- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of fluconazole.
Candidal infection of the oesophagus: treatment
Candidal infections in patients with prolonged neutropenia: prophylaxis
Candidal skin infections
Chronic mucocutaneous candidiasis
Denture stomatitis due to candida
Invasive candidiasis: treatment
Oropharyngeal candidiasis: treatment
Oropharyngeal/oesophageal candidiasis in HIV+ pts.: prevention of relapse
Prevention of relapse of cryptococcal meningitis in patients at risk
Recurrent vulvovaginal candidiasis
Vaginitis - due to candida
Acute or recurrent vaginal candidiasis, candidal balanitis. Consider treatment of partners who present with symptomatic genital candidiasis.
Mucosal candidiasis including oropharyngeal, oesophageal, candiduria, chronic mucocutaneous candidiasis and chronic oral atrophic candidiasis (denture sore mouth).
Tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal Candida infections.
Tinea unguium (onychomycosis) when other agents considered unsuitable.
Treatment of invasive candidiasis, coccidioidomycosis and cryptococcal meningitis
Prevention of cryptococcal meningitis in patients with high risk of recurrence.
Prophylaxis of candidal infections in patients with prolonged neutropenia.
Prophylaxis against recurrent vaginal candidiasis.
Prevention of oropharyngeal or oesophageal candidiasis in patients infected with HIV who are at high risk of relapse.
Not all brands or formulations are indicated for all uses.
Tinea capitis: treatment
Tinea capitis in children
The daily dose should be based on the nature and severity of the fungal infection.
Therapy for infections requiring multiple dose treatment should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection.
Candidal vaginitis or balanitis: 150mg single dose.
Vaginal candidiasis prophylaxis and treatment (four or more episodes yearly): 150mg every 72 hours for three doses followed by 150mg once weekly maintenance dose for six months.
Oropharyngeal and oesophageal candidiasis: 200mg to 400mg loading dose on first day followed by 100mg to 200mg daily.
Treatment of oropharyngeal candidiasis is for seven to twenty one days.
Treatment of oesophageal candidiasis is for fourteen to thirty days.
However, longer treatment may be necessary in severe immunocompromised patients.
Oropharyngeal and oesophageal candidiasis in HIV positive patients at risk of relapse: 100mg to 200mg daily or 200mg three times weekly. Treatment is indefinite in patients with chronic immune suppression.
Chronic mucocutaneous candidiasis: 50mg to 100mg daily. Treatment is for up to twenty eight days. However, longer treatment may be necessary in patients with severe infection or in immunocompromised patients.
Chronic atrophic oral candidiasis associated with dentures: 50mg daily for fourteen days.
Candiduria: 200mg to 400mg daily. Treatment duration is for seven to twenty one days.
Tinea pedis, corporis, cruris, and dermal candidiasis: 50mg once daily or 150mg once weekly. Treatment is usually for two to four weeks. Tinea pedis may require treatment for up to six weeks.
Pityriasis versicolor: 50mg once daily for two to four weeks or 300mg to 400mg once weekly for one to three weeks.
Tinea unguium (onychomycosis): 150mg once weekly. Treatment should be continued until uninfected nail grows. Usually three to six months for fingernails and six to twelve months for toenails.
Coccidioidomycosis: 200mg to 400mg daily. Treatment is for eleven months but can be increased to longer than twenty four months. 800mg daily may be necessary for some infections and in particular for meningeal disease.
Invasive candidiasis: 800mg on day 1, followed by 400mg daily. Treatment duration for candidaemia is two weeks after first negative blood culture result and resolution of signs and symptoms of infection.
Cryptococcal meningitis: 400mg day 1, followed by 200mg to 400mg daily. In life threatening infections, increase daily dose to 800mg daily. Duration of treatment is at least six to eight weeks for cryptococcal meningitis.
Cryptococcal meningitis maintenance in patients with risk of recurrence: 200mg daily indefinitely.
Candidal infection prophylaxis in patients with prolonged neutropenia: 200mg to 400mg daily.
Start several days before the expected onset of neutropenia and continue for seven days after neutrophil count rises above 1000 cells per cubic mm.
Maximum dose is 400mg daily.
