WHO Model Prescribing Information: Drugs Used in Skin Diseases
(1997; 132 pages) [French] [Spanish] Ver el documento en el formato PDF
Índice de contenido
Ver el documentoPreface
Ver el documentoIntroduction
Abrir esta carpeta y ver su contenidoParasitic infections
Abrir esta carpeta y ver su contenidoInsect and arachnid bites and stings
Abrir esta carpeta y ver su contenidoSuperficial fungal infections
Abrir esta carpeta y ver su contenidoSubcutaneous fungal infections
Abrir esta carpeta y ver su contenidoBacterial infections
Abrir esta carpeta y ver su contenidoViral infections
Abrir esta carpeta y ver su contenidoEczematous diseases
Abrir esta carpeta y ver su contenidoScaling diseases
Abrir esta carpeta y ver su contenidoPapulosquamous diseases
Ver el documentoCutaneous reactions to drugs
Abrir esta carpeta y ver su contenidoPigmentary disorders
Abrir esta carpeta y ver su contenidoPremalignant lesions and malignant tumours
Abrir esta carpeta y ver su contenidoPhotodermatoses
Abrir esta carpeta y ver su contenidoBullous dermatoses
Ver el documentoAlopecia areata
Ver el documentoUrticaria
Abrir esta carpeta y ver su contenidoConditions common in children
Ver el documentoAcne vulgaris
Ver el documentoPruritus
Ver el documentoTropical ulcers
Abrir esta carpeta y ver su contenidoAntimicrobial drugs
Cerrar esta carpetaAntifugal drugs
Ver el documentoAmphotericin B
Ver el documentoBenzoic acid + salicylic acid (Whitfield’s ointment)
Ver el documentoClotrimazole
Ver el documentoEconazole
Ver el documentoFluconazole
Ver el documentoFlucytosine
Ver el documentoGriseofulvin
Ver el documentoItraconazole
Ver el documentoKetoconazole
Ver el documentoMiconazole
Ver el documentoNystatin
Ver el documentoPotassium iodide
Ver el documentoSelenium sulfide
Ver el documentoSodium thiosulfate
Ver el documentoTerbinafine
Abrir esta carpeta y ver su contenidoAntiseptic agents
Abrir esta carpeta y ver su contenidoKeratoplastic and keratolytic agents
Abrir esta carpeta y ver su contenidoScabicides and pediculicides
Abrir esta carpeta y ver su contenidoAnti-inflammatory and antipruritic drugs1
Abrir esta carpeta y ver su contenidoAntiallergics and drugs used in anaphylaxis
Abrir esta carpeta y ver su contenidoUltraviolet radiation-blocking agents (sunscreens)
Abrir esta carpeta y ver su contenidoMiscellaneous drugs
Abrir esta carpeta y ver su contenidoAnnex
Ver el documentoSelected WHO Publications of Related Interest
Ver el documentoBack cover


Capsule, 100 mg

General information

Itraconazole is a triazole derivative with a broad spectrum of antifungal activity. It is well absorbed and passes readily across the blood-brain barrier into the cerebrospinal fluid. The plasma half-life is about 30 hours. It is metabolized in the liver and eliminated in the urine.

The drug is currently expensive, which may limit its availability.

Clinical information


Treatment of:

• oropharyngeal and vulvovaginal candidosis
• resistant dermatophyte infections of the skin
• subcutaneous fungal infections, including sporotrichosis, chromomycosis and zygomycosis
• systemic fungal infections, including histoplasmosis and paracoccidioido-mycosis,1 with skin involvement.

1 For further information, see WHO model prescribing information: drugs used in sexually transmitted diseases and HIV infection. Geneva, World Health Organization, 1995.

Dosage and administration

All doses are suitable for adults and children over 12 years.

Oropharyngeal candidosis:

100 mg daily for 15 days.

Vulvovaginal candidosis:

400 mg in two divided doses taken on the same day.

Resistant dermatophyte infections of the skin:

200 mg daily for 15-30 days.

Higher dosages may be needed in patients with associated infections of the nails: 400 mg daily for 7 consecutive days per month for 3 months.

Subcutaneous and systemic fungal infections:

200-400 mg daily for as long as lesions persist.


• Known hypersensitivity to azole derivatives.
• Severe hepatic impairment.
• Age under 12 years.


Dosage should be reduced in accordance with the creatinine clearance rate in patients with renal impairment.

Hepatic function should be monitored when treatment is prolonged.

Women of child-bearing age should take effective contraceptive precautions during treatment and for several weeks thereafter.

Use in pregnancy and lactation

Itraconazole has been shown to have teratogenic potential when given in high doses to experimental animals. The need for treatment must be determined by the condition of the mother. Breast-feeding should be interrupted during treatment.

Adverse effects

Itraconazole is generally well tolerated. Nausea is the most frequently reported adverse effect. Vomiting and abdominal distension and discomfort have also been reported.

Elevation of hepatic enzyme levels, which occurs in a small percentage of individuals, is readily reversible in the early stages. Treatment should be discontinued if signs develop that are suggestive of hepatic disease.

Itraconazole should be withdrawn if skin rashes progress during treatment. Exfoliative skin disorders have been reported, but a causal association has not been established.

Anaphylaxis occurs rarely.

Drug interactions

The hepatic metabolism of other lipid-soluble drugs, including ciclosporin, phenytoin, sulfonylureas, theophylline and warfarin, is inhibited.

Rifampicin accelerates the clearance of itraconazole.

Concomitant administration of terfenadine should be avoided since it has been associated with serious, sometimes fatal, cardiac dysrhythmias.


No experience has been gained with overdosage of itraconazole. Induction of emesis and gastric lavage may be tried in the case of accidental overdosage.


Capsules should be kept in well-closed containers, protected from light.

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