PRECEDEXTM
DEXMEDETOMIDINE HYDROCHLORIDE Injection
DESCRIPTION
PRECEDEXTM (dexmedetomidine hydrochloride injection) is a sterile, nonpyrogenic solution suitable for intravenous infusion following dilution. Dexmedetomidine hydrochloride is the S-enantiomer of medetomidine and is chemically described as (+)-4-(S)-[1-(2,3-dimethylphenyl)ethyl]-1H-imidazole monohydrochloride. Dexmedetomidine has a molecular weight of 236.7. The empirical formula is

Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in-octanol:water at pH 7.4 is 2.89. PRECEDEX is supplied as a clear, colorless, isotonic solution with a pH of 4.5 to 7.0. Each 1 mL of PRECEDEX contains 118 mcg of dexmedetomidine HCl (equivalent to 100 mcg dexmedetomidine base) and 9 mg of sodium chloride in water. The solution is preservative-free and contains no additives or chemical stabilizers.