Desflurane

DESFLURANE- desflurane liquid
Sandoz Inc.

1 INDICATIONS AND USAGE

1.1 Induction of Anesthesia

Desflurane, USP, Liquid for Inhalation is indicated as an inhalation agent for induction of anesthesia for inpatient and outpatient surgery in adults.

Desflurane, USP, Liquid for Inhalation is contraindicated as an inhalation agent for the induction of anesthesia in pediatric patients because of a high incidence of moderate to severe upper airway adverse events.

1.2 Maintenance of Anesthesia

Desflurane, USP, Liquid for Inhalation is indicated as an inhalation agent for maintenance of anesthesia for inpatient and outpatient surgery in adults and in pediatric patients.

After induction of anesthesia with agents other than Desflurane, USP, Liquid for Inhalation, and tracheal intubation, Desflurane, USP, Liquid for Inhalation is indicated for maintenance of anesthesia in infants and children. Desflurane, USP, Liquid for Inhalation is not approved for maintenance of anesthesia in non-intubated children due to an increased incidence of respiratory adverse reactions, including coughing, laryngospasm, and secretions [See Warnings and Precautions (5.3) and Clinical Studies (14.5)] .

2 DOSAGE AND ADMINISTRATION

Only persons trained in the administration of general anesthesia should administer Desflurane, USP, Liquid for Inhalation. Only a vaporizer specifically designed and designated for use with desflurane should be utilized for its administration. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available.

Desflurane, USP, Liquid for Inhalation is administered by inhalation. The administration of general anesthesia must be individualized based on the patient’s response. Hypotension and respiratory depression increase as anesthesia with Desflurane, USP, Liquid for Inhalation is deepened. The minimum alveolar concentration (MAC) of Desflurane, USP, Liquid for Inhalation decreases with increasing patient age. The MAC for Desflurane, USP, Liquid for Inhalation is also reduced by concomitant N 2 O administration (See Table 1) . The dose should be adjusted accordingly. The following table provides mean relative potency based upon age and effect of N 2 O in predominately ASA physical status I or II patients.

Benzodiazepines and opioids decrease the MAC of Desflurane, USP, Liquid for Inhalation [See Drug Interactions (7.1, Table 3)] . Desflurane, USP, Liquid for Inhalation also decreases the doses of neuromuscular blocking agents required [See Drug Interactions (7.2, Table 4)] . The dose should be adjusted accordingly.

Table 1

Effect of Age on Minimum Alveolar Concentration of Desflurane Mean ± SD (percent atmospheres)

Age

N

O 2 100%

N

N 2 O 60%/40% O 2

2 weeks

6

9.2 ± 0

10 weeks

5

9.4 ± 0.4

9 months

4

10 ± 0.7

5

7.5 ± 0.8

2 years

3

9.1 ± 0.6

3 years

5

6.4 ± 0.4

4 years

4

8.6 ± 0.6

7 years

5

8.1 ± 0.6

25 years

4

7.3 ± 0

4

4 ± 0.3

45 years

4

6 ± 0.3

6

2.8 ± 0.6

70 years

6

5.2 ± 0.6

6

1.7 ± 0.4

N = number of crossover pairs (using up-and-down method of quantal response)

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