Active Ingredient: Voriconazole
Treatment of invasive aspergillosis.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
8 - 12 mg per kg of body weight
From 4 To 6 mg per kg of body weight 2 time(s) per day every day
12 mg per kg of body weight
8 mg per kg of body weight
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:
| Intravenous | Oral | ||
|---|---|---|---|
| Patients 40 kg and above* | Patients less than 40 kg* | ||
| Loading dose regimen (first 24 hours) | 6 mg/kg every 12 hours | 400 mg every 12 hour | 200 mg every 12 hours |
| Maintenance dose (after first 24 hours) | 4 mg/kg twice daily | 200 mg twice daily | 100 mg twice daily |
* This also applies to patients aged 15 years and older
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.
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.
It is recommended that voriconazole is administered at a maximum rate of 3 mg/kg per hour over 1 to 3 hours.
Oral
200 - 800 mg
From 100 To 400 mg 2 time(s) per day every day
800 mg
200 mg
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:
| Intravenous | Oral | ||
|---|---|---|---|
| Patients 40 kg and above* | Patients less than 40 kg* | ||
| Loading dose regimen (first 24 hours) | 6 mg/kg every 12 hours | 400 mg every 12 hour | 200 mg every 12 hours |
| Maintenance dose (after first 24 hours) | 4 mg/kg twice daily | 200 mg twice daily | 100 mg twice daily |
* This also applies to patients aged 15 years and older
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.
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.
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