SPL Set ID: 7f2e0784-8e48-f565-e053-2991aa0a0746

Voriconazole, an azole antifungal agent is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration, and as a powder for oral suspension. The structural formula is: Voriconazole is designated chemically as (2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1 H -1,2,4-triazol-1-yl)-2-butanol with an empirical formula of C 16 H 14 F 3 N 5 O and a molecular weight of 349.3. Voriconazole drug substance is a white to light-colored powder. Voriconazole for injection is a white lyophilized powder containing nominally 200 mg voriconazole and 3,200 mg sulfobutyl ether beta-cyclodextrin sodium in a 30 mL Type I clear glass vial. Voriconazole for injection is intended for administration by intravenous infusion. It is a single-dose, unpreserved product. Vials containing 200 mg lyophilized voriconazole are intended for reconstitution with Water for Injection to produce a solution containing 10 mg/mL voriconazole and 160 mg/mL of sulfobutyl ether beta-cyclodextrin sodium. The resultant solution is further diluted prior to administration as an intravenous infusion [see Dosage and Administration (2)] . voriconazole01.jpg