Children aged 12 to 18 years
Children have a higher fluconazole clearance than observed for adults. A dose of 100mg, 200mg and 400mg in adults corresponds to a 3mg/kg, 6mg/kg and 12mg/kg dose in children, respectively.
If no suitable alternative is available (See Dosage; Adults).
Children aged 1 month to 12 years
6mg/kg on day 1, subsequent dose of 3mg/kg daily, maximum dose 100mg daily.
Treatment given for seven to fourteen days in oropharyngeal candidiasis (longer if required in severely immunocompromised patients).
Treatment given for fourteen to thirty days in other mucosal infections (oesophagitis, candiduria, non-invasive bronchopulmonary infections).
Invasive candidiasis and cryptococcal meningitis
6mg/kg to 12mg/kg daily, maximum dose 800mg daily. Treatment given for at least eight weeks.
Maintenance therapy to prevent relapse of cryptococcal meningitis in patients with high risk of recurrence
Prophylaxis of Candida infections in immunocompromised patients
3mg/kg to 12mg/kg daily, maximum 400mg daily.
The following unlicensed dosage schedules may be suitable:
Tinea pedis, corporis, cruris, pityriasis versicolor, and dermal candidiasis
Children aged 1 month to 18 years: 3mg/kg daily, maximum dose 50mg daily, for two to four weeks (up to a maximum duration of six weeks in tinea pedis).
Children aged 1 to 18 years: 6mg/kg daily, maximum 300mg daily, for two to four weeks.
Recurrent vulvovaginal candidiasis
Children aged under 18 years (post puberty): 150mg every 72 hours for three doses, then 150mg once a week for six months.
Neonates aged 15 to 27 days: 6mg/kg on day 1. Subsequent dose of 3mg/kg every 48 hours. Maximum dose of 12mg/kg every 48 hours.
Neonates aged under 15 days: 6mg/kg on day 1. Subsequent dose of 3mg/kg every 72 hours. Maximum dose of 12mg/kg every 72 hours.
Invasive candidiasis and cryptococcal meningitis
Neonates aged 15 to 27 days: 6mg/kg to 12mg/kg every 48 hours. Maximum dose 12mg/kg every 48 hours.
Neonates aged under 15 days: 6mg/kg to 12mg/kg every 72 hours. Maximum dose 12mg/kg every 72 hours.
Treatment should continue for at least eight weeks in cryptococcal meningitis.
Prophylaxis of candidal infections in immunocompromised patients
Neonates aged 15 to 27 days: 3mg/kg to 12mg/kg every 48 hours. Maximum dose 12mg/kg every 48 hours.
Neonates aged under 15 days: 3mg/kg to 12mg/kg every 72 hours. Maximum dose of 12mg/kg every 72 hours.
Patients with Renal Impairment
No adjustments in single dose therapy are required.
For multiple dose therapy, the normal recommended dose (according to indication) should be given on day 1, followed by a daily dose depending on creatinine clearance:
Creatinine clearance more than 50ml per minute: 100% of the recommended dose
Creatinine clearance equal to or less than 50ml per minute (no dialysis): 50% of the recommended dose
Regular dialysis: 100% of the recommended dose after each dialysis. On non-dialysis days, patients should receive a reduced dose according to their creatinine clearance
The Renal Drug Handbook suggests the following doses for multiple dose therapy:
Glomerular filtration rate (GFR) 10 to 50ml per minute: 50 to 100% of normal dose
GFR less than 10ml per minute: 50% of normal dose
Additional Dosage Information
When transferring from the oral route to the intravenous route or vice versa, there is no need to change the daily dose.
Long QT syndrome
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
History of torsade de pointes
Renal impairment - creatinine clearance below 51ml/minute
Correct electrolyte disorders before treatment
Advise ability to drive/operate machinery may be affected by side effects
Consult national/regional policy on the use of anti-infectives
Not all available brands are licensed for all age groups
Not all presentations are licensed for all indications
Some formulations contain lactose
Some formulations contain sucrose
Perform ECG before and during treatment
Monitor hepatic function on long term therapy
Monitor serum electrolytes
Advise patients to report signs of hepatic damage (malaise, jaundice etc.)
