▶Rare or very rare
▶With oral useErectile dysfunction.hearing impairment.
leucopenia.sensation abnormal.serum sickness.urinary
frequency increased
SIDE-EFFECTS, FURTHER INFORMATIONPotentially life-
threatening hepatotoxicity reported very rarely—
discontinue if signs of hepatitis develop.
lCONCEPTION AND CONTRACEPTIONEnsure effective
contraception during treatment and until the next
menstrual period following end of treatment.
lPREGNANCYManufacturer advises use only in life-
threatening situations (toxicity at high doses inanimal
studies).
lBREAST FEEDINGSmall amounts present in milk—may
accumulate; manufacturer advises avoid.
lHEPATIC IMPAIRMENTUse only if potential benefit
outweighs risk of hepatotoxicity.
Dose adjustmentsDose reduction may be necessary.
lRENAL IMPAIRMENTRisk of congestive heart failure.
▶With oral useBioavailability of oral formulations possibly
reduced.
▶With intravenous useUse intravenous infusion with caution
if estimated glomerularfiltration rate
30 – 80 mL/minute/ 1. 73 m^2 (monitor renal function); avoid
intravenous infusion if estimated golmerularfiltration rate
less than 30 mL/minute/ 1. 73 m^2.
lMONITORING REQUIREMENTS
▶Absorption reduced in AIDS and neutropenia (monitor
plasma-itraconazole concentration and increase dose if
necessary).
▶Monitor liver function if treatment continues for longer
than one month, if receiving other hepatotoxic drugs, if
history of hepatotoxicity with other drugs, or in hepatic
impairment.
lDIRECTIONS FOR ADMINISTRATION
▶With intravenous useForintravenous infusion, dilute 250 mg
with 50 mL Sodium Chloride 0. 9 % and give requisite dose
through an in-linefilter ( 0. 2 micron) over 60 minutes.
▶With oral useFororal liquid, do not take with food; swish
around mouth and swallow, do not rinse afterwards.
lPRESCRIBING AND DISPENSING INFORMATIONFlavours of
oral liquid formulations may include cherry.
lPATIENT AND CARER ADVICEPatients should be told how
to recognise signs of liver disorder and advised to seek
prompt medical attention if symptoms such as anorexia,
nausea, vomiting, fatigue, abdominal pain or dark urine
develop.
▶With oral usePatients or carers should be given advice on
how to administer itraconazole oral liquid.
lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug. Forms available from special-order
manufacturers include: oral suspension, oral solution
Solution for infusion
EXCIPIENTS:May contain Propylene glycol
▶Sporanox(Janssen-Cilag Ltd)
Itraconazole 10 mg per 1 mlSporanox I.V. 250 mg/ 25 ml solution for
infusion ampoules and diluent| 1 ampouleP£ 79. 71
Oral solution
CAUTIONARY AND ADVISORY LABELS9, 23
▶Itraconazole (Non-proprietary)
Itraconazole 10 mg per 1 mlItraconazole 50 mg/ 5 ml oral solution
sugar free sugar-free| 150 mlP£ 58. 34 DT = £ 58. 34
▶Sporanox(Janssen-Cilag Ltd)
Itraconazole 10 mg per 1 mlSporanox 50 mg/ 5 ml oral solution
sugar-free| 150 mlP£ 58. 34 DT = £ 58. 34
Capsule
CAUTIONARY AND ADVISORY LABELS5, 9, 21, 25
▶Itraconazole (Non-proprietary)
Itraconazole 100 mgItraconazole 100 mg capsules|
15 capsuleP£ 13. 77 DT = £ 3. 40 | 60 capsuleP£ 13. 60 –
£ 56. 21
▶Sporanox(Janssen-Cilag Ltd)
Itraconazole 100 mgSporanox-Pulse 100 mg capsules|
28 capsuleP£ 25. 72
Sporanox 100 mg capsules| 4 capsuleP£ 3. 67 | 15 capsuleP
£ 13. 77 DT = £ 3. 40 | 60 capsuleP£ 55. 10Voriconazole
lINDICATIONS AND DOSE
Invasive aspergillosis|Serious infections caused by
Scedosporiumspp.,Fusariumspp., or invasive
fluconazole-resistantCandidaspp. (includingC. krusei)
▶BY MOUTH
▶Child 2–11 years:Treatment should be initiated with
intravenous regimen, and oral regimen should be
considered only after there is a significant clinical
improvement; maintenance 9 mg/kg every 12 hours,
adjusted in steps of 1 mg/kg and increased if necessary
up to 350 mg every 12 hours, then adjusted in steps of
50 mg as required
▶Child 12–14 years (body-weight up to 50 kg):Treatment
should be initiated with intravenous regimen, and oral
regimen should be considered only after there is a
significant clinical improvement; maintenance 9 mg/kg
every 12 hours, adjusted in steps of 1 mg/kg and
increased if necessary up to 350 mg every 12 hours,
then adjusted in steps of 50 mg as required
▶Child 12–14 years (body-weight 50 kg and above):Initially
400 mg every 12 hours for 2 doses, then 200 mg every
12 hours, increased if necessary to 300 mg every
12 hours
▶Child 15–17 years (body-weight up to 40 kg):Initially
200 mg every 12 hours for 2 doses, then 100 mg every
12 hours, increased if necessary to 150 mg every
12 hours
▶Child 15–17 years (body-weight 40 kg and above):Initially
400 mg every 12 hours for 2 doses, then 200 mg every
12 hours, increased if necessary to 300 mg every
12 hours
▶BY INTRAVENOUS INFUSION
▶Child 2–11 years:Initially 9 mg/kg every 12 hours for
2 doses, then 8 mg/kg every 12 hours; adjusted in steps
of 1 mg/kg as required; for max. 6 months
▶Child 12–14 years (body-weight up to 50 kg):Initially
9 mg/kg every 12 hours for 2 doses, then 8 mg/kg every
12 hours; adjusted in steps of 1 mg/kg as required; for
max. 6 months
▶Child 12–14 years (body-weight 50 kg and above):Initially
6 mg/kg every 12 hours for 2 doses, then 4 mg/kg every
12 hours; reduced if not tolerated to 3 mg/kg every
12 hours; for max. 6 months
▶Child 15–17 years:Initially 6 mg/kg every 12 hours for
2 doses, then 4 mg/kg every 12 hours; reduced if not
tolerated to 3 mg/kg every 12 hours; for max. 6 months
DOSE ADJUSTMENTS DUE TO INTERACTIONS
▶Manufacturer advises increasing the maintenance dose
with concurrent use of fosphenytoin, phenytoin, or
rifabutin—no specific recommendations made for
children.lCONTRA-INDICATIONSAcute porphyrias p. 603
lCAUTIONSAvoid exposure to sunlight.bradycardia.
cardiomyopathy.electrolyte disturbances.history of QT
interval prolongation.patients at risk of pancreatitis.
symptomatic arrhythmias
lINTERACTIONS→Appendix 1 : antifungals, azolesBNFC 2018 – 2019 Fungal infection 377
Infection5