Drug Detail:Bridion (Sugammadex [ soo-gam-ma-dex ])
Generic Name: SUGAMMADEX SODIUM 100mg in 1mL
Dosage Form: injection, solution
Drug Class: Miscellaneous central nervous system agents
Important Dosing and Administration Information
BRIDION dosing is based on actual body weight.
BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents.
Doses and timing of BRIDION administration should be based on monitoring for twitch responses and the extent of spontaneous recovery that has occurred.
Administer BRIDION intravenously as a single bolus injection. The bolus injection may be given over 10 seconds, into an existing intravenous line. BRIDION has only been administered as a single bolus injection in clinical trials.
From the time of BRIDION administration until complete recovery of neuromuscular function, monitor the patient to assure adequate ventilation and maintenance of a patent airway. Satisfactory recovery should be determined through assessment of skeletal muscle tone and respiratory measurements in addition to the response to peripheral nerve stimulation.
The recommended dose of BRIDION does not depend on the anesthetic regimen.
Preparation of dilution for pediatric use:
BRIDION 100 mg/mL may be diluted to a concentration of 10 mg/mL, using 0.9% sodium chloride injection, USP, to increase the accuracy of dosing in the pediatric population.
- To prepare the required dose, aseptically transfer all the contents of the 2 mL vial of BRIDION 2-mL single-dose vials containing 200 mg sugammadex (100 mg/mL) to a bottle (or intravenous bag) containing 18 mL of 0.9% sodium chloride injection, to achieve a final concentration of 10 mg/mL sugammadex. The diluted solution should be used immediately.
- BRIDION injection is a single-dose sterile solution without preservatives. Discard any unused portion from the vial.
Recommended Dosing
BRIDION can be used to reverse different levels of rocuronium- or vecuronium-induced neuromuscular blockade.
For rocuronium and vecuronium:
- A dose of 4 mg/kg BRIDION is recommended if spontaneous recovery of the twitch response has reached 1 to 2 post-tetanic counts (PTC) and there are no twitch responses to train-of-four (TOF) stimulation following rocuronium- or vecuronium-induced neuromuscular blockade [see Warnings and Precautions (5.8)].
- A dose of 2 mg/kg BRIDION is recommended if spontaneous recovery has reached the reappearance of the second twitch (T2) in response to TOF stimulation following rocuronium- or vecuronium-induced neuromuscular blockade [see Warnings and Precautions (5.8)].
For rocuronium only:
- A dose of 16 mg/kg BRIDION is recommended if there is a clinical need to reverse neuromuscular blockade soon (approximately 3 minutes) after administration of a single dose of 1.2 mg/kg of rocuronium. The efficacy of the 16 mg/kg dose of BRIDION following administration of vecuronium has not been studied. Immediate reversal in pediatric patients has not been studied [see Clinical Studies (14.1)].
Drug Compatibility
May inject BRIDION into the intravenous line of a running infusion with the following intravenous solutions:
- 0.9% sodium chloride
- 5% dextrose
- 0.45% sodium chloride and 2.5% dextrose
- 5% dextrose in 0.9% sodium chloride
- isolyte P with 5% dextrose
- Ringer's lactate solution
- Ringer's solution
Ensure the infusion line is adequately flushed (e.g., with 0.9% sodium chloride) between administration of BRIDION and other drugs.
Do not mix BRIDION with other products except those listed above.
BRIDION is physically incompatible with verapamil, ondansetron, and ranitidine.
Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever the solution and container permit.