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Perth Children’s Hospital
Children’s Antimicrobial Management
Program (ChAMP)
MONOGRAPH
Fluconazole Monograph – Paediatric
Scope (Staff): Medical, Pharmacy, Nursing
Scope (Area): All Clinical Areas
Child Safe Organisation Statement of Commitment CAHS commits to being a child safe organisation by applying the National Principles for Child Safe Organisations. This is a commitment to a strong culture supported by robust policies and procedures to reduce the likelihood of harm to children and young people.
This document should be read in conjunction with this DISCLAIMER
QUICKLINKS
Dosage/Dosage Adjustments
Administration Compatibility Monitoring
DRUG CLASS
Azole antifungal(1)
INDICATIONS AND RESTRICTIONS
Fluconazole is indicated in the treatment of systemic fungal infections due to yeasts (some Candida spp. and Cryptococcus) and as an alternative treatment for dermatophyte infections not involving the scalp or nails.(1)
Fluconazole is also used in the primary and secondary prevention of candida infection in immunocompromised patients.(1)
Oral and IV: Monitored (orange) antifungal
If the 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
Hypersensitivity to fluconazole, related azole antifungal or any component of the formulation.(2-
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, 5)
PRECAUTIONS
Care should be taken in patients with hepatic impairment due to the risk of serious liver
toxicity.(3, 6)
Each 200mg (100mL) of IV solution contains 15mmol of sodium.(7)
Use in pregnancy should be avoided and effective contraceptive should be used throughout therapy and for at least one week after the final dose. Single dose therapy should be avoided in the first trimester due to a potential risk of spontaneous abortion.(1, 4-6)
FORMULATIONS
Listed below are products available at PCH, other formulations may be available, check with
pharmacy if required:
100mg/50mL solution for injection vial
50mg, 100mg and 200mg capsules
50mg/5mL oral suspension
Imprest location: Formulary One
DOSAGE & DOSAGE ADJUSTMENTS
Neonates: Refer to Neonatal Medication Protocols
Children ≥4 weeks:
Candidaemia or other systemic infections: IV: 12mg/kg/dose (to a maximum of 800mg) once daily(1, 3)^ 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 one day, then 3mg/kg/dose (to a maximum of 100mg) once daily thereafter.(8)
For oesophageal infection, the higher dose of 12mg/kg/dose (to a maximum of 400mg) once daily may be used.(8)
Vaginal candidiasis :
Oral: 150mg as a single dose (in post-pubertal females).(8)
COMPATIBILITY (LIST IS NOT EXHAUSTIVE)
Compatible fluids:
Glucose 5%
Sodium chloride 0.9%
Hartmann’s
Ringer’s Solution.(7)
Compatible at Y-site:
Compatibilities of IV drugs must be checked when two or more drugs are given concurrently.
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, 6, 11)
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.
ADVERSE EFFECTS
Common: rash, headache, nausea, vomiting, abdominal pain, diarrhoea, elevated liver enzymes.(1, 11)
Infrequent: anorexia, fatigue, dizziness, flatulence, altered taste.(1, 11)
Rare: oliguria, alopecia, hypokalaemia, dizziness, constipation, seizures, severe cutaneous adverse reactions (SCARs), prolonged QT interval, torsades de pointes, thrombocytopenia, blood dyscrasias, serious hepatotoxicity including hepatic failure, anaphylactic/anaphylactoid reactions,.(1, 3, 6, 11)
STORAGE
Vials : Store below 25˚C, do not refrigerate and protect from light.(5, 7)
Capsules: Store below 30˚C.(6)
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.(5)
INTERACTIONS
This medication may interact with other medications; consult PCH approved references (e.g.
Clinical Pharmacology), a clinical pharmacist or PCH Medicines Information Service on extension
63546 for more information.
**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 CAHS internal policies, procedures and guidelines
Antimicrobial Stewardship Policy
ChAMP Empiric Guidelines and Monographs
KEMH Neonatal Medication Protocols
References
- Rossi S, editor. Australian Medicines Handbook. Adelaide, S. Aust.: Australian Medicines Handbook; 2021.
- Pediatric Injectable Drugs. Maryland: American Society of Health -System Pharmacists;
- Clinical Pharmacology [Internet]. Elsvier BV. 2021 [cited 18/11/2021]. Available from: http://www.clinicalpharmacology-ip.com.pklibresources.health.wa.gov.au/default.aspx.
- IBM Micromedex [Internet]. Truven Health Analytics. 2021 [cited 14/10/2021]. Available from: http://www-micromedexsolutions- com.pklibresources.health.wa.gov.au/micromedex2/librarian.
- Fluconazole - Pediatric drug information [Internet]. Lexicomp. 2021 [cited 06/12/2021].
- MIMS Australia. MIMS online [full product information]. St Leonards, N.S.W: CMP Medica Australia.; 2021. p. 1v. (various pagings).
- Symons K. Ermer J. (editors). Australian injectable drugs handbook. Collingwood: The Society of Hospital Pharmacists of Australia; 2020.
- 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; 2020.
- McEvoy Ge, editor. AHFS Drug Information. 60th Edition ed. Maryland: American Society of Health-System Pharmacists; 2018.
- Antibiotic Writing Group. eTG complete. West Melbourne: Therapeutic Guidelines Ltd;
- Available from: https://tgldcdp-tg-org-au.pklibresources.health.wa.gov.au/etgAccess.
- Paediatric Formulary Committee. BNF for Children: 2020. London: BMJ Group Pharmaceutical Press; 2021.
