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LUSEDRA(TM) (fospropofol disodium) Injection CIV for Monitored Anesthesia Care (MAC) Sedation Now Available
Date:11/16/2009

diopulmonary resuscitation must be immediately available.

The following serious adverse reactions have been reported with the use of LUSEDRA.

  • Respiratory depression
    • Apnea was reported in 1/455 (< 1%) patients treated with LUSEDRA using the standard or modified dosing regimen.
  • Hypoxemia
    • Hypoxemia was reported in 20/455 (4%) patients treated with LUSEDRA using the standard or modified dosing regimen. Retention of purposeful responsiveness did not prevent patients from becoming hypoxemic following administration of LUSEDRA.
  • Loss of purposeful responsiveness
    • LUSEDRA has not been studied for use in general anesthesia. However, administration of LUSEDRA may inadvertently cause patients to become unresponsive or minimally responsive to vigorous tactile or painful stimulation. The incidence of patients who became minimally responsive or unresponsive to vigorous tactile or painful stimulation was 7/183 (4%) for colonoscopy and 24/149 (16%) for bronchoscopy. The duration of minimal or complete unresponsiveness ranged from 2 to 16 minutes in colonoscopy patients and from 2 to 20 minutes in bronchoscopy patients.
  • Hypotension
    • Hypotension was reported in 18/455 (4%) patients treated with LUSEDRA using the standard or modified dosing regimen.
    • Patients with compromised myocardial function, reduced vascular tone, or who have reduced intravascular volume may be at an increased risk for hypotension.

The use of supplemental oxygen is recommended in all patients receiving LUSEDRA. Airway assistance maneuvers may be required. LUSEDRA may produce additive cardiorespiratory effects when administered with other cardiorespiratory depressants such as benzodiazepines and narcotic analgesics. When LUSEDRA is used at greater than the recommended doses, the incidence of serious adverse reactions is increased.

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SOURCE Eisai Inc.
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