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PMS-SUGAMMADEX is a brand name for Sugammadex, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: pms-SUGAMMADEX (sugammadex injection) is indicated for the: reversal of moderate to deep neuromuscular blockade induced by rocuronium or vecuronium in adult and pediatric patients undergoing surgery. 1.1 Pediatrics Based on the data submitted and reviewed by Health Canada, the safety and efficacy of sugammadex…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • pms-SUGAMMADEX 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 pms-SUGAMMADEX administration should be based on monitoring for twitch responses and the extent of spontaneous recovery that has occurred. • The recommended dose of pms-SUGAMMADEX does not depend on the anesthetic regimen, but rather on the level of neuromuscular blockade to be reversed.
The anesthetic regimen may affect the recovery of the respiratory function and the reversal of the neuromuscular blockade independent of the reversal with pms-SUGAMMADEX. • The use of pms-SUGAMMADEX to reverse neuromuscular blockade induced by other steroidal neuromuscular blockers is not recommended.
g. atracurium and cisatracurium). 2 Recommended Dose and Dosage Adjustment • Pediatrics (birth-17 years of age): As for adults, the dose calculation is based on actual body weight. A dose of 2 mg/kg pms-SUGAMMADEX is recommended when spontaneous recovery has reached the reappearance of T2 (moderate blockade) following rocuronium or vecuronium induced neuromuscular blockade.
A dose of 4 mg/kg pms-SUGAMMADEX is recommended for reversal of rocuronium or vecuronium induced blockade if spontaneous recovery has reached at least 1-2 post-tetanic counts (PTC), and there is no twitch response to train-of-four (TOF) stimulation (deep blockade).
Immediate reversal has not been studied in the pediatric population. Doses higher than 4 mg/kg are not recommended for routine reversal of neuromuscular blockade as they may be associated with higher incidence of hypersensitivity and other adverse reactions.
9. 2 Pharmacodynamics). 0 mg/kg pms-SUGAMMADEX is recommended when spontaneous recovery has reached the reappearance of T2 (moderate blockade) following rocuronium or vecuronium induced neuromuscular blockade. 0 mg/kg pms-SUGAMMADEX is recommended for reversal of rocuronium or vecuronium induced blockade if spontaneous recovery has reached at least 1-2 post-tetanic counts (PTC), and there is no twitch response to train-of-four (TOF) stimulation (deep blockade) following administration of rocuronium or vecuronium induced neuromuscular blockade.
). Patients should be closely monitored for hemodynamic changes during and after reversal of neuromuscular blockade. Treatment with anti-cholinergic agents such as atropine should be administered if clinically significant bradycardia is observed.
2 Pharmacodynamics). pms-SUGAMMADEX (sugammadex injection) Product Monograph Page 10 of 44 Hematologic • Effect on Hemostasis: Sugammadex doses up to 16 mg/kg were associated with limited (≤25%) and transient (≤1 hour) increases in the coagulation parameters activated partial thromboplastin time (aPTT) and prothrombin time international normalized ratio [PT(INR)] in healthy volunteers.
In surgical patients concomitantly treated with an anticoagulant, small and transient increases were observed in aPTT and PT(INR) associated with sugammadex 4 mg/kg, which did not translate into an increased bleeding risk with sugammadex compared with usual treatment.
In in vitro experiments additional aPTT and PT(INR) prolongations were noted for sugammadex in combination with vitamin K antagonists, unfractionated heparin, low molecular weight heparinoids, rivaroxaban and dabigatran up to ~25% and ~50% at Cmax levels of sugammadex corresponding to 4 mg/kg and 16 mg/kg doses, respectively.
Since bleeding risk has not been studied systematically at higher doses than sugammadex 4 mg/kg, coagulation parameters should be carefully monitored according to routine clinical practice in patients with known coagulopathies and in patients using anticoagulants who receive a dose of sugammadex higher than 4 mg/kg.
Hepatic In patients with hepatic impairment, recovery times may be prolonged. In patients with hepatic impairment accompanied by coagulopathy, hemostasis may be affected (see 7 WARNINGS AND PRECAUTIONS, Hematologic). Neurologic • Driving and Operating Machinery: pms-SUGAMMADEX is not expected to have an effect on alertness and concentration, or on the recovery from anesthetics.
2 Clinical Trial Adverse Reactions). 1 Dosing Considerations • pms-SUGAMMADEX 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 pms-SUGAMMADEX administration should be based on monitoring for twitch responses and the extent of spontaneous recovery that has occurred. • The recommended dose of pms-SUGAMMADEX does not depend on the anesthetic regimen, but rather on the level of neuromuscular blockade to be reversed.
