Sivextro Description

Film-coated tablet: SIVEXTRO tablets contain 200 mg of tedizolid phosphate.
Lyophilized powder for solution for infusion: SIVEXTRO for injection is a sterile, white to off-white sterile lyophilized powder for injection in single-use vials of 200 mg. Each 200 mg vial must be reconstituted with Sterile Water for Injection and subsequently diluted only with 0.9% Sodium Chloride Injection, USP.
SIVEXTRO (tedizolid phosphate), a phosphate prodrug, is converted to tedizolid in the presence of phosphatases.
Tedizolid phosphate has the chemical name [(5R)-(3-{3-Fluoro-4-[6-(2-methyl-2H-tetrazol-5-yl) pyridin-3-yl]phenyl}-2-oxooxazolidin-5-yl]methyl hydrogen phosphate.
Its empirical formula is C₁₇H₁₆FN₆O₆P and its molecular weight is 450.32.
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.
Excipients/Inactive Ingredients: Film-coated tablet: microcrystalline cellulose, mannitol, crospovidone, povidone, and magnesium stearate.
Film coating: polyvinyl alcohol, titanium dioxide, polyethylene glycol/macrogol, talc, and yellow iron oxide.
Lyophilized powder for solution for infusion: mannitol (105 mg), sodium hydroxide, and hydrochloric acid, which is used in minimal quantities for pH adjustment.