Rocuronium B. Braun Solution for Injection/Infusion

Rocuronium Br

Adjunct to general anaesth to facilitate tracheal intubation during routine sequence induction & to provide skeletal muscle relaxation during surgery in adult & paed patients (from term neonates to adolescents, 0-<18 yr). Facilitates tracheal intubation during rapid sequence induction & for short-term use as adjunct in ICU to facilitate intubation & mechanical ventilation in adults.

IV Individualised dosage. Tracheal intubation in surgery &/or ICU Adult Standard intubation dose during routine anaesth: 0.6 mg/kg. Dose during rapid sequence induction of anaesth: 1 mg/kg. Maintenance: 0.15 mg/kg. In case of long-term inhalational anaesth, reduce to 0.075-0.1 mg/kg. Continuous infusion Loading dose: 0.6 mg/kg, then start administration by infusion when neuromuscular block starts to recover. Infusion rate under IV anaesth: 0.3-0.6 mg/kg/hr. Infusion rate under inhalational anaesth: 0.3-0.4 mg/kg/hr. Paed patient Same intubation dose w/ adult during routine anaesth & maintenance dose. For continuous infusion, higher infusion rates might be necessary. Elderly patient & patient w/ hepatic &/or biliary tract disease &/or renal failure Standard intubation dose during routine anaesth & dose during rapid sequence induction of anaesth: 0.6 mg/kg. Maintenance: 0.075-0.1 mg/kg. Infusion rate: 0.3-0.4 mg/kg/hr. Pregnant patient undergoing Caesarean section 0.6 mg/kg. Overwt & obese patient Doses should be reduced taking into account the lean body mass.

Hypersensitivity to rocuronium Br or to Br ion.

Anaphylactic reactions can occur after administration. Reports of allergic cross-reactivity to neuromuscular blocking agents. Ventilatory support is mandatory until adequate spontaneous respiration is restored. Reports of residual curarization. Dose levels >0.9 mg/kg may increase heart rate. Risk of prolonged paralysis &/or skeletal muscle weakness following long-term use in ICU. Strongly recommended to monitor neuromuscular transmission throughout use. Reports of myopathy after long-term co-administration w/ corticosteroids. If suxamethonium is used for intubation, delay rocuronium administration until patient recovers from suxamethonium-induced neuromuscular block. Conditions associated w/ prolonged circulation time eg, CV diseases, advanced age & oedematous state resulting in an increased vol of distribution; hypothermic conditions in surgery; hypokalaemia, hypermagnesaemia, hypocalcaemia, hypoproteinaemia, dehydration, acidosis, hypercapnia, cachexia. Patients w/ neuromuscular disease or after poliomyelitis; w/ myasthenia gravis or myasthenic (Eaton-Lambert) syndrome; obese patients; patients w/ burns. Not recommended to use potentially dangerous machinery or to drive during the 1st 24 hr after full recovery from neuromuscular blocking action. Patients w/ clinically significant hepatic &/or biliary diseases &/or renal failure. Pregnancy & lactation. Patients receiving Mg salts for toxemia of pregnancy. Not recommended for facilitation of tracheal intubation during rapid sequence induction in paed patients.

Pain &/or local reactions around inj site, changes in vital functions, prolonged neuromuscular block.

Increased effect w/ halogenated volatile anaesth; w/ high doses of thiopental, methohexital, ketamine, fentanyl, gammahydroxybutyrate, etomidate, propofol; after intubation w/ or prior administration of suxamethonium; long-term concomitant use w/ corticosteroids in ICU; antibiotics eg, aminoglycosides, lincosamides (lincomycin & clindamycin), polypeptide antibiotics, acylamino-penicillin antibiotics, tetracyclines, high doses of metronidazole; diuretics, quinidine & its isomer quinine, protamine, adrenergic blocking agents, Mg salts, Ca channel blocking agents, lithium salts & local anaesth (lidocaine IV, bupivacaine epidural) & acute administration of phenytoin or β-blocking agents. Reports of recurarization after post-op administration of aminoglycoside, lincosamide, polypeptide & acylamino-penicillin antibiotics, quinidine, quinine & Mg salts. Decreased effect w/ neostigmine, edrophonium, pyridostigmine, aminopyridine derivatives; prior chronic administration of phenytoin or carbamazepine; PIs. Attenuated/potentiated neuromuscular block w/ other non-depolarising neuromuscular blocking agents. Faster onset of lidocaine effect.

Neuromuscular Blocking Agents

M03AC09 - rocuronium bromide ; Belongs to the class of other quaternary ammonium-containing agents used as peripherally-acting muscle relaxants.

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