In premarketing clinical studies, one case of accidental overdose with RAPLON^TM (rapacuronium bromide) for injection was reported. A 22-year-old obstetric patient received 5mg/kg of RAPLON^TM during rapid sequence induction for Cesarean section. The patient did not meet extubating criteria until more than two hours after administration of RAPLON^TM. Complete recovery was reached 19 minutes after the sixth dose of 1.0 mg of neostigmine. There was no evidence of recurarization or respiratory distress in the recovery room. The premature newborn did not demonstrate evidence of neuromuscular weakness.

Overdosage with neuromuscular blocking agents may result in neuromuscular block extending beyond the time needed for surgery and anesthesia. The primary treatment is maintenance of a patent airway and controlled ventilation until recovery of neuromuscular function is assured.

ANTAGONISM OF NEUROMUSCULAR BLOCKADE

THE USE OF A NERVE STIMULATOR TO DOCUMENT RECOVERY AND ANTAGONISM OF NEUROMUSCULAR BLOCKADE IS RECOMMENDED.

Patients should be evaluated for adequate clinical evidence of antagonism. E.g., 5 second head lift, ventilation, and upper airway maintenance. Ventilation must be supported until recovery of normal respiration is assured. A 1.5 mg/kg or 2.5 mg/kg dose of RAPLON^TM (rapacuronium bromide) for injection may be reversed 2 minutes after administration with neostigmine 50 mg/kg in order to reduce the duration by approximately 50%.

Antagonism may be delayed in the presence of debilitation, carcinomatosis, and concomitant use of certain broad-spectrum antibiotics, anesthetic agents, and other drugs that enhance neuromuscular blockade or separately cause respiratory depression. Under such circumstances, clinical management is the same as that for prolonged neuromuscular blockade.

RAPLON^TM (rapacuronium bromide) or injection is contraindicated in patients known to have hypersensitivity to rapacuronium bromide.

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