Perth Children’s Hospital

Children’s Antimicrobial Management

Program (ChAMP)

MONOGRAPH

Fluconazole Monograph - Paediatric

Scope (Staff): Medical, Nursing, Pharmacy
Scope (Area): Perth Children’s Hospital (PCH)

This document should be read in conjunction with this DISCLAIMER

DESCRIPTION Fluconazole is a fungistatic azole antifungal; it impairs ergosterol synthesis

in fungal cell membranes resulting in cell breakdown.(1)

INDICATIONS AND Fluconazole is indicated for the treatment of systemic fungal infections due
RESTRICTIONS to yeasts (some Candida spp. and Cryptococcus) and as an alternative
treatment for dermatophyte infections not involving the scalp or nails.(1,2)
It is also used in the primary and secondary prevention of candida infection
in immunocompromised patients. (1,2)
IV and Oral: Monitored (orange) antifungal
 Where use is consistent with a standard approved indication, this must
be communicated to ChAMP by documenting that indication on all
prescriptions (inpatient and outpatient).
 The ChAMP team will review if ongoing therapy is required and/or if the
order does not meet ChAMP Standard Indications.
 If use is not for a standard approved indication, phone approval must
be obtained from ChAMP before prescribing.

CONTRAINDICATIONS  Fluconazole is contraindicated in patients with a known hypersensitivity

to fluconazole or related azole antifungal or any excipient of the
product.(3-6)
 Fluconazole has been shown to prolong the QT interval and should not
be used in combination with other drugs that prolong the QT interval
and drugs that are metabolised by CYP3A4.(1, 3, 4, 6)

PRECAUTIONS Care should be taken in patients with hepatic impairment due to the risk of
serious liver toxicity.(6)

FORMULATIONS Available at PCH:

 100mg/50mL solution for injection vial
 50mg, 100mg and 200mg capsules
 50mg/5mL oral suspension
Other formulations available
 50mg, 100mg and 200mg capsules (multiple generic brands)

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 Fluconazole Monograph - Paediatric
 150mg single dose capsule
 200mg/100mL solution for injection

DOSAGE  The doses listed below fall within the standard range.
 Higher doses may be prescribed for certain situations in consultation
with an infectious diseases or clinical microbiology consultant.
Neonates (<1 month):
 Please refer to neonatal clinical care drug protocols
Systemic infections:
 Oral/IV: 12mg/kg/dose (to a maximum of 800mg) once daily on day
one, followed by 6mg/kg/dose (to a maximum of 400mg) once daily
thereafter.(7)
 The higher dose may be continued in severe infections or
immunocompromised patients on discussion with infectious diseases
or clinical microbiology consultants.(7)
 Step-down to oral therapy should only be done in consultation with
infectious diseases.
Superficial and oral candidiasis:
 Oral/IV: 6mg/kg/dose (to a maximum of 200mg) once daily for 1 day,
then 3mg/kg/dose (to a maximum of 100mg) once daily thereafter.(6, 7)
Vaginal candidiasis:
 Oral: 150mg as a single dose (in post-pubertal females).(6, 8)
Prophylaxis (immunocompromised patients):
 Oral: 6mg/kg/dose (to a maximum of 400mg) once daily.(6)

DOSAGE Dosage adjustment required in renal impairment:

ADJUSTMENT
 Dosage adjustment may be required in cases of impaired renal
function (with creatinine clearance of less than 50mL/min).(3, 6)
 To calculate the estimated glomerular filtration rate (eGFR) use the
following formula:
eGFR (mL/min/1.73m2) = 36.5 x height (in cm)
Serum creatinine (micromol/L)
 CrCl: > 50mL/minute : Normal dose
 CrCl: 10-50mL/minute: Give the normal loading dose then use 50% of
the recommended maintenance dose 24 hourly.
 CrCl: <10mL/minute : Give the normal loading dose then use 50% of
the recommended maintenance dose 48 hourly.(3, 6)
 No dosage adjustment is required in hepatic impairment. However
ongoing monitoring of hepatic function is required due to the risk of
severe hepatic toxicity.(3, 6)

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 Fluconazole Monograph - Paediatric
RECONSTITUTION IV:
 Not applicable
Oral:
 Tap the closed bottle several times to loosen the powder, add the
volume of purified water according to the manufacturer’s instruction to
the powder and shake well.
 Store reconstituted solution between 5 and 30ºC and discard any
remaining suspension after 14 days.

