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SEDATIVE-HYPNOTIC CLEARED FOR ICU SEDATION USE; FIRST COMPOUND TO OFFER RAPID, PREDICTABLE RECOVERY IN MINUTES AFTER LONG-TERM ADMINISTRATION

 WILMINGTON, Del., March 10 /PRNewswire/ -- Stuart Pharmaceuticals, a business unit of Zeneca Inc., announced today that Diprivan(R) (propofol) Injection is now indicated for use in sedating intubated, mechanically ventilated -- or respirator-controlled -- adult patients in intensive care units (ICU). Prior to this new indication, critical care patients have primarily been managed with agents such as benzodiazepines and opiates.
 Diprivan provides medical professionals the ability to rapidly increase or decrease depth of sedation, the state of drowsiness or light sleep that occurs after the administration of a sedative drug, within minutes. It can also provide continuous sedation and control of stress responses.
 "Due to its pharmacokinetic and pharmacodynamic profile, Diprivan offers the unique ability to rapidly change a patient's sedative depth," said T. James Gallagher, M.D., professor of anesthesiology and surgery and director of critical care at University of Florida, Gainesville. "Depending on their needs, patients can be placed in a deeper state of sedation to avoid stress and/or discomfort or can be wakened to allow CNS evaluation or interaction with medical professionals or family members."
 Diprivan Injection was compared to benzodiazepines and/or opioids in 14 clinical trials involving a total of 550 ICU patients. Critically ill patients classified as medical, surgical, coronary artery bypass graft (CABG) or head trauma were studied. Of these, 302 received Diprivan and comprise the overall safety database for ICU sedation. Although this is the first agent to have a labeled indication for sedation in critically ill patients, Diprivan has been used in Europe for this purpose since 1990.
 The basis for dosage recommendations and the adverse event profile was obtained from studies carried out in the United States and Canada. Four medical/surgical ICU studies comparing Diprivan to benzodiazepines administered by intravenous (IV) infusion or bolus injection found no apparent differences in maintenance of adequate sedation or laboratory findings.
 Sedation should be initiated slowly by continuous infusion to achieve the desired clinical effect and minimize hypotension. The agent is rapidly distributed, metabolized, and eliminated, with no active metabolites produced and little clinically significant accumulation in blood at recommended doses.
 Due to its pharmacokinetic profile, Diprivan provides easily controlled sedation in intubated, mechanically ventilated/critically ill adult patients by continuous IV infusion. It is available in single patient use, ready-to-use 50 mL infusion vials or 20 mL ampules containing 10 mg/mL of propofol. In the ICU setting, Diprivan Injection should be administered only by persons skilled in the management of critically ill patients and trained in cardiovascular resuscitation and airway management. Strict aseptic techniques must always be maintained during handling as Diprivan Injection is a single patient use parenteral product and contains no antimicrobial preservatives. The vehicle is capable of supporting rapid growth of microorganisms. When Diprivan Injection is administered from a vial, a sterile vent spike and sterile tubing must be used. Administration of Diprivan should commence promptly and must be completed within 12 hours after the vial has been spiked.
 Diprivan was originally indicated in 1989 for induction and maintenance of general anesthesia. It offers intraoperative benefits and a significantly more rapid and better quality recovery from anesthesia due to a low incidence of side effects such as nausea and vomiting. This improved recovery profile enhances patient satisfaction. Additional benefits of Diprivan include the ability for easy resedation of patients, a quicker awakening, and excellent hemodynamic stability.
 The introduction of the ICU sedation indication for Diprivan reflects the continuing commitment of Stuart Pharmaceuticals to develop new agents which improve the overall quality of patient care. A business unit of Zeneca Inc., Stuart Pharmaceuticals has sites in Wilmington and Newark, Del.
 -0- 3/10/93
 /CONTACT: Jeff Soper of Stuart Pharmaceuticals, 302-886-7433, or John Quick of Ruder Finn, 212-593-6343, for Stuart Pharmaceuticals/


CO: Stuart Pharmaceuticals; Zeneca Inc. ST: Delaware IN: MTC SU: PDT

GK-OS -- NY015 -- 4844 03/10/93 09:59 EST
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Date:Mar 10, 1993
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