SOJOURN

CLINICAL STUDIES Sevoflurane was administered to a total of 3185 patients. The types of patients are summarized as follows: Table 5. Patients Receiving Sevoflurane in Clinical Studies Type of Patients Number Studied ADULT 2223 Cesarean Delivery 29 Cardiovascular and patients at risk of myocardial ischemia 246 Neurosurgical 22 Hepatic impairment 8 Renal impairment 35 PEDIATRIC 962 Clinical experience with these patients is described below. Adult Anesthesia The efficacy of sevoflurane in comparison to isoflurane, enflurane, and propofol was investigated in 3 outpatient and 25 inpatient studies i...

ADVERSE REACTIONS Clinical Trials Experience Adverse events are derived from controlled clinical studies conducted in the United States, Canada, and Europe. The reference drugs were isoflurane, enflurane, and propofol in adults and halothane in pediatric patients. The studies were conducted using a variety of premedications, other anesthetics, and surgical procedures of varying length. Most adverse events reported were mild and transient, and may reflect the surgical procedures, patient characte...

CONTRAINDICATIONS

• Known or suspected genetic susceptibility to malignant hyperthermia (see WARNINGS - Malignant Hyperthermia, CLINICAL PHARMACOLOGY - Pharmacogenomics ).
• Known or suspected sensitivity to sevoflurane or to other halogenated inhalational anesthetics.

Drug Interactions In clinical studies, no significant adverse reactions occurred with other drugs commonly used in the perioperative period, including central nervous system depressants, autonomic drugs, skeletal muscle relaxants, anti-infective agents, hormones and synthetic substitutes, blood derivatives, and cardiovascular drugs. Epinephrine Epinephrine administered with sevoflurane may increas...