Safety

Suprane (desflurane, USP)

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

February 2015

Summary View

CONTRAINDICATIONS

  • Patients with a history of moderate to severe hepatic dysfunction following anesthesia with SUPRANE or other halogenated agents and not otherwise explained.

WARNINGS AND PRECAUTIONS

Malignant Hyperthermia
  • Fatal outcome of malignant hyperthermia has been reported with desflurane
Respiratory Adverse Reactions in Pediatric Patients
  • Children, particularly if 6 years old or younger, who are under an anesthetic maintenance of SUPRANE delivered via laryngeal mask airway (LMA™ mask) are at increased risk for adverse respiratory reactions, e.g., coughing and laryngospasm, especially with removal of the laryngeal mask airway under deep anesthesia [see Clinical Studies (14.5)]. Therefore, closely monitor these patients for signs and symptoms associated with laryngospasm and treat accordingly.
  • When SUPRANE is used for maintenance of anesthesia in children with asthma or a history of recent upper airway infection, there is an increased risk for airway narrowing and increases in airway resistance. Therefore, closely monitor these patients for signs and symptoms associated with airway narrowing and treat accordingly.

ADVERSE REACTIONS

Post-Marketing Experience
  • Cardiac Disorders: atrial fibrillation

 

September 2013

Summary View

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)].

 

Page Last Updated: 03/11/2015
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