Contraindications: Sevoflurane can cause malignant hyperthermia. It should not be used in patients with known sensitivity to sevoflurane or to other halogenated agents nor in patients with known or suspected susceptibility to malignant hyperthermia.
Warnings: Although data from controlled clinical studies at low flow rates are limited, findings from patient and animal studies suggest that there is a potential for renal injury which is presumed due to Compound A. Animal and human studies demonstrate that sevoflurane administered for more than 2 MAC·hours and at fresh gas flow rates of <2L/min may be associated with proteinuria and glycosuria.
Adverse Reactions: Adverse events are derived from controlled clinical trials 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 characteristics (including disease) and/or medications administered.
Overdosage: In the event of overdosage, or what may appear to be overdosage, the following action should be taken: discontinue administration of sevoflurane, maintain a patent airway, initiate assisted or controlled ventilation with oxygen, and maintain adequate cardiovascular function.
How Supplied: Sevoflurane is available in unit packages of 250 mL amber-colored glass bottles.
Storage Conditions: Store at 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F). See USP controlled room temperature.