Several different formulations of tigecycline are available and excipients vary among them.2915; 3459; 3460 Some formulation differences have been demonstrated to result in some differing compatibilities.2951; 3459; 3460
Tigecycline is available as a 50-mg orange lyophilized powder or cake in single-dose (unpreserved) vials containing lactose monohydrate 100 mg (Tygacil, Wyeth),2915 maltose monohydrate 100 mg (Accord),3459 or arginine 82.6 mg (Fresenius Kabi).3460 In each formulation, the pH is adjusted with hydrochloric acid and, if necessary, sodium hydroxide.2915; 3459; 3460
Each 50-mg vial should be reconstituted with 5.3 mL of sodium chloride 0.9%; dextrose 5%; or Ringer’s injection, lactated.2915; 3459; 3460 The vials contain an excess of drug, and this reconstitution volume yields a reconstituted solution with a tigecycline concentration of 10 mg/mL.2915; 3459; 3460 Vials should be swirled gently until the drug has dissolved.2915; 3459; 3460 The reconstituted solution must be further diluted prior to administration.2915; 3459; 3460 The appropriate volume of the reconstituted solution should be withdrawn from the vial(s) and transferred to a 100-mL infusion bag of sodium chloride R0.9%; dextrose 5%; or Ringer’s injection, lactated to yield a solution for infusion with a maximum tigecycline concentration of 1 mg/mL.2915; 3459; 3460 The reconstituted solution should be yellow to orange; the solution should be discarded if it does not have the correct color.2915; 3459; 3460
Trade Name(s)
Tygacil
Tigecycline is administered by intravenous infusion over 30 to 60 minutes only after dilution of the reconstituted solution.2915; 3459; 3460
The diluted solution for infusion may be administered through a dedicated intravenous line or through a Y-site.2915; 3459; 3460 If a common infusion line is being used to administer other drugs in addition to tigecycline, the manufacturer states that the line should be flushed prior to and following infusion of tigecycline with sodium chloride 0.9%; dextrose 5%; or Ringer’s injection, lactated.2915; 3459; 3460 The solution used for flushing should be compatible both with tigecycline and with any other drug administered via the line.2915; 3459; 3460
Intact vials of tigecycline should be stored at controlled room temperature.2915; 3459; 3460 The reconstituted solution of tigecycline may be stored at room temperature (not exceeding 25°C) for up to 24 hours (up to 6 hours as the reconstituted solution in the vial with the remaining time in the infusion bag).2915; 3459; 3460 If storage conditions after reconstitution exceed 25°C, the drug should be diluted as directed and used immediately.2915; 3459; 3460 If further diluted immediately after reconstitution, a solution diluted for infusion in sodium chloride 0.9% or dextrose 5% may be stored for up to 48 hours at 2 to 8°C.2915; 3459; 3460
The reconstituted solution should be yellow to orange; solutions should be inspected for particulate matter and discoloration (e.g., the formation of a green or black discoloration).2915; 3459; 3460 Discolored solutions should be discarded.2915; 3459; 3460
Y-Site Injection Compatibility (1:1 Mixture)
Additional Compatibility Information
Peritoneal Dialysis Solutions
Tigecycline (Pfizer) was evaluated for stability in Dianeal PD-4 with dextrose 1.5% (Baxter) and Extraneal with icodextrin 7.5% (Baxter) at a concentration of 2 mg/L with bags stored at 4, 25, and 37°C.3195 The drug also was evaluated for stability in 2-compartment pH-neutral Balance with dextrose 1.5% (Fresenius).3195 Bags of 2-compartment pH-neutral Balance with dextrose 1.5% contained tigecycline 4 mg/L in the non-dextrose (i.e., buffer solution) compartment for storage at 4 and 25°C; for bags intended for storage at 37°C, the initial concentration of tigecycline in the non-dextrose compartment also was 4 mg/L; however, the 2 compartments were combined immediately prior to storage at 37°C for a final tigecycline concentration of 2 mg/L.3195 No color change or precipitation was noted on visual assessment and no meaningful pH changes occurred.3195 In Dianeal PD-4 with dextrose 1.5% and Extraneal with icodextrin 7.5%, tigecycline loss was 5 and 4%, respectively, in 14 days at 4°C; 7 and 9%, respectively, in 3 days at 25°C; and 4 and 4%, respectively, in 12 hours at 37°C.3195 In pH-neutral Balance with dextrose 1.5%, tigecycline loss was 6% in 7 days at 4°C, 8% in 3 days at 25°C, and 6% in 8 hours at 37°C.3195
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