Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
VORICONAZOLE (UNII: JFU09I87TR) (VORICONAZOLE - UNII:JFU09I87TR)
Alvogen Inc.
VORICONAZOLE
VORICONAZOLE 10 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Voriconazole for injection 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 for injection 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 for injection is indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (EC) [see Clinical Studies (14.3, 14.5) and Microbiology (12.4)] . Voriconazole for injection is indicated for the trea
Powder for Solution for Injection Voriconazole for injection is supplied in a single-dose vial as a sterile lyophilized powder equivalent to 200 mg voriconazole and 3,200 mg sulfobutyl ether beta-cyclodextrin sodium (SBECD). NDC 47781-466-71 1 single-dose vial per carton Voriconazole for injection unreconstituted vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Voriconazole for injection is a single-dose unpreserved sterile lyophile. From a microbiological point of view, following reconstitution of the lyophile with Water for Injection, the reconstituted solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2° to 8°C (36° to 46°F). Chemical and physical in-use stability has been demonstrated for 24 hours at 2° to 8°C (36° to 46°F). This medicinal product is for single use only and any unused solution should be discarded. Only clear solutions without particles should be used [see Dosage and Administration (2.1)] .
Abbreviated New Drug Application
VORICONAZOLE- VORICONAZOLE INJECTION, POWDER, FOR SOLUTION ALVOGEN INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VORICONAZOLE FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VORICONAZOLE FOR INJECTION. VORICONAZOLE FOR INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2002 RECENT MAJOR CHANGES Warnings and Precautions, Photosensitivity (5.6) 10/2022 INDICATIONS AND USAGE Voriconazole for injection is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: 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 AND ADMINISTRATION DOSAGE IN ADULTS (2.3) 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 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 administration in adult patients with moderate to severe renal impairment (creatinine clearance <50 mL/min) (2.6) DOSAGE IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER (2.4) For pediatric patients 2 to less than 12 years of age and 12 to 14 years of age weighing less than 50 kg see Table below. INFECTION LOADING DO Olvassa el a teljes dokumentumot