"A new consumer-friendly form ( is now available for making reports to MedWatch, the Food and Drug Administration's (FDA) on-line system for collecting information about serious problems with drugs, medical devices and other FDA-"...
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.
DOSAGE AND ADMINISTRATION
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).
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.
Sevoflurane has a nonpungent odor and does not cause respiratory irritability; it is suitable for mask induction in pediatrics and adults.
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
|Age of Patient (years)||Sevoflurane in Oxygen||Sevoflurane in 65% N2O/35% O2|
|0 - 1 months #||3.30%|
|1 - < 6 months||3.00%|
|6 months - < 3 years||2.80%||2.0%@|
|# Neonates are full-term gestational age. MAC in
premature infants has not been determined.
@ In 1 - < 3 year old pediatric patients, 60% N2O/40% O2 was used.
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
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) (see ADVERSE REACTIONS).
Store at controlled room temperature, 15° - 30°C (59° - 86°F). See USP.
Product inquiries should be directed to AbbVie Inc., North Chicago, IL 60064, USA. Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA under license from Maruishi Pharmaceutical Company LTD. 2-3-5, Fushimi-machi, Chuo-Ku, Osaka , Japan. January 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/1/2014
Additional Ultane Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.