Fluconazole (Paediatric)

SOURCE: eMC UK SPC, productName 'Fluconazole 150 mg capsules', §4.2 (the SPC carries the full multi-indication posology table). Duration of therapy: cryptococcal meningitis usually at least 6 to 8 weeks; maintenance to prevent relapse of cryptococcal meningitis — 200 mg once daily indefinitely; coccidioidomycosis — 200 mg to 400 mg once daily for 11 months up to 24 months or longer; invasive candidiasis — generally 2 weeks after the first negative blood culture and resolution of signs and symptoms attributable to candidaemia; oropharyngeal candidiasis 7 to 21 days, oesophageal candidiasis 14 to 30 days (longer in severely compromised immune function); candiduria — 200 mg to 400 mg once daily for 7 to 21 days; chronic atrophic candidiasis — 50 mg once daily for 14 days; chronic mucocutaneous candidiasis — 50 mg to 100 mg once daily for up to 28 days; prevention of relapse of mucosal candidiasis in HIV patients at high risk — 100 mg to 200 mg once daily or 200 mg three times per week, indefinitely in chronic immune suppression; recurrent vaginal candidiasis (4 or more episodes a year) — 150 mg every third day for a total of 3 doses (days 1, 4 and 7) followed by 150 mg once weekly maintenance for 6 months; tinea pedis, corporis, cruris and candida skin infections — 150 mg once weekly or 50 mg once daily for 2 to 4 weeks (tinea pedis may need up to 6 weeks); tinea versicolor — 300 mg to 400 mg once weekly for 1 to 3 weeks, or 50 mg once daily for 2 to 4 weeks; tinea unguium (onychomycosis) — 150 mg once weekly until the infected nail is replaced; prophylaxis of candidal infections in prolonged neutropenia — 200 mg to 400 mg once daily starting several days before the anticipated onset of neutropenia and continuing for 7 days after the neutrophil count rises above 1000 cells per mm3. ELDERLY: adjust dosage based on renal function. Source §4.4, §4.6 and §4.8 were truncated at the source-fetch limit and §4.5 was not retrieved in full.

dosePerKg is left null because the SPC gives per-kg RANGES by indication, not a single figure. VERBATIM §4.2, infants, toddlers and children (from 28 days to 11 years old): mucosal candidiasis — 'Initial dose: 6 mg/kg, Subsequent dose: 3 mg/kg once daily', the initial dose being used on the first day to reach steady state more rapidly; invasive candidiasis and cryptococcal meningitis — 'Dose: 6 to 12 mg/kg once daily' depending on severity of disease; maintenance therapy to prevent relapse of cryptococcal meningitis in children at high risk of recurrence — '6 mg/kg once daily'; prophylaxis of Candida in immunocompromised patients — '3 to 12 mg/kg once daily' depending on the extent and duration of the induced neutropenia. TERM NEWBORN INFANTS (0 to 27 days) excrete fluconazole slowly: give the same mg/kg dose as for infants, toddlers and children but every 72 hours (0 to 14 days) or every 48 hours (15 to 27 days); there are few pharmacokinetic data to support this posology. ADOLESCENTS (12 to 17 years): 'Depending on the weight and pubertal development, the prescriber would need to assess which posology (adults or children) is the most appropriate'; if treatment for genital candidiasis is imperative in this age group the adult posology should be used. EQUIVALENCE NOTE from §4.2: 'A dose of 100, 200 and 400 mg in adults corresponds to a 3, 6 and 12 mg/kg dose in children to obtain a comparable systemic exposure.' Safety and efficacy for the genital candidiasis indication in the paediatric population has not been established. Pharmacokinetics have not been studied in paediatric patients with renal insufficiency. Verify all under-18 dosing against a children's formulary.