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DESFLURANE is a brand name for Desflurane, supplied as a liquid. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE................................................................................................................. 3 CONTRAINDICATIONS ...................................................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Drug Reaction Overview The most serious reported adverse events in alphabetical order are apnea, bronchospasm, cardiac arrest, hepatic failure, hyperkalemia, hypotension, malignant hyperthermia, and respiratory depression. The most frequent adverse events (incidence > 10%) are cough, nausea, vomiting, salivary hypersecretion and oxyhemoglobin desaturation.
All of the adverse events that are listed in this section may result in the need for clinical diagnosis or treatment. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug- related adverse events and for approximating rates. Adverse event information is derived from controlled clinical trials. The studies were conducted using a variety of premedications, other anesthetics, and surgical procedures of varying length.
Of the 1,843 patients exposed to desflurane in clinical trials, 1,209 were used in estimating the incidence of adverse events below. Of these, 370 adults and 152 children were induced with desflurane alone and 687 patients were maintained principally with desflurane.
Frequencies reflect the percent of patients with the event and each patient was counted once for each type of adverse event. They are listed by organ class, then by decreasing frequency. DESFLURANE (desflurane, USP) Page 12 of 47 Table 1 –Treatment-Emergent Adverse Events with Incidence ≥ 1% - Induction (use as a mask inhalation agent) Induction (use as a mask inhalation agent) System Organ Class (SOC) Adverse Event (Preferred MedDRA Term) Incidence (%) Adult Patients (N=370) Pediatric Patients (N=152) GASTROINTESTINAL DISORDERS Increased secretions 9 21 INFECTIONS AND INFESTATIONS Pharyngitis 4 - PSYCHIATRIC DISORDERS Breath holding 27 63 RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS Coughing 34 72 Apnea 15 - Laryngospasm 8 50 Oxyhemoglobin desaturation (SpO2 < 90%) 8 26 Bronchospasm - 3 DESFLURANE (desflurane, USP) Page 13 of 47 Table 2 – Treatment-Emergent Adverse Events with Incidence ≥ 1% - Maintenance or Recovery Maintenance or Recovery (Incidence ≥ 1%) System Organ Class (SOC) Adverse Event (Preferred MedDRA Term) Incidence (%) Adult and *Pediatric Patients (N=687) CARDIAC DISORDERS Bradycardia 1 Hypertension 1 Nodal arrhythmia 1 Tachycardia 1 EYE DISORDERS Conjunctivitis (conjunctival hyperemia) 2 GASTROINTESTINAL DISORDERS Nausea 27 Vomiting 16 Increased salivation 1 INFECTIONS AND INFESTATIONS Pharyngitis 1 NERVOUS SYSTEM DISORDERS Headache 1 PSYCHIATRIC DISORDERS Breath holding 2 RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS Apnea 7 Cough increased 4 Laryngospasm 3 * Includes data for intubated pediatric patients DESFLURANE (desflurane, USP) Page 14 of 47 Table 3 – Treatment-Emergent Adverse Events with Incidence > 1% - Maintenance in Non- intubated Pediatric Patients Maintenance in Non-intubated Pediatric Patients (face mask or LMA used; N=300) All Respiratory Events* (>1% of All Pediatric Patients) All Ages (N=300) 2-6 yr (N=150) 7-11 yr (N=81) 12-16 yr (N=69) Any respiratory events 39% 42% 33% 39% Airway obstruction 4% 5% 4% 3% Breath-holding 3% 2% 3% 4% Coughing 26% 33% 19% 22% Laryngospasm 13% 16% 7% 13% Secretion 12% 13% 10% 12% Non-specific desaturation 2% 2% 1% 1% *Minor, moderate and severe respiratory events Less Common Clinical Trial Adverse Drug Reactions (<1%) Treatment-emergent adverse events with incidence less than 1% and reported in 3 or more patients, regardless of severity (N=1,843) Cardiac Disorders: Myocardial Infarction, Myocardial Ischemia, Arrhythmia, Bigeminy General Disorders: Fever Musculoskeletal, Connective Tissue and Bone Disorders: Myalgia Nervous System Disorders: Dizziness Psychiatric Disorders: Agitation Respiratory, Thoracic, and Mediastinal Disorders: Hypoxia, Asthma, Dyspnea Skin and Appendages: Pruritus Vascular Disorders: Vasodilation, Hemorrhage See WARNINGS AND PRECAUTIONS for information regarding pediatric use and malignant hyperthermia.
