Individual generic drug information

itraconazole

Reference monograph

Part of registered formulation

ITRACONAZOLE

Reference record: Itraconazole
Source: BNF 80 (2020–2021)
Printed source pages: 654, 655
Age groups indexed: 1

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 Itraconazole only.

Indications And Dose

Vulvovaginal candidiasis ▶BY MOUTH ▶Adult: 200 mg twice daily for 1 day Vulvovaginal candidiasis (recurrent) ▶BY MOUTH ▶Adult: 50–100 mg daily for 6 months Oral or oesophageal candidiasis that has not responded to fluconazole ▶BY MOUTH USING ORAL SOLUTION ▶Adult: 100–200 mg twice daily for 2 weeks (continue for another 2 weeks if no response; the higher dose should not be used for longer than 2 weeks if no signs of improvement) Oral or oesophageal candidiasis in HIV-positive or other immunocompromised patients ▶BY MOUTH USING ORAL SOLUTION ▶Adult: 200 mg daily in 1–2 divided doses for 1 week (continue for another week if no response) Systemic candidiasis where other antifungal drugs inappropriate or ineffective ▶BY MOUTH ▶Adult: 100–200 mg once daily ▶BY INTRAVENOUS INFUSION ▶Adult: 200 mg every 12 hours for 2 days, then 200 mg once daily for max. 12 days Systemic candidiasis (invasive or disseminated) where other antifungal drugs inappropriate or ineffective ▶BY MOUTH ▶Adult: 200 mg twice daily Pityriasis versicolor ▶BY MOUTH ▶Adult: 200 mg once daily for 7 days Tinea pedis | Tinea manuum ▶BY MOUTH ▶Adult: 100 mg once daily for 30 days, alternatively 200 mg twice daily for 7 days Tinea corporis | Tinea cruris ▶BY MOUTH ▶Adult: 100 mg once daily for 15 days, alternatively 200 mg once daily for 7 days Onychomycosis ▶BY MOUTH ▶Adult: 200 mg once daily for 3 months, alternatively 200 mg twice daily for 7 days, subsequent courses repeated after 21-day intervals; ﬁngernails 2 courses, toenails 3 courses Aspergillosis ▶BY MOUTH ▶Adult: 200 mg twice daily Systemic aspergillosis where other antifungal drugs inappropriate or ineffective ▶BY INTRAVENOUS INFUSION ▶Adult: 200 mg every 12 hours for 2 days, then 200 mg once daily for max. 12 days Histoplasmosis ▶BY MOUTH ▶Adult: 200 mg 3 times a day for 3 days, then 200 mg 1–2 times a day ▶BY INTRAVENOUS INFUSION ▶Adult: 200 mg every 12 hours for 2 days, then 200 mg once daily for max. 12 days Systemic cryptococcosis including cryptococcal meningitis where other antifungal drugs inappropriate or ineffective ▶BY MOUTH ▶Adult: 200 mg once daily, dose increased in invasive or disseminated disease and in cryptococcal meningitis, increased to 200 mg twice daily ▶BY INTRAVENOUS INFUSION ▶Adult: 200 mg every 12 hours for 2 days, then 200 mg once daily for max. 12 days Maintenance in HIV-infected patients to prevent relapse of underlying fungal infection and prophylaxis in neutropenia when standard therapy inappropriate ▶BY MOUTH ▶Adult: 200 mg once daily, then increased to 200 mg twice daily, dose increased only if low plasma- itraconazole concentration Prophylaxis of deep fungal infections (when standard therapy inappropriate) in patients with haematological malignancy or undergoing bone-marrow transplantation who are expected to become neutropenic ▶BY MOUTH USING ORAL SOLUTION ▶Adult: 5 mg/kg daily in 2 divided doses, to be started before transplantation or before chemotherapy (taking care to avoid interaction with cytotoxic drugs) and continued until neutrophil count recovers, safety and efﬁcacy not established in elderly patients

Source pages 654, 655

Dose Adjustments

DUE TO INTERACTIONS ▶Manufacturer advises max. dose 200 mg daily with concurrent use of cobicistat. l UNLICENSED USE Itraconazole doses in BNF may differ from those in product literature.

