Each vial of Revonto (dantrolene sodium for injection) should be reconstituted by adding 60 mL of sterile water for injection USP (without a bacteriostatic agent), and the vial shaken for approximately 20 seconds or until the solution is clear. 5% Dextrose Injection USP, 0.9% Sodium Chloride Injection USP, and other acidic solutions are not compatible with Revonto and should not be used. The contents of the vial must be protected from direct light and used within 6 hours after reconstitution. Store reconstituted solution at 20-25° C (68-77° F) [see USP Controlled Room Temperature] protected from direct light. Each vial of dantrolene sodium for injection should be reconstituted by adding 60 mL of sterile water for injection USP (without a bacteriostatic agent), and the vial shaken for approximately 20 seconds or until the solution is clear.
Reconstituted Revonto should not be transferred to large glass bottles for prophylactic infusion due to precipitate formation observed with the use of some glass bottles as reservoirs.
For prophylactic infusion, the required number of individual vials of Revonto should be reconstituted as outlined above. The contents of individual vials are then transferred to a larger volume sterile intravenous plastic bag. Stability data on file indicate commercially available sterile plastic bags are acceptable drug delivery devices. However, it is recommended that the prepared infusion be inspected carefully for cloudiness and/or precipitation prior to dispensing and administration. Such solutions should not be used. While stable for 6 hours, it is recommended that the infusion be prepared immediately prior to the anticipated dosage administration time.