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Raplon Side Effects Center
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.
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The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Raplon FDA Prescribing Information: Side Effects
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) »
Additional Raplon Information
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