Posaconazole Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Aspergillosis - Invasive

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
Oral suspension: 200 mg orally three times a day

Duration of therapy: Should be based on recovery from immunosuppression or neutropenia

Comments:
-The delayed-release tablet is the preferred oral formulation; generally provides higher plasma drug exposures than the oral suspension (under fed and fasted conditions).

Uses: For 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

Usual Adult Dose for Candidemia

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
Oral suspension: 200 mg orally three times a day

Duration of therapy: Should be based on recovery from immunosuppression or neutropenia

Comments:
-The delayed-release tablet is the preferred oral formulation; generally provides higher plasma drug exposures than the oral suspension (under fed and fasted conditions).

Uses: For 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

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 for 13 days

Oropharyngeal candidiasis refractory to itraconazole and/or fluconazole: 400 mg orally twice a day
Duration of therapy: Should be based on severity of patient's underlying disease and clinical response

Usual Pediatric Dose for Aspergillosis - Invasive

13 years or older:
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 three times a day

Duration of therapy: Should be based on recovery from immunosuppression or neutropenia

Comments:
-The delayed-release tablet is the preferred oral formulation; generally provides higher plasma drug exposures than the oral suspension (under fed and fasted conditions).

Uses: For 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

Usual Pediatric Dose for Candidemia

13 years or older:
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 three times a day

Duration of therapy: Should be based on recovery from immunosuppression or neutropenia

Comments:
-The delayed-release tablet is the preferred oral formulation; generally provides higher plasma drug exposures than the oral suspension (under fed and fasted conditions).

Uses: For 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

Usual Pediatric Dose for Oral Thrush

13 years or older:
Oral suspension:
Oropharyngeal candidiasis:
-Loading dose: 100 mg orally twice a day on the first day
-Maintenance dose: 100 mg orally once a day for 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

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.

Comments: Serum creatinine levels should be monitored closely; if levels increase, switching to oral posaconazole therapy should be considered.

Oral:
Mild to moderate renal dysfunction (eGFR 20 to 80 mL/min/1.73 m2): No adjustment recommended.
Severe renal dysfunction (eGFR less than 20 mL/min/1.73 m2): No adjustment recommended; patients 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

Safety and efficacy of the delayed-release tablets and oral suspension have not been established in patients younger than 13 years. Safety and efficacy of the injection have not been established in patients younger than 18 years; it should not be used.

Consult WARNINGS section for additional precautions.

Dialysis

This drug is not removed by hemodialysis.

Other Comments

Administration advice:
-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; never 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 in use for other IV therapy; when multiple dosing is needed, infuse via a central venous line.
-Do not use the delayed-release tablets and oral suspension interchangeably; dosing is different for each formulation.
-Take delayed-release tablets with food to enhance absorption and optimize plasma levels; swallow whole (do not divide, crush, or chew); use only for the prophylaxis indication.
-Take each dose of the oral suspension during or within 20 minutes after a full meal to enhance absorption and optimize plasma levels; shake well before use.
-In patients unable to eat a full meal, and the delayed-release tablets or injection are not options, give each dose of the oral suspension 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.
-The manufacturer product information should be consulted regarding missed doses.

Storage requirements:
-Injection: Store refrigerated at 2C to 8C (36F to 46F); once admixed, may store refrigerated up to 24 hours.
-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.

Reconstitution/preparation techniques:
-The manufacturer product information should be consulted.

IV compatibility:
-Compatible diluents: 5% dextrose in water, sodium chloride 0.9%
-Compatible drug products (if prepared in a compatible diluent): Amikacin sulfate, caspofungin, ciprofloxacin, daptomycin, dobutamine hydrochloride (HCl), famotidine, filgrastim, gentamicin sulfate, hydromorphone HCl, levofloxacin, lorazepam, meropenem, micafungin, morphine, norepinephrine bitartrate, potassium chloride, vancomycin HCl

Monitoring:
-General: For breakthrough fungal infections (e.g., patients with severe diarrhea or vomiting using an oral formulation, patients weighing more than 120 kg)
-Hepatic: Liver function tests (start of and during therapy); for more severe liver injury in patients with abnormal liver function tests (during therapy); hepatic function (especially liver function tests and bilirubin) for patient management (during therapy)
-Renal: Serum creatinine levels in patients with moderate or severe renal dysfunction using the injection

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