SUPRANE
Generic: DESFLURANE
Basic Information
Manufacturer
Baxter Healthcare Corporation
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
RESPIRATORY (INHALATION)
FDA Set ID
3fe3d468-d283-4dd0-a1a7-29291a9b2d0b
Indications & Usage
1 INDICATIONS AND USAGE SUPRANE, a general anesthetic, is an inhalation agent indicated: • for induction and/or maintenance of anesthesia in adults ( 1.1 ) • for maintenance of anesthesia in pediatric patients following induction with agents other than SUPRANE and intubation.
1.1 Induction of Anesthesia SUPRANE is indicated as an inhalation agent for induction of anesthesia for inpatient and outpatient surgery in adults.
SUPRANE 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 SUPRANE 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, and tracheal intubation, SUPRANE is indicated for maintenance of anesthesia in infants and children.
SUPRANE 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) ].
1.1 Induction of Anesthesia SUPRANE is indicated as an inhalation agent for induction of anesthesia for inpatient and outpatient surgery in adults.
SUPRANE 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 SUPRANE 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, and tracheal intubation, SUPRANE is indicated for maintenance of anesthesia in infants and children.
SUPRANE 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) ].
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (incidence> 10%) are coughing, breath holding, apnea, nausea, vomiting.
(6) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-800-262-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse event information is derived from controlled clinical trials, the majority of which were conducted in the United States.
The studies were conducted using a variety of premedications, other anesthetics, and surgical procedures of varying length.
Most adverse events reported were mild and transient, and may reflect the surgical procedures, patient characteristics (including disease) and/or medications administered.
Of the 2,143 patients exposed to SUPRANE in clinical trials, 370 adults and 152 children were induced with desflurane alone and 987 patients were maintained principally with desflurane.
The frequencies given reflect the percent of patients with the event.
Each patient was counted once for each type of adverse event.
They are presented in alphabetical order according to body system.
Table 2 Frequency of Events Occurring in Greater Than 1% of Clinical Trial Patients (in Reports Deemed “Probably Causally Related”) Induction (use as a mask inhalation agent) Adult Patients (N=370): Coughing 34%, breathholding 30%, apnea 15%, increased secretions Incidence of events 3% - 10% , laryngospasm , oxyhemoglobin desaturation (SpO 2 < 90%) , pharyngitis .
Maintenance or Recovery Adult and Intubated Pediatric Patients (N=687): Body as a Whole Headache Cardiovascular Bradycardia, hypertension, nodal arrhythmia, tachycardia Digestive Nausea 27%, vomiting 16% Nervous system Increased salivation Respiratory Apnea , breathholding, cough increased , laryngospasm , pharyngitis Special Senses Conjunctivitis (conjunctival hyperemia) Frequency of Events Occurring in Less Than 1% of Patients (in Reports Deemed “Probably Causally Related”) Reported in 3 or more patients, regardless of severity Adverse reactions reported only from postmarketing experience or in the literature, not seen in clinical trials, are considered rare and are italicized.
Cardiovascular Arrhythmia, bigeminy, abnormal electrocardiogram, myocardial ischemia, vasodilation Digestive Hepatitis Nervous System Agitation, dizziness Respiratory Asthma, dyspnea, hypoxia Frequency of Events Occurring in Less Than 1% of Clinical Trial Patients (in Reports Deemed “Causal Relationship Unknown”) Reported in 3 or more patients, regardless of severity Body as a Whole Fever Cardiovascular Hemorrhage, myocardial infarction Metabolic and Nutrition Increased creatinine phosphokinase Musculoskeletal System Myalgia Skin and Appendages Pruritus 6.2 Post-Marketing Experience The following adverse reactions have been identified during post-approval use of SUPRANE.
Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders : Coagulopathy Metabolism and Nutrition Disorders : Hyperkalemia, Hypokalemia, metabolic acidosis Psychiatric Disorders: Delirium Nervous System Disorders : Convulsion, Post-operative agitation in children Eye Disorders: Ocular icterus Cardiac Disorders: Cardiac arrest, electrocardiogram QT prolonged, torsade de pointes, ventricular failure, ventricular hypokinesia, atrial fibrillation Vascular Disorders: Malignant hypertension, hemorrhage, hypotension, shock Respiratory, Thoracic and Mediastinal Disorders: Respiratory arrest, respiratory failure, respiratory distress, bronchospasm, hemoptysis Gastrointestinal Disorders : Pancreatitis acute, abdominal pain Hepatobiliary Disorders: Hepatic failure, hepatic necrosis, hepatitis, cytolytic hepatitis, cholestasis, jaundice, hepatic function abnormal, liver disorder Skin and Subcutaneous Tissue Disorder : Urticaria, erythema Musculoskeletal, Connective Tissue and Bone Disorders: Rhabdomyolysis General Disorders and Administration Site Conditions: Hyperthermia malignant, asthenia, malaise Investigations: Electrocardiogram ST-T change, electrocardiogram T-wave inversion, tranaminases increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, coagulation test abnormal, ammonia increased Injury, Poisoning, and Procedural Complications*: Tachyarrhythmia, palpitations, eye burns, blindness transient, encephalopathy, ulcerative keratitis, ocular hyperemia, visual acuity reduced, eye irritation, eye pain, dizziness, migraine, fatigue, accidental exposure, skin burning sensation, drug administration error *Reactions categorized within this System Organ Class (SOC) were accidental exposures to non-patients.
