Invasive Candida infection

Active Ingredient: Voriconazole

Indication for Voriconazole

Population group: only children (1 year - 12 years old)

Treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei).

For this indication, competent medicine agencies globally authorize below treatments:

16-18 mg/kg in 2 divided doses daily

Route of admnistration

Intravenous

Defined daily dose

16 - 18 mg per kg of body weight

Dosage regimen

From 8 To 9 mg per kg of body weight 2 time(s) per day every day

Loading dose

18 mg per kg of body weight

Maintenance dose

16 mg per kg of body weight

Detailed description

Children (2 to <12 years) and young adolescents with low body weight (12 to 14 years and <50 kg)

Voriconazole should be dosed as children as these young adolescents may metabolize voriconazole more similarly to children than to adults.

The recommended dosing regimen is as follows:

 IntravenousOral
Loading Dose Regimen (first 24 hours)9 mg/kg every 12 hoursNot recommended
Maintenance Dose (after first 24 hours)8 mg/kg twice daily9 mg/kg twice daily (a maximum dose of 350 mg twice daily

Note: Based on a population pharmacokinetic analysis in 112 immunocompromised paediatric patients aged 2 to <12 years and 26 immunocompromised adolescents aged 12 to <17 years.

It is recommended to initiate the therapy with intravenous regimen, and oral regimen should be considered only after there is a significant clinical improvement. It should be noted that an 8 mg/kg intravenous dose will provide voriconazole exposure approximately 2-fold higher than a 9 mg/kg oral dose.

Dosage adjustment

If patient response to treatment is inadequate, the intravenous dose may be increased by 1 mg/kg steps. If patient is unable to tolerate treatment, reduce the intravenous dose by 1 mg/kg steps.

Dosage considerations

It is recommended that voriconazole is administered at a maximum rate of 3 mg/kg per hour over 1 to 3 hours.

18 mg/kg in 2 divided doses daily

Route of admnistration

Oral

Defined daily dose

18 - 18 mg per kg of body weight

Dosage regimen

From 9 To 9 mg per kg of body weight 2 time(s) per day every day

Detailed description

Children (2 to <12 years) and young adolescents with low body weight (12 to 14 years and <50 kg)

Voriconazole should be dosed as children as these young adolescents may metabolize voriconazole more similarly to children than to adults.

The recommended dosing regimen is as follows:

 IntravenousOral
Loading Dose Regimen (first 24 hours)9 mg/kg every 12 hoursNot recommended
Maintenance Dose (after first 24 hours)8 mg/kg twice daily9 mg/kg twice daily (a maximum dose of 350 mg twice daily

Note: Based on a population pharmacokinetic analysis in 112 immunocompromised paediatric patients aged 2 to <12 years and 26 immunocompromised adolescents aged 12 to <17 years.

It is recommended to initiate the therapy with intravenous regimen, and oral regimen should be considered only after there is a significant clinical improvement. It should be noted that an 8 mg/kg intravenous dose will provide voriconazole exposure approximately 2-fold higher than a 9 mg/kg oral dose.

Dosage adjustment (Children [2 to <12 years] and young adolescents with low body weight [12 to 14 years and <50 kg])

If patient response to treatment is inadequate, the intravenous dose may be increased by 1 mg/kg steps. If patient is unable to tolerate treatment, reduce the intravenous dose by 1 mg/kg steps.

Active ingredient

Voriconazole

Voriconazole is a triazole antifungal agent. The primary mode of action of voriconazole is the inhibition of fungal cytochrome P450-mediated 14 alpha-lanosterol demethylation, an essential step in fungal ergosterol biosynthesis.

Read more about Voriconazole

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