Formulary
Posaconazole: Indications, Dosing, Side Effects and Interactions
Posaconazole clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 8 min read
Posaconazole: Indications, Dosing, Side Effects and Interactions
Posaconazole clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Invasive aspergillosis**
- **Adult** (By Mouth Using Tablets, Or By Intravenous Infusion): Loading dose 300 mg twice daily on first day, then 300 mg once daily for 6-12 weeks, switch from intravenous to oral route when appropriate.
**Invasive aspergillosis either refractory to, or in patients intolerant of, itraconazole or amphotericin B,Fusariosis either refractory to, or in patients intolerant of, amphotericin B,Chromoblastomycosis and mycetoma either refractory to, or in patients intolerant of, itraconazole,Coccidioidomycosis either refractory to, or in patients intolerant of, amphotericin B, itraconazole, or fluconazole**
- **Adult** (By Mouth Using Oral Suspension): 400 mg twice daily, to be taken with food, alternatively 200 mg 4 times a day, to be used if unable to tolerate food.
- **Adult** (By Mouth Using Tablets, Or By Intravenous Infusion): Loading dose 300 mg twice daily on first day, then 300 mg once daily, switch from intravenous to oral route when appropriate.
**Oropharyngeal candidiasis (severe infection or in immunocompromised patients only)**
- **Adult** (By Mouth Using Oral Suspension): Loading dose 200 mg once daily on first day, dose to be taken with food, then 100 mg once daily for 13 days, dose to be taken with food.
**Prophylaxis of invasive fungal infections in patients at high risk and undergoing high-dose immunosuppressive therapy**
- **Adult** (By Mouth Using Oral Suspension): for haematopoietic stem cell transplantation or receiving chemotherapy for acute myeloid leukaemia or myelodysplastic syndrome and expected to develop prolonged neutropenia 200 mg 3 times a day, dose to be taken with food, for chemotherapy patients, start several days before the expected onset of neutropenia and continue for 7 days after neutrophil count rises above 500 cells/mm 3 .
- **Adult** (By Mouth Using Tablets, Or By Intravenous Infusion): Loading dose 300 mg twice daily on first day, then 300 mg once daily, switch from intravenous to oral route when appropriate, for chemotherapy patients, start several days before the expected onset of neutropenia and continue for 7 days after neutrophil count rises above 500 cells/mm 3 .
**Invasive aspergillosis either refractory to, or in patients intolerant of, itraconazole or amphotericin B, Fusariosis either refractory to, or in patients intolerant of, amphotericin B, Chromoblastomycosis and mycetoma either refractory to, or in patients intolerant of, itraconazole, Coccidioidomycosis either refractory to, or in patients intolerant of, amphotericin B, itraconazole, or fluconazole for posaconazole**
- **Child 2-17 years (body-weight 41 kg and above)** (By mouth using tablets): Loading dose 300 mg twice daily on first day, then 300 mg once daily.
- **Child 2-17 years** (By intravenous infusion): Loading dose 6 mg/kg twice daily (max. per dose 300 mg) on first day, then 6 mg/kg once daily (max. per dose 300 mg), switch from intravenous to oral route when appropriate.
**Prophylaxis of invasive fungal infections in patients at high risk and undergoing high-dose immunosuppressive therapy for haematopoietic stem cell transplantation or receiving chemotherapy for acute myeloid leukaemia or myelodysplastic syndrome and expected to develop prolonged neutropenia for posaconazole**
- **Child 2-17 years (body-weight 41 kg and above)** (By mouth using tablets): Loading dose 300 mg twice daily on first day, then 300 mg once daily, for chemotherapy patients, start several days before the expected onset of neutropenia and continue for 7 days after neutrophil count rises above 500 cells/mm3.
- **Child 2-17 years** (By intravenous infusion): Loading dose 6 mg/kg twice daily (max. per dose 300 mg) on first day, then 6 mg/kg once daily (max. per dose 300 mg), switch from intravenous to oral route when appropriate, for chemotherapy patients, start several days before the expected onset of neutropenia and continue for 7 days after neutrophil count rises above 500 cells/mm3.
**Invasive aspergillosis either refractory to, or in patients intolerant of, itraconazole or amphotericin B, Fusariosis either refractory to, or in patients intolerant of, amphotericin B, Chromoblastomycosis and mycetoma either refractory to, or in patients intolerant of, itraconazole, Coccidioidomycosis either refractory to, or in patients intolerant of, amphotericin B, itraconazole, or fluconazole for Noxafil gastro-resistant powder and solvent for oral suspension**
- **Child 2-17 years (body-weight 10-11 kg)** (By mouth using oral suspension): Loading dose 90 mg twice daily on first day, then 90 mg once daily.
- **Child 2-17 years (body-weight 12-16 kg)** (By mouth using oral suspension): Loading dose 120 mg twice daily on first day, then 120 mg once daily.
- **Child 2-17 years (body-weight 17-20 kg)** (By mouth using oral suspension): Loading dose 150 mg twice daily on first day, then 150 mg once daily.
- **Child 2-17 years (body-weight 21-25 kg)** (By mouth using oral suspension): Loading dose 180 mg twice daily on first day, then 180 mg once daily.
- **Child 2-17 years (body-weight 26-35 kg)** (By mouth using oral suspension): Loading dose 210 mg twice daily on first day, then 210 mg once daily.
- **Child 2-17 years (body-weight 36-40 kg)** (By mouth using oral suspension): Loading dose 240 mg twice daily on first day, then 240 mg once daily.
