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Uses
SUPRANE (desflurane, USP) is indicated as an inhalation agent for induction of anesthesia for inpatient and outpatient surgery in adults.
SUPRANE (desflurane, USP) is not recommended for induction of anesthesia in pediatric patients because of a high incidence of moderate to severe upper airway adverse events [see Warnings and Precautions (5.3)].
SUPRANE (desflurane, USP) 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 SUPRANE (desflurane, USP), and tracheal intubation, SUPRANE (desflurane, USP) is indicated for maintenance of anesthesia in infants and children. SUPRANE (desflurane, USP) 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)].
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Other Information
SUPRANE (desflurane, USP), a nonflammable liquid administered via vaporizer, is a general inhalation anesthetic. It is (±)1,2,2,2-tetrafluoroethyl difluoromethyl ether:
Desflurane is nonflammable as defined by the requirements of International Electrotechnical Commission 601-2-13.
Desflurane is a colorless, volatile liquid below 22.8°C. Data indicate that desflurane is stable when stored under normal room lighting conditions according to instructions.
Desflurane is chemically stable. The only known degradation reaction is through prolonged direct contact with soda lime producing low levels of fluoroform (CHF3). The amount of CHF3 obtained is similar to that produced with MAC-equivalent doses of isoflurane. No discernible degradation occurs in the presence of strong acids.
Desflurane does not corrode stainless steel, brass, aluminum, anodized aluminum , nickel plated brass, copper, or beryllium.
Sources
Suprane Manufacturers
-
General Injectables & Vaccines, Inc
Suprane | General Injectables & Vaccines, Inc
Only persons trained in the administration of general anesthesia should administer SUPRANE (desflurane, USP). 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.
SUPRANE (desflurane, USP) 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 is deepened. The minimum alveolar concentration (MAC) of SUPRANE (desflurane, USP) decreases with increasing patient age. The MAC for SUPRANE (desflurane, USP) is also reduced by concomitant N2O administration (see Table 1). The dose should be adjusted accordingly. The following table provides mean relative potency based upon age and effect of N2O in predominately ASA physical status I or II patients.
Benzodiazepines and opioids decrease the MAC of SUPRANE (desflurane, USP) [see Drug Interactions (7.1, Table 3)]. SUPRANE (desflurane, USP) also decreases the doses of neuromuscular blocking agents required [see Drug Interactions (7.2, Table 4)]. The dose should be adjusted accordingly.
Issues such as whether or not to premedicate and the choice of premedication(s) must be individualized. In clinical studies, patients scheduled to be anesthetized with desflurane frequently received IV preanesthetic medication, such as opioid and/or benzodiazepine.
2.2 InductionIn adults, some premedicated with opioid, a frequent starting concentration was 3% desflurane, increased in 0.5-1.0% increments every 2 to 3 breaths. End-tidal concentrations of 4-11%, desflurane with and without N2O, produced anesthesia within 2 to 4 minutes. When desflurane was tested as the primary anesthetic induction agent, the incidence of upper airway irritation (apnea, breathholding, laryngospasm, coughing and secretions) was high. During induction in adults, the overall incidence of oxyhemoglobin desaturation (SpO2 < 90%) was 6% [see Adverse Reactions (6.1)].
After induction in adults with an intravenous drug such as thiopental or propofol, desflurane can be started at approximately 0.5-1 MAC, whether the carrier gas is O2 or N2O/O2.
Inspired concentrations of SUPRANE (desflurane, USP) greater than 12% have been safely administered to patients, particularly during induction of anesthesia. Such concentrations will proportionately dilute the concentration of oxygen; therefore, maintenance of an adequate concentration of oxygen may require a reduction of nitrous oxide or air if these gases are used concurrently.
2.3 MaintenanceSurgical levels of anesthesia in adults may be maintained with concentrations of 2.5-8.5% SUPRANE (desflurane, USP) with or without the concomitant use of nitrous oxide. In children, surgical levels of anesthesia may be maintained with concentrations of 5.2-10% SUPRANE (desflurane, USP) with or without the concomitant use of nitrous oxide.
During the maintenance of anesthesia with inflow rates of 2 L/min or more, the alveolar concentration of desflurane will usually be within 10% of the inspired concentration [Fa/FI, see Figure 2 in Clinical Pharmacology (12.3)].
