Raplon
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Raplon
Please Note: This Brand Name drug is no longer available in the US.(Generic versions may still be available.)
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.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Raplon FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Pre-Marketing Clinical Trial Experience
The safety of RAPLONTM (rapacuronium bromide) Injection was evaluated in 2036 subjects in prospective clinical trails. The majority of use in clinical trials was single bolus intravenous exposure.
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 | RAPLONTM n=1956 | Succinylcholine n=572 |
Other Active Controls n=141 |
| Hypotension | 5.2% | 6.5% | 4.3% |
| 3.2% | 0.52% | 1.4% | |
| 1.5% | 1% | 2.1% | |
| Bronchospasm | 3.2% | 2.1% | 0.71% |
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.
Body as a Whole: Infrequent: fever, rigors, back pain, hypothermia, chest pain, peripheral edema, pain; Rare: asthenia, fatigue, non-inflammatory swelling, therapeutic response decrease.
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.
Hemic and Lymphatic: infrequent thrombosis, post-operative bleeding, Rare: epistaxis, coagulation factor decrease, purpura, anemia, hemoperitoneum.
Metabolic and Nutritional: Rare: acidosis.
Musculoskeletal: Infrequent: myalgia; Rare: muscle weakness, neonatal hypotonia.
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.
Skin: Frequent: erythematous rash; infrequent; injection site reaction, injection site pain, rash, urticaria, pruritis, sweating increased; Rare; paravenous injection.
Special Senses: Rare: corneal ulceration, meiosis decreased hearing.
Urogenital: Infrequent: Urinary retention, oliguria, Rare: abnormal renal function, urinary tract infection, pelvic inflammation, vaginal bleeding.
Read the entire FDA prescribing information for Raplon (Rapacuronium) »
Additional Raplon Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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