"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(Generic versions may still be available.)
RAPLONTM (rapacuronium bromide) for Injection
THIS DRUG SHOULD BE ADMINISTERED BY ADEQUATELY TRAINED INDIVIDUALS FAMILIAR WITH ITS ACTIONS, CHARACTERISTICS AND HAZARDS.
RAPLONTM (rapacuronium bromide) for injection is a nondepolarizing neuromuscular blocking agent its chemical name is 1-[(2b , 3a , 5a , 16b , 17b )-3-(Acetyloxy)-17-(1-oxopropoxy)-2-(1-piperidiny)androstan-16-yl]-1-(2-propenyl) piperidinium bromide. The chemical formula of the bromide salt is C37H81BrN2O4 with a molecular weight of 677.78.
RAPLOMTM is a synthetic steroid molecule with a mono-quaternary structure in the form of a bromide salt. This chemical structure has a basic steroid framework similar to other neuromuscular blocking agents like vecuronium, pancuronium, rocuronium, and pipecuronium. Rapacuronium bromide is distinguished as being a propenyl bromide ammonium salt with a 17-hydroxy propionate carboxyester that has the same basic steroid backbone as the rest of the family of steroid neuromuscular blockers.
RAPLON (rapacuronium) Ò is supplied as a sterile, nonpyrogenic lyophilized cake in 5-mL and 10-mL vials. Each 5-mL vial contains 100 mg of rapacuronium bromide base. 35.8 mg citric acid anhydrous. 7.5 mg of sodium phosphate dibasic anhydrous. 137.5 mg of mannitol, and sodium hydroxide and/or phosphoric acid to buffer and adjust the pH. When the 5-mL vial is reconstituted to a volume of 5 mL with sterile water for injection or bacteriostatic water for injection, an isotonic preparation for intravenous injection is obtained at a pH of 4.0 with a concentration of 20 mg of rapacuronium bromide based per mL. Each10-mL vial contains 200 mg of rapacuronium bromide based, 71.5 mg of citric acid an hydroxide and/or phosphoric acide to buffer and adjust the pH. When the 10-mL vial is reconstituted to a volume of 10 mL with sterile water for injection or bacteriostatic water for injection, an isotonic preparation for intravenous injection is obtained at a pH of 4.0 with a concentration of 20 mg of rapacuronium bromide base per mL.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
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