Medical Editor: John P. Cunha, DO, FACOEP
Raplon (rapacuronium bromide) for injection is a nondepolarizing neuromuscular blocking agent used as an adjunct to general anesthesia to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgical procedures. The brand name Raplon is discontinued, but generic versions may be available. Common side effects of Raplon (rapacuronium bromide) include:
- high blood pressure
- fast or slow heart rate, or
The recommended initial dose of Raplon for injection in adult and geriatric patients is 1.5 mg/kg for short surgical procedures. Raplon may interact with inhalation or local anesthetics, anticonvulsants, antibiotics, magnesium salts, lithium, procainamide, and quindine. Tell your doctor all medications and supplements you use. During pregnancy, Raplon should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Raplon (rapacuronium bromide) for injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pre-Marketing Clinical Trial Experience
Incidence of Adverse Events in Controlled Clinical Trials
The most common adverse event with an incidence of >5% seen with RAPLON (rapacuronium) TM in controlled clinical trials was hypotension (5.2%). Table 18 lists treatment-emergent signs and symptoms that occurred in at least 1% of patients receiving RAPLON (rapacuronium) TM in controlled clinical trials that were numerically more frequent than in the active control.
TABLE 18: Most Frequent Adverse Events Seen with RAPLON (rapacuronium) TM in Controlled Clinical Trials
Body System Adverse Clinical Experience
Other Active Controls n=141
a Active Controls include rocuronium bromide, vecuronium bromide, and mivacurium
Incidence of Other Adverse Events During Premarketing Evaluation of RAPLON (rapacuronium) TM † in all Treated Patients
In the following tabulation, the frequencies represent the proportion of the 1,956 patients exposed to at least one dose of RAPLON (rapacuronium) TM who experienced an event of the type cited on at least one occasion while receiving RAPLON (rapacuronium) TM. All events reported are included except those already listed in the previous table. Although events reported occurred during treatment with RAPLONTM (rapacuronium) , a causal relationship has not necessarily been established.
Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/10000 patients.
Cardiovascular: Infrequent: hypertension, extrasystoles, abnormal ECG, arrhythmia, cerebrovascular disorder, ventricular fibrillation, atrial fibrillation, ventricular tachycardia; Rare: atria arrhythmia, cardiac failure, right cardiac failurem, cardio-respiratory arrest, cardiac arrest, thrombophlebitis, supraventricular extrasystoles, supraventricular tachycardia, myocardial infarction, left bundle branch block.
Digestive: Frequent: vomiting, nausea; Infrequent: ileus, saliva increased; Rare: abdominal pain, cholelithiasis, nonspecific gastrointestinal disorder, rectal hemorrhage, esophagospasm, oral hemorrhage, tooth disorder.
Nervous: Infrequent: hyposthesia, hemiparesis, hypertonia, prolonged neuromuscular block, prolonged anesthesia emergence: Rare: headache, cerebral hemomhage, intracranial pressure increased. Migraine, ptosis, tetany, breath holding, confusion, anxiety.
Respiratory: Infrequent: hypoxia, increased airway pressure, hypoventilation, laryngismus, coughing, apnea, respiratory depression, upper airway obstruction, neonatal respiratory distress syndrome, pneumothorax, pulmonary edema, respiratory insufficiency, stridor; Rare: pharyngitis, larynx edema, dyspnea, neonatal respiratory depression, hyperventilation, minitis, sputum increase.
Read the entire FDA prescribing information for Raplon (Rapacuronium)
© Raplon Patient Information is supplied by Cerner Multum, Inc. and Raplon Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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