Source page 655

Contra Indications

Acute porphyrias p. 1120

Source page 655

Cautions

Active liver disease. elderly. history of hepatotoxicity with other drugs. susceptibility to congestive heart failure CAUTIONS, FURTHER INFORMATION ▶Susceptibility to congestive heart failure There have been reports of heart failure associated with itraconazole. Those at risk may include patients receiving higher daily doses and longer courses, patients with cardiac disease, patients with chronic lung disease, and patients receiving treatment with calcium channel blockers. Manufacturer advises avoid in patients with ventricular dysfunction, such as history of congestive heart failure, unless the infection is serious.

Source page 655

Prescribing And Dispensing Information

Flavours of oral liquid formulations may include cherry.

Source page 655

Safety

Extracted information for Itraconazole only.

Interactions

→Appendix 1: antifungals, azoles

Source page 655

Side Effects

GENERAL SIDE-EFFECTS ▶Common or very common Alopecia. constipation. diarrhoea. dyspnoea. gastrointestinal discomfort. headache. heart failure. hepatic disorders. hyperbilirubinaemia. nausea. oedema. pulmonary oedema. skin reactions. vision disorders. vomiting ▶Uncommon Hearing loss. taste altered ▶Rare or very rare Angioedema. hypersensitivity vasculitis. hypertriglyceridaemia. pancreatitis. photosensitivity reaction. severe cutaneous adverse reactions (SCARs) ▶Frequency not known Peripheral neuropathy (discontinue) SPECIFIC SIDE-EFFECTS ▶Common or very common ▶With intravenous use Chest pain. confusion. cough. dizziness. drowsiness. electrolyte imbalance. fatigue. gastrointestinal disorder. granulocytopenia. hyperglycaemia. hyperhidrosis. hypersensitivity. hypertension. hypotension. myalgia. pain. renal impairment. tachycardia. tremor. urinary incontinence ▶Uncommon ▶With intravenous use Dysphonia. numbness. thrombocytopenia ▶With oral use Flatulence. increased risk of infection. menstrual disorder ▶Rare or very rare ▶With oral use Erectile dysfunction. leucopenia. sensation abnormal. serum sickness. tinnitus. urinary frequency increased SIDE-EFFECTS, FURTHER INFORMATION Potentially life- threatening hepatotoxicity reported very rarely — discontinue if signs of hepatitis develop.

Source page 655

Conception And Contraception

Ensure effective contraception during treatment and until the next menstrual period following end of treatment.

Source page 655

Pregnancy

Manufacturer advises use only in life- threatening situations (toxicity at high doses in animal studies).

Source page 655

Breast Feeding

Small amounts present in milk—may accumulate; manufacturer advises avoid.

Source page 655

Hepatic Impairment

Manufacturer advises use only in serious or life-saving situations where potential beneﬁt outweighs risk of hepatotoxicity.

Source page 655

Renal Impairment

Risk of congestive heart failure. ▶With oral use Bioavailability of oral formulations possibly reduced. Infection ▶With intravenous use Use intravenous infusion with caution if eGFR 30–80 mL/minute/1.73 m2; avoid intravenous infusion if eGFR less than 30 mL/minute/1.73 m2.

Source page 655

Monitoring Requirements

▶Absorption reduced in AIDS and neutropenia (monitor plasma-itraconazole concentration and increase dose if necessary). ▶Monitor liver function if treatment continues for longer than one month, if receiving other hepatotoxic drugs, or if history of hepatotoxicity with other drugs.

Source page 655

Dose and formulations

Extracted information for Itraconazole only.

