Levetiracetam is available as a 100-mg/mL concentrate for injection in 5-mL single-dose vials.2833 The concentrate must be diluted prior to administration.2833
Levetiracetam also is available as a ready-to-use solution for intravenous infusion in 100-mL single-dose plastic bags containing levetiracetam 250 mg in 50-mL of sodium chloride solution (5 mg/mL) or levetiracetam 500 mg, 1 g, or 1.5 g in 100 mL of sodium chloride solution (5, 10, or 15 mg/mL, respectively).2834
Both the concentrate and the ready-to-use formulations contain water for injection and sodium chloride as well as glacial acetic acid and sodium acetate trihydrate to adjust the pH.2833; 2834
pH
The concentrate and ready-to-use solutions are buffered to a pH of approximately 5.5.2833; 2834
Osmolality
Levetiracetam 100-mg/mL concentrate for injection has an osmolality of approximately 950 mOsm/kg.2835 Following dilution of 500 mg of the concentrate in 100 mL of sodium chloride 0.9%, the solution has an osmolality of approximately 430 mOsm/kg.2835
Trade Name(s)
Keppra
Levetiracetam concentrate for injection is administered by intravenous infusion over 15 minutes after dilution in 100 mL of a compatible diluent.2833 If a smaller infusion volume is required (e.g., for pediatric patients or fluid-restricted patients), the final concentration of the diluted solution should not exceed 15 mg/mL.2833
Ready-to-use solutions of levetiracetam should not be further diluted prior to intravenous infusion.2834 The ready-to-use solution is administered by intravenous infusion over 15 minutes.2834
Levetiracetam concentrate and diluted solutions should be clear and colorless.2833; 2834 Intact vials of levetiracetam concentrate and ready-to-use bags of levetiracetam solution should be stored at controlled room temperature.2833; 2834 Discolored products or products containing particulate matter should not be used.2833; 2834
The unused contents of an opened vial or a partially used infusion bag should be discarded.2833; 2834 Diluted solutions for infusion should not be stored for more than 4 hours at controlled room temperature.2833
Sorption
The manufacturer states that infusion bags composed of polyvinyl chloride (PVC) may be used for preparation of diluted solutions.2833
Syringes
Levetiracetam (Hospira) was diluted to a concentration of 40 mg/mL in sodium chloride 0.9% and packaged as 25 mL in 30-mL polypropylene syringes (Becton Dickinson).3114 The syringes were stored for 14 days at 2 to 8°C.3114 Neither changes in color or clarity nor appreciable changes in pH from baseline values occurred.3114 Samples exhibited a loss of less than 6% of levetiracetam concentration at 14 days.3114
For a list of references cited in the text of this monograph, search the monograph titled References.