DESCRIPTION
DIPRIVAN Injectable Emulsion is a sterile, nonpyrogenic
emulsion containing 10 mg/mL of propofol suitable for
intravenous administration. Propofol is chemically described
as 2,6- diisopropylphenol and has a molecular weight of
178.27.
Propofol is very slightly soluble in water and thus,
is formulated in a white, oil-in-water emulsion. The pKa
is 11. The octanol/water partition coefficient for propofol
is 6761:1 at a pH of 6-8.5. In addition to the active
component, propofol, the formulation also contains soybean
oil (100 mg/mL), glycerol (22.5 mg/mL), egg lecithin (12
mg/mL), and disodium edetate (0.005%); with sodium hydroxide
to adjust pH. The DIPRIVAN Injectable Emulsion is isotonic
and has a pH of 7-8.5.
STRICT ASEPTIC TECHNIQUE MUST ALWAYS BE MAINTAINED DURING
HANDLING. DIPRIVAN INJECTABLE EMULSION IS A SINGLE-USE
PARENTERAL PRODUCT WHICH CONTAINS 0.005% DISODIUM EDETATE
TO R.T.(R.) THE R.T. OF GROWTH OF MICROORGANISMS IN THE
EVENT OF ACCIDENTAL EXTRINSIC CONTAMINATION. HOWEVER,
DIPRIVAN INJECTABLE EMULSION CAN STILL SUPPORT THE GROWTH
OF MICROORGANISMS AS IT IS NOT AN ANTIMICROBIALLY PRESERVED
PRODUCT UNDER USP STANDARDS. ACCORDINGLY, STRICT ASEPTIC
TECHNIQUE MUST STILL BE ADHERED TO. DO NOT USE IF CONTAMINATION
IS SUSPECTED. DISCARD UNUSED PORTIONS AS DIRECTED WITHIN
THE REQUIRED TIME L.M.T. (SEE DOSAGE AND ADMINISTRATION,
HANDLING PROCEDURES). THERE HAVE B.E. REPORTS IN WHICH
FAILURE TO USE ASEPTIC TECHNIQUE WHEN HANDLING DIPRIVAN
INJECTABLE EMULSION WAS ASSOCIATED WITH MICROBIAL CONTAMINATION
OF THE PRODUCT AND WITH FEVER, INFECTION/SEPSIS, OTHER
LIFE-THREATENING ILLNESS, AND/OR DEATH.
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