SPL Set ID: 75672079-589f-451a-bdbf-eaebcfcc80a9

SIVEXTRO (tedizolid phosphate), a phosphate prodrug, is converted to tedizolid in the presence of phosphatases. Tedizolid phosphate has the chemical name [(5 R )-(3-{3-Fluoro-4-[6-(2-methyl-2 H -tetrazol- 5-yl) pyridin-3-yl]phenyl}-2-oxooxazolidin- 5-yl]methyl hydrogen phosphate. Its empirical formula is C 17 H 16 FN 6 O 6 P and its molecular weight is 450.32. Its structural formula is: Tedizolid phosphate is a white to yellow solid and is administered orally or by intravenous infusion. The pharmacologically active moiety, tedizolid, is an antibacterial agent of the oxazolidinone class. SIVEXTRO Tablets contain 200 mg of tedizolid phosphate, and the following inactive ingredients: crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, and povidone. In addition, the film coating contains the following inactive ingredients: polyethylene glycol/macrogol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide. SIVEXTRO for Injection is a sterile, white to off-white sterile lyophilized powder supplied in a clear glass single-dose vial. Each vial contains 200 mg of tedizolid phosphate and the inactive ingredient, mannitol (105 mg). Sodium hydroxide and hydrochloric acid are used as needed for pH adjustment. When reconstituted as directed with 4 mL of Sterile Water for Injection, each mL contains 50 mg of tedizolid phosphate. The pH of the reconstituted solution is 7.4 to 8.1. Chemical Structure