This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Presentation

Oral formulations of fluconazole.

Drugs List

  • AZOCAN-P 150mg capsules
  • CANESTEN THRUSH ORAL 150mg capsules
  • DIFLUCAN 150mg capsules
  • DIFLUCAN 200mg capsules
  • DIFLUCAN 200mg/5ml suspension
  • DIFLUCAN 50mg capsules
  • DIFLUCAN 50mg/5ml suspension
  • fluconazole 150mg capsules
  • fluconazole 200mg capsules
  • fluconazole 200mg/5ml oral suspension
  • fluconazole 50mg capsules
  • fluconazole 50mg/5ml oral suspension
  • Therapeutic Indications

    Uses

    Candidal balanitis
    Candidal infection of the oesophagus: treatment
    Candidal infections in patients with prolonged neutropenia: prophylaxis
    Candidal skin infections
    Candiduria
    Chronic mucocutaneous candidiasis
    Coccidioidomycosis: treatment
    Cryptococcal meningitis
    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
    Tinea corporis
    Tinea cruris
    Tinea pedis
    Tinea unguium
    Tinea versicolor
    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.

    Unlicensed Uses

    Tinea capitis: treatment

    Tinea capitis in children

    Dosage

    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.

    Adults

    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.

    Children

    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.
    Genital candidiasis
    If no suitable alternative is available (See Dosage; Adults).

    Children aged 1 month to 12 years
    Mucosal candidiasis
    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
    6mg/kg daily.

    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).

    Tinea capitis
    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

    Mucosal candidiasis
    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.

    Contraindications

    Acute porphyria
    Long QT syndrome
    Torsade de pointes

    Precautions and Warnings

    Family history of long QT syndrome
    Breastfeeding
    Electrolyte imbalance
    Galactosaemia
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    Hereditary fructose intolerance
    History of torsade de pointes
    Lactose intolerance
    Pregnancy
    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

    Pregnancy

    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.

    Lactation

    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.

    Side Effects

    Abdominal discomfort
    Abdominal pain
    Acute generalised exanthematous pustulosis
    Agranulocytosis
    Alopecia
    Anaemia
    Anaphylaxis
    Angioedema
    Asthenia
    Cholestasis
    Constipation
    Decreased appetite
    Diarrhoea
    Dizziness
    Drug rash with eosinophilia and systemic symptoms (DRESS)
    Dry mouth
    Dyspepsia
    Exfoliative dermatitis
    Facial oedema
    Fatigue
    Fever
    Fixed drug eruption
    Flatulence
    Headache
    Hepatic failure
    Hepatitis
    Hepatocellular damage
    Hepatocellular necrosis
    Hepatotoxicity
    Hypercholesterolaemia
    Hypersensitivity reactions
    Hypertriglyceridaemia
    Hypokalaemia
    Increase in alkaline phosphatase
    Increase in serum transaminases
    Increased sweating
    Insomnia
    Jaundice
    Leucopenia
    Malaise
    Myalgia
    Nausea
    Neutropenia
    Paraesthesia
    Prolongation of QT interval
    Pruritus
    Rash
    Seizures
    Serum bilirubin increased
    Somnolence
    Stevens-Johnson syndrome
    Taste disturbances
    Thrombocytopenia
    Torsades de pointes
    Toxic epidermal necrolysis
    Tremor
    Urticaria
    Vertigo
    Vomiting

    Overdosage

    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 ).

    Further Information

    Last Full Review Date: January 2016

    Reference Sources

    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

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

    FDB Logo

    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.