VORICONAZOLE tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

McKesson Corporation dba SKY Packaging

INN (nemzetközi neve):

VORICONAZOLE

Összetétel:

VORICONAZOLE 200 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Voriconazole tablets are 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)] . 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

Termék összefoglaló:

Product: 63739-707 NDC: 63739-707-33 10 TABLET, FILM COATED in a BLISTER PACK / 3 in a BOX, UNIT-DOSE

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

VORICONAZOLE- VORICONAZOLE TABLET, FILM COATED
MCKESSON CORPORATION DBA SKY PACKAGING
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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
Indications and Usage (1)
1/2019
Dosage and Administration (2)
1/2019
Contraindications (4)
1/2019
Warnings and Precautions (5)
1/2019
INDICATIONS AND USAGE
Voriconazole tablets are an azole antifungal drug 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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INFE C TIO N
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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INFE C TIO N
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
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
_Hepatic I