A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Ultane Indications, Dosage, Storage, Stability - Sevoflurane
Ultane Indications, Dosage, Storage, Stability - Sevoflurane
INDICATIONS AND USAGE
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 before administration of sevoflurane. 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. Extremely rare cases of spontaneous fire in the respiratory circuit of the anesthesia machine have been reported during sevoflurane use in conjunction with the use of a desiccated CO2 absorbent. Rapid changes in the color of some CO2 absorbents or an unusually delayed rise in the delivered (inspired) gas concentration of sevoflurane compared with the vaporizer setting may indicate excessive heating of the CO2 absorbent canister and chemical breakdown of sevoflurane.
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
|
|
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. |
HOW SUPPLIED
ULTANE (sevoflurane), Volatile Liquid for Inhalation, is packaged in amber colored bottles containing 250 mL sevoflurane, List 4456, NDC # 0074-4456-02 (glass) and 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 August, 2003
Reference: 58-7208
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.
©Abbott 2003 Printed in USA, ABBOTT LABORATORIES, NORTH CHICAGO, IL 60064, USA, 04F-125-E076-1
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