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| | | ![]() FDA Approves Raplon For Outpatient Surgical Procedures WEST ORANGE, NJ -- Aug. 19, 1999 -- The United States Food and Drug Administration has approved Organon Inc.’s Raplon(TM) (rapacuronium bromide) for Injection as an adjunct to general anesthesia to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgical procedures. Raplon was proven in studies to be an effective alternative to succinylcholine with a rapid onset and a short duration of action with the recommended dose. Raplon is the first and only nondepolarizing neuromuscular blocking agent that combines both rapid onset with short duration for tracheal intubations and many short procedures including appendectomy, tonsillectomy, cystectomy, tubal ligation and Caesarean section. Outpatient surgical procedures account for approximately 60 percent of all surgeries performed in the U.S., according to estimates. "Anesthesiologists now have an important new option with fewer side effects such as malignant hyperthermia, masseter muscle rigidity and hyperkalemia," said Dennis Fisher, MD, professor of anesthesiology and pediatrics at the University of California, San Francisco. "Clinical studies have shown Raplon to have a very rapid onset and a short duration of action, which is ideal for both doctors and patients in today's health care environment." "Raplon offers an excellent alternative to both succinylcholine and mivacurium for patients undergoing outpatient [ambulatory] surgery because of its rapid onset and short recovery and favourable side effect profile," said Paul White, PhD, MD, professor at the University of Texas Southwestern Medical Center, Dallas. The recommended dose of Raplon is 1.5 mg/kg, which offers a short clinical duration between 15 and 20 minutes.
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