Individual generic drug information

fluconazole

Reference monograph

Part of registered formulation

FLUCONAZOLE

Reference record: Fluconazole
Source: BNF 80 (2020–2021)
Printed source pages: 652, 653
Age groups indexed: 2

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Fluconazole only.

Indications And Dose

Candidal balanitis ▶BY MOUTH ▶Child 16–17 years: 150 mg for 1 dose ▶Adult: 150 mg for 1 dose Vaginal candidiasis ▶BY MOUTH ▶Adult: 150 mg for 1 dose Vulvovaginal candidiasis (recurrent) ▶BY MOUTH ▶Adult: Initially 150 mg every 72 hours for 3 doses, then 150 mg once weekly for 6 months Mucosal candidiasis (except genital) ▶BY MOUTH, OR BY INTRAVENOUS INFUSION ▶Child 1 month–11 years: 3–6 mg/kg, dose to be given on ﬁrst day, then 3 mg/kg daily (max. per dose 100 mg) for 7–14 days in oropharyngeal candidiasis (max. 14 days except in severely immunocompromised patients); for 14–30 days in other mucosal infections (e.g. oesophagitis, candiduria, non-invasive bronchopulmonary infections) ▶Child 12–17 years: 50 mg daily for 7–14 days in oropharyngeal candidiasis (max. 14 days except in severely immunocompromised patients); for 14–30 days in other mucosal infections (e.g. oesophagitis, candiduria, non-invasive bronchopulmonary infections); increased to 100 mg daily, increased dose only for unusually difﬁcult infections ▶BY MOUTH ▶Adult: 50 mg daily given for 7–14 days in oropharyngeal candidiasis (max. 14 days except in severely immunocompromised patients); for 14 days in atrophic oral candidiasis associated with dentures; for 14–30 days in other mucosal infections (e.g. oesophagitis, candiduria, non-invasive bronchopulmonary infections; increased to 100 mg daily, increased dose only for unusually difﬁcult infections Tinea pedis, corporis, cruris, pityriasis versicolor | Dermal candidiasis ▶BY MOUTH ▶Adult: 50 mg daily for 2–4 weeks (for up to 6 weeks in tinea pedis); max. duration of treatment 6 weeks Invasive candidal infections (including candidaemia and disseminated candidiasis) and cryptococcal infections (including meningitis) ▶BY MOUTH, OR BY INTRAVENOUS INFUSION ▶Child: 6–12 mg/kg daily (max. per dose 800 mg), treatment continued according to response (at least 8 weeks for cryptococcal meningitis) ▶Adult: 400 mg, dose to be given on ﬁrst day, then 200–400 mg daily (max. per dose 800 mg once daily), treatment continued according to response (at least 8 weeks for cryptococcal meningitis), maximum dose for use in severe infections Prevention of fungal infections in immunocompromised patients ▶BY MOUTH, OR BY INTRAVENOUS INFUSION ▶Child: 3–12 mg/kg daily (max. per dose 400 mg), commence treatment before anticipated onset of neutropenia and continue for 7 days after neutrophil count in desirable range, dose given according to extent and duration of neutropenia ▶Adult: 50–400 mg daily, commence treatment before anticipated onset of neutropenia and continue for 7 days after neutrophil count in desirable range, dose adjusted according to risk Prevention of fungal infections in immunocompromised patients (for patients with high risk of systemic infections e.g. following bone-marrow transplantation) ▶BY MOUTH, OR BY INTRAVENOUS INFUSION ▶Adult: 400 mg daily, commence treatment before anticipated onset of neutropenia and continue for 7 days after neutrophil count in desirable range Prevention of relapse of cryptococcal meningitis in HIV- infected patients after completion of primary therapy ▶BY MOUTH, OR BY INTRAVENOUS INFUSION ▶Adult: 200 mg daily

Source page 652

Contra Indications

Acute porphyrias p. 1120

Source page 652

Cautions

Susceptibility to QT interval prolongation

Source page 652

Prescribing And Dispensing Information

Flavours of oral liquid formulations may include orange.

Source page 653

Exceptions To Legal Category

Fluconazole capsules can be sold to the public for vaginal candidiasis and associated candidal balanitis in those aged 16–60 years, in a container or packaging containing not more than 150 mg and labelled to show a max. dose of 150 mg.

Source page 653

Safety

Extracted information for Fluconazole only.

