FDA approves Bridion treatment to enhance surgical outcomes
To reverse any adverse effects caused by certain bromides used in adult surgery, the U.S. Food and Drug Administration (FDA) recently announced its approval of Bridion (Sugammadex) via intravenous injection from its Silver Spring, Maryland, offices.
The medication -- intended to mitigate neuromuscular blockade caused by rocuronium bromide and vecuronium bromide in surgical treatment -- is endorsed as a single bolus injection through an existing IV in anesthetized surgery patients. The FDA stipulated parameters for each type of bromide-induced reaction, including exact dosages.
Emphasizing that approved dosages should be applied, the administration noted that use of lower than recommended amounts could lead to a higher chance of neuromuscular blockade recurring after initial reversal. For reversal of both rocuronium and vecuronium, the recommended dosage is four mg/kg or two mg/kg, depending on twitch response; while for rocuronium reversal only, 16 mg/kg is advised within three minutes of rocuronium administration.
Vecuronium bromide is a muscle relaxant. Rocuronium bromide is a neuromuscular blocking agent prescribed as an adjunct to general anesthesia in providing skeletal muscle relaxation to facilitate endotracheal intubation.
The FDA also listed potential drug interactions, laboratory test interferences and population risks based on experiments and clinical studies. While adverse reactions may be more likely in patients with impaired renal function, no other significant risk was seen in elderly individuals.
Guidelines were set for safety as well as efficacy, with common side effects listed as vomiting, pain, nausea, hypotension and headache -- plus possible drug hypersensitivity and bradycardia.
Organizations in this story
U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD 20903