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Sugammadex Mylan is a brand name for Sugammadex. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults. For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in paediatric patients from birth to 17 years.
Verbatim from this product's EMA label. Tap a section to expand.
Posology Sugammadex should only be administered by, or under the supervision of an anaesthetist. 4). The recommended dose of sugammadex depends on the level of neuromuscular blockade to be reversed. The recommended dose does not depend on the anaesthetic regimen.
Sugammadex can be used to reverse different levels of rocuronium or vecuronium induced neuromuscular blockade: Adults Routine reversal: A dose of 4 mg/kg sugammadex is recommended if recovery has reached at least 1-2 post-tetanic counts (PTC) following rocuronium or vecuronium induced blockade.
1). A dose of 2 mg/kg sugammadex is recommended, if spontaneous recovery has occurred up to at least the reappearance of T2 following rocuronium or vecuronium induced blockade. 1). 1).
Immediate reversal of rocuronium-induced blockade:
If there is a clinical need for immediate reversal following administration of rocuronium a dose of 16 mg/kg sugammadex is recommended. 1). There is no data to recommend the use of sugammadex for immediate reversal following vecuronium induced blockade.
4) after an initial dose of 2 mg/kg or 4 mg/kg sugammadex, a repeat dose of 4 mg/kg sugammadex is recommended. Following a second dose of sugammadex, the patient should be closely monitored to ascertain sustained return of neuromuscular function.
Re-administration of rocuronium or vecuronium after sugammadex:
For waiting times for re-administration of rocuronium or vecuronium after reversal with sugammadex, see section
Summary of the safety profile Sugammadex Mylan is administered concomitantly with neuromuscular blocking agents and anaesthetics in surgical patients. The causality of adverse events is therefore difficult to assess. The most commonly reported adverse reactions in surgical patients were cough, airway complication of anaesthesia, anaesthetic complications, procedural hypotension and procedural complication (Common (≥ 1/100 to < 1/10)).
Table 2:
Tabulated list of adverse reactions The safety of sugammadex has been evaluated in 3 519 unique subjects across a pooled phase I-III safety database. 4) Procedural hypotension Procedural complication Description of selected adverse reactions Drug hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis, have occurred in some patients and volunteers (for information on volunteers, see Information on healthy volunteers below).
In clinical trials of surgical patients these reactions were reported uncommonly and for post-marketing reports the frequency is unknown. e. anaphylaxis, anaphylactic shock) and have occurred in patients with no prior exposure to sugammadex.
Symptoms associated with these reactions can include: flushing, urticaria, erythematous rash, (severe) hypotension, tachycardia, swelling of tongue, swelling of pharynx, bronchospasm and pulmonary obstructive events. Severe hypersensitivity reactions can be fatal.
In postmarketing reports, hypersensitivity has been observed for sugammadex as well as for sugammadex-rocuronium complex.
Airway complication of anaesthesia:
Airway complications of anaesthesia included bucking against the endotracheal tube, coughing, mild bucking, arousal reaction during surgery, coughing during the anaesthetic procedure or during surgery, or anaesthetic procedure-related spontaneous breath of patient.
4. 4). 1). For mild and moderate renal impairment (creatinine clearance ≥ 30 and < 80 mL/min): the dose recommendations are the same as for adults without renal impairment. 6 minutes. 4).
Obese patients:
In obese patients, including morbidly obese patients (body mass index 40 kg/m2), the dose of sugammadex should be based on actual body weight. The same dose recommendations as for adults should be followed.
Hepatic impairment:
Studies in patients with hepatic impairment have not been conducted. 4). For mild to moderate hepatic impairment: as sugammadex is mainly excreted renally no dose adjustments are required. 6). Routine reversal: 4 A dose of 4 mg/kg sugammadex is recommended for reversal of rocuronium induced blockade if recovery has reached at least 1-2 PTC.
1).
Immediate reversal:
Immediate reversal has not been investigated in the paediatric population. Method of administration Sugammadex should be administered intravenously as a single bolus injection. 6). Sugammadex has only been administered as a single bolus injection in clinical trials.
