Source: FDA, National Drug Code (US) Revision Year: 2020
Each glass, single-patient-use, sterile vial of BYFAVO (remimazolam) for injection contains 20 mg remimazolam, equivalent to 27.2 mg remimazolam besylate.
Remimazolam is a benzodiazepine. Its chemical description is 4H-imidazol[1,2-a][1,4]benzodiazepine-4-propionic acid, 8-bromo-1-methyl-6-(2-pyridinyl)(4S), methyl ester, benzenesulfonate (1:1). The structural formulas are shown below.
Molecular weight of BYFAVO (free base): 439.3 g/mol.
Molecular weight of BYFAVO besylate: 597.5 g/mol.
BYFAVO besylate powder is sparingly soluble in water.
BYFAVO 20 mg contains: 82 mg dextran 40 and 55 mg lactose monohydrate as bulking agents/stabilizers. The pH is adjusted with hydrochloride/sodium hydroxide. Upon reconstitution with saline, BYFAVO has a pH of 2.9 to 3.9.
| Dosage Forms and Strengths |
|---|
|
Single-patient-use vial: Each glass, single-patient-use vial of BYFAVO (remimazolam) for injection contains 20 mg remimazolam white to off-white lyophilized powder, equivalent to 27.2 mg remimazolam besylate. |
| How Supplied |
|---|
|
BYFAVO (remimazolam) for injection, for intravenous use is supplied as follows: NDC 71390-011-11: Carton of 10 × 12 mL vials. Each 12 mL glass vial of BYFAVO (NDC 71390-011-00) provides a sterile lyophilized white to off-white powder intended for single-patient use only and contains 20 mg remimazolam (equivalent to 27.2 mg remimazolam besylate) ready for reconstitution. |
| Drug | Countries | |
|---|---|---|
| BYFAVO | Estonia, Finland, Croatia, Ireland, Lithuania, Poland, Romania, United Kingdom, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