During the maintenance of anesthesia, increasing concentrations of SUPRANE (desflurane, USP) produce dose-dependent decreases in blood pressure. Excessive decreases in blood pressure may be due to depth of anesthesia and in such instances may be corrected by decreasing the inspired concentration of SUPRANE (desflurane, USP).
Concentrations of desflurane exceeding 1 MAC may increase heart rate. Thus with this drug, an increased heart rate may not serve reliably as a sign of inadequate anesthesia.
2.4 Maintenance of Anesthesia in Intubated Pediatric PatientsSUPRANE (desflurane, USP) is approved for maintenance of anesthesia in infants and children after induction of anesthesia with agents other than desflurane, and tracheal intubation.
SUPRANE (desflurane, USP), with or without N2O, and halothane, with or without N2O were studied in three clinical trials of pediatric patients aged 2 weeks to 12 years (median 2 years) and ASA physical status I or II. The concentration of SUPRANE (desflurane, USP) required for maintenance of general anethesia is age-dependent [see Clinical Studies (14.5)].
Changes in blood pressure during maintenance of and recovery from anesthesia with desflurane/N2O/O2 are similar to those observed with halothane/N2O/O2. Heart rate during maintenance of anesthesia is approximately 10 beats per minute faster with desflurane than with halothane. Patients were judged fit for discharge from post-anesthesia care units within one hour with both desflurane and halothane. There were no differences in the incidence of nausea and vomiting between patients receiving desflurane or halothane.
2.5 RecoveryThe recovery from general anethesia should be assessed carefully before patients are discharged from the post anesthesia care unit (PACU).
2.6 Use in Patients with Coronary Artery DiseaseIn patients with coronary artery disease, maintenance of normal hemodynamics is important to prevent myocardial ischemia. Desflurane should not be used as the sole agent for anesthetic induction in patients with coronary artery disease or patients where increases in heart rate or blood pressure are undesirable. It should be used with other medications, preferably intravenous opioids and hypnotics [see Clinical Studies (14.2)].
2.7 Neurosurgical UseSUPRANE (desflurane, USP) may produce a dose-dependent increase in cerebrospinal fluid pressure (CSFP) when administered to patients with intracranial space occupying lesions. Desflurane should be administered at 0.8 MAC or less, and in conjunction with a barbiturate induction and hyperventilation (hypocapnia) until cerebral decompression in patients with known or suspected increases in CSFP. Appropriate attention must be paid to maintain cerebral perfusion pressure [see Clinical Studies (14.4)].
-
Baxter Healthcare Corporation
Suprane | Baxter Healthcare Corporation
Only persons trained in the administration of general anesthesia should administer SUPRANE. 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.
SUPRANE (desflurane, USP) 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 SUPRANE is deepened. The minimum alveolar concentration (MAC) of SUPRANE decreases with increasing patient age. The MAC for SUPRANE is also reduced by concomitant N2O administration (see Table 1). The dose should be adjusted accordingly. The following table provides mean relative potency based upon age and effect of N2O in predominately ASA physical status I or II patients.
Benzodiazepines and opioids decrease the MAC of SUPRANE [see Drug Interactions (7.1, Table 3)]. SUPRANE also decreases the doses of neuromuscular blocking agents required [see Drug Interactions (7.2, Table 4)]. The dose should be adjusted accordingly.
Table 1Effect of Age on Minimum Alveolar Concentration of Desflurane Mean ± SD (percent atmospheres)
Age
N
O2 100%
N
N2O 60%/40% O2
2 weeks
6
9.2 ± 0.0
-
-
10 weeks
5
9.4 ± 0.4
-
-
9 months
4
10.0 ± 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 ± 0.0
4
4.0 ± 0.3
45 years
4
6.0 ± 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)
2.1 Preanesthetic MedicationIssues such as whether or not to premedicate and the choice of premedication(s) must be individualized. In clinical studies, patients scheduled to be anesthetized with SUPRANE frequently received IV preanesthetic medication, such as opioid and/or benzodiazepine.
