Remimazolam besylate is available as a lyophilized powder in single-patient-use (preservative-free) vials containing 20 mg of remimazolam as the besylate salt.3671 Each vial also contains dextran 40 82 mg and lactose monohydrate 55 mg with hydrochloride/sodium hydroxide to adjust the pH.3671
The contents of each 20-mg single-patient-use vial should be reconstituted with 8.2 mL of sodium chloride 0.9%, directing the stream of diluent toward the vial wall.3671 The vial should be gently swirled until the contents are dissolved; vials should not be shaken.3671 The reconstituted solution should be visually inspected for particulate matter and discoloration prior to administration; if either is present, the solution should be discarded.3671 The reconstituted solution has a remimazolam concentration of 2.5 mg/mL.3671
pH
The pH of the reconstituted solution prepared with sodium chloride ranges from 2.9 to 3.9.3671
Equivalency
Remimazolam besylate 27.2 mg is equivalent to 20 mg of remimazolam base.3671
Trade Name(s)
Byfavo
Remimazolam besylate is administered as an intravenous injection.3671 Initial (induction) doses should be administered over a period of 1 minute; supplemental (maintenance) doses should be administered, as needed, over 15 seconds.3671
Remimazolam besylate is a white to off-white powder that forms a clear, colorless to pale yellow solution upon reconstitution.3671 Intact vials should be stored at controlled room temperature.3671 Once removed from packaging, vials should be protected from light.3671 The manufacturer states that the product must be prepared immediately prior to use; however, if the reconstituted solution is not used immediately, it may be stored in the vial for up to 8 hours at 20 to 25°C.3671
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