The anesthetic regimen may affect the recovery of the respiratory function and the reversal of the neuromuscular blockade independent of the reversal with pms-SUGAMMADEX. • The use of pms-SUGAMMADEX to reverse neuromuscular blockade induced by other steroidal neuromuscular blockers is not recommended.
g. atracurium and cisatracurium). 2 Recommended Dose and Dosage Adjustment • Pediatrics (birth-17 years of age): As for adults, the dose calculation is based on actual body weight. A dose of 2 mg/kg pms-SUGAMMADEX is recommended when spontaneous recovery has reached the reappearance of T2 (moderate blockade) following rocuronium or vecuronium induced neuromuscular blockade.
A dose of 4 mg/kg pms-SUGAMMADEX is recommended for reversal of rocuronium or vecuronium induced blockade if spontaneous recovery has reached at least 1-2 post-tetanic counts (PTC), and there is no twitch response to train-of-four (TOF) stimulation (deep blockade).
Immediate reversal has not been studied in the pediatric population. Doses higher than 4 mg/kg are not recommended for routine reversal of neuromuscular blockade as they may be associated with higher incidence of hypersensitivity and other adverse reactions.
9. 2 Pharmacodynamics). 0 mg/kg pms-SUGAMMADEX is recommended when spontaneous recovery has reached the reappearance of T2 (moderate blockade) following rocuronium or vecuronium induced neuromuscular blockade. 0 mg/kg pms-SUGAMMADEX is recommended for reversal of rocuronium or vecuronium induced blockade if spontaneous recovery has reached at least 1-2 post-tetanic counts (PTC), and there is no twitch response to train-of-four (TOF) stimulation (deep blockade) following administration of rocuronium or vecuronium induced neuromuscular blockade.
pms-SUGAMMADEX is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
e. anaphylaxis, or anaphylactic reactions), have occurred in individuals with or without prior exposure to sugammadex (see
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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pms-SUGAMMADEX (sugammadex injection) Product Monograph Page 6 of 44 A dose higher than 4 mg/kg pms-SUGAMMADEX is not recommended for routine reversal of neuromuscular blockade induced by rocuronium or vecuronium, as it has not been studied and is possibly associated with higher incidence of hypersensitivity reactions.
2 mg/kg rocuronium for intubation. The efficacy of 16 mg/kg sugammadex injection for such use was studied in surgical patients without airway emergency. The efficacy of the 16 mg/kg dose of sugammadex injection following administration of vecuronium has not been studied (see 10 CLINICAL PHARMACOLOGY) This dose is associated with a 1-2% risk of an anaphylaxis in addition to higher frequencies of other less serious hypersensitivity reactions in studies of healthy volunteers (see 10 CLINICAL PHARMACOLOGY).
• Waiting Times for Re-Administration of Neuromuscular Blocking Agents for Intubation Following Reversal with pms-SUGAMMADEX: A minimum waiting time is necessary before administration of a steroidal neuromuscular blocking agent after administration of pms-SUGAMMADEX.
Recommendations are based upon a clinical study in healthy volunteers and simulations from a PK- PD model; the actual clinical patient response may vary significantly (see 10 CLINICAL PHARMACOLOGY). If neuromuscular blockade is required before the recommended waiting time has elapsed, use a nonsteroidal neuromuscular blocking agent.
The onset of a depolarizing neuromuscular blocking agent might be slower than expected, because a substantial fraction of postjunctional nicotinic receptors can still be occupied by the neuromuscular blocking agent. For re-administration of rocuronium and vecuronium, the suggested minimum waiting time is outlined in the table below.
2 mg/kg is administered within 30 minutes after reversal with pms- pms-SUGAMMADEX (sugammadex injection) Product Monograph Page 7 of 44 SUGAMMADEX, the onset of neuromuscular blockade may be delayed up to approximately 4 minutes and the duration of neuromuscular blockade may be shortened up to approximately 15 minutes.
For re-administration of rocuronium or administration of vecuronium after reversal of rocuronium with 16 mg/kg pms-SUGAMMADEX, a waiting time of 24 hours is suggested. Renal Impairment: pms-SUGAMMADEX is not recommended for use in patients with severe (CrCl <30 mL/min) renal impairment including those requiring dialysis (see 7 WARNINGS AND PRECAUTIONS).
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The patient’s ability to drive and use machines must be assessed based on adequate recovery of motor strength and coordination, as well as mental alertness and concentration. Exercise caution when driving or operating a vehicle or potentially dangerous machinery.
• Use in Intensive Care Unit (ICU): pms-SUGAMMADEX has not been investigated in the ICU setting.
