Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
VORICONAZOLE (UNII: JFU09I87TR) (VORICONAZOLE - UNII:JFU09I87TR)
Teva Pharmaceuticals USA, Inc.
VORICONAZOLE
VORICONAZOLE 50 mg
ORAL
PRESCRIPTION DRUG
Voriconazole tablets are indicated for use in patients 12 years of age and older in the treatment of the following fungal infections: 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) and Clinical Pharmacology (12.4) ]. [see Clinical Studies (14.2) and Clinical Pharmacology (12.4) ] [see Clinical Studies (14.3) and Clinical Pharmacology (12.4) ] [see Clinical Studies (14.4) and Clinical Pharmacology (12.4) ] Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly. - Voriconazole tablets are contraindicated in patients wit
Voriconazole Tablets, 50 mg are available as white to off-white, round shaped, unscored, film-coated tablets, debossed with “TEVA” on one side and “5289” on the other side and packaged in bottles of 30 tablets (NDC 0093-5289-56). Voriconazole Tablets, 200 mg are available as white to off-white, oval shaped, unscored, film-coated tablets, debossed with “TEVA” on one side and “5290” on the other side and packaged in bottles of 30 tablets (NDC 0093-5290-56). Voriconazole Tablets should be stored at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
VORICONAZOLE- VORICONAZOLE TABLET, FILM COATED TEVA PHARMACEUTICALS USA, INC. ---------- 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 INDICATIONS AND USAGE Voriconazole tablets are an azole antifungal indicated for use in the treatment of: Invasive aspergillosis (1.1) Candidemia (nonneutropenics) and disseminated candidiasis in skin, abdomen, kidney, bladder wall, and wounds (1.2) Esophageal candidiasis (1.3) Serious 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 RECOMMENDED DOSAGE (2.3) INFE C TIO N LOADING DOSE MAINTENANCE DOSE IV IV ORAL INVASIVE ASPERGILLOSIS 6 mg/kg q12h for the first 24 hours 4 mg/kg q12h 200 mg q12h CANDIDEMIA IN NONNEUTROPENICS AND OTHER DEEP TISSUE _CANDIDA_ INFECTIONS 3 to 4 mg/kg q12h 200 mg q12h SCEDOSPORIOSIS AND FUSARIOSIS 4 mg/kg q12h 200 mg q12h ESOPHAGEAL CANDIDIASIS Not Evaluated not evaluated 200 mg q12h Adult patients weighing less than 40 kg: oral maintenance dose 100 or 150 mg q12 hours DOSAGE FORMS AND STRENGTHS Film-coated tablets: 50 mg, 200 mg (3) CONTRAINDICATIONS Hypersensitivity to voriconazole or its excipients (4) Coadministration with terfenadine, astemizole, cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions (4, 7) Coadministration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids, and St. John’s Wort due to risk of loss of efficacy (4, 7) WARNINGS AND PRECAUTIONS _Clinically Significant Drug Interactions_: Review patient’s concomitant medications (5.1, 7) _Hepatic Toxicity_: Serious hepatic reactions reported. Evaluate liver function tests at start of and during voriconazole therapy (5.2) _Visual Disturbances Прочитајте комплетан документ