2.2 InductionIn adults, some premedicated with opioid, a frequent starting concentration was 3% SUPRANE, increased in 0.5-1.0% increments every 2 to 3 breaths. End-tidal concentrations of 4-11%, SUPRANE with and without N2O, produced anesthesia within 2 to 4 minutes. When SUPRANE was tested as the primary anesthetic induction agent, the incidence of upper airway irritation (apnea, breathholding, laryngospasm, coughing and secretions) was high. During induction in adults, the overall incidence of oxyhemoglobin desaturation (SpO2 < 90%) was 6% [see Adverse Reactions (6.1)].
After induction in adults with an intravenous drug such as thiopental or propofol, SUPRANE can be started at approximately 0.5-1 MAC, whether the carrier gas is O2 or N2O/O2.
Inspired concentrations of SUPRANE greater than 12% have been safely administered to patients, particularly during induction of anesthesia. Such concentrations will proportionately dilute the concentration of oxygen; therefore, maintenance of an adequate concentration of oxygen may require a reduction of nitrous oxide or air if these gases are used concurrently.
2.3 MaintenanceSurgical levels of anesthesia in adults may be maintained with concentrations of 2.5-8.5% SUPRANE with or without the concomitant use of nitrous oxide. In children, surgical levels of anesthesia may be maintained with concentrations of 5.2-10% SUPRANE with or without the concomitant use of nitrous oxide.
During the maintenance of anesthesia with inflow rates of 2 L/min or more, the alveolar concentration of SUPRANE will usually be within 10% of the inspired concentration [FA/FI, see Figure 2 in Clinical Pharmacology (12.3)].
During the maintenance of anesthesia, increasing concentrations of SUPRANE produce dose-dependent decreases in blood pressure. Excessive decreases in blood pressure may be due to depth of anesthesia and in such instances may be corrected by decreasing the inspired concentration of SUPRANE.
Concentrations of SUPRANE exceeding 1 MAC may increase heart rate. Thus with this drug, an increased heart rate may not serve reliably as a sign of inadequate anesthesia.
2.4 Maintenance of Anesthesia in Intubated Pediatric PatientsSUPRANE is indicated for maintenance of anesthesia in infants and children after induction of anesthesia with agents other than SUPRANE, and tracheal intubation.
SUPRANE, with or without N2O, and halothane, with or without N2O were studied in three clinical trials of pediatric patients aged 2 weeks to 12 years (median 2 years) and ASA physical status I or II. The concentration of SUPRANE required for maintenance of general anesthesia is age-dependent [see Clinical Studies (14.5)].
Changes in blood pressure during maintenance of and recovery from anesthesia with SUPRANE/N2O/O2 are similar to those observed with halothane/N2O/O2. Heart rate during maintenance of anesthesia is approximately 10 beats per minute faster with SUPRANE than with halothane. Patients were judged fit for discharge from post-anesthesia care units within one hour with both SUPRANE and halothane. There were no differences in the incidence of nausea and vomiting between patients receiving SUPRANE or halothane.
2.5 RecoveryThe recovery from general anesthesia should be assessed carefully before patients are discharged from the post anesthesia care unit (PACU).
2.6 Use in Patients with Coronary Artery DiseaseIn patients with coronary artery disease, maintenance of normal hemodynamics is important to prevent myocardial ischemia. A rapid increase in desflurane concentration is associated with marked increase in pulse rate, mean arterial pressure and levels of epinephrine and norepinephrine. SUPRANE should not be used as the sole agent for anesthetic induction in patients with coronary artery disease or patients where increases in heart rate or blood pressure are undesirable. It should be used with other medications, preferably intravenous opioids and hypnotics [see Clinical Studies (14.2)].
2.7 Neurosurgical UseSUPRANE may produce a dose-dependent increase in cerebrospinal fluid pressure (CSFP) when administered to patients with intracranial space occupying lesions. SUPRANE should be administered at 0.8 MAC or less, and in conjunction with a barbiturate induction and hyperventilation (hypocapnia) until cerebral decompression in patients with known or suspected increases in CSFP. Appropriate attention must be paid to maintain cerebral perfusion pressure [see Clinical Studies (14.4)].
