País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
VORICONAZOLE (UNII: JFU09I87TR) (VORICONAZOLE - UNII:JFU09I87TR)
Major Pharmaceuticals
VORICONAZOLE
VORICONAZOLE 50 mg
ORAL
PRESCRIPTION DRUG
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)]. Voricona
Voriconazole Tablets, 50 mg are white to off-white, round, biconvex, film-coated tablet debossed with "735" on one side and plain on the other side and are supplied as follows: Carton of 30 tablets (10 tablets each blister pack x 3) NDC 0904-6596-04 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container (USP).
Abbreviated New Drug Application
VORICONAZOLE- voriconazole tablet Major Pharmaceuticals ---------- FDA-Approved Patient Labeling Voriconazole (vor i KON a zole) Tablets Read the Patient Information that comes with Voriconazole Tablets before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your condition or treatment. What are Voriconazole Tablets? Voriconazole Tablets are a prescription medicine used to treat certain serious fungal infections in your blood and body. These infections are called "aspergillosis," "esophageal candidiasis," "Scedosporium," "Fusarium," and "candidemia". It is not known if voriconazole tablets are safe and effective in children younger than 2 years old. Do not take Voriconazole Tablets if you: • are allergic to voriconazole or any of the ingredients in Voriconazole Tablets . See the end of this leaflet for a complete list of ingredients in Voriconazole Tablets. • are taking any of the following medicines: • cisapride • pimozide • quinidine • sirolimus • rifampin • carbamazepine • long-acting barbiturates like phenobarbital • efavirenz • ritonavir • rifabutin • ergotamine, dihydroergotamine (ergot alkaloids) • St. John's Wort (herbal supplement) Ask your healthcare provider or pharmacist if you are not sure if you are taking any of the medicines listed above. Do not start taking a new medicine without talking to your healthcare provider or pharmacist. Before you take voriconazole , tell your healthcare provider about all of your medical conditions, including if you: • have or ever had heart disease, or an abnormal heart rate or rhythm. Your healthcare provider may order a test to check your heart (EKG) before starting Voriconazole Tablets. • have liver or kidney problems. Your healthcare provider may do blood tests to make sure you can take Voriconazole Tablets. • have trouble digesting dairy products, lactose (milk sugar), or regular table sugar. Voriconazole Table Llegiu el document complet
VORICONAZOLE- VORICONAZOLE TABLET MAJOR PHARMACEUTICALS ---------- 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 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 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 • • • • • INFECTION LOADING DOSE MAINTENANCE DOSE INTRAVENOUS INFUSION INTRAVENOUS INFUSION ORAL INVASIVE ASPERGILLOSIS 9 mg/kg every12 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 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 or 150 mg every 12 hours Hepatic Impairment: Use half the maintenance dose in adult patients with m Llegiu el document complet