Sevoflurane is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery.

Sevoflurane should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. Since level of anesthesia may be altered rapidly, only vaporizers producing predictable concentrations of sevoflurane should be used.

The concentration of sevoflurane being delivered from a vaporizer during anesthesia should be known. This may be accomplished by using a vaporizer calibrated specifically for sevoflurane. The administration of general anesthesia must be individualized based on the patient's response.

Replacement of Desiccated CO₂ Absorbents: When a clinician suspects that the CO₂ absorbent may be desiccated, it should be replaced. The exothermic reaction that occurs with sevoflurane and CO₂ absorbents is increased when the CO₂ absorbent becomes desiccated, such as after an extended period of dry gas flow through the CO₂ absorbent canisters (see PRECAUTIONS).

Pre-anesthetic Medication: No specific premedication is either indicated or contraindicated with sevoflurane. The decision as to whether or not to premedicate and the choice of premedication is left to the discretion of the anesthesiologist.

Induction: Sevoflurane has a nonpungent odor and does not cause respiratory irritability; it is suitable for mask induction in pediatrics and adults.

Maintenance: Surgical levels of anesthesia can usually be achieved with concentrations of 0.5 - 3% sevoflurane with or without the concomitant use of nitrous oxide. Sevoflurane can be administered with any type of anesthesia circuit.

Table 9: MAC Values for Adults and Pediatric Patients According to Age

ULTANE (sevoflurane), Volatile Liquid for Inhalation, is packaged in amber colored bottles containing 250 mL sevoflurane, List 4456, NDC # 0074-4456-04 (plastic).

Safety And Handling

Occupational Caution

There is no specific work exposure limit established for sevoflurane. However, the National Institute for Occupational Safety and Health has recommended an 8 hour time-weighted average limit of 2 ppm for halogenated anesthetic agents in general (0.5 ppm when coupled with exposure to N₂O).

Storage

Store at controlled room temperature, 15° - 30°C (59° - 86°F). See USP.

Revised September, 2006. Product of Japan, Product inquiries should be directed to Abbott Laboratories, North Chicago, IL 60064, USA. Manufactured by: Abbott Laboratories, North Chicago, IL 60064, USA under license from Maruishi Pharmaceutical Company LTD. 2-3-5, Fushimi-machi, Chuo-Ku, Osaka, Japan. FDA revision date: 6/27/2006

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