Raplon

(Generic versions may still be available.)

DRUG DESCRIPTION

RAPLON^TM (rapacuronium bromide) for Injection

THIS DRUG SHOULD BE ADMINISTERED BY ADEQUATELY TRAINED INDIVIDUALS FAMILIAR WITH ITS ACTIONS, CHARACTERISTICS AND HAZARDS.

RAPLON^TM (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.

RAPLOM^TM 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.