Nutley, N.J., March 18, 1997 -- Roche Laboratories announced today that it has received
marketing clearance for the use of VERSED® (midazolam HCl) by continuous intravenous infusion for sedation of mechanically ventilated patients in critical care settings. This new indication complements the previous indication for VERSED for intermittent IV injection for sedation for therapeutic and diagnostic procedures in the ICU."One of the advantages of continuous infusion with VERSED is the lack of peaks and troughs often associated with intermittent IV injections," says Eran Geller, M.D., professor of anesthesia at Stanford University School of Medicine. "This allows patients to be maintained at a steady state of sedation, without tying up nursing staff by having to administer frequent injections."
Other important benefits include:
- rapid onset
- pronounced amnestic effects
- hemodynamic stability
- non-lipid based vehicle
- easy titration for predictable response
- VERSED can be administered by either intermittent injection or via continuous infusion in mechanically-ventilated patients, which offers flexibility of dosing options.
With VERSED, the rate of infusion can be increased or decreased as required, or supplemental intravenous doses of VERSED can be administered to increase or maintain the desired effect. Frequent assessment using standard sedation scales is recommended.
VERSED generally is well tolerated. Because serious and life-threatening cardiorespiratory adverse events have been reported with VERSED, provide for continuous monitoring of respiratory and cardiac function (i.e., pulse oximetry). Immediate availability of resuscitative drugs and age- and size-specific equipment and personnel trained in their use should be assured. (See attached package insert for complete prescribing information.) VERSED should always be titrated slowly. Respiratory depression and/or arrest may result from excess doses or rapid or single bolus. VERSED is three to four times as potent per mg as diazepam.
Specific Safety Information for Adult Continuous Infusion
Drug elimination may be delayed in patients receiving erythromycin and/or other P4503a enzyme inhibitors and in patients with liver dysfunction, low cardiac output (especially those requiring inotropic support) and in neonates.
After extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed.
Individual response to VERSED is variable. The infusion rate should be titrated to the desired level of sedation, taking into account the patient's age, clinical status and current drug use. In general, VERSED should be infused at the lowest rate that produces the desired level of sedation.
When VERSED is given in conjunction with opioids or other sedatives, the potential for respiratory depression/airway obstruction is increased and the minimum effective VERSED dose is generally reduced.
About Hoffmann-La Roche
Headquartered in Nutley, N.J., Hoffmann-La Roche Inc. is an affiliate of the multinational group of companies headed by Roche Holding Ltd of Basel, Switzerland. One of the world's leading research-intensive health care companies, Roche has discovered, developed and introduced numerous important prescription pharmaceuticals. The company also is a major provider of diagnostic products and services as well as vitamins, premixes and other products for human and animal nutrition and health. Recognized for excellence in biotechnology and chemistry, Roche also is widely known for its current efforts in the research, development and commercialization of polymerase chain reaction (PCR), a revolutionary advance in diagnostics and other fields, including biomedical research, forensics and environmental testing.
Contact: Amy Sunshine
Hoffmann-La Roche
201-562-2882Amy Sunshine
Hoffmann-La Roche
201-562-2882