Recommended Topic Related To:

Raplon

"A new consumer-friendly form ( is now available for making reports to MedWatch, the Food and Drug Administration's (FDA) on-line system for collecting information about serious problems with drugs, medical devices and other FDA-"...

Raplon

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Indications
Dosage
How Supplied

INDICATIONS

RAPLONTM (rapacuronium bromide) for injection is indicated as an adjunct to general anesthesia to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgical procedures.

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

Lactated Ringers

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.

Alfentanil

Lidocaine

Aminophylline(compatible if used within 4 hours)

Methohexital

Atropine sulfate

Metoclopramide

Droperidol

Midazolam

Epinephrine

morphine

Fentanyl

Potassium chloride

Gentamycin

Propranolol

Glycopyrrolate

Ranitidine

Heparin sulfate

Remifentanil

Ketamine

Sufentanil

Labetalol

Verapamil

RAPLON (rapacuronium) TM is physically incompatible when mixed with the following drugs:

cefuroxime

danaparoid sodium

diazeparn

nitroglycerin

thiopental

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

There is no specific work-exposure limit for RAPLONTM (rapacuronium bromide) for injection. In case of eye contact, flush with water for at least 10 minutes.

HOW SUPPLIED

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

Storage at 2-25oC (36-77oF).

After reconstitution

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 07052

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
A A A

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.


Women's Health

Find out what women really need.


NIH talks about Ebola on WebMD