Voriconazole

VORICONAZOLE- voriconazole tablet, film coated
Golden State Medical Supply, Inc.

1 INDICATIONS AND USAGE

1.1 Invasive Aspergillosis

. Voriconazole tablets is indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive apergillosis (IA). In clinical trials, the majority of isolates recovered were Aspergillus fumigatus. There was a small number of cases of culture-proven disease due to species of Aspergillus other than A. fumigatus [see Clinical Studies (14.1, 14.5) and Microbiology (12.4)] .

1.2 Candidemia in Non-neutropenic Patients and Other Deep Tissue Candida Infections

Voriconazole tablets is indicated in adults and pediatric patients (2 years of age and older) for the treatment of candidemia in non-neutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds [see Clinical Studies (14.2, 14.5) and Microbiology (12.4)] .

1.3 Esophageal Candidiasis

Voriconazole tablets is indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (EC) in adults and pediatric patients 2 years of age and older [see Clinical Studies (14.3, 14.5) and Microbiology (12.4)].

1.4 Scedosporiosis and Fusariosis

Voriconazole tablets is indicated for the treatment of serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii) and Fusarium spp. including Fusarium solani, in adults and pediatric patients (2 years of age and older) intolerant of, or refractory to, other therapy [see Clinical Studies (14.4) and Microbiology (12.4)].

1.5 Usgae

Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions for Use in All Patients

l. Voriconazole tablets should be taken at least one hour before or after a meal.

2.3 Recommended Dosing Regimen in Adults


Invasive aspergillosis and serious fungal infections due to Fusarium spp. and Scedosporium apiospermum

See Table 1. Therapy must be initiated with the specified loading dose regimen of intravenous voriconazole on Day 1 followed by the recommended maintenance dose (RMD) regimen. Intravenous treatment should be continued for at least 7 days. Once the patient has clinically improved and can tolerate medication given by mouth, the oral tablet form or oral suspension form of voriconazole may be utilized. The recommended oral maintenance dose of 200 mg achieves a voriconazole exposure similar to 3 mg/kg Intravenously; a 300 mg oral dose achieves an exposure similar to 4 mg/kg Intravenously. Switching between the intravenous and oral formulations is appropriate because of the high bioavailability of the oral formulation in adults [ see Clinical Pharmacology ( 12) ].


Candidemia in non-neutropenic patients and other deep tissue Candida infections

See Table 1. Patients should be treated for at least 14 days following resolution of symptoms or following last positive culture, whichever is longer.

Esophageal Candidiasis

See Table 1. Patients should be treated for a minimum of 14 days and for at least 7 days following resolution of symptoms.

Table 1: Recommended Dosing Regimen (Adults)

Infection

Loading Dose

Maintenance Dose a,b

Intravenous infusion

Intravenous infusion

Oral c

Invasive Aspergillosis d

6 mg/kg every 12 hours for the first 24 hours

4 mg/kg every 12 hours

200 mg every 12 hours

Candidemia in non-neutropenic patients and other deep tissue Candida infections

6 mg/kg every 12 hours for the first 24 hours

3–4 mg/kg every 12 hours e

200 mg every 12 hours

Esophageal Candidiasis

Not Evaluated

Not Evaluated

200 mg every 12 hours

Scedosporiosis and Fusariosis

6 mg/kg every 12 hours for the first 24 hours

4 mg/kg every 12 hours

200 mg every 12 hours

a Increase dose when voriconazole is co-administered with phenytoin or efavirenz ( 7); Decrease dose in patients with hepatic impairment ( 2.5)

b In healthy volunteer studies, the 200 mg oral every12h dose provided an exposure (AUC τ ) similar to a 3 mg/kg intravenous infusion every 12 hours dose; the 300 mg oral every12 hours dose provided an exposure (AUC τ ) similar to a 4 mg/kg intravenous infusion every 12 hours dose ( 12)

c Adult patients who weigh less than 40 kg should receive half of the oral maintenance dose.

d In a clinical study of IA, the median duration of intravenous voriconazole therapy was 10 days (range 2 to 85 days). The median duration of oral voriconazole therapy was 76 days (range 2 to 232 days) (14.1)

e In clinical trials, patients with candidemia received 3 mg/kg intravenous infusion every 12 hours as primary therapy, while patients with other deep tissue Candida infections received 4 mg/kg every 12 hours as salvage therapy. ppropriate dose should be based on the severity and nature of the infection.

f Not evaluated in patients with EC


Method for Adjusting the Dosing Regimen in Adults
If patient’s response is inadequate, the oral maintenance dose may be increased from 200 mg every 12 hours (similar to 3 mg/kg intravenously every 12 hours) to 300 mg every 12 hours (similar to 4 mg/kg intravenously every 12 hours). For adult patients weighing less than 40 kg, the oral maintenance dose may be increased from 100 mg every 12 hours to 150 mg every 12 hours. If patient is unable to tolerate 300 mg orally every 12 hours, reduce the oral maintenance dose by 50 mg steps to a minimum of 200 mg every 12 hours (or to 100 mg every 12 hours for adult patients weighing less than 40 kg).

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