- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
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Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Baley et al. have shown that there is strong inter-individual variation in the pharmacokinetics of flucytosine in neonates (N=13). The half-life in neonates is 4-34 hours. As a result of the immature renal function, the flucytosine serum concentration in neonates is considerably higher than in older children. The serum concentration in older children (3 months – 12 years) is equivalent to the serum concentration reported in adults.
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
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Dosages
| Generalized mycoses caused by sensitive pathogens (combined with amphotericin B in chronic and difficult-to-treat forms of mycosis) |
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Renal impaiment in children > 3 months
Adjustment in renal impairment as specified:
GFR 50-80 ml/min/1.73 m2
Dose adjustment not neededGFR 30-50 ml/min/1.73 m2
On day 1: 100% of normal single dose and interval between 2 doses: 12 hours. Thereafter, adjust according to bloodlevels.GFR 10-30 ml/min/1.73 m2
On day 1: 100% of normal single dose and interval between two doses: 24 hours. Thereafter, adjust according to bloodlevels.GFR < 10 ml/min/1.73 m2
On day 1: 100% of normal single dose and interval between two doses: 24 hours. Thereafter, adjust according to levels.A second drug has not been selected yet.
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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects in children
Nausea, vomiting, diarrhoea, headache, sleepiness, confusion, hallucinations, blood abnormalities, elevated serum liver enzymes, impaired liver function.
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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications
No information available on specific contra indications in children.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions in children
Flucytosine should only be prescribed in consultation with a paediatrician/infectiologist and/or a medical microbiologist. Blood count and hepatic and renal function must be checked regularly before and during the treatment. Combination with amphotericin B in particular requires careful monitoring of the renal function.
Level determination in intravenous/oral administration:
< include information if warranted from www.tdm-monografie.org>
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Antibiotics | ||
|---|---|---|
| J02AA01 | ||
| Triazole and tetrazole derivatives | ||
|---|---|---|
| J02AC01 | ||
| J02AC02 | ||
| J02AC03 | ||
| Other antimycotics for systemic use | ||
|---|---|---|
| J02AX06 | ||
| J02AX04 | ||
| J02AX05 | ||
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References
- Hartwig NC, et al, Vademecum pediatrische antimicrobiele therapie, 2005
- Baley JE, et al, Pharmacokinetics, outcome of treatment, and toxic effects of amphotericin B and 5-fluorocytosine in neonates, J Pediatr., 1990, 116, 791-7
- Hope WW, et al, Optimization of the dosage of flucytosine in combination with amphotericin B for disseminated candidiasis: a pharmacodynamic rationale for reduced dosing, Antimicrob Agents Chemother., 2007, 51(10), 3760-2
- Pasqualotto AC, et al, Flucytosine therapeutic monitoring: 15 years experience from the UK, J Antimicrob Chemother, 2007, 59, 791-3
- Soltani M, et al, Evidence of excessive concentrations of 5-flucytosine in children aged below 12 years: a 12-year review of serum concentrations from a UK clinical assay reference laboratory, Int J Antimicrob Agents, 2006, 28, 574-7
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Changes
Changes
