WHO Model Prescribing Information: Drugs Used in Skin Diseases
(1997; 132 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentPreface
View the documentIntroduction
Open this folder and view contentsParasitic infections
Open this folder and view contentsInsect and arachnid bites and stings
Open this folder and view contentsSuperficial fungal infections
Open this folder and view contentsSubcutaneous fungal infections
Open this folder and view contentsBacterial infections
Open this folder and view contentsViral infections
Open this folder and view contentsEczematous diseases
Open this folder and view contentsScaling diseases
Open this folder and view contentsPapulosquamous diseases
View the documentCutaneous reactions to drugs
Open this folder and view contentsPigmentary disorders
Open this folder and view contentsPremalignant lesions and malignant tumours
Open this folder and view contentsPhotodermatoses
Open this folder and view contentsBullous dermatoses
View the documentAlopecia areata
View the documentUrticaria
Open this folder and view contentsConditions common in children
View the documentAcne vulgaris
View the documentPruritus
View the documentTropical ulcers
Open this folder and view contentsAntimicrobial drugs
Close this folderAntifugal drugs
View the documentAmphotericin B
View the documentBenzoic acid + salicylic acid (Whitfield’s ointment)
View the documentClotrimazole
View the documentEconazole
View the documentFluconazole
View the documentFlucytosine
View the documentGriseofulvin
View the documentItraconazole
View the documentKetoconazole
View the documentMiconazole
View the documentNystatin
View the documentPotassium iodide
View the documentSelenium sulfide
View the documentSodium thiosulfate
View the documentTerbinafine
Open this folder and view contentsAntiseptic agents
Open this folder and view contentsKeratoplastic and keratolytic agents
Open this folder and view contentsScabicides and pediculicides
Open this folder and view contentsAnti-inflammatory and antipruritic drugs1
Open this folder and view contentsAntiallergics and drugs used in anaphylaxis
Open this folder and view contentsUltraviolet radiation-blocking agents (sunscreens)
Open this folder and view contentsMiscellaneous drugs
Open this folder and view contentsAnnex
View the documentSelected WHO Publications of Related Interest
View the documentBack cover


Capsule or tablet, 50 mg, 100 mg, 150 mg, 200 mg
Powder for oral suspension, 10 mg or 40 mg in 25-ml bottle

General information

Fluconazole 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 slowly eliminated unchanged in the urine.

Fluconazole is currently expensive, which may limit its availability.

Clinical information


Treatment of:

• resistant oropharyngeal candidosis in patients with HIV infection
• vaginal candidosis
• cryptococcal meningitis1
• serious systemic candidal infections, in particular of the urinary tract, peritoneum and lungs, 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

Resistant oropharyngeal candidosis:

200 mg as an initial loading dose, followed by 100 mg daily for 21 days.

Systemic candidosis:

400 mg as an initial loading dose, followed by 200 mg daily for at least 4 weeks.

Vaginal candidosis:

150 mg as a single oral dose.


3-6 mg/kg as an initial loading dose, followed by 3 mg/kg daily for up to 4 weeks.


Hypersensitivity to azole derivatives.


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. Anaphylaxis occurs rarely.

Use in pregnancy and lactation

Fluconazole 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

Fluconazole 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.

Fluconazole 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, such as ciclosporin, phenytoin, sulfonylureas, theophylline and warfarin, is inhibited.

Rifampicin accelerates the clearance of fluconazole.

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 fluconazole. Induction of emesis and gastric lavage may be tried in the case of accidental overdosage.


Fluconazole capsules, tablets and powder for oral suspension should be kept in well-closed containers, protected from light. After reconstitution the oral suspension is stable for up to 14 days below 30 °C.

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