Directions For Administration

▶With intravenous use For intravenous infusion (Sporanox ®), give intermittently in Sodium Chloride 0.9%; dilute 250 mg in 50 mL infusion ﬂuid and infuse only 60 mL through an in-line ﬁlter (0.2 micron) over 60 minutes. ▶With oral use For oral liquid, do not take with food; swish around mouth and swallow, do not rinse afterwards.

Source page 655

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Forms available from special-order manufacturers include: oral suspension, oral solution Solution for infusion EXCIPIENTS: May contain Propylene glycol ▶Sporanox (Janssen-Cilag Ltd) Itraconazole 10 mg per 1 ml Sporanox I.V. 250mg/25ml solution for infusion ampoules and diluent | 1 ampoule P £79.71 Oral solution CAUTIONARY AND ADVISORY LABELS 9, 23 ▶Itraconazole (Non-proprietary) Itraconazole 10 mg per 1 ml Itraconazole 50mg/5ml oral solution sugar-free | 150 ml P £59.28 DT = £59.28 ▶Sporanox (Janssen-Cilag Ltd) Itraconazole 10 mg per 1 ml Sporanox 50mg/5ml oral solution sugar-free | 150 ml P £58.34 DT = £59.28 Capsule CAUTIONARY AND ADVISORY LABELS 5, 9, 21, 25 ▶Itraconazole (Non-proprietary) Itraconazole 100 mg Itraconazole 100mg capsules | 15 capsule P £13.77 DT = £3.55 | 60 capsule P £14.20–£55.10 ▶Sporanox (Janssen-Cilag Ltd) Itraconazole 100 mg Sporanox-Pulse 100mg capsules | 28 capsule P £25.72 Sporanox 100mg capsules | 4 capsule P £3.67 | 15 capsule P £13.77 DT = £3.55 | 60 capsule P £55.10

Source page 655

Clinical care

Extracted information for Itraconazole only.

Patient And Carer Advice

Patients should be told how to recognise signs of liver disorder and advised to seek prompt medical attention if symptoms such as anorexia, nausea, vomiting, fatigue, abdominal pain or dark urine develop. ▶With oral use Patients or carers should be given advice on how to administer itraconazole oral liquid.

Source page 655

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

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

200 mg twice daily for 1 day

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

Candidate age grouping · source page 654

Adults

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

50–100 mg daily for 6 months

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

Candidate age grouping · source page 654

Adults

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

100–200 mg twice daily for 2 weeks (continue

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

Candidate age grouping · source page 654

Adults

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

200 mg daily in 1–2 divided doses for 1 week

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

Candidate age grouping · source page 654

Adults

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

100–200 mg once daily

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

Candidate age grouping · source page 654

Adults

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

200 mg every 12 hours for 2 days, then 200 mg

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

Candidate age grouping · source page 654

Adults

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

200 mg twice daily

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

Candidate age grouping · source page 654

Adults

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

200 mg once daily for 7 days

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

Candidate age grouping · source page 654

Adults

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

100 mg once daily for 30 days, alternatively

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

Candidate age grouping · source page 654

Adults

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

100 mg once daily for 15 days, alternatively

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

Candidate age grouping · source page 654

Adults

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

200 mg once daily for 3 months, alternatively

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

Candidate age grouping · source page 654

Adults

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

200 mg twice daily

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

Candidate age grouping · source page 654

Adults

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

200 mg every 12 hours for 2 days, then 200 mg

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

Candidate age grouping · source page 654

Adults

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

200 mg 3 times a day for 3 days, then 200 mg

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

Candidate age grouping · source page 654

Adults

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

200 mg every 12 hours for 2 days, then 200 mg

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

Candidate age grouping · source page 654

Adults

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

200 mg once daily, dose increased in invasive or

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

Candidate age grouping · source page 654

Adults

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

200 mg every 12 hours for 2 days, then 200 mg

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

Candidate age grouping · source page 654

Adults

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

200 mg once daily, then increased to 200 mg

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

Candidate age grouping · source page 654

Adults

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

5 mg/kg daily in 2 divided doses, to be started

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

Candidate age grouping · source page 655

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

itraconazole

Reference monograph

Part of registered formulation

ITRACONAZOLE

Reference record: Itraconazole
Source: BNF 80 (2020–2021)
Printed source pages: 654, 655
Age groups indexed: 1

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 Itraconazole only.