2.8 Observations Related to Vaporizer UseYellow discoloration of SUPRANE sometimes accompanied by particulates, has been observed through the vaporizer sight glass or after draining the vaporizer. The presence of discoloration or particulates in these situations, does not alter the quality or efficacy of SUPRANE. If observed, refer to the respective vaporizer Instructions For Use (IFU) for recommended actions or contact Baxter Product Surveillance.
-
Baxter Healthcare Corporation
Suprane | Baxter Healthcare Corporation
Only persons trained in the administration of general anesthesia should administer SUPRANE. 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.
SUPRANE 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 SUPRANE is deepened. The minimum alveolar concentration (MAC) of SUPRANE decreases with increasing patient age. The MAC for SUPRANE is also reduced by concomitant N2O administration (see Table 1). The dose should be adjusted accordingly. The following table provides mean relative potency based upon age and effect of N2O in predominately ASA physical status I or II patients.
Benzodiazepines and opioids decrease the MAC of SUPRANE [see Drug Interactions (7.1, Table 3)]. SUPRANE also decreases the doses of neuromuscular blocking agents required [see Drug Interactions (7.2, Table 4)]. The dose should be adjusted accordingly.
Table 1 N = number of crossover pairs (using up-and-down method of quantal response)Effect of Age on Minimum Alveolar Concentration of Desflurane
Mean ± SD (percent atmospheres)
Age
N
O2 100%
N
N2O 60%/40% O2
2 weeks
6
9.2 ± 0.0
-
-
10 weeks
5
9.4 ± 0.4
-
-
9 months
4
10.0 ± 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 ± 0.0
4
4.0 ± 0.3
45 years
4
6.0 ± 0.3
6
2.8 ± 0.6
70 years
6
5.2 ± 0.6
6
1.7 ± 0.4
2.1 Preanesthetic MedicationIssues such as whether or not to premedicate and the choice of premedication(s) must be individualized. In clinical studies, patients scheduled to be anesthetized with SUPRANE frequently received IV preanesthetic medication, such as opioid and/or benzodiazepine.
2.2 InductionIn adults, some premedicated with opioid, a frequent starting concentration was 3% SUPRANE , increased in 0.5-1.0% increments every 2 to 3 breaths. End-tidal concentrations of 4-11%, SUPRANE with and without N2O, produced anesthesia within 2 to 4 minutes. When SUPRANE was tested as the primary anesthetic induction agent, the incidence of upper airway irritation (apnea, breathholding, laryngospasm, coughing and secretions) was high. During induction in adults, the overall incidence of oxyhemoglobin desaturation (SpO2 < 90%) was 6% [see Adverse Reactions (6.1)].
After induction in adults with an intravenous drug such as thiopental or propofol, SUPRANE can be started at approximately 0.5-1 MAC, whether the carrier gas is O2 or N2O/O2.
Inspired concentrations of SUPRANE greater than 12% have been safely administered to patients, particularly during induction of anesthesia. Such concentrations will proportionately dilute the concentration of oxygen; therefore, maintenance of an adequate concentration of oxygen may require a reduction of nitrous oxide or air if these gases are used concurrently.
2.3 MaintenanceSurgical levels of anesthesia in adults may be maintained with concentrations of 2.5-8.5% SUPRANE with or without the concomitant use of nitrous oxide. In children, surgical levels of anesthesia may be maintained with concentrations of 5.2-10% SUPRANE with or without the concomitant use of nitrous oxide.
During the maintenance of anesthesia with inflow rates of 2 L/min or more, the alveolar concentration of SUPRANE will usually be within 10% of the inspired concentration [FA/FI, see Figure 2 in Clinical Pharmacology (12.3)].
During the maintenance of anesthesia, increasing concentrations of SUPRANE produce dose-dependent decreases in blood pressure. Excessive decreases in blood pressure may be due to depth of anesthesia and in such instances may be corrected by decreasing the inspired concentration of SUPRANE .
Concentrations of SUPRANE exceeding 1 MAC may increase heart rate. Thus with this drug, an increased heart rate may not serve reliably as a sign of inadequate anesthesia.
2.4 Maintenance of Anesthesia in Intubated Pediatric PatientsSUPRANE is indicated for maintenance of anesthesia in infants and children after induction of anesthesia with agents other than SUPRANE, and tracheal intubation.
