VORICONAZOLE tablet, coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Solco Healthcare U.S., LLC

INN (nemzetközi neve):

VORICONAZOLE

Összetétel:

VORICONAZOLE 50 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Voriconazole tablets are indicated in adults and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) 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 (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) 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 (aged 12 to 14

Termék összefoglaló:

Click here to enter How Supplied Voriconazole tablets, 50 mg are white to off-white, round, biconvex film coated tablets debossed with “283” on one side and “S” on the other side. Bottles of 30 (NDC 43547-377-03) Bottles of 500 (NDC 43547-377-50) Voriconazole tablets, 200 mg are white to off-white, capsule shaped, biconvex film coated tablets debossed with “285” on one side and “S” on the other side. Bottles of 30 (NDC 43547-378-03) Bottles of 500 (NDC 43547-378-50) Voriconazole tablets should be stored at 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

VORICONAZOLE- VORICONAZOLE TABLET, COATED
SOLCO HEALTHCARE U.S., LLC
----------
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
Voriconazole tablets are azole antifungal indicated for the treatment
of adults and pediatric patients aged
12 to 14 years weighing greater than or equal to 50 kg and those aged
15 years and older regardless of
body weight with:
•
•
•
•
DOSAGE AND ADMINISTRATION
• INFECTION (2) LOADING DOSE (2)
MAINTENANCE DOSE (2) INTRAVENOUS INFUSION
(2) INTRAVENOUS INFUSION
(2)
ORAL (2)
INVASIVE ASPERGILLOSIS
(2)
6 mg/kg every (2)
12 hours for the first 24
hours (2)
4 mg/kg every (2)
12 hours (2)
200 mg every (2)
12 hours (2)
CANDIDEMIA IN
NONNEUTROPENICS AND
OTHER DEEP TISSUE
CANDIDA INFECTIONS (2)
3-4 mg/kg every (2)
12 hours (2)
200 mg every (2)
12 hours (2)
SCEDOSPORIOSIS AND
FUSARIOSIS (2)
4 mg/kg every (2)
12 hours (2)
200 mg every (2)
12 hours (2)
ESOPHAGEAL
CANDIDIASIS (2)
Not Evaluated (2)
Not Evaluated (2)
200 mg every (2)
12 hours (2)
o
o
o
•
o
o
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
Contraindications (4) 1/2021
Warnings and Precautions (5.5) 9/2020
Warnings and Precautions (5.8) 1/2021
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 Impairment_: Use half the maintenance dose in adult patients
with mild to moderate hepatic
impairment (Child-Pugh Class A and B) (2.5)
_Renal Impairment_: Avoid intravenous adm