ADMINISTRATION IV infusion:
 Infuse undiluted (2mg/mL) over at least 60 minutes. Higher doses
>6mg/kg should be administered over 2 hours. (9)
 Do not exceed a rate of 200mg/hour. (9)
Oral:
 May be administered with or without food.(3, 4, 6)
 Shake the suspension well before measuring out the dose.(4, 5)

MONITORING  Renal, hepatic, haematological function, platelets and potassium levels

should be monitored at baseline and routinely with prolonged therapy
(i.e. longer than 7 days).(1, 3, 4, 6, 8)
 Patients should be counselled to report any unusual tiredness, nausea
or loss of appetite, dark urine or pale faeces or any signs of jaundice
whilst taking fluconazole.(1)
 ECG monitoring should also be conducted in those patients with pro-
arrhythmic conditions or additional medications that may prolong the
QT interval.(4)

ADVERSE EFFECTS  Common: rash, headache, dizziness, nausea, vomiting, abdominal

pain, diarrhoea, flatulence, elevated liver enzymes.(1,5, 8)
 Rare: constipation, anorexia, fatigue, thrombocytopenia, blood
dyscrasias, serious hepatotoxicity including hepatic failure,
anaphylactic/anaphylactoid reactions, alopecia (especially with
prolonged courses), peripheral neuropathy, oliguria, hypokalaemia,
seizures, Stevens-Johnson syndrome; prolonged QT interval, torsades
de pointes, dyspepsia, hyperlipidaemia and taste disturbance. (1,5, 8)

COMPATIBILE FLUIDS  Glucose 5%

 Sodium chloride 0.9%
 Hartmann’s
 Ringer’s Solution.(9)

STORAGE  Vials: Store below 25˚C, do not refrigerate and protect from light. (9)
 Capsules: Store below 30˚C.(5)

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 Fluconazole Monograph - Paediatric
 Powder for oral suspension: Prior to reconstitution, store below
30˚C. After reconstitution, store between 5 ˚C and 30 ˚C for up to 14
days.(3, 6)

INTERACTIONS  Fluconazole may interact with other medications; please consult

PCH approved references (e.g. Clinical Pharmacology), your ward
pharmacist or Pharmacy on extension 63546 for more
information.
 Fluconazole may cause QT prolongation and should not be used in
combination with other medications that cause QT prolongation AND
are metabolised by CYP3A4.
 Fluconazole may inhibit the metabolism of many medications including;
carbamazepine, phenytoin, diazepam, midazolam, fentanyl, ibuprofen,
ivacaftor, omeprazole, bosentan, ciclosporin, celecoxib and parecoxib.
Increasing the concentration and the risk of adverse events. Dosage
adjustment may be required.(1, 8)
 Fluconazole may increase the anticoagulant effect of coumarin
anticoagulants (such as warfarin) close monitoring and dose
adjustment is required.
 Rifampicin increases the metabolism of fluconazole thereby reducing
its concentration.(8)

COMMENTS  Fluconazole has excellent oral bioavailability – consider switching to

oral dosing as soon as clinically appropriate.(5) For systemic infections
step-down to oral therapy should only be done in consultation with
infectious diseases. Fluconazole has good tissue and CNS
penetration.(2)
 Each 200mg (100mL) of IV solution contains 15mmol of sodium.(5, 9)

MANUFACTURER To access to the Manufacturer SDS for this product, use the following link
SAFETY DATA SHEET to ChemAlert.
(SDS)
**Please note: The information contained in this guideline is to assist with the preparation and administration
of fluconazole. Any variations to the doses recommended should be clarified with the prescriber prior to
administration**

Related internal policies, procedures and guidelines

Antimicrobial Stewardship Policy (Medication Management Manual)

ChAMP Empiric Guidelines

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 Fluconazole Monograph - Paediatric
References

1. Rossi S, editor. Australian Medicines Handboook 2019. Adelaide, S. Aust.: Australian

Medicines Handbook; 2019.
2. Antibiotic Writing Group. Therapeutic Guidelines - Antibiotic. West Melbourne:
Therapeutic Guidelines Ltd; 2019. Available from:
http://online.tg.org.au.pklibresources.health.wa.gov.au/ip/.
3. Clinical Pharmacology [Internet]. Elsvier BV. 2019 [cited 11/12/2019]. Available from:
http://pklibresources.health.wa.gov.au/login?url=http://www.clinicalpharmacology-
ip.com/?id=24317714.
4. Micromedex 2.0 [Internet]. Truven Health Analytics. 2019 [cited 11/12/2019].
5. MIMS Australia. MIMS online [full product information]. St Leonards, N.S.W: CMP
Medica Australia.; 2019. p. 1v. (various pagings).
6. Taketomo CK, Hodding JH, Kraus DM, Hodding JH. Pediatric and Neonatal dosage
handbook with international trade names index. 24th ed. Ohio: Lexi-comp; 2017-2018.
7. Royal Australian College of General Practitioners, Pharmaceutical Society of Australia,
Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists.
AMH: Children's Dosing Companion. Adelaide: Australian Medicines Handbook Pty
Ltd; 2019.
8. Paediatric Formulary Committee. BNF for Children: 2019. London: BMJ Group
Pharmaceutical Press; 2019.
9. Burridge N Deidun D Collard N (editors). Australian injectable drugs handbook.
Collingwood: The Society of Hospital Pharmacists of Australia; 2019.

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File Path: W:\Safety & Quality\CAHS\CLOVERS MEDICAL Pharmacy\Procedures Protocols and

Guidelines\ChAMP
Document Owner: Infectious Diseases Head of Department
Reviewer / Team: Children’s Antimicrobial Management Program
Date First Issued: October 2013 Last Reviewed: February 2020 Review Date: February 2023
Approved by: Drug and Therapeutics Committee Date: February 2020
Endorsed by: Drug and Therapeutics Committee Date: February 2020
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