When general anesthesia is contraindicated. Known sensitivity to DESFLURANE (desflurane), other halogenated anesthetics, or component of the container. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the product monograph.
Patients with a history of hepatitis due to a halogenated inhalational anesthetic or in whom liver dysfunction, jaundice or unexplained fever, leucocytosis, or eosinophilia has occurred after a previous halogenated anesthetic administration (see WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic).
Known or suspected genetic susceptibility to malignant hyperthermia or in patients with a history of malignant hyperthermia (see WARNINGS AND PRECAUTIONS, Malignant Hyperthermia (MH)). Desflurane is contraindicated for use as an inhalation induction agent in pediatric patients because of the frequent occurrence of cough, breath holding, apnea, laryngospasm and increased secretions (see INDICATIONS, Pediatrics).
WARNINGS AND PRECAUTIONS Serious Warnings and Precautions Administration only by qualified individuals trained in general anesthesia using a vaporizer specific to desflurane in adequately equipped facilities (see General section below); DESFLURANE (desflurane) can react with desiccated carbon dioxide absorbents to produce carbon monoxide resulting in elevated carboxyhemoglobin levels (see General section below); DESFLURANE may trigger Malignant Hyperthermia in susceptible individuals and fatal outcomes have been reported (see Malignant Hyperthermia section below); DESFLURANE use may lead to Perioperative Hyperkalemia in patients with neuromuscular disorders (see Perioperative Hyperkalemia section below); In pediatric patients, DESFLURANE is not recommended for induction of anesthesia because of moderate to severe upper airway adverse events observed in clinical studies (see CONTRAINDICATIONS and Special Populations, Pediatrics).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Desflurane in Canada.
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DESFLURANE (desflurane, USP) Page 15 of 47 Abnormal Hematologic and Clinical Chemistry Findings Transient elevations in glucose and white blood cell count may occur as with the use of other anesthetic agents. Abnormal liver function tests were observed in < 1% of patients.
Hepatitis has been reported very rarely. Post-Market Adverse Events In addition to the treatment-emergent adverse events noted in clinical trials, the following adverse events have been reported in the post-marketing experience. These adverse events are listed by MedDRA System Organ Class (SOC), then by Preferred Term in order of severity.
Blood and Lymphatic System Disorders:
Coagulopathy Metabolism and Nutrition Disorders: Hyperkalemia, Hypokalemia, Metabolic acidosis Nervous System Disorders: Convulsion Eye Disorders: Ocular icterus Cardiac Disorders: Cardiac arrest, 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, Transaminases increased, Alanine aminotransferase increased, Aspartate aminotransferase […]
DESFLURANE (desflurane, USP) Page 5 of 47 General DESFLURANE should be administered only by persons trained in the administration of general anesthesia, using a vaporizer specifically designed and designated for use with desflurane.
Facilities and equipment for maintenance of a patent airway, artificial ventilation, oxygen enrichment and circulatory resuscitation must be immediately available. Hypotension and respiratory depression increase as anesthesia is deepened.
Safe use of CO2 Absorbents DESFLURANE can react with desiccated carbon dioxide (CO2) absorbents to produce carbon monoxide, which may result in elevated levels of carboxyhemoglobin in some patients. In clinical practice, cases of elevated carboxyhemoglobin have been reported in association with desflurane.
Case reports suggest that barium hydroxide lime and soda lime become desiccated when fresh gases are passed through the CO2 absorbent canister at high flow rates over many hours or days. When a clinician suspects that CO2 absorbent may be desiccated, it should be replaced before the administration of DESFLURANE.
The color indicator of most CO2 absorbents does not necessarily change as a result of desiccation