Source: FDA, National Drug Code (US) Revision Year: 2022
ULTANE is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery.
ULTANE 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 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.
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# | 3.3% | |
| 1 - <6 months | 3.0% | |
| 6 months - <3 years | 2.8% | 2.0% @ |
| 3-12 | 2.5% | |
| 25 | 2.6% | 1.4% |
| 40 | 2.1% | 1.1% |
| 60 | 1.7% | 0.9% |
| 80 | 1.4% | 0.7% |
# 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.
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.
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.
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