VORICONAZOLE tablet, film coated

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

VORICONAZOLE (UNII: JFU09I87TR) (VORICONAZOLE - UNII:JFU09I87TR)

Disponibbli minn:

Sandoz Inc

INN (Isem Internazzjonali):

VORICONAZOLE

Kompożizzjoni:

VORICONAZOLE 50 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Voriconazole tablets are indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (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)] . Voriconazole tablets are 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)]. Voriconazole tablets are 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)]. Voricona

Sommarju tal-prodott:

Voriconazole tablets, 50 mg are white to off-white, round, biconvex, film coated tablets with 'SZ' debossed on one side and '132' debossed on the other side. NDC 0781-5667-31, Bottles of 30 Tablets NDC 0781-5667-05, Bottles of 500 Tablets NDC 0781-5667-10, Bottles of 1000 Tablets NDC 0781-5667-13, Carton of 100 Tablets (10 x 10 Unit-dose) Voriconazole tablets, 200 mg are white to off-white, capsule shaped, biconvex, film coated tablets with 'SZ' debossed on one side and '133' debossed on the other side. NDC 0781-5668-31, Bottles of 30 Tablets NDC 0781-5668-05, Bottles of 500 Tablets NDC 0781-5668-10, Bottles of 1000 Tablets NDC 0781-5668-13, Carton of 100 Tablets (10 x 10 Unit-dose) Voriconazole tablets should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

VORICONAZOLE- VORICONAZOLE TABLET, FILM COATED
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VORICONAZOLE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
VORICONAZOLE TABLETS.
VORICONAZOLE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2002
RECENT MAJOR CHANGES
Warnings and Precautions, Photosensitivity (5.6) 10/2022
INDICATIONS AND USAGE
Voriconazole tablets are an azole antifungal indicated for the
treatment of adults and pediatric patients 2
years of age and older with:
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DOSAGE AND ADMINISTRATION
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INFECTION
LOADING DOSE
MAINTENANCE DOSE
INTRAVENOUS INFUSION
INTRAVENOUS INFUSION ORAL
INVASIVE ASPERGILLOSIS
6 mg/kg every 12 hours for
the first 24 hours
4 mg/kg every 12
hours
200 mg every 12
hours
CANDIDEMIA IN
NONNEUTROPENICS AND
OTHER DEEP TISSUE
_CANDIDA_ INFECTIONS
3 to 4 mg/kg every 12
hours
200 mg every 12
hours
SCEDOSPORIOSIS AND
FUSARIOSIS
4 mg/kg every 12
hours
200 mg every 12
hours
ESOPHAGEAL CANDIDIASIS Not Evaluated
Not Evaluated
200 mg every 12
hours
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•
•
•
•
INFECTION
LOADING DOSE
MAINTENANCE DOSE
INTRAVENOUS INFUSION
INTRAVENOUS INFUSION
ORAL
INVASIVE ASPERGILLOSIS
9 mg/kg every 12 hours for
the first 24 hours
8 mg/kg every 12 hours
after the first 24 hours
9 mg/kg every 12
hours (maximum dose
of 350 mg every 12
hours)
CANDIDEMIA IN
NONNEUTROPENICS AND
OTHER DEEP TISSUE
_CANDIDA_ INFECTIONS
SCEDOSPORIOSIS AND
FUSARIOSIS
ESOPHAGEAL
CANDIDIASIS
Not Evaluated
4 mg/kg every 12 hours
9 mg/kg every 12
hours (maximum dose
of 350 mg every 12
hours)
Invasive aspergillosis (1.1)
Candidemia in non-neutropenics and other deep tissue _Candida_
infections (1.2)
Esophageal candidiasis (1.3)
Serious fungal infections caused by _Scedosporium apiospermum_ and
_Fusarium_ species including
_Fusarium solani_, in patients intolerant of, or refractory to, other
therapy (1.4)
DOSAGE IN ADULTS (2.3)
Adult patients weighing less than 40 kg: oral maintenance dose 100 mg
or 150 mg every 12 hours
_Hep