Label Changes for:

Suprane (desflurane, USP)

September 2013

Changes have been made to the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

September 2013

4 CONTRAINDICATIONS

  • added ..... Induction of anesthesia in pediatric patients

5 WARNINGS AND PRECAUTIONS

5.3 Respiratory Adverse Reactions in Pediatric Patients
  • SUPRANE (desflurane, USP) is not approved for maintenance of anesthesia in nonintubated children due to an increased incidence of respiratory adverse reactions, including coughing, laryngospasm and secretions [see Clinical Studies (14.5)].

7 DRUG INTERACTIONS 

7.2 Neuromuscular Blocking Agents
  • data changed/updated in Table 4

8 USE IN SPECIFIC POPULATIONS

8.4 Pediatric Use
Respiratory Adverse Reactions in Pediatric Patients
  • SUPRANE (desflurane, USP) is indicated for maintenance of anesthesia in infants and children after induction of anesthesia with agents other than SUPRANE (desflurane, USP), and tracheal intubation. SUPRANE (desflurane, USP) is not approved for maintenance of anesthesia in nonintubated children due to an increased incidence of respiratory adverse reactions, including coughing (26%), laryngospasm (13%) and secretions (12%) [see Clinical Studies (14.5)].
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