voriconazole 200 MG Oral Tablet
1 INDICATIONS AND USAGE Voriconazole tablets are 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 ) 1.1 Invasive Aspergillosis 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) ] . 1.2 Candidemia in Non-neutropenic Patients and Other Deep Tissue Candida Infections 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) ] . 1.3 Esophageal Candidiasis 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) ] . 1.4 Scedosporiosis and Fusariosis Voriconazole is indicated for the treatment of serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii ) and Fusarium spp. including Fusarium solani , in adults and pediatric patients (2 years of age and older) intolerant of, or refractory to, other therapy [see Clinical Studies (14.4) and Microbiology (12.4) ] . 1.5 Usage 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.
Mylan Institutional Inc.
OVAL WHITE M164
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voriconazole 50 MG Oral Tablet
Mylan Institutional Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
VORICONAZOLE Tablets are available containing 50 mg or 200 mg of
VORICONAZOLE, USP. The 50 mg tablets are white to off-white, film coated, oval, unscored tablets debossed with V26 on one side and plain on the other. They are available as follows: NDC 51079-164-03 – Unit dose blister packages of 30 (3 cards of 10 tablets each). The 200 mg tablets are white to off-white, film coated, capsule shaped, unscored tablets debossed with M164 on one side and plain on the other. They are available as follows: NDC 51079-165-03 – Unit dose blister packages of 30 (3 cards of 10 tablets each). 16.2 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
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