SUPRANE, with or without N2O, and halothane, with or without N2O were studied in three clinical trials of pediatric patients aged 2 weeks to 12 years (median 2 years) and ASA physical status I or II. The concentration of SUPRANE required for maintenance of general anesthesia is age-dependent [see Clinical Studies (14.5)].
Changes in blood pressure during maintenance of and recovery from anesthesia with SUPRANE /N2O/O2 are similar to those observed with halothane/N2O/O2. Heart rate during maintenance of anesthesia is approximately 10 beats per minute faster with SUPRANE than with halothane. Patients were judged fit for discharge from post-anesthesia care units within one hour with both SUPRANE and halothane. There were no differences in the incidence of nausea and vomiting between patients receiving SUPRANE or halothane.
2.5 RecoveryThe recovery from general anesthesia should be assessed carefully before patients are discharged from the post anesthesia care unit (PACU).
2.6 Use in Patients with Coronary Artery DiseaseIn patients with coronary artery disease, maintenance of normal hemodynamics is important to prevent myocardial ischemia. A rapid increase in desflurane concentration is associated with marked increase in pulse rate, mean arterial pressure and levels of epinephrine and norepinephrine. SUPRANE should not be used as the sole agent for anesthetic induction in patients with coronary artery disease or patients where increases in heart rate or blood pressure are undesirable. It should be used with other medications, preferably intravenous opioids and hypnotics [see Clinical Studies (14.2)].
2.7 Neurosurgical UseSUPRANE may produce a dose-dependent increase in cerebrospinal fluid pressure (CSFP) when administered to patients with intracranial space occupying lesions. SUPRANE should be administered at 0.8 MAC or less, and in conjunction with a barbiturate induction and hyperventilation (hypocapnia) until cerebral decompression in patients with known or suspected increases in CSFP. Appropriate attention must be paid to maintain cerebral perfusion pressure [see Clinical Studies (14.4)].
2.8 Observations Related to Vaporizer UseYellow discoloration of SUPRANE sometimes accompanied by particulates, has been observed through the vaporizer sight glass or after draining the vaporizer. The presence of discoloration or particulates in these situations, does not alter the quality or efficacy of SUPRANE. If observed, refer to the respective vaporizer Instructions For Use (IFU) for recommended actions or contact Baxter Product Surveillance.
-
Baxter Healthcare Corporation
Suprane | Baxter Healthcare Corporation
Only persons trained in the administration of general anesthesia should administer SUPRANE. 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.
SUPRANE 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 SUPRANE is deepened. The minimum alveolar concentration (MAC) of SUPRANE decreases with increasing patient age. The MAC for SUPRANE is also reduced by concomitant N2O administration (see Table 1). The dose should be adjusted accordingly. The following table provides mean relative potency based upon age and effect of N2O in predominately ASA physical status I or II patients.
Benzodiazepines and opioids decrease the MAC of SUPRANE [see Drug Interactions (7.1, Table 3)]. SUPRANE also decreases the doses of neuromuscular blocking agents required [see Drug Interactions (7.2, Table 4)]. The dose should be adjusted accordingly.
Table 1Effect of Age on Minimum Alveolar Concentration of Desflurane
Mean ± SD (percent atmospheres)
Age
N
O2 100%
N
N2O 60%/40% O2
2 weeks
6
9.2 ± 0.0
-
-
10 weeks
5
9.4 ± 0.4
-
-
9 months
4
10.0 ± 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 ± 0.0
4
4.0 ± 0.3
45 years
4
6.0 ± 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)
2.1 Preanesthetic MedicationIssues such as whether or not to premedicate and the choice of premedication(s) must be individualized. In clinical studies, patients scheduled to be anesthetized with SUPRANE frequently received IV preanesthetic medication, such as opioid and/or benzodiazepine.
2.2 InductionIn adults, some premedicated with opioid, a frequent starting concentration was 3% SUPRANE, increased in 0.5-1.0% increments every 2 to 3 breaths. End-tidal concentrations of 4-11%, SUPRANE with and without N2O, produced anesthesia within 2 to 4 minutes. When SUPRANE was tested as the primary anesthetic induction agent, the incidence of upper airway irritation (apnea, breathholding, laryngospasm, coughing and secretions) was high. During induction in adults, the overall incidence of oxyhemoglobin desaturation (SpO2 < 90%) was 6% [see Adverse Reactions (6.1)].
