Roculax^®

Roculax is a nondepolarizing neuromuscular blocking agent, supplied as a sterile, nonpyrogenic, isotonic solution for intravenous injection only.

Each ampoule of Roculax contains Rocuronium bromide 10 mg/mL.

Pharmacodynamics :
Rocuronium bromide acts by competing for cholinergic receptors at the motor end-plate. This action is antagonized by acetylcholinesterase inhibitors, such as neostigmine and edrophonium. The recovery of neuromuscular function is satisfactory. The neuromuscular blocking action of rocuronium bromide may be enhanced in the presence of potent inhalation anaesthetics.

Pharmacokinetics :
Rocuronium is a nondepolarizing neuromuscular agent with rapid to intermediate onset depending on dose, and intermediate duration. The rapid distribution half-life is 1-2 minutes and the slower distribution half-life is 14-18 minutes. Rocuronium is approximately 30% bound to human plasma proteins. Rocuronium is eliminated primarily by the liver. The metabolite of rocuronium,17-desacetyl-rocuronium, has been rarely observed in the plasma or urine of humans administered single doses of 0.5-1 mg/kgBW with or without a subsequent infusion of rocuronium.
 

Roculax is contraindicated in :
- Patients known to have hypersensitivity to rocuronium bromide or to bromide ion.
- Pregnancy.
 

- Roculax should be administered in carefully adjusted dosages under the supervision of experienced clinicians who are familiar with the drug’s actions and the possible complications of its use.
- Roculax administration must be accompanied by adequate anaesthesia or sedation.
- Roculax should not be mixed with alkaline solutions.
- In the use of Roculax, increases or decreases in MAP and tachycardia may occurred.
- Roculax is not recommended for rapid induction in cesarean section patients.
- Severe acid-base and/or electrolyte abnormalities may potentiate or cause resistance to the neuromuscular blocking action of Roculax.
- Extravasation of Roculax may result signs or symptoms of local irritation.
- Burns, disuse atrophy, denervation, direct muscle trauma, and cerebral palsy may result the development of resistance to nondepolarizing muscle relaxants.
- Anaphylactic reactions to neuromuscular blocking agents in general have been reported..
- Clinicians should be familiar with early signs, confirmatory diagnosis and treatment of malignant hyperthermia prior to the start of any anaesthesia.
- Roculax should be used with caution in patients with hepatic and/ or billiary tract diseases and/ or renal failure, patients with pulmonary hypertension or valvular heart disease, neuromuscular disease or after poliomyelitis, and myasthenia gravis.
- In surgery under hypothermic condition, the neuromuscular blocking effect of Roculax is increased and the duration prolonged.
- Roculax may exhibit a prolonged duration and a prolonged spontaneous recovery in obese patients.
- Roculax should be given to lactating women only when the physician decides that the benefits outweigh the risk.
- It is not recommended to use potentially dangerous machinery or drive a car within 24 hours after the full recovery from the neuromuscular blocking action of Roculax.
 

Prolonged neuromuscular block is associated with neuromuscular blockers.
Adverse experiences with probable or unknown relationship:
Cardiovascular            : arrhythmia, abnormal electrocardiogram, tachycardia, hypotension, hypertension.
Digestive                     : nausea, vomiting.
Respiratory                 : asthma (bronchospasm, wheezing, or rhonchi), hiccup.
Skin and Appendages : allergic reactions (rash, pruritus, anaphylactic and anaphylactoid), injection site edema.
 

• Endotracheal Intubation :
  The dose is 0.6-1.2 mg/kgBW.
• Maintenance Dose:
  The maintenance dose is 0.1- 0.2 mg/kgBW.
• Use by Continuous Infusion:
  It is recommended to give loading dose of 0.6 mg Roculax/kgBW, when neuromuscular block starts to recover, to start administration by infusion. In adults under i.v anaesthesia, the infusion rate required to maintain neuromuscular block at this level ranges from 5-10 g/kgBW/min. Continuous monitoring of neuromuscular block is essential since infusion rate requirements vary from patient to patient and with the anaesthetic method used.
• Pediatrics :
  The initial dose is 0.6 mg/kgBW. The maintenance dose is 0.075-0.125 mg/kgBW.
  A continuous infusion of Roculax initiated at a rate of 0.012 mg/kgBW/min may also be used to maintain neuromuscular blockade in pediatric patients.
  There are no data to support the recommendation for the use of rocuronium bromide in neonates (0-3 months).
• Geriatrics ( ≥ 65 years) and patients with hepatic and/or biliary tract disease and/or renal failure :
  The dose is 0.6 - 1.2 mg/kgBW. The maintenance dose is 0.075-0.1 mg/kgBW.
  The recommended infusion rate is 5-6 g/kgBW/min.
• Obese Patients :
  When used in overweight or obese patients (defined as patients with a body weight of 30% or more above ideal body weight) doses should be reduced taking into account a lean body mass.
  
  Administration: Roculax administered intravenously either as a bolus injection or as a continuous infusion.