Sivextro Description


Merck Sharp & Dohme


Zuellig Pharma
Full Prescribing Info
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.
FC tablet: SIVEXTRO tablets contain 200 mg of tedizolid phosphate.
Powder for infusion: SIVEXTRO is supplied as a 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.
Excipients/Inactive Ingredients: FC tablet: Microcrystalline cellulose, mannitol, crospovidone, povidone, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol/macrogol, talc, and yellow iron oxide.
Powder for infusion: The inactive ingredients are mannitol (105 mg), sodium hydroxide, and hydrochloric acid, which is used in minimal quantities for pH adjustment.
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