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
Discontinue if severe skin reaction occurs
Discontinue if symptoms of hepatic disease occur
Consider dose reduction in renal impairment
Pregnancy is inadvisable for 1 week after treatment completion
Advise patients to report skin rash
Hepatotoxicity (including fatalities) has been observed during treatment but the abnormalities have usually been reversible on discontinuation of fluconazole. Patients who develop abnormal liver tests should be monitored for the development of more serious hepatic injury. Discontinue treatment if clinical signs or symptoms consistent with liver disease develop during treatment.
Liver function monitoring is advised for patients on long term treatment with fluconazole to reduce the risk of more serious hepatic injury.
Exfoliative cutaneous reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely. If a rash develops in a patient treated for a superficial fungal infection which may be attributed to fluconazole, discontinue treatment. If patients with invasive/systemic fungal infections develop rashes, they should be closely monitored and fluconazole discontinued if bullous lesions or erythema multiforme develop.
Prescribers are advised to take into account the prevalence of resistance in various Candida species to fluconazole as alternative antifungal therapy secondary to treatment failure may be required.
The manufacturer recommends a washout period of around 1 week after a single-dose or discontinuation of a course of treatment before becoming pregnant.
Pregnancy and Lactation
Use fluconazole with caution in pregnancy.
The manufacturer does not recommend the use of standard doses or short-term use of fluconazole during pregnancy unless clearly necessary. The manufacturer also recommends that fluconazole should not be used during pregnancy for high or prolonged doses unless in cases of potentially life-threatening infections. The manufacturer recommends a washout period of around 1 week after a single-dose or discontinuation of a course of treatment before becoming pregnant.
Fluconazole appears to be teratogenic in the first trimester of pregnancy with continual doses of 400mg per day or greater. In one large study, exposure to oral cumulative doses 450mg or less of fluconazole in first trimester was associated with a small increased risk of musculoskeletal malformations. Lower doses of fluconazole suggest low to minimal risk of adverse reactions. Data shows no increase in the overall risk of malformations in the fetus when pregnant women being treated with cumulative dose of 150mg or less with fluconazole. Briggs (2015) recommends to inform patient of the potential risk to the fetus if continual high doses of fluconazole are essential during the first trimester of pregnancy.
Treatment during pregnancy is not an indication for the termination of pregnancy, but a detailed ultrasound examination of fetal anatomy should be considered after first trimester use.
Use fluconazole with caution in breastfeeding.
The manufacturer does not recommend repeated or high dose fluconazole use during breastfeeding and that fluconazole use can be continued after a single use of a standard dose of 150mg fluconazole or less during breastfeeding.
Fluconazole is found in breast milk at concentrations lower than those in plasma.
Although the effects on the breastfeeding infant are unknown, the safe use of fluconazole in infants has been documented.
Acute generalised exanthematous pustulosis
Drug rash with eosinophilia and systemic symptoms (DRESS)
Fixed drug eruption
Increase in alkaline phosphatase
Increase in serum transaminases
Prolongation of QT interval
Serum bilirubin increased
Torsades de pointes
Toxic epidermal necrolysis
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: January 2016
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Azocan 50mg capsules. FDC International Ltd. Revised June 2016.
Summary of Product Characteristics: Azocan 150mg capsules. FDC International Ltd. Revised June 2016.
Summary of Product Characteristics: Azocan 200mg capsules. FDC International Ltd. Revised June 2016.
Summary of Product Characteristics: Azocan-P 150mg capsules. FDC International Ltd. Revised March 2020.
Summary of Product Characteristics: Canesten Oral Capsule. Bayer Plc. Revised February 2012
Summary of Product Characteristics: Diflucan 50 Capsules. Pfizer Ltd. Revised May 2022.
Summary of Product Characteristics: Diflucan 150 Capsules. Pfizer Ltd. Revised May 2022.
Summary of Product Characteristics: Diflucan 200 Capsules. Pfizer Ltd. Revised May 2022.
Summary of Product Characteristics: Diflucan 10 mg/ml powder for oral suspension. Pfizer Ltd. Revised May 2022.
Summary of Product Characteristics: Diflucan 40 mg/ml powder for oral suspension. Pfizer Ltd. Revised May 2022.
The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.
NAPOS - The Drug Database for Acute Porphyria.
Available at: https://www.drugs-porphyria.com
Last accessed: 16 May 2019
NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed: 16 May 2016
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Fluconazole. Last revised: 31 October 2018
Last accessed: 16 May 2019
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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