Drug Characteristics
  • Formulation

    Tablet: 50 mg, 200 mg

    Suspension: 40mg/ml

    Injection: 200 mg

  • Dose

    Fluconazole-resistant serious invasive Candida (including C krusei)

    Oral dose (tablets and suspension)

    >40 kg 400 mg (10ml) every 12 hours (for the first 24 hours) then 200 mg twice a day

    <40kg 200 mg (5ml) every 12 hours (for the first 24 hours) then 100 mg twice a day

    Intravenous

    6 mg/kg every 12 hours (for the first 24 hours) then 4 mg/kg twice a day

    Invasive pulmonary aspergillosis

    Acute therapy

    6 mg/kg every 12 hours (for the first 24 hours) then 4 mg/kg twice a day for at least 7 days, followed by

    >40kg 200 mg orally twice a day or if

    <40kg 100mg orally twice a day

    to complete a total of 12 weeks therapy

    Maintenance therapy

    Consider oral voriconazole or itraconazole in patients with low immunity

    Oral biovailability 96%

  • Side Effects

    Influenza-like illness, gastroenteritis, thrombocytopenia, anaemia, leukopenia, pancytopenia, sinusitis, hypoglycaemia, hypokalaemia, anxiety, depression, hallucination, headache, dizziness, visual disturbance, oedema peripheral, respiratory distress, pulmonary oedema, chest pain, abdominal pain, nausea, vomiting, diarrhoea, cholestatic jaundice, rash, erythema face oedema, pruritis

  • Interactions

    Co-administration of the CYP3A4 substrates, terfenadine, astemizole, cisapride, pimozide or quinidine is contraindicated since increased plasma concentrations of these medicinal products can lead to QT prolongation and rare occurrences of torsades de pointes.

    Co-administration of voriconazole with rifampicin, carbamazepine and phenobarbital is contraindicated since these medicinal products are likely to decrease plasma voriconazole concentrations significantly.

    Phenytoin, methadone and rifabutin levels may increase with voriconazole and may result in toxicity.

    Check specific SmPC for specific drug interactions with antiretrovirals.

    Some examples include:

    When voriconazole and efavirenz are co-prescribed the dose of voriconazole should be increased to 400 mg every 12 hours and efavirenz should be decreased to 300 mg every 24 hours

    Low-dose ritonavir boosting may reduce levels of voriconazole –caution

  • Renal

    Dose in renal impairment GFR (ml/min)

    Oral dosing: No dosage reduction in renal impairment

    IV infusion formulation:

    <50: accumulation of the vehicle within the formulation occurs and the oral preparation should be used and serum creatinine carefully monitored in renally impaired patients

  • Hepatic

    No dosage adjustment is required in patients with acute hepatic damage

    Monitor LFTs closely

    In patients with mild to moderate hepatic cirrhosis (Child–Pugh A and B) the standard loading dose should be used followed by half the maintenance dose.

    There is no data in patients with severe chronic hepatic cirrhosis

  • Pregnancy

    No Human Data – Animal Data Suggest Risk

  • Other Information