NEODOSE

INDICATIONS

Rocuronium 0.45 mg/kg or 0.6 mg/kg IV under isoflurane anesthesia in newborns (N=20) achieved good to excellent intubation conditions in most patients within 60 seconds in a randomized study; a few patients experienced poor conditions with respect to position andmovement of vocal cords. Recovery of neuromuscular blockade for 0.45 mg/kg and 0.6 mg/kg, respectively, were 56.4 minutes and 100.8 minutes for T1 = 75% of baseline and 62.3 minutes and 94.8 minutes for train-of-four ratio of 0.7.

FDA APPROVED INDICATION

Adjunct to general anesthesia to facilitate routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Not recommended for rapid sequence intubation in pediatric patients.

CONTRAINDICATIONS/PRECAUTIONS

• Administration:
  • Confirm proper selection of injected product and avoid confusion with other injectable solutions in the critical care setting as administration results in paralysis, which may lead to respiratory arrest and death; progression may be more likely in individuals whom administration is unintended.
  • Must be accompanied by adequate anesthesia or sedation.
  • If extravasation occurs, immediately terminate the infusion and restart in another vein.
• Cardiovascular:
  • An increased circulatory delayed time, which may occur with cardiovascular disease, may delay onset time.
  • QT interval prolongation may occur with concomitant use of general anesthetics in pediatric patients.
• Concomitant Use: Do not mix with alkaline solutions(eg, barbiturate solutions) in the same syringe or administer simultaneously during IV infusion through the same needle.
• Endocrine & Metabolic:
  • Malignant hyperthermia may occur.
  • Acid-base or electrolyte abnormalities may potentiate or cause resistance to neuromuscular blockade
• Immunologic: Severe, life-threatening, and fatal anaphylactic reactions have been reported; caution advised in patients with previous anaphylactic reactions to other neuromuscular blocking agents due to potential for cross – reactivity.
• Musculoskeletal:
  • Skeletal muscle weakness may occur while weaning from a ventilator after chronic administration in the ICU; continuous monitoring recommended.
  • Myopathy has been reported after long-term administration of other nondepolarizing neuromuscular blocking agents in the ICU as monotherapy or when combined with corticosteroids; when combined with a corticosteroid, limit period of use of neuromuscular blocker and use in settings where benefits outweigh risks.
  • Myasthenia gravis or myasthenic (Eaton-Lambert) syndrome; monitoring recommended due to risk of profound neuromuscular blocking effects.
• Neurologic:
  • Residual paralysis after extubation may occur. Extubate only after sufficient recovery from neuromuscular blockade.
  • Prolonged paralysis may occur while weaning from a ventilator after chronic administration in the ICU; continuous monitoring recommended.
  • Potentiation of, or resistance to neuromuscular blockade may occur in cachectic or debilitated patients, those with neuromuscular diseases, or carcinomatosis, or with concomitant inhalation anesthetics(eg, enflurane, isoflurane), antibiotics, magnesium salts, lithium, local anesthetics, procainamide, or quinidine; initial dosage adjustment may be required.
  • Resistance to neuromuscular blocking agents can occur with an increased risk in patients with burns, disuse atrophy, denervation, direct muscle trauma, cerebral palsy, or chronic exposure to anticonvulsants(eg, carbamazepine, phenytoin) or nondepolarizing agents; higher infusion rates may be required.
• Respiratory: Increased pulmonary vascular resistance may occur; increased risk with underlying pulmonary hypertension or valvular heart disease.
• TolranceTolerance may develop with chronic administration in the ICU; continuous monitoring recommended

ADVERSE EFFECTS

The use of rocuronium in infants has only been studied in patients under halothane anesthesia. The overall analysis of ECG data in pediatric patients indicates that the concomitant use of rocuronium with general anesthetic agents can prolong the QTc interval. Most pediatric patients anesthetized with halothane who did not receive atropine for induction experienced a transient increase (30% or greater) in heart rate after intubation, whereas only 1 of 19 infants anesthetized with halothane and fentanyl who received atropine for induction experienced this magnitude of change. Aminoglycosides, vancomycin, and hypermagnesemia may enhance neuromuscular blockade. Propofol has no effect. Phenytoin may diminish neuromuscular blockade. Respiratory and metabolic acidosis prolong the recovery time, respiratory alkalosis shortens it. Rocuronium may be associated with increased pulmonary vascular resistance, so caution is appropriate in patients with pulmonary hypertension. Extravasations cause local tissue irritation. The package insert statement that rocuronium is not recommended for rapid sequence intubations in pediatric patients is due to the lack of studies.

ADMINISTRATION

• Must be accompanied by adequate analgesia and/or sedation
• Administer IV push over 5 to 10 seconds. Available as a 10 mg/mL solution. May also give as continuous IV infusion in compatible diluent at a concentration up to 5 mg/mL
• Do not mix with alkaline solutions (eg, barbiturate solutions) in the same syringe or administer simultaneously during IV infusion through the same needle.

MONITORING

Assess vital signs frequently and blood pressure continuously if possible.