Sugammadex
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Pronunciation | soo GAM ma dex |
Trade names | Bridion |
Other names | ORG-25969 |
AHFS/Drugs.com | Monograph |
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Intravenous | |
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Sugammadex, sold under the brand name Bridion, is a medication for the reversal of
The most common side effects include cough, airway problems due to the anaesthesia wearing off, reduced blood pressure and other complications such as changes in heart rate.[6]
Sugammadex is available as a generic medication.[9]
Medical uses
Sugammadex is indicated for the reversal of neuromuscular blockade induced by
Pharmacology
Pharmacodynamics
Sugammadex is a modified γ-cyclodextrin, with a lipophilic core and a hydrophilic periphery. This gamma cyclodextrin has been modified from its natural state by placing eight carboxyl thio ether groups at the sixth carbon positions. These extensions extend the cavity size allowing greater encapsulation of the rocuronium molecule. These negatively charged extensions electrostatically bind to the quaternary nitrogen of the target as well as contribute to the aqueous nature of the cyclodextrin. Sugammadex's binding encapsulation of rocuronium is one of the strongest among cyclodextrins and their guest molecules. The rocuronium molecule (a modified steroid) bound within sugammadex's lipophilic core, is rendered unavailable to bind to the acetylcholine receptor at the neuromuscular junction.
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Right: Space-filling model of a sugammadex sodium molecule in the same orientation.
Sugammadex, unlike
When muscle relaxant with rapid onset and short duration of action is required, there has been little choice apart from
'Recurarisation', a phenomenon of recurrence of neuromuscular block, may occur where the reversal agents wear off before a neuromuscular blocking drug is completely cleared. This is very unusual with all but the longest acting neuromuscular blocking drugs (such as
Sugammadex has been shown to have affinity for two other aminosteroid neuromuscular blocking agents,
Efficacy
A study was carried out in Europe looking at its suitability in
A
Tolerability
Sugammadex was generally well tolerated in clinical trials in surgical patients or healthy volunteers. In pooled analyses, the tolerability profile of sugammadex was generally similar to that of placebo or neostigmine plus
History
Sugammadex was discovered by the pharmaceutical company Organon at the Newhouse Research Site in Scotland.[19] Organon was acquired by Schering-Plough in 2007; Schering-Plough merged with Merck in 2009. Sugammadex is now owned and sold by Merck.
The US Food and Drug Administration (FDA) initially rejected Schering-Plough's New Drug Application for sugammadex in 2008,[20] but finally approved the medication for use in the United States in December 2015.[21][22] Sugammadex was approved for use in the European Union in July 2008.[6][23]
References
- ^ SUGAMMADEX ACCORD (Accord Healthcare Pty Ltd) Archived 2022-10-12 at the Wayback Machine Department of Health and Aged Care. Retrieved 30 March 2023
- ^ SUGAMMADEX SANDOZ (Sandoz Pty Ltd) Archived 2022-10-12 at the Wayback Machine Department of Health and Aged Care. Retrieved 30 March 2023
- ^ "Health Canada New Drug Authorizations: 2016 Highlights". Health Canada. 14 March 2017. Retrieved 7 April 2024.
- ^ "Bridion 100 mg/ml solution for injection - Summary of Product Characteristics (SmPC)". (emc). 18 March 2021. Archived from the original on 27 June 2021. Retrieved 27 June 2021.
- ^ a b c d "Bridion- sugammadex injection, solution". DailyMed. 14 December 2018. Archived from the original on 10 June 2020. Retrieved 10 June 2020.
- ^ a b c d "Bridion EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 10 June 2020. Retrieved 10 June 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^ "Sugammadex Adroiq". Union Register of medicinal products. 30 May 2023. Retrieved 6 June 2023.
- ^ "Dosing for Bridion (sugammadex)". www.merckconnect.com. Archived from the original on 2019-01-12. Retrieved 2019-01-11.
- ^ "Sugammadex Adroiq". European Medicines Agency. 16 June 2023. Retrieved 19 June 2023.
- PMID 17312188.
- S2CID 34811540.
- PMID 17048555.
- ^ Decoopman M (2007). "Reversal of pancuronium-induced block by the selective relaxant binding agent sugammadex". Eur J Anaesthesiol. 24(Suppl 39):110-111.
- PMID 18648227.
- PMID 19821409.
- ^ PMID 28806470.
- PMID 25935840.
- from the original on 2011-10-08. Retrieved 2010-03-29.
- PMID 17312211.
- ^ "U.S. FDA Issues Action Letter for Sugammadex" (Press release). Schering-Plough. 2008-08-01. Archived from the original on 2008-08-10. Retrieved 2008-08-02.
- ^ "Bridion (sugammadex) Injection". U.S. Food and Drug Administration (FDA). 4 February 2016. Archived from the original on 10 June 2020. Retrieved 10 June 2020.
- ^ "FDA approves Bridion to reverse effects of neuromuscular blocking drugs used during surgery" (Press release). Food and Drug Administration. 2015-12-15. Archived from the original on 2015-12-15. Retrieved 2015-12-15.
- ^ "Bridion (sugammadex) Injection - First and Only Selective Relaxant Binding Agent - Approved in European Union" (Press release). Schering-Plough. 2008-07-29. Archived from the original on 2008-09-24. Retrieved 2008-08-02.