Finished product reference

Sugammadex

Injection, Solution · Parenteral · 100 mg/1mL · 5 mL

List code
52300
Salt form
Sodium

What it is and how it works

Mechanism of Action Sugammadex injection is a modified gamma cyclodextrin. It forms a complex with the neuromuscular blocking agents rocuronium and vecuronium, and it reduces the amount of neuromuscular blocking agent available to bind to nicotinic cholinergic receptors in the neuromuscular junction. This results in the reversal of neuromuscular blockade induced by rocuronium and vecuronium.

Indications

Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC’s BRIDION ® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC’s marketing exclusivity rights, this drug product is not labeled with that information . Sugammadex injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery.

Dosage and administration (summary)

• Dosing is based on actual body weight • Monitor for twitch responses to determine the timing and dose for sugammadex injection administration. • Administer as a single bolus injection. 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 mg/kg is recommended if spontaneous recovery has reached the reappearance of the second twitch in response to TOF stimulation.

Contraindications

Sugammadex injection 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 . Known hypersensitivity to sugammadex or any of its components.

Warnings and precautions

Anaphylaxis : Be prepared for hypersensitivity reactions (including anaphylactic reactions) and take necessary precautions. 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. Respiratory Function Monitoring : Ventilatory support is mandatory until adequate spontaneous respiration is restored and the ability to maintain a patent airway is assured.

Pregnancy

Pregnancy Risk Summary There are no clinical trial data on sugammadex injection use in pregnant women to inform any drug-associated risks. The available data from the pharmacovigilance safety database and published literature on sugammadex injection use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, mi…

Storage and supply

Sugammadex injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion. Sugammadex injection is available in the following presentations: Sugammadex injection 2-mL single-dose vials containing 200 mg sugammadex (100 mg/mL) Carton of 10 NDC 72266-268-10 Sugammadex injection 5-mL…

Source: Sugammadex (Sugammadex) — US FDA prescribing information, 2026-04-03, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Other presentations of the same active ingredient

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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