Sugammadex

Registered South African indications:

• Neuromuscular blockade reversal

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• Severe renal impairment
• Severe hepatic impairment
• Coagulopathy
• Hereditary vitamin K dependant clotting factor deficiencies
• Use in intensive care units
• Cardiovascular disease
• Oedematous states
• Sodium controlled diet

Forms avail. in SA and covered in this monograph: inj

Reversal of neuromuscular blockade by vecuronium and rocuronium
- Immediate reversal

• IV: 16mg/kg, as a single dose

Reversal of neuromuscular blockade by vecuronium and rocuronium
- 1-2 post-tetanic counts

• IV: 4mg/kg, as a single dose

Reversal of neuromuscular blockade by vecuronium and rocuronium
- Spontaneous recovery occurred to reappearance of T2 (second twitch of train-of-four)

• IV: 2mg/kg, as a single dose

Paed. forms avail. in SA and covered in this monograph: inj

Reversal of neuromuscular blockade by vecuronium and rocuronium
- Spontaneous recovery occurred to reappearance of T2 (second twitch of train-of-four)

Younger than 2 years

• Not established for use

Between 2-17 years

• IV: 2mg/kg, as a single dose

Older than 17 years

• See adult dosage

Pregnancy

• Caution
• For sugammadex no clinical data on exposed pregnancies are available.  Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development

Breastfeeding

• Caution 
• It is unknown whether sugammadex is excreted in human breast milk. Animal studies have shown excretion of sugammadex in breast milk. Oral absorption of cyclodextrins, in general, is low and no effect on the breastfeeding child is anticipated following a single dose to the breastfeeding woman. Sugammadex may be used during breastfeeding

Renal Impairment

• CrCl 30-80ml/min: No dose adjustment recommended
• CrCl <30ml/min: Caution; no dose adjustment recommended
  Use not recommended

Hepatic Impairment

• Mild to moderate: No dose adjustment recommended
• Severe: Caution; no dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Cardiovascular Disorders

• Hypotension

Respiratory Disorders

• Cough

Immune, Blood and Lymphatic System Disorders

• Drug hypersensitivity reactions

• Toremifene
• Fusidic acid
• Hormonal contraceptives

None routine

Sugammadex is a modified gamma cyclodextrin which is a selective relaxant binding agent. It forms a complex with the neuromuscular blocking agents rocuronium or vecuronium in plasma and thereby reduces the amount of neuromuscular blocking agent available to bind to nicotinic receptors in the neuromuscular junction. This results in the reversal of neuromuscular blockade induced by rocuronium or vecuronium.

Injection (per ml) 100mg

• Bridion Solution (MSD) originator