Sugamex

Sugamex

sugammadex

Manufacturer:

Labesfal

Distributor:

Fresenius Kabi
Concise Prescribing Info
Contents
Sugammadex
Indications/Uses
Reversal of rocuronium- or vecuronium-induced neuromuscular blockade in adults. Routine reversal of rocuronium-induced blockade in childn & adolescents 2-17 yr.
Dosage/Direction for Use
Single bolus IV inj (rapidly w/in 10 sec). Adult Routine reversal Recommended dose: 4 mg/kg if recovery has reached at least 1-2 post-tetanic counts (PTC), or 2 mg/kg if spontaneous recovery has occurred up to at least the reappearance of T2 following rocuronium- or vecuronium-induced blockade. Immediate reversal of rocuronium-induced blockade 16 mg/kg. Re-administration Repeat dose of 4 mg/kg after an initial dose of 2 or 4 mg/kg in exceptional situation of neuromuscular blockade recurrence post-op. Childn & adolescent Routine reversal of rocuronium-induced blockade Recommended dose: 4 mg/kg if recovery has reached at least 1-2 PTC, or 2 mg/kg at reappearance of T2.
Contraindications
Special Precautions
Monitor for hypersensitivity reactions, including anaphylaxis. Ventilatory support is mandatory until adequate spontaneous respiration is restored, might still be required even if recovery is complete. Provide adequate ventilation should neuromuscular blockade reoccur following extubation. Use of lower than recommended doses is not recommended, due to increased risk of recurrence of neuromuscular blockade. Monitor haemostasis & coagulation parameters in patients w/ hereditary vit K dependent clotting factor deficiencies; pre-existing coagulopathies; on coumarin derivatives & at an INR >3.5; using anticoagulants who receive 16 mg/kg sugammadex. If neuromuscular blockade is reversed while anaesth is continued, observe for signs of light anaesth, & give additional doses of anaesth &/or opioid as clinically indicated. Rare instances of marked bradycardia; closely monitor patients for hemodynamic changes during & after reversal of neuromuscular blockade. Has not been investigated in patients receiving rocuronium or vecuronium in ICU setting. Should not be used to reverse block induced by nonsteroidal neuromuscular blocking agents (eg, succinylcholine or benzylisoquinolinium compd) or steroidal neuromuscular blocking agents other than rocuronium or vecuronium. Longer recovery times may be associated in conditions associated w/ prolonged circulation time eg, CV disease, old age or oedematous state (eg, severe hepatic impairment). Not recommended in patients w/ severe renal impairment, including those requiring dialysis. Caution in patients w/ severe hepatic impairment or when hepatic impairment is accompanied by coagulopathy. Exercise caution when administering to pregnant women. Discontinue breast-feeding or discontinue/abstain from therapy taking into account the benefit of breast-feeding for the child & of the therapy for the woman. Not recommended in term newborns & infants.
Adverse Reactions
Cough; airway complication of anaesth, anaesth complication, procedural hypotension, procedural complication.
Drug Interactions
Displacement interaction w/ toremifene or fusidic acid, potentially affecting sugammadex efficacy. May decrease exposure of progestogen, which might lead to reduction in effectiveness. Interference w/ serum progesterone assay. In in vitro experiments, pharmacodynamic interaction (aPTT & prothrombin time prolongation) was noted w/ vit K antagonists, unfractionated heparin, LMWH, rivaroxaban & dabigatran.
MIMS Class
Antidotes & Detoxifying Agents
ATC Classification
V03AB35 - sugammadex ; Belongs to the class of antidotes. Used to reverse neuromuscular blockade caused by rocuronium or vecuronium.
Presentation/Packing
Form
Sugamex soln for inj 100 mg/mL
Packing/Price
5 mL x 10 × 1's;2 mL x 10 × 1's