After induction in adults with an intravenous drug such as thiopental or propofol, SUPRANE can be started at approximately 0.5-1 MAC, whether the carrier gas is O2 or N2O/O2.
Inspired concentrations of SUPRANE greater than 12% have been safely administered to patients, particularly during induction of anesthesia. Such concentrations will proportionately dilute the concentration of oxygen; therefore, maintenance of an adequate concentration of oxygen may require a reduction of nitrous oxide or air if these gases are used concurrently.
2.3 MaintenanceSurgical levels of anesthesia in adults may be maintained with concentrations of 2.5-8.5% SUPRANE with or without the concomitant use of nitrous oxide. In children, surgical levels of anesthesia may be maintained with concentrations of 5.2-10% SUPRANE with or without the concomitant use of nitrous oxide.
During the maintenance of anesthesia with inflow rates of 2 L/min or more, the alveolar concentration of SUPRANE will usually be within 10% of the inspired concentration [FA/FI, see Figure 2 in Clinical Pharmacology (12.3)].
During the maintenance of anesthesia, increasing concentrations of SUPRANE produce dose-dependent decreases in blood pressure. Excessive decreases in blood pressure may be due to depth of anesthesia and in such instances may be corrected by decreasing the inspired concentration of SUPRANE.
Concentrations of SUPRANE exceeding 1 MAC may increase heart rate. Thus with this drug, an increased heart rate may not serve reliably as a sign of inadequate anesthesia.
2.4 Maintenance of Anesthesia in Intubated Pediatric PatientsSUPRANE is indicated for maintenance of anesthesia in infants and children after induction of anesthesia with agents other than SUPRANE, and tracheal intubation.
SUPRANE, with or without N2O, and halothane, with or without N2O were studied in three clinical trials of pediatric patients aged 2 weeks to 12 years (median 2 years) and ASA physical status I or II. The concentration of SUPRANE required for maintenance of general anesthesia is age-dependent [see Clinical Studies (14.5)].
Changes in blood pressure during maintenance of and recovery from anesthesia with SUPRANE /N2O/O2 are similar to those observed with halothane/N2O/O2. Heart rate during maintenance of anesthesia is approximately 10 beats per minute faster with SUPRANE than with halothane. Patients were judged fit for discharge from post-anesthesia care units within one hour with both SUPRANE and halothane. There were no differences in the incidence of nausea and vomiting between patients receiving SUPRANE or halothane.
2.5 RecoveryThe recovery from general anesthesia should be assessed carefully before patients are discharged from the post anesthesia care unit (PACU).
2.6 Use in Patients with Coronary Artery DiseaseIn patients with coronary artery disease, maintenance of normal hemodynamics is important to prevent myocardial ischemia. A rapid increase in desflurane concentration is associated with marked increase in pulse rate, mean arterial pressure and levels of epinephrine and norepinephrine. SUPRANE should not be used as the sole agent for anesthetic induction in patients with coronary artery disease or patients where increases in heart rate or blood pressure are undesirable. It should be used with other medications, preferably intravenous opioids and hypnotics [see Clinical Studies (14.2)].
2.7 Neurosurgical UseSUPRANE may produce a dose-dependent increase in cerebrospinal fluid pressure (CSFP) when administered to patients with intracranial space occupying lesions. SUPRANE should be administered at 0.8 MAC or less, and in conjunction with a barbiturate induction and hyperventilation (hypocapnia) until cerebral decompression in patients with known or suspected increases in CSFP. Appropriate attention must be paid to maintain cerebral perfusion pressure [see Clinical Studies (14.4)].
2.8 Observations Related to Vaporizer UseYellow discoloration of SUPRANE sometimes accompanied by particulates, has been observed through the vaporizer sight glass or after draining the vaporizer. The presence of discoloration or particulates in these situations, does not alter the quality or efficacy of SUPRANE. If observed, refer to the respective vaporizer Instructions For Use (IFU) for recommended actions or contact Baxter Product Surveillance.
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