Peri-Operative Considerations • Anesthetic Complication:
The depth of anesthesia should be carefully monitored and maintained whenever a neuromuscular relaxant is used, as well as when its effects are reversed. If neuromuscular blockade is reversed while anesthesia is continued, anesthetic management may need to be adjusted as clinically indicated (see 8 ADVERSE REACTIONS).
e. when investigating urgent reversal, signs of light anesthesia were noted occasionally (movement, pms-SUGAMMADEX (sugammadex injection) Product Monograph Page 11 of 44 coughing, grimacing and suckling of the tracheal tube). Awareness under surgical anesthesia is a serious complication associated with excessive neuromuscular blockade without adequate analgesia and sedation.
Excessive use of rocuronium or vecuronium may potentially obscure the signs of inadequate anesthesia. Its use without adequate management of the depth of anesthesia is associated with an increase frequency of this complication. Such practice should be avoided even when pms-SUGAMMADEX can be used to accelerate the reversal of deep neuromuscular blockade induced by rocuronium or vecuronium.
After reversal of neuromuscular blockade with pms-SUGAMMADEX, care must be taken to assess the recovery from the effects of the anesthetics, while observing any signs of hypersensitivity reactions. Clinical trial data indicate that the speed of emergence from anesthesia may vary considerably from patient to patient, depending on the residual effects of the anesthetics given during surgery.
• Delayed Recovery: Prolonged recovery times after administration of pms-SUGAMMADEX are possible. Patients should be monitored for adequate recovery. , severe hepatic impairment) may be associated with longer recovery times. • Respiratory Function Monitoring During Recovery: Ventilatory support is mandatory for patients until adequate spontaneous respiration is restored following reversal of neuromuscular blockade.
Even if recovery from neuromuscular blockade is complete, other medicinal products used in the peri - and postoperative period could depress respiratory function and therefore ventilatory support might still be required. • Risk of Prolonged Neuromuscular Blockade: In clinical trials, a small number of patients experienced a delayed or minimal response to the administration of sugammadex injection.
Adequate anesthetic management, including ventilation support is mandatory until the patient has adequately emerged from anesthesia. • Risk of Recurrence of Neuromuscular Blockade: Patients should be monitored for recurrence of neuromuscular blockade after reversal.
Should neuromuscular blockade reoccur following extubation, adequate ventilation should be provided. The use of lower than recommended doses may lead to an increased risk of recurrence of neuromuscular blockade after initial reversal and is not recommended (see 8 ADVERSE REACTIONS).
3 Pharmacokinetics). Effect of mild or moderate renal […]
pms-SUGAMMADEX (sugammadex injection) Product Monograph Page 6 of 44 A dose higher than 4 mg/kg pms-SUGAMMADEX is not recommended for routine reversal of neuromuscular blockade induced by rocuronium or vecuronium, as it has not been studied and is possibly associated with higher incidence of hypersensitivity reactions.
2 mg/kg rocuronium for intubation. The efficacy of 16 mg/kg sugammadex injection for such use was studied in surgical patients without airway emergency. The efficacy of the 16 mg/kg dose of sugammadex injection following administration of vecuronium has not been studied (see 10 CLINICAL PHARMACOLOGY) This dose is associated with a 1-2% risk of an anaphylaxis in addition to higher frequencies of other less serious hypersensitivity reactions in studies of healthy volunteers (see 10 CLINICAL PHARMACOLOGY).
• Waiting Times for Re-Administration of Neuromuscular Blocking Agents for Intubation Following Reversal with pms-SUGAMMADEX: A minimum waiting time is necessary before administration of a steroidal neuromuscular blocking agent after administration of pms-SUGAMMADEX.
Recommendations are based upon a clinical study in healthy volunteers and simulations from a PK- PD model; the actual clinical patient response may vary significantly (see 10 CLINICAL PHARMACOLOGY). If neuromuscular blockade is required before the recommended waiting time has elapsed, use a nonsteroidal neuromuscular blocking agent.
The onset of a depolarizing neuromuscular blocking agent might be slower than expected, because a substantial fraction of postjunctional nicotinic receptors can still be occupied by the neuromuscular blocking agent. For re-administration of rocuronium and vecuronium, the suggested minimum waiting time is outlined in the table below.
2 mg/kg is administered within 30 minutes after reversal with pms- pms-SUGAMMADEX (sugammadex injection) Product Monograph Page 7 of 44 SUGAMMADEX, the onset of neuromuscular blockade may be delayed up to approximately 4 minutes and the duration of neuromuscular blockade may be shortened up to approximately 15 minutes.
For re-administration of rocuronium or administration of vecuronium after reversal of rocuronium with 16 mg/kg pms-SUGAMMADEX, a waiting time of 24 hours is suggested. Renal Impairment: pms-SUGAMMADEX is not recommended for use in patients with severe (CrCl <30 mL/min) renal impairment including those requiring dialysis (see 7 WARNINGS AND […]