• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
Pediatric Labeling Date:  12/15/2006
Trade Name:  Suprane
Generic Name or Proper Name (*):  desflurane
Indications Studied:  Safety study of 2 agents used for maintenance of anesthesia in non-intubated patients
Label Changes Summary:  * Not indicated for maintenance of anesthesia in non-intubated pediatric patients * In a clinical safety trial in patients 2 - 16 years, desflurane and isoflurane were compared for maintenance of anesthesia in non-intubated patients to assess the incidence of respiratory adverse events. Desflurane was associated with higher rates of coughing, laryngospasm and secretions with an overall rate of respiratory events of 39%. 5% of pediatric patients 2-16 years old exposed to desflurane, experienced severe laryngospasm * The incidence of respiratory events was highest in children aged 2-6 years; therefore, similar studies in children under the age of 2 years were not initiated. * Additional information on clinical studies and AEs
Product Labeling:  Labeling  Opens a new window
Sponsor:  Baxter
Pediatric Exclusivity Granted Date:  09/13/2006
Therapeutic Category:  Anesthetic agent