Invasive Candida infection

Active Ingredient: Voriconazole

Indication for Voriconazole

Population group: only adolescents (12 years - 18 years old) , adults (18 years old or older)

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

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

8-12 mg/kg in 2 divided doses daily

Route of admnistration

Intravenous

Defined daily dose

8 - 12 mg per kg of body weight

Dosage regimen

From 4 To 6 mg per kg of body weight 2 time(s) per day every day

Loading dose

12 mg per kg of body weight

Maintenance dose

8 mg per kg of body weight

Detailed description

Therapy must be initiated with the specified loading dose regimen of either intravenous or oral voriconazole to achieve plasma concentrations on Day 1 that are close to steady state. On the basis of the high oral bioavailability (96%), switching between intravenous and oral administration is appropriate when clinically indicated.

Detailed information on dosage recommendations is provided in the following table:

 IntravenousOral
Patients 40 kg and above*Patients less than 40 kg*
Loading dose regimen (first 24 hours)6 mg/kg every 12 hours400 mg every 12 hour200 mg every 12 hours
Maintenance dose (after first 24 hours)4 mg/kg twice daily200 mg twice daily100 mg twice daily

* This also applies to patients aged 15 years and older

Duration of treatment

Treatment duration should be as short as possible depending on the patient’s clinical and mycological response. Long term exposure to voriconazole greater than 180 days (6 months) requires careful assessment of the benefit-risk balance.

Dosage adjustment (Adults)

If patient is unable to tolerate intravenous treatment at 4 mg/kg twice daily, reduce the dose to 3 mg/kg twice daily.

If patient response to treatment is inadequate, the maintenance dose may be increased to 300 mg twice daily for oral administration. For patients less than 40 kg the oral dose may be increased to 150 mg twice daily.

If patient is unable to tolerate treatment at a higher dose reduce the oral dose by 50 mg steps to the 200 mg twice daily (or 100 mg twice daily for patients less than 40 kg) maintenance dose.

Dosage considerations

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

8-12 mg/kg in 2 divided doses daily

Route of admnistration

Oral

Defined daily dose

200 - 800 mg

Dosage regimen

From 100 To 400 mg 2 time(s) per day every day

Loading dose

800 mg

Maintenance dose

200 mg

Detailed description

Therapy must be initiated with the specified loading dose regimen of either intravenous or oral voriconazole to achieve plasma concentrations on Day 1 that are close to steady state. On the basis of the high oral bioavailability (96%), switching between intravenous and oral administration is appropriate when clinically indicated.

Detailed information on dosage recommendations is provided in the following table:

 IntravenousOral
Patients 40 kg and above*Patients less than 40 kg*
Loading dose regimen (first 24 hours)6 mg/kg every 12 hours400 mg every 12 hour200 mg every 12 hours
Maintenance dose (after first 24 hours)4 mg/kg twice daily200 mg twice daily100 mg twice daily

* This also applies to patients aged 15 years and older

Duration of treatment

Treatment duration should be as short as possible depending on the patient’s clinical and mycological response. Long term exposure to voriconazole greater than 180 days (6 months) requires careful assessment of the benefit-risk balance.

Dosage adjustment (Adults)

If patient is unable to tolerate intravenous treatment at 4 mg/kg twice daily, reduce the dose to 3 mg/kg twice daily.

If patient response to treatment is inadequate, the maintenance dose may be increased to 300 mg twice daily for oral administration. For patients less than 40 kg the oral dose may be increased to 150 mg twice daily.

If patient is unable to tolerate treatment at a higher dose reduce the oral dose by 50 mg steps to the 200 mg twice daily (or 100 mg twice daily for patients less than 40 kg) maintenance dose.

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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