Country: United States
Language: English
Source: NLM (National Library of Medicine)
SUGAMMADEX SODIUM (UNII: ERJ6X2MXV7) (SUGAMMADEX - UNII:361LPM2T56)
Medical Purchasing Solutions, LLC
INTRAVENOUS
PRESCRIPTION DRUG
BRIDION ® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION is contraindicated in patients with known hypersensitivity to sugammadex or any of its components. Hypersensitivity reactions that occurred varied from isolated skin reactions to serious systemic reactions (i.e., anaphylaxis, anaphylactic shock) and have occurred in patients with no prior exposure to sugammadex [see Warnings and Precautions (5.1), Adverse Reactions (6)] . Risk Summary There are no data on BRIDION use in pregnant women to inform any drug-associated risks. In animal reproduction studies, there was no evidence of teratogenicity following daily intravenous administration of sugammadex to rats and rabbits during organogenesis at exposures of up to 6 and 8 times, respectively, the maximum recommended human dose (MRHD) of 16 mg/kg. However, there was an increase in the incide
BRIDION (sugammadex) injection is a clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion. BRIDION is available in the following presentations: The packaging of this product is not made with natural rubber latex. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature). Protect from light. When not protected from light, the vial should be used within 5 days.
New Drug Application
BRIDION- SUGAMMADEX INJECTION, SOLUTION MEDICAL PURCHASING SOLUTIONS, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BRIDION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BRIDION. BRIDION (SUGAMMADEX) INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2015 INDICATIONS AND USAGE BRIDION is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. ( 1) DOSAGE AND ADMINISTRATION Monitor for twitch responses to determine the timing and dose for BRIDION administration. ( 2) Administer as a single bolus injection. ( 2) _For rocuronium and vecuronium:_ 4 mg/kg 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. ( 2.1) 2 mg/kg is recommended if spontaneous recovery has reached the reappearance of the second twitch in response to TOF stimulation. ( 2.1) _For rocuronium only:_ 16 mg/kg 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. ( 2.1) DOSAGE FORMS AND STRENGTHS 200 mg/2 mL (100 mg/mL) in a single-dose vial for bolus injection ( 3) 500 mg/5 mL (100 mg/mL) in a single-dose vial for bolus injection ( 3) CONTRAINDICATIONS Known hypersensitivity to sugammadex or any of its components. ( 4) WARNINGS AND PRECAUTIONS Anaphylaxis: Anaphylaxis has occurred in 0.3% of healthy volunteers. Observe patients for an appropriate period of time after administration. ( 5.1) Marked Bradycardia: Cases of marked bradycardia, some of which have resulted in cardiac arrest, have been observed within minutes after administration. Monitor for hemodynamic changes and administer anticholinergic agents such as atropine if clinically significant bradycardia is observed. ( 5.2) Respiratory Function Monitoring: Ventilatory support is mand Read the complete document