DIPRIVAN®(propofol) Injectable Emulsion
are thus recommended for initiation and maintenance of sedation/anesthesia in elderly patients. (See CLINICAL PHARMACOLOGY - Individualization of Dosage.)
Pediatrics: The pharmacokinetics of propofol were studied in 53 children between the ages of 3 and 12 years who received DIPRIVAN Injectable Emulsion
for periods of approximately 1-2 hours. The observed distribution and clearance of propofol in these children were similar to adults.
Organ Failure: The pharmacokinetics of propofol do not appear to be different in people with chronic hepatic cirrhosis or chronic renal impairment
compared to adults with normal hepatic and renal function. The effects of acute hepatic or renal failure on the pharmacokinetics of propofol have not been
Anesthesia and Monitored Anesthesia Care (MAC) Sedation
DIPRIVAN Injectable Emulsion was compared to intravenous and inhalational anesthetic or sedative agents in 91 trials involving a total of 5,135 patients.
Of these, 3,354 received DIPRIVAN Injectable Emulsion and comprised the overall safety database for anesthesia and MAC sedation. Fifty-five of these trials,
20 for anesthesia induction and 35 for induction and maintenance of anesthesia or MAC sedation, were carried out in the US or Canada and provided the basis
for dosage recommendations and the adverse event profile during anesthesia or MAC sedation.
DIPRIVAN Injectable Emulsion was studied in 14 clinical trials involving 691 pediatric patients, including 42 cardiac surgical patients. Of the total
691 patients, 90 were less than 3 years of age and 601 were 3 years of age or older. Of these, 506 were from US/Canadian clinical trials and comprised the
overall safety and efficacy database for Pediatric Anesthesia. The majority of the remaining patients were healthy ASA I/II patients. (See Table 1)
TABLE 1. PEDIATRIC INDUCTION OF ANESTHESIA
Patients Receiving DIPRIVAN Injectable Emulsion Median and (Range)
No. of Patients