Tedizolid phosphate is a prodrug that is metabolized in vivo to tedizolid.2913 Tedizolid phosphate is available as a lyophilized powder or cake in preservative-free, single-dose vials containing 200 mg of tedizolid phosphate and mannitol 105 mg.2913 Sodium hydroxide and hydrochloric acid are used as needed to adjust the pH.2913
Each 200-mg vial should be reconstituted with 4 mL of sterile water for injection to yield a solution with a tedizolid phosphate concentration of 50 mg/mL.2913 Gently swirl the vial and allow it to stand until the cake has completely dissolved and any foam has disappeared.2913 To minimize foaming, vigorous agitation or shaking should be avoided during and after reconstitution.2913 Inspect vial to ensure that the solution contains no particulate matter and that no undissolved cake or powder remains attached to the vial wall; if undissolved drug remains, the vial should be inverted and gently swirled to dissolve the remainder.2913
The vial should not be inverted during withdrawal of the dose; instead, keeping the vial in the upright position, a syringe with an appropriately sized needle should be used to withdraw 4 mL of the reconstituted solution from the bottom corner of the tilted vial.2913
Adults and pediatric patients weighing at least 35 kg: To prepare a diluted solution for infusion, the appropriate volume of the reconstituted solution should be diluted in 250 mL of sodium chloride 0.9% or dextrose 5%.2913 The bag should be inverted gently to mix; do not shake because foaming may occur.2913
Pediatric patients weighing less than 35 kg: To prepare a diluted solution for infusion, first prepare a stock solution by diluting 1.6 mL of the reconstituted solution in an infusion bag containing 98.4 mL of sodium chloride 0.9% or dextrose 5% to yield 100 mL of stock solution with a tedizolid phosphate concentration of 0.8 mg/mL.2913 The appropriate volume of the stock solution, based on patient weight, should then be transferred to an adequately-sized infusion bag or infusion syringe for administration.2913
pH
Reconstituted solution: 7.4 to 8.1.2913
Trade Name(s)
Sivextro
Tedizolid phosphate is administered by intravenous infusion over 1 hour.2913 If a common infusion line is being used to administer other drugs, the line should be flushed with sodium chloride 0.9% prior to and following infusion of tedizolid phosphate.2913 Tedizolid phosphate is incompatible with any solutions containing divalent cations (e.g., calcium, magnesium), including Ringer’s injection, lactated, and Hartmann's solution.2913
Intact vials of tedizolid phosphate should be stored at controlled room temperature.2913 Tedizolid phosphate is a white to off-white powder that forms a clear, colorless to pale yellow solution following reconstitution and dilution.2913 The manufacturer states that the reconstituted drug and the diluted solution may be stored under refrigeration or at room temperature; however, the total time from reconstitution to dilution to end of administration should not exceed 24 hours.2913
Filtration
Tedizolid phosphate (Cubist) was filtered through a 0.22-µm inline filter.2914 No significant loss in potency or changes in appearance or impurity levels were observed.2914
For a list of references cited in the text of this monograph, search the monograph titled References.