Indications And Dose

Source pages 654, 655

Dose Adjustments

DUE TO INTERACTIONS ▶Manufacturer advises max. dose 200 mg daily with concurrent use of cobicistat. l UNLICENSED USE Itraconazole doses in BNF may differ from those in product literature.

Source page 655

Contra Indications

Acute porphyrias p. 1120

Source page 655

Cautions

Source page 655

Prescribing And Dispensing Information

Flavours of oral liquid formulations may include cherry.

Source page 655

Safety

Extracted information for Itraconazole only.

Interactions

→Appendix 1: antifungals, azoles

Source page 655

Side Effects

Source page 655

Conception And Contraception

Ensure effective contraception during treatment and until the next menstrual period following end of treatment.

Source page 655

Pregnancy

Manufacturer advises use only in life- threatening situations (toxicity at high doses in animal studies).

Source page 655

Breast Feeding

Small amounts present in milk—may accumulate; manufacturer advises avoid.

Source page 655

Hepatic Impairment

Manufacturer advises use only in serious or life-saving situations where potential beneﬁt outweighs risk of hepatotoxicity.

Source page 655

Renal Impairment

Source page 655

Monitoring Requirements

Source page 655

Dose and formulations

Extracted information for Itraconazole only.

Directions For Administration

Source page 655

Medicinal Forms

Source page 655

Clinical care

Extracted information for Itraconazole only.

Patient And Carer Advice

Source page 655

Dose text by age group

Filter the extracted dose blocks for this individual drug.

Adults

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

200 mg twice daily for 1 day

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

Candidate age grouping · source page 654

Adults

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

50–100 mg daily for 6 months

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

Candidate age grouping · source page 654

Adults

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

100–200 mg twice daily for 2 weeks (continue

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

Candidate age grouping · source page 654

Adults

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

200 mg daily in 1–2 divided doses for 1 week

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

Candidate age grouping · source page 654

Adults

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

100–200 mg once daily

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

Candidate age grouping · source page 654

Adults

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

200 mg every 12 hours for 2 days, then 200 mg

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

Candidate age grouping · source page 654

Adults

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

200 mg twice daily

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

Candidate age grouping · source page 654

Adults

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

200 mg once daily for 7 days

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

Candidate age grouping · source page 654

Adults

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

100 mg once daily for 30 days, alternatively

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

Candidate age grouping · source page 654

Adults

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

100 mg once daily for 15 days, alternatively

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

Candidate age grouping · source page 654

Adults

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

200 mg once daily for 3 months, alternatively

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

Candidate age grouping · source page 654

Adults

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

200 mg twice daily

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

Candidate age grouping · source page 654

Adults

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

200 mg every 12 hours for 2 days, then 200 mg

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

Candidate age grouping · source page 654

Adults

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

200 mg 3 times a day for 3 days, then 200 mg

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

Candidate age grouping · source page 654

Adults

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

200 mg every 12 hours for 2 days, then 200 mg

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

Candidate age grouping · source page 654

Adults

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

200 mg once daily, dose increased in invasive or

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

Candidate age grouping · source page 654

Adults

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

200 mg every 12 hours for 2 days, then 200 mg

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

Candidate age grouping · source page 654

Adults

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

200 mg once daily, then increased to 200 mg

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

Candidate age grouping · source page 654

Adults

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

5 mg/kg daily in 2 divided doses, to be started

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

Candidate age grouping · source page 655

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.