解毒劑 Reversal of neuromuscular blockade induced by rocuronium or vecuronium in pediatric patients ≥2 years of age and adults <20211124>
#仿單變更2021

Antidote; Selective Relaxant Binding Agent
Sugammadex, a modified gamma cyclodextrin, reverses neuromuscular blockade by forming a complex with rocuronium or vecuronium in plasma, reducing the amount of neuromuscular blocking agent available to bind to nicotinic receptors in the neuromuscular junction .

Distribution: Vd: 11 to 14 L
Excretion: Renal: 96%; at least 95% unchanged
Dialyzable: Hemo (yes, via high-flux filter)
Elimination Half Life: 2 hours

Hypersensitivity to sugammadex or any component of the product

Fetal risk cannot be ruled out

Infant risk cannot be ruled out (MDX)

Common:
Gastrointestinal: Nausea (23% to 26% ), Vomiting (11% to 15% )
Neurologic: Headache (5% to 10% )
Serious:
Cardiovascular: Bradyarrhythmia (1% to 5% ), Prolonged QT interval (Up to 6% )
Immunologic: Anaphylaxis (Up to 1% ), Hypersensitivity reaction (Up to 9% )
Musculoskeletal: Increased creatine kinase level (25% )
Respiratory: Complication of anesthesia, Airway (1% to 9% ).

Routine reversal of rocuronium- or vecuronium:
1. If spontaneous twitch response recovery has reached 1 to 2 post-tetanic counts and no twitch response to train-of-four stimulation: 4 mg/kg IV bolus based (on actual body weight).
2. If spontaneous recovery has reached reappearance of second twitch (T2) in response to train-of-four stimulation: 2 mg/kg IV bolus based on actual body weight.
Immediate reversal of Rocuronium:
If clinical need for reversal soon (about 3 minutes) after administration of a single 1.2 mg/kg dose of rocuronium: 16 mg/kg IV bolus based on actual body weight.
Obesity, including morbidobesity (BMI≥40kg/m²) <20210923>:
use actual body weight

Severe renal impairment (CrCl<30 mL/min), Dialysis: Use not recommended

仿單：
1. Bridion 注射液是一種不含防腐劑的單劑量無菌溶液，丟棄小瓶中任何未使用的部分。
2. 如果不立即使用，稀釋後的溶液可以在冷藏或室溫下保存長達48小時。<20211124>