Omadacycline tosylate is available as a lyophilized powder or cake in single-dose vials containing the equivalent of 100 mg of omadacycline with 100 mg of sucrose.3435 Vials also may include hydrochloric acid and/or sodium hydroxide for pH adjustment.3435
Each 100-mg vial should be reconstituted with 5 mL of sterile water for injection, sodium chloride 0.9%, or dextrose 5%.3435 Vials should be swirled gently and then left to stand until the cake has dissolved completely and any foam has dispersed; vials should not be shaken.3435 The reconstituted solution should be visually inspected for particulate matter and discoloration prior to further dilution.3435 If necessary, vials may be inverted and swirled gently to dissolve any remaining powder.3435
The appropriate dose of the reconstituted solution should be further diluted immediately (within 1 hr) to a volume of 100 mL with sodium chloride 0.9% or dextrose 5% to a final omadacycline concentration of 1 or 2 mg/mL.3435 The diluted solution should be visually inspected for particulate matter and discoloration prior to administration.3435
Equivalency
Omadacycline tosylate 131 mg is equivalent to 100 mg of omadacycline.3435
Trade Name(s)
Nuzyra
Omadacycline tosylate is administered by intravenous infusion through a dedicated intravenous line or through a Y-site after reconstitution and further dilution; 100-mg doses should be infused over 30 minutes and 200-mg doses should be infused over 60 minutes.3435 If a common infusion line is being used to administer other drugs in addition to omadacycline tosylate, the line should be flushed with sodium chloride 0.9% or dextrose 5% prior to and following infusion of omadacycline tosylate.3435 Omadacycline tosylate must not be administered through the same intravenous line with any solution containing multivalent cations (e.g., calcium, magnesium).3435
Omadacycline tosylate is a yellow to dark orange powder that forms a yellow to dark orange solution upon reconstitution.3435 Intact vials should be stored at controlled room temperature.3435 The reconstituted solution of omadacycline should be diluted immediately (within 1 hour).3435 The diluted solution in sodium chloride 0.9% or dextrose 5% should be used within 24 hours if stored at room temperature (not exceeding 25°C) or within 7 days if stored at 2 to 8°C.3435 If the diluted solution has been stored under refrigeration, it should be allowed to come to room temperature prior to use.3435
Freezing Solutions
The manufacturer states that diluted solutions of omadacycline should not be frozen.3435
Elastomeric Reservoir Pumps
Omadacycline tosylate (Paratek Pharmaceuticals), reconstituted as recommended and diluted in SMARTeZ elastomeric reservoirs (Epic Medical) to an omadacycline concentration of 1 mg/mL in both dextrose 5% and sodium chloride 0.9%, was stored refrigerated at 2 to 8°C in the dark.3969 After storage for 9 days at 2 to 8°C in the dark followed by 30 minutes at room temperature, the solutions remained physically stable (i.e., no change in appearance, pH, or particulate matter) with no more than 0.7% loss of omadacycline.3969
Y-Site Injection Compatibility (1:1 Mixture)
Additional Compatibility Information
Infusion Solutions
Omadacycline tosylate must not be administered through the same intravenous line with any solution containing multivalent cations (e.g., calcium, magnesium).3435
For a list of references cited in the text of this monograph, search the monograph titled References.