देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
VORICONAZOLE (UNII: JFU09I87TR) (VORICONAZOLE - UNII:JFU09I87TR)
Greenstone LLC
VORICONAZOLE
VORICONAZOLE 50 mg
ORAL
PRESCRIPTION DRUG
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
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.
New Drug Application Authorized Generic
VORICONAZOLE- VORICONAZOLE POWDER, FOR SUSPENSION VORICONAZOLE- VORICONAZOLE TABLET, FILM COATED GREENSTONE LLC ---------- 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 पूरा दस्तावेज़ पढ़ें