voriconazole 50 MG Oral Tablet
1 INDICATIONS AND USAGE Voriconazole 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 ) 1.1 Invasive Aspergillosis 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 )]. 1.2 Candidemia in Non-neutropenic Patients and Other Deep Tissue Candida Infections 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 )]. 1.3 Esophageal Candidiasis 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 )]. 1.4 Scedosporiosis and Fusariosis Voriconazole tablets are 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.
Zydus Pharmaceuticals (USA) Inc.
ROUND WHITE 735
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 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: NDC 68382-735-06 in bottles of 30 tablets NDC 68382-735-16 in bottles of 90 tablets NDC 68382-735-01 in bottles of 100 tablets NDC 68382-735-05 in bottles of 500 tablets NDC 68382-735-10 in bottles of 1000 tablets NDC 68382-735-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Voriconazole Tablets, 200 mg are white to off-white, oval, biconvex, film-coated tablet debossed with "736" on one side and plain on the other side and are supplied as follows: NDC 68382-736-06 in bottles of 30 tablets NDC 68382-736-16 in bottles of 90 tablets NDC 68382-736-01 in bottles of 100 tablets NDC 68382-736-05 in bottles of 500 tablets NDC 68382-736-10 in bottles of 1000 tablets NDC 68382-736-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets 16.2 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] . Dispense in a tight container (USP).
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