**Prophylaxis of invasive fungal infections in patients at high risk and undergoing high-dose immunosuppressive therapy for haematopoietic stem cell transplantation or receiving chemotherapy for acute myeloid leukaemia or myelodysplastic syndrome and expected to develop prolonged neutropenia for Noxafil gastro-resistant powder and solvent for oral suspension**
- **Child 2-17 years (body-weight 10-11 kg)** (By mouth using oral suspension): Loading dose 90 mg twice daily on first day, then 90 mg once daily, for chemotherapy patients, start several days before the expected onset of neutropenia and continue for 7 days after neutrophil count rises above 500 cells/mm3.
- **Child 2-17 years (body-weight 12-16 kg)** (By mouth using oral suspension): Loading dose 120 mg twice daily on first day, then 120 mg once daily, for chemotherapy patients, start several days before the expected onset of neutropenia and continue for 7 days after neutrophil count rises above 500 cells/mm3.
- **Child 2-17 years (body-weight 17-20 kg)** (By mouth using oral suspension): Loading dose 150 mg twice daily on first day, then 150 mg once daily, for chemotherapy patients, start several days before the expected onset of neutropenia and continue for 7 days after neutrophil count rises above 500 cells/mm3.
- **Child 2-17 years (body-weight 21-25 kg)** (By mouth using oral suspension): Loading dose 180 mg twice daily on first day, then 180 mg once daily, for chemotherapy patients, start several days before the expected onset of neutropenia and continue for 7 days after neutrophil count rises above 500 cells/mm3.
- **Child 2-17 years (body-weight 26-35 kg)** (By mouth using oral suspension): Loading dose 210 mg twice daily on first day, then 210 mg once daily, for chemotherapy patients, start several days before the expected onset of neutropenia and continue for 7 days after neutrophil count rises above 500 cells/mm3.
- **Child 2-17 years (body-weight 36-40 kg)** (By mouth using oral suspension): Loading dose 240 mg twice daily on first day, then 240 mg once daily, for chemotherapy patients, start several days before the expected onset of neutropenia and continue for 7 days after neutrophil count rises above 500 cells/mm3.
Cautions
Administration by intravenous infusion, particularly by peripheral catheter (increased risk of QTc interval prolongation); body-weight over 120 kg (risk of treatment failure possibly increased); body-weight under 50 kg (risk of side-effects increased); bradycardia; cardiomyopathy; history of QTc interval prolongation; symptomatic arrhythmias
Contraindications
Acute porphyrias
Side effects
Common or very common Appetite decreased; asthenia; constipation; diarrhoea; dizziness; drowsiness; dry mouth; electrolyte imbalance; fever; gastrointestinal discomfort; gastrointestinal disorders; headache; hypertension; nausea; neutropenia; sensation abnormal; skin reactions; taste altered; vomiting Uncommon Alopecia; anaemia; aphasia; arrhythmias; burping; chest discomfort; chills; confusion; cough; embolism and thrombosis; eosinophilia; feeling jittery; haemorrhage; hepatic disorders; hiccups; hyperglycaemia; hypoglycaemia; hypotension; leucopenia; long QT syndrome; lymphadenopathy; malaise; menstrual disorder; mucositis; nasal congestion; oedema; oral disorders; pain; palpitations; pancreatitis; peripheral neuropathy; renal impairment; respiratory disorders; seizure; sleep disorders; splenic infarction; thrombocytopenia; tremor; vasculitis; vision disorders Rare or very rare Adrenal insufficiency; breast pain; cardiac arrest; coagulation disorder; depression; encephalopathy; haemolytic uraemic syndrome; hearing impairment; heart failure; interstitial lung disease; myocardial infarction; nephritis tubulointerstitial; pancytopenia; pseudoaldosteronism; psychotic disorder; pulmonary hypertension; renal tubular acidosis; Stevens-Johnson syndrome; stroke; sudden cardiac death; syncope Frequency not known Photosensitivity reaction
Interactions
**Severe interactions:**
- Concomitant administration of azole antifungals, including posaconazole, with vincristine has been associated with serious adverse reactions (see section 4.4).
- Posaconazole may increase the plasma concentrations of vinca alkaloids which may lead to neurotoxicity and other serious adverse reactions.
- Cases of elevated ciclosporin levels resulting in serious adverse reactions, including nephrotoxicity and one fatal case of leukoencephalopathy, were reported in clinical efficacy studies.
- Clinically significant interactions resulting in hospitalisation and/or posaconazole discontinuation were reported in clinical efficacy studies.
**Other interactions (62):**
- Effects of other medicinal products on posaconazole Posaconazole is metabolised via UDP glucuronidation (phase 2 enzymes) and is a substrate for p-glycoprotein (P-gp) efflux in vitro .
- Therefore, inhibitors (e.g.
- Rifabutin Rifabutin (300 mg once a day) decreased the C max (maximum plasma concentration) and AUC (area under the plasma concentration time curve) of posaconazole to 57 % and 51 %, respectively.
- Concomitant use of posaconazole and rifabutin and similar inducers (e.g.
- See also below regarding the effect of posaconazole on rifabutin plasma levels.
- Flucloxacillin Flucloxacillin (a CYP450 inducer) may decrease plasma posaconazole concentrations.
Pregnancy
Manufacturer advises avoid unless potential benefit outweighs risk; toxicity in animal studies.
Breast feeding
Manufacturer advises avoid-present in milk in animal studies.
Hepatic impairment
Manufacturer advises caution (risk of increased exposure, limited information available).
Renal impairment
With intravenous use: Monitor efficacy in severe impairment (variable exposure expected). M With intravenous use: M Caution if creatinine clearance less than 50 mL/minute (intravenous vehicle may accumulate). See Prescribing in renal impairment .
Medicinal forms
Tablet,Suspension,Solution
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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