1. 4 Special warnings and precautions for use As is normal post-anaesthetic practice following neuromuscular blockade, it is recommended to monitor the patient in the immediate post-operative period for untoward events including recurrence of neuromuscular blockade.
Monitoring respiratory function 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 post-operative period could depress respiratory function and therefore ventilatory support might still be required.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Anaesthetic complication:
Anaesthetic complications, indicative of the restoration of neuromuscular function, include movement of a limb or the body or coughing during the anaesthetic procedure or during surgery, grimacing, or suckling on the endotracheal tube.
4 light anaesthesia.
Procedural complication:
Procedural complications included coughing, tachycardia, bradycardia, movement, and increase in heart rate. 4). 4).
Information on healthy volunteers:
A randomised, double-blind study examined the incidence of drug hypersensitivity reactions in healthy volunteers given up to 3 doses of placebo (N=76), sugammadex 4 mg/kg (N=151) or sugammadex 16 mg/kg (N=148). Reports of suspected hypersensitivity were adjudicated by a blinded committee.
5% in the placebo, sugammadex 4 mg/kg and sugammadex 16 mg/kg groups, respectively. There were no reports of anaphylaxis after placebo or sugammadex 4 mg/kg. 7%). There was no evidence of increased frequency or severity of hypersensitivity with repeat dosing of sugammadex.
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Additional information on special populations Pulmonary patients:
In post-marketing data and in one dedicated clinical trial in patients with a history of pulmonary complications, bronchospasm was reported as a possibly related adverse event. As with all patients with a history of pulmonary complications the physician should be aware of the possible occurrence of bronchospasm.
Paediatric population 10 In studies of paediatric patients from birth to 17 years of age, the safety profile of sugammadex (up to 4 mg/kg) was generally similar to the profile observed in adults. Morbidly obese patients In one dedicated clinical trial in morbidly obese patients, the safety profile was generally similar to the profile in adult patients in pooled Phase 1 to 3 studies (see Table 2).
Patients with severe systemic disease In a trial in patients who were assessed as American Society of Anesthesiologists (ASA) Class 3 or 4 (patients with severe systemic disease or patients with severe systemic disease that is a constant threat to life), the adverse reaction profile in these ASA Class 3 and 4 patients was generally similar to that of adult […]
Should neuromuscular blockade reoccur following extubation, adequate ventilation should be provided. 20% was observed for recurrence of neuromuscular blockade as based on neuromuscular monitoring or clinical evidence. 8).
Effect on haemostasis:
In a study in volunteers doses of 4 mg/kg and 16 mg/kg of sugammadex resulted in maximum mean prolongations of the activated partial thromboplastin time (aPTT) by 17 and 22% respectively and prothrombin time international normalised ratio [PT(INR)] by 11 and 22% respectively.
These limited mean aPTT and PT(INR) prolongations were of short duration (≤ 30 minutes). Based on the clinical data-base (N=3 519) and on a specific study in 1 184 patients undergoing hip fracture/major joint replacement surgery there was no clinically relevant effect of sugammadex 4 mg/kg alone or in combination with anticoagulants on the incidence of peri- or post-operative bleeding complications.
In in vitro experiments a pharmacodynamic interaction (aPTT and PT prolongation) was noted with vitamin K antagonists, unfractionated heparin, low molecular weight heparinoids, rivaroxaban and dabigatran. In patients receiving routine post-operative prophylactic anticoagulation this pharmacodynamic interaction is not clinically relevant.
Caution should be exercised when considering the use of sugammadex in patients receiving therapeutic anticoagulation for a pre-existing or comorbid condition. 5; • using anticoagulants who receive a dose of 16 mg/kg sugammadex. If there is a medical need to give sugammadex to these patients the anaesthesiologist needs to decide if the benefits outweigh the possible risk of bleeding complications taking into consideration the patients history of bleeding episodes and type of surgery scheduled.
If sugammadex is administered to these patients monitoring of haemostasis and coagulation parameters is recommended. Waiting times for re-administration with neuromuscular blocking agents after reversal with sugammadex: Table 1: Re-administration of rocuronium or vecuronium after routine reversal (up to 4 mg/kg […]