VORICONAZOLE powder, for suspension VORICONAZOLE tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Greenstone LLC

INN (mednarodno ime):

VORICONAZOLE

Sestava:

VORICONAZOLE 50 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Voriconazole is 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 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)] . Voriconazole 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)]. Voriconazole is indicated for t

Povzetek izdelek:

Tablets Voriconazole 50 mg tablets; white, film-coated, round, debossed with "Pfizer" on one side and "VOR50" on the reverse. Voriconazole 200 mg tablets; white, film-coated, capsule shaped, debossed with "Pfizer" on one side and "VOR200" on the reverse. Powder for Oral Suspension Voriconazole for Oral Suspension is supplied in 100 mL high density polyethylene (HDPE) bottles. Each bottle contains 45 grams of powder for oral suspension, which contain 3 g of voriconazole. Following reconstitution, the volume of the suspension is 75 mL, providing a usable volume of 70 mL. Each mL of the oral suspension contains 40 mg of voriconazole (200 mg of voriconazole per 5 mL). A 5 mL oral dispenser and a press-in bottle adaptor are also provided. (NDC 59762-0935-3) Voriconazole tablets should be stored at 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Voriconazole powder for Oral Suspension should be stored at 2° C to 8°C (36° F to 46° F) (in a refrigerator) before reconstitution. The shelf-life of the powder for oral suspension is 24 months. The reconstituted suspension should be stored at 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not refrigerate or freeze. Keep the container tightly closed. The shelf-life of the reconstituted suspension is 14 days. Any remaining suspension should be discarded 14 days after reconstitution.

Status dovoljenje:

New Drug Application Authorized Generic

Lastnosti izdelka

VORICONAZOLE- VORICONAZOLE POWDER, FOR SUSPENSION
VORICONAZOLE- VORICONAZOLE TABLET, FILM COATED
GREENSTONE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VORICONAZOLE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VORICONAZOLE.
VORICONAZOLE TABLETS, FOR ORAL USE
VORICONAZOLE FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2002
RECENT MAJOR CHANGES
Warnings and Precautions, Photosensitivity (5.6)
10/2022
INDICATIONS AND USAGE
Voriconazole is an azole antifungal indicated for the treatment of
adults and pediatric patients 2 years of
age and older with:
•
•
•
•
DOSAGE AND ADMINISTRATION
•
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
3–4 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
o
o
o
•
o
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_
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 (2.2)
Adult patients weighing less than 40 kg: oral maintenance dose 100 mg
or 150 mg every 12 hours
(2.2)
_Hepatic Impairment_: Use half the maintenance dose in adult patients
with mild to moderate hepatic
impairmen