pugh A, B, or C): No adjustment recommended
Precautions
CONTRAINDICATIONS:
- Known hypersensitivity to the active component or other azole antifungal agents
- Coadministration with sirolimus
- Coadministration with CYP450 3A4 substrates that prolong QT interval (e.g., pimozide, quinidine)
- Coadministration with HMG-CoA reductase inhibitors primarily metabolized through CYP450 3A4 (e.g., atorvastatin, lovastatin, simvastatin)
- Coadministration with ergot alkaloids (ergotamine, dihydroergotamine)
- Coadministration with venetoclax at initiation and during the dose-titration phase in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma
- Powder for delayed-release oral suspension: Known/suspected hereditary fructose intolerance
Safety and efficacy have not been established in patients younger than 2 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Comments:
- This drug is not removed by hemodialysis.
Other Comments
Administration advice:
IV:
- Administer the injection through a 0.22-micron polyethersulfone (PES) or polyvinylidene difluoride (PVDF) filter.
- Administer the injection via a central venous line, including a central venous catheter or peripherally inserted central catheter (PICC) by slow IV infusion over about 90 minutes; do not administer as an IV bolus injection.
- If a central venous catheter is not available, the injection may be administered through a peripheral venous catheter by slow IV infusion over about 30 minutes only as a single dose before central venous line placement or to bridge the period when a central venous line is replaced or is in use for other IV therapy; when multiple dosing is needed, infuse via a central venous line.
- The oral suspension is not substitutable with the delayed-release tablets or the powder for delayed-release oral suspension due to differences in dosing of each formulation; follow specific dosing recommendations for each formulation.
- Delayed-Release Tablets:
- Administer with or without food.
- Swallow tablets whole; do not divide, crush, or chew.
- In patients unable to eat a full meal, use the delayed-release tablets (instead of the oral suspension) for the prophylaxis indication; in general, the delayed-release tablets provide higher plasma drug exposures than the oral suspension (under fed and fasted conditions).
- If a dose is missed, take as soon as remembered; if it is not remembered until within 12 hours of the next dose, skip the missed dose and return to the regular schedule. Do not double the next dose or take more than the prescribed dose.
- Oral Suspension:
- Shake well before use; administer with the provided measured dosing spoon.
- Administer each dose during or within 20 minutes after a full meal.
- In patients unable to eat a full meal, use the delayed-release tablets instead of the oral suspension for the prophylaxis indication; the delayed-release tablets provide higher plasma drug exposures than the oral suspension under fasted conditions.
- In patients unable to eat a full meal, and the delayed-release tablets or injection are not options, administer each dose with a liquid nutritional supplement or an acidic carbonated beverage (e.g., ginger ale).
- For patients unable to eat a full meal or tolerate an oral nutritional supplement or an acidic carbonated beverage, and the delayed-release tablets or injection are not options, consider alternative antifungal therapy or monitor patients closely for breakthrough fungal infections.
- If this drug is administered via a nasogastric tube, monitor patients closely for breakthrough fungal infections.
- In general, avoid concomitant use of agents that can decrease plasma levels of this drug unless benefit outweighs risk; if such agents are needed, monitor patients closely for breakthrough fungal infections.
- If a dose is missed, take as soon as remembered; if it is almost time for the next dose, skip the missed dose and return to the regular schedule. Do not double the next dose or take more than the prescribed dose.
- Powder for Delayed-Release Oral Suspension:
- Consult the manufacturer product information (Instructions for Use) for details regarding administration.
- Administer with food; do not administer with alcohol.
- Administer the reconstituted suspension within 1 hour; discard the unused portion of the prepared product.
- To ensure the correct dose is delivered, only use the provided notched tip syringes for preparation and administration (design prevents aggregation of the suspension); select the correct syringe based on the prescribed dose.
- This formulation is not recommended for use in patients weighing greater than 40 kg as the recommended dosage cannot be achieved; the maximum dose that can be accurately withdrawn from the mixing cup after reconstitution is 240 mg.
Storage requirements:
- Injection:
- In vial: Store refrigerated at 2C to 8C (36F to 46F); equilibrate refrigerated vial to room temperature before preparation.
- Diluted solution: Once admixed, should administer immediately; if immediate administration is not possible, may store up to 24 hours refrigerated at 2C to 8C (36F to 46F)
- Delayed-release tablets: Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
- Oral suspension: Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86F); do not freeze.
- Powder for delayed-release oral suspension: Store entire kit at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F) in a clean, dry place; do not open foil packet until ready for use.
Reconstitution/preparation techniques:
- IV: The manufacturer product information should be consulted; final concentration should be between 1 and 2 mg/mL.
- Powder for delayed-release oral suspension: The manufacturer product information (Instructions for Use) should be consulted for details regarding preparation; the provided notched tip syringes must be used for preparation and administration (design prevents aggregation of the suspension).
IV compatibility:
- Compatible Diluents: 0.45% sodium chloride, 0.9% sodium chloride, 5% dextrose in water, 5% dextrose and 0.45% sodium chloride, 5% dextrose and 0.9% sodium chloride, 5% dextrose and 20 mEq potassium chloride
- This drug can be infused at the same time through the same IV line (or cannula) with these compatible diluents.
- Use of other diluents is not recommended as they may cause particulate formation; any diluents not listed above should not be coadministered through the same IV line (or cannula).
- Compatible Drug Products (if prepared in 5% dextrose in water or 0.9% sodium chloride): Amikacin sulfate, caspofungin, ciprofloxacin, daptomycin, dobutamine hydrochloride (HCl), famotidine, filgrastim, gentamicin sulfate, hydromorphone HCl, levofloxacin, lorazepam, meropenem, micafungin, morphine sulfate, norepinephrine bitartrate, potassium chloride, vancomycin HCl
- This drug can be infused at the same time through the same IV line (or cannula) with the above drug products prepared in 5% dextrose in water or 0.9% sodium chloride; coadministration of drug products prepared in other diluents may cause particulate formation.
- Any drug products not listed above should not be coadministered through the same IV line (or cannula).
- Incompatible Diluents: Lactated Ringer's solution, 5% dextrose with Lactated Ringer's solution, 4.2% sodium bicarbonate
Monitoring:
- General: For breakthrough fungal infections (e.g., patients with severe diarrhea/vomiting using an oral formulation, patients weighing more than 120 kg [particularly when using the oral suspension])
- Hepatic: Liver tests (at the start of and during therapy); for more severe liver injury in patients with abnormal liver tests (during therapy); hepatic function, especially liver tests and bilirubin, for patient management (during therapy)
- Metabolic: Electrolyte disturbances, especially involving potassium, magnesium, or calcium levels (before and during therapy)
- Renal: Serum creatinine levels in patients with moderate or severe renal dysfunction using the injection
Patient advice:
- Read the US FDA-approved patient information (Patient Information and Instructions for Use).
- Notify physician at once if severe diarrhea or vomiting develops or if you notice a change in heart rate or heart rhythm.
- Inform physician immediately if signs/symptoms of liver problems (e.g., itching, nausea/vomiting, yellowing of eyes/skin, feeling more tired than usual, influenza-like symptoms) develop.
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