Sivextro Description




Zuellig Pharma
Full Prescribing Info
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 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.
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.
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.
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