(6) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-800-262-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse event information is derived from controlled clinical trials, the majority of which were conducted in the United States.
The studies were conducted using a variety of premedications, other anesthetics, and surgical procedures of varying length.
Most adverse events reported were mild and transient, and may reflect the surgical procedures, patient characteristics (including disease) and/or medications administered.
Of the 2,143 patients exposed to SUPRANE in clinical trials, 370 adults and 152 children were induced with desflurane alone and 987 patients were maintained principally with desflurane.
The frequencies given reflect the percent of patients with the event.
Each patient was counted once for each type of adverse event.
They are presented in alphabetical order according to body system.
Table 2 Frequency of Events Occurring in Greater Than 1% of Clinical Trial Patients (in Reports Deemed “Probably Causally Related”) Induction (use as a mask inhalation agent) Adult Patients (N=370): Coughing 34%, breathholding 30%, apnea 15%, increased secretions Incidence of events 3% - 10% , laryngospasm , oxyhemoglobin desaturation (SpO 2 < 90%) , pharyngitis .
Maintenance or Recovery Adult and Intubated Pediatric Patients (N=687): Body as a Whole Headache Cardiovascular Bradycardia, hypertension, nodal arrhythmia, tachycardia Digestive Nausea 27%, vomiting 16% Nervous system Increased salivation Respiratory Apnea , breathholding, cough increased , laryngospasm , pharyngitis Special Senses Conjunctivitis (conjunctival hyperemia) Frequency of Events Occurring in Less Than 1% of Patients (in Reports Deemed “Probably Causally Related”) Reported in 3 or more patients, regardless of severity Adverse reactions reported only from postmarketing experience or in the literature, not seen in clinical trials, are considered rare and are italicized.
Cardiovascular Arrhythmia, bigeminy, abnormal electrocardiogram, myocardial ischemia, vasodilation Digestive Hepatitis Nervous System Agitation, dizziness Respiratory Asthma, dyspnea, hypoxia Frequency of Events Occurring in Less Than 1% of Clinical Trial Patients (in Reports Deemed “Causal Relationship Unknown”) Reported in 3 or more patients, regardless of severity Body as a Whole Fever Cardiovascular Hemorrhage, myocardial infarction Metabolic and Nutrition Increased creatinine phosphokinase Musculoskeletal System Myalgia Skin and Appendages Pruritus 6.2 Post-Marketing Experience The following adverse reactions have been identified during post-approval use of SUPRANE.
Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders : Coagulopathy Metabolism and Nutrition Disorders : Hyperkalemia, Hypokalemia, metabolic acidosis Psychiatric Disorders: Delirium Nervous System Disorders : Convulsion, Post-operative agitation in children Eye Disorders: Ocular icterus Cardiac Disorders: Cardiac arrest, electrocardiogram QT prolonged, torsade de pointes, ventricular failure, ventricular hypokinesia, atrial fibrillation Vascular Disorders: Malignant hypertension, hemorrhage, hypotension, shock Respiratory, Thoracic and Mediastinal Disorders: Respiratory arrest, respiratory failure, respiratory distress, bronchospasm, hemoptysis Gastrointestinal Disorders : Pancreatitis acute, abdominal pain Hepatobiliary Disorders: Hepatic failure, hepatic necrosis, hepatitis, cytolytic hepatitis, cholestasis, jaundice, hepatic function abnormal, liver disorder Skin and Subcutaneous Tissue Disorder : Urticaria, erythema Musculoskeletal, Connective Tissue and Bone Disorders: Rhabdomyolysis General Disorders and Administration Site Conditions: Hyperthermia malignant, asthenia, malaise Investigations: Electrocardiogram ST-T change, electrocardiogram T-wave inversion, tranaminases increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, coagulation test abnormal, ammonia increased Injury, Poisoning, and Procedural Complications*: Tachyarrhythmia, palpitations, eye burns, blindness transient, encephalopathy, ulcerative keratitis, ocular hyperemia, visual acuity reduced, eye irritation, eye pain, dizziness, migraine, fatigue, accidental exposure, skin burning sensation, drug administration error *Reactions categorized within this System Organ Class (SOC) were accidental exposures to non-patients.