Interactions

→Appendix 1: antifungals, azoles

Source page 652

Side Effects

GENERAL SIDE-EFFECTS ▶Common or very common Diarrhoea. gastrointestinal discomfort. headache. nausea. skin reactions. vomiting ▶Uncommon Dizziness. ﬂatulence. hepatic disorders. seizure. taste altered ▶Rare or very rare Agranulocytosis. alopecia. dyslipidaemia . hypokalaemia. leucopenia. neutropenia. QT interval prolongation. severe cutaneous adverse reactions (SCARs) . thrombocytopenia. torsade de pointes SPECIFIC SIDE-EFFECTS ▶Uncommon ▶With parenteral use Anaemia. appetite decreased. asthenia. constipation. drowsiness. dry mouth. fever. hyperhidrosis. insomnia. malaise. myalgia. paraesthesia. vertigo ▶Rare or very rare ▶With parenteral use Angioedema. face oedema. tremor ▶Frequency not known ▶With oral use Cardio-respiratory distress. oedema SIDE-EFFECTS, FURTHER INFORMATION If rash occurs, discontinue treatment (or monitor closely if infection invasive or systemic); severe cutaneous reactions are more likely in patients with AIDS.

Source pages 652, 653

Pregnancy

Manufacturer advises avoid—multiple congenital abnormalities reported with long-term high doses.

Source page 653

Breast Feeding

Present in milk but amount probably too small to be harmful.

Source page 653

Hepatic Impairment

Manufacturer advises caution— limited information available.

Source page 653

Renal Impairment

Dose adjustments ▶In adults Usual initial dose then halve subsequent doses if eGFR less than 50 mL/minute/1.73 m2. ▶In children Usual initial dose then halve subsequent doses if estimated glomerular ﬁltration rate less than 50 mL/minute/1.73 m2.

Source page 653

Monitoring Requirements

Monitor liver function with high doses or extended courses—discontinue if signs or symptoms of hepatic disease (risk of hepatic necrosis).

Source page 653

Dose and formulations

Extracted information for Fluconazole only.

Directions For Administration

▶With intravenous use in children For intravenous infusion, give over 10–30 minutes; do not exceed an infusion rate of 5–10 mL/minute.

Source page 653

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Infusion ▶Fluconazole (Non-proprietary) Fluconazole 2 mg per 1 ml Fluconazole 200mg/100ml infusion bags | 5 bag P £19.45 (Hospital only) | 10 bag P £65.00 (Hospital only) Fluconazole 400mg/200ml infusion bags | 5 bag P £72.50 (Hospital only) Solution for infusion ELECTROLYTES: May contain Sodium ▶Fluconazole (Non-proprietary) Fluconazole 2 mg per 1 ml Fluconazole 200mg/100ml solution for infusion vials | 1 vial P £15.00–£29.28 DT = £29.28 Fluconazole 100mg/50ml solution for infusion vials | 5 vial P £12.60 (Hospital only) Fluconazole 50mg/25ml solution for infusion vials | 1 vial P £20.00 Fluconazole 200mg/100ml solution for infusion bottles | 10 bottle P £392.30 | 20 bottle P £603.17 Oral suspension CAUTIONARY AND ADVISORY LABELS 9 ▶Fluconazole (Non-proprietary) Fluconazole 10 mg per 1 ml Fluconazole 50mg/5ml oral suspension | 35 ml P £25.85 DT = £25.85 ▶Diflucan (Pfizer Ltd) Fluconazole 10 mg per 1 ml Diflucan 50mg/5ml oral suspension | 35 ml P £16.61 DT = £25.85 Fluconazole 40 mg per 1 ml Diflucan 200mg/5ml oral suspension | Infection 35 ml P £66.42 DT = £66.42 Capsule CAUTIONARY AND ADVISORY LABELS 9 (50 mg and 200 mg strengths only) ▶Fluconazole (Non-proprietary) Fluconazole 50 mg Fluconazole 50mg capsules | 7 capsule P £5.00 DT = £0.94 Fluconazole 150 mg Fluconazole 150mg capsules | 1 capsule p s DT = £0.90 | 1 capsule P £8.50 DT = £0.90 Fluconazole 200 mg Fluconazole 200mg capsules | 7 capsule P £6.02 DT = £4.88 ▶Canesten (fluconazole) (Bayer Plc) Fluconazole 150 mg Canesten Thrush Oral 150mg capsules | 1 capsule p £6.33 DT = £0.90 ▶Diflucan (Pfizer Ltd) Fluconazole 50 mg Diflucan 50mg capsules | 7 capsule P £16.61 DT = £0.94 Fluconazole 150 mg Diflucan 150mg capsules | 1 capsule P £7.12 DT = £0.90 Fluconazole 200 mg Diflucan 200mg capsules | 7 capsule P £66.42 DT = £4.88

Source page 653

Clinical care

Extracted information for Fluconazole only.

Patient And Carer Advice

Medicines for Children leaflet: Fluconazole for yeast and fungal infections www.medicinesforchildren.org.uk/fluconazole-yeast- and-fungal-infections l PROFESSION SPECIFIC INFORMATION Dental practitioners’ formulary Fluconazole Capsules 50 mg may be prescribed. Fluconazole Oral Suspension 50 mg/5 mL may be prescribed.

Source page 653

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Children

First line only; read the complete Indications and dose section above.

150 mg for 1 dose

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Adults

First line only; read the complete Indications and dose section above.

150 mg for 1 dose

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Adults

First line only; read the complete Indications and dose section above.

150 mg for 1 dose

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Adults

First line only; read the complete Indications and dose section above.

Initially 150 mg every 72 hours for 3 doses, then

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Children

First line only; read the complete Indications and dose section above.

3–6 mg/kg, dose to be given on

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Children

First line only; read the complete Indications and dose section above.

50 mg daily for 7–14 days in

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Adults

First line only; read the complete Indications and dose section above.

50 mg daily given for 7–14 days in

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Adults

First line only; read the complete Indications and dose section above.

50 mg daily for 2–4 weeks (for up to 6 weeks in

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Children

First line only; read the complete Indications and dose section above.

6–12 mg/kg daily (max. per dose 800 mg),

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Adults

First line only; read the complete Indications and dose section above.

400 mg, dose to be given on ﬁrst day, then

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Children

First line only; read the complete Indications and dose section above.

3–12 mg/kg daily (max. per dose 400 mg),

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Adults

First line only; read the complete Indications and dose section above.

50–400 mg daily, commence treatment before

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Adults

First line only; read the complete Indications and dose section above.

400 mg daily, commence treatment before

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Adults

First line only; read the complete Indications and dose section above.

200 mg daily

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.

Individual generic drug information

fluconazole

Reference monograph

Part of registered formulation

FLUCONAZOLE

Reference record: Fluconazole
Source: BNF 80 (2020–2021)
Printed source pages: 652, 653
Age groups indexed: 2

Individual active ingredientSource records are displayed separately

Some source sections could not be separated reliably in the extraction. Review the printed source pages when a field is missing or incomplete.

Overview

Extracted information for Fluconazole only.

Indications And Dose

Source page 652

Contra Indications

Acute porphyrias p. 1120

Source page 652

Cautions

Susceptibility to QT interval prolongation

Source page 652

Prescribing And Dispensing Information

Flavours of oral liquid formulations may include orange.

Source page 653

Exceptions To Legal Category

Source page 653

Safety

Extracted information for Fluconazole only.

Interactions

→Appendix 1: antifungals, azoles

Source page 652

Side Effects

Source pages 652, 653

Pregnancy

Manufacturer advises avoid—multiple congenital abnormalities reported with long-term high doses.

Source page 653

Breast Feeding

Present in milk but amount probably too small to be harmful.

Source page 653

Hepatic Impairment

Manufacturer advises caution— limited information available.

Source page 653

Renal Impairment

Source page 653

Monitoring Requirements

Monitor liver function with high doses or extended courses—discontinue if signs or symptoms of hepatic disease (risk of hepatic necrosis).

Source page 653

Dose and formulations

Extracted information for Fluconazole only.

Directions For Administration

▶With intravenous use in children For intravenous infusion, give over 10–30 minutes; do not exceed an infusion rate of 5–10 mL/minute.

Source page 653

Medicinal Forms

Source page 653

Clinical care

Extracted information for Fluconazole only.

Patient And Carer Advice

Source page 653

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Children

First line only; read the complete Indications and dose section above.

150 mg for 1 dose

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Adults

First line only; read the complete Indications and dose section above.

150 mg for 1 dose

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Adults

First line only; read the complete Indications and dose section above.

150 mg for 1 dose

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Adults

First line only; read the complete Indications and dose section above.

Initially 150 mg every 72 hours for 3 doses, then

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Children

First line only; read the complete Indications and dose section above.

3–6 mg/kg, dose to be given on

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Children

First line only; read the complete Indications and dose section above.

50 mg daily for 7–14 days in

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Adults

First line only; read the complete Indications and dose section above.

50 mg daily given for 7–14 days in

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Adults

First line only; read the complete Indications and dose section above.

50 mg daily for 2–4 weeks (for up to 6 weeks in

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Children

First line only; read the complete Indications and dose section above.

6–12 mg/kg daily (max. per dose 800 mg),

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Adults

First line only; read the complete Indications and dose section above.

400 mg, dose to be given on ﬁrst day, then

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Children

First line only; read the complete Indications and dose section above.

3–12 mg/kg daily (max. per dose 400 mg),

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Adults

First line only; read the complete Indications and dose section above.

50–400 mg daily, commence treatment before

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Adults

First line only; read the complete Indications and dose section above.

400 mg daily, commence treatment before

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Adults

First line only; read the complete Indications and dose section above.

200 mg daily

This is a first-line fragment. Read the full Indications and Dose section above.

Candidate age grouping · source page 652

Age labels are extracted from the printed dose headings and require clinical review. Confirm current local guidance, dose, route, formulation, contraindications and interactions before prescribing.