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Fluconazole is authorised in the world under the following brand names: Biocanol, Biozolene, Diflucan, Elazor, Flucazol, Flucostat, Flukezol, Flunizol, Flusol, Pritenzol, Triflucan.

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Fluconazole: Uses and Administration

Fluconazole is a triazole antifungal used for superficial mucosal (oropharyngeal, oesophageal, or vaginal) candidiasis and for fungal skin infections. It is also given for systemic infections including systemic candidiasis, coccidioidomycosis, and cryptococcosis, and has been tried in blastomycosis, histoplasmosis, and sporotrichosis. The place of fluconazole in the treatment of fungal infections is discussed in the various sections under Choice of Antifungal.

Fluconazole is given by mouth or intravenous infusion in similar doses.

For intravenous infusion it is given as a solution containing 2 mg/mL at a rate of 5 to 10 mL/minute (300 to 600 mL/hour). In the USA, a maximum infusion rate of 100 mL/hour is recommended.

For superficial mucosal candidiasis (other than genital candidiasis), the usual dose of fluconazole in the UK is 50 mg daily by mouth, although 100 mg daily may be given if necessary.

Treatment usually continues for 7 to 14 days in oropharyngeal candidiasis (except in severely immunocompromised patients), for 14 days in atrophic oral candidiasis associated with dentures, and for 14 to 30 days in other mucosal candidal infections including oesophagitis. Higher doses are recommended in the USA where an initial dose of fluconazole 200 mg is followed by 100 mg daily and where the minimum treatment period is 14 days for oropharyngeal infection, or a minimum of 21 days and at least 14 days after resolution of symptoms for oesophageal infections doses of up to 400 mg daily may be used for oesophageal candidiasis if necessary.

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Fluconazole 150 mg as a single oral dose may be used for genital candidiasis (vaginal candidiasis or candidal balanitis). Dermatophytosis, pityriasis versicolor, and Candida infections of the skin may be treated with fluconazole 50 mg daily by mouth for up to 6 weeks.

Systemic candidiasis, cryptococcal meningitis, and other cryptococcal infections may be treated with fluconazole orally or by intravenous infusion the initial dose is 400 mg followed by 200 to 400 mg daily. Duration of therapy is based on clinical and mycological response, but is usually at least 6 to 8 weeks in cryptococcal meningitis in the USA, treatment for 10 to 12 weeks after the CSF cultures become negative is recommended.

Fluconazole may also be used in daily doses of 100 to 200 mg orally or intravenously to prevent relapse after a primary course of antifungal treatment for acute cryptococcal meningitis in patients with AIDS. In immunocompromised patients at risk of fungal infections, fluconazole may be given prophylactically in a dose of 50 to 400 mg daily orally or by intravenous infusion, although long-term prophylaxis has been associated with the emergence of resistant organisms (see under Intermittent Doses, below). Doses for children over 4 weeks of age are 3 mg/kg daily for superficial infections (a loading dose of 6 mg/kg may be used on the first day if necessary), and 6 to 12 mg/kg daily for systemic infections. For prophylaxis in immunocompromised children, a dose of 3 to 12 mg/kg daily may be given. For infants under 2 weeks of age, all these doses should be given once every 72 hours for those aged between 2 and 4 weeks, the doses should be given every 48 hours.

A maximum dose of 400 mg daily should not be exceeded in children, or 12 mg/kg at appropriate intervals in infants. Dosage may need to be reduced in patients with renal impairment.

Administration

HIGH DOSES

Doses higher than those recommended by licensed product information for fluconazole have been tried in patients with life-threatening infections caused by Candida spp., Cryptococcus neoformans, and Coccidioides immitis.

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Dose finding studies have found daily doses of 800 to 1000 mg of fluconazole to be effective and well tolerated. In a study of 11 HIV-infected patients who received fluconazole 800 to 1000 mg daily intravenously for 3 weeks then orally until the CSF culture became negative, 6 patients had responded at 10 weeks and another 2 improved clinically. Daily doses of up to 800 mg have been used in blastomycosis and coccidioidomycosis, and doses of 10 mg/kg daily have been tried in disseminated candidiasis.

INTERMITTENT DOSES

Concern has been expressed about the increasingly widespread use of fluconazole and, in particular, about the impact of continuous fluconazole therapy in immunocompromised patients on the development of resistance (see under Antimicrobial Action, above). Nevertheless, fluconazole remains popular for primary and secondary prophylaxis. Some investigators have suggested the use of intermittent doses' although this could further increase the risk of infections with resistant organisms. Once-weekly treatment with fluconazole has been tried in onychomycosis and tinea capitis.

Administration in renal impairment

Patients with renal impairment may require dosage reduction. Normal loading or initial doses of fluconazole should be given on the first day of treatment and subsequent doses should be adjusted according to creatinine clearance (CC):

  • CC more than 50 mL/minute: 100% of the standard recommended dose
  • CC less than 50 mL/minute and not receiving dialysis: 50% of the standard recommended dose
  • patients on regular haemodialysis: 100% of the standard recommended dose after each dialysis session No dosage adjustment is needed in patients with renal impairment given single-dose therapy.

Leishmaniasis

Fluconazole has been tried in the treatment of cutaneous leishmaniasis caused by Leishmania major. In a randomised, double-blind, placebo-controlled study, 80 patients received a six-week course of oral fluconazole 200 mg daily, of whom 63 had complete healing of lesions after 3 months, compared with 22 of 65 patients who received placebo. However, others have reported a response rate not significantly different from placebo.

Preparations

International Brand Drug Names

The information about drugs around the world. Many drugs are marketed under different names in different countries.

Proprietary Preparations

Argentina: Candimicol; Damicol; Femixol; Fluconovag; Fluzol; Fungocina; Fungototal; Honguil Plus; Klonazol; Micolis Novo; Mutum; Naxo C; Nifurtox; Niofen; Periplum; Ponaris; Proseda F; Triflucan; Brazil: Candix; Candizol; Celozol; Farmazol; Floltec; Flucanil; Flucanol; Flucazol; Flucodan; Flucoltrix; Flucomed; Fluconal; Fluconax; Fluconeo; Flucozen; Flucozix; Flunal; Flunazol; Flutec; Fungnon; Glyflucan; Helmicin; Monipax; Pantec; Pronazol; Riconazol; Triazol; Unizol; Zelix; Zolanix; Zolmic; Zolstatin; Zoltec; Zoltren; Chile: Diflucan; Felsol; Flucoxan; Fluctin; Fungimax; Ibarin; Micofin; Microvaccin; Plusgin; Tavor; Hong Kong: Diflucan; Flucoric; Flucozal; Fludicon; Forcan; Lucon; Nofung; Stalene; Indonesia: Cancid; Candizol; Cryptal; Diflucan; Flucess; Flucoral; Govazol; Zemyc; Malaysia: Biozole; Diflucan; Flucoric; Flugal; Fukole; Medoflucon; Stalene; Zolstan; Mexico: Afungil; Bioxel; Candizol; Diflucan; Difusel; Fectrin; Flucoxan; Fludisol; Fluhexal; Flukezol; Fluxes; Fluxicap; Fluzor; Funser; Lanfluzol; Neofomiral; Ongicil; Oxifungol; Solarisol; Terplex; Zoldicam; New Zealand: Canesten Fluconazole; Diflucan; Flucazole; Philippines: Diflucan; Funzela; Syscan; Singapore: Diflucan; Medoflucon; Mycorest; Omastin; Stalene; Thailand: Biozole; Diflucan; Flucozole; Fludizol; Flunco; Funa; Kyrin; Stalene; Venezuela: Aflumicort; Albesin; Diflucan; Flucess; Flucon; Flunal; Fluval; Fugin; Fungomax; Funizol; Micoflux; Mutum; Zolstan.  

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