"The US Food and Drug Administration (FDA) is investigating the "rare but serious" risk for slowed or difficult breathing in children 17 and younger treated with the opioid analgesic tramadol.
"This risk may be increased in children tr"...
(Generic versions may still be available.)
DOSAGE AND ADMINISTRATION
RAPLONTM (rapacuronium bromide) FOR INJECTION IS INTENDED FOR INTRAVENOUS USE ONLY THIS DRUG SHOULD BE ADMINISTERED BY OR UNDER THE SUPERVISION OF EXPERIENCED CLINICIANS FAMILIAR WITH THE USE OF NEUROMUSCULAR BLOCKING AGENTS. THE DOSAGE INFORMATION PROVIDED BELOW IS INTENDED AS A GUIDE ONLY (see CLINICAL PHARMACOLOGY). THE USE OF ADEQUATE NEUROMUSCULAR MONITORING EQUIPMENT SUCH AS A PERIPHERAL NERVE STIMULATOR, WILL PERMIT THE MOST ADVANTAGEOUS USE OF RAPLON (rapacuronium) TM, MINIMIZE THE POSSIBILITY OF OVERDOSAGE OR UNDERDOSAGE, AND ASSIST IN THE EVALUATION OF RECOVERY.
Dose for Tracheal intubation
The recommended initial dose of RAPLON (rapacuronium) TM (rapauronium bromide) for injection in adult and geriatric patients is 1.5 mg/kg for short surgical procedures. In US and European studies, acceptable intubation scores were present in at lease 85% of patients within 60 seconds after administration of 1.5 mg/kg of RAPLON (rapacuronium) TM. Maximum block was achieved in most patients by 90 seconds. This dose had a mean clinical duration of approximately 15 minutes. In patients undergoing Cesarean section, the recommended RAPLON (rapacuronium) TM intubating dose, with thiopental induction, is 2.5 mg/kg.
Repeat Dosing in Adults (Bolus) Following an intubating dose of 1.5 mg/kg. Up to three maintenance doses of 0.50 mg/kg of RAPLON (rapacuronium bromide) for injection, administered at 25% recovery of control T1 provided a mean clinical duration of 12 † 16 minutes under opioid/nitrous oxide/ oxygen anesthesia. The duration of neuromuscular blockade was noted to increase with each additional dose. Repeat dosing should always be guided based on the clinical duration of the previous dose and should not be administered until recovery of neuromuscular function is evident (See PRECAUTIONS, Repeat Dosing).
Use in Pediatrics.
Initial doses of RAPLON (rapacuronium) TM of 2 mg/kg intravenously in pediatric patients (ages 1 month to 12 years) under halothane anesthesia produced acceptable intubating conditions within 60 seconds. Mean maximum block occurred within 90 seconds in most pediatric patients and had a mean clinical duration of approximately 15 minutes. When administration is being considered for patients 13 to 17 years of age, clinicians should consider the physical maturnity, height, and weight of the patient in determining the dose of RAPLON (rapacuronium) TM. The adult (1.5 mg/kg), pediatric (2.0 mg/kg), and Cesarean Section (2.5 mg/kg) dosing recommendations may serve as a general guideline in determining an intubating dose in this age group.
Use in geriatrics
The clinical duration of RAPLONTM (rapacuronium bromide) for injection is not prolonged in geriatric patients at a dose of 1.5 mg/kg. And the median spontaneous recovery time is not different from that in other adults. No dosage adjustment is recommended in elderly patients.
Compatibility RAPLONTM (rapacuronium bromide) for injection is compatible in solution with:
0.9% NaCi solution
Sterile water for injection
5% dextrose in water
5% dextrose in saline
Bacteriostatic water for injection
Use within 24 hours of mixing with the above solutions. Prepared solutions may be stored at room temperature.
Studies have shown that RAPLON (rapacuronium) TM is physically compatible when mixed with the following drugs.
Aminophylline(compatible if used within 4 hours)
RAPLON (rapacuronium) TM is physically incompatible when mixed with the following drugs:
Parenteral drug products should be inspect visually for particulate matter and clarity prior to administration, whenever solution and container permit. Do not use solution if particulate matter is present.
Safety and Handling
RAPLONTM (rapacuronium bromide) for Injection is available in the following forms:
5-mL vials containing 100 mg of rapacuronium bromide base and when reconstituted to 5 mL with sterile water for injection or bacteriostatic water for injection providing 20 mg of rapacuronium bromide base per milliliter (20 mg/mL) at a pH of 4.0
Boxes of 10 NDC No. 0052-0490-15
10-mL vials containing 200 mg of rapacuronium bromide base and when reconstituted to 10 mL with sterile water for injection or bacteriostatic water for injection providing 20 mg of rapacuronium bromide base per milliliter (20 mg/mL) at a pH of 4.0
Boxes of 10 NDC No. 0052-0490-16
The packaging of this product contains no natural rubber (latex).
Storage at 2-25oC (36-77oF).
When reconstituted with sterile water for injection or other compatible I.V. solutions, keep vial at room temperature or refrigerated 2-25oC (36-77oF) and use within 24 hours. Discard unused portion. Single use only.
When reconstituted with bacteriostatic water for injection, keep vial at room temperature or refrigerated 2-25oC (36-77oF) and use within 24 hours. Bacteriostatic water for injection CONTAINS BENZYL ALCOHOL, WHICH IS NOT INTENDED FOR USE IN NEWBORNS.
Organon Inc., West Orange, NJ 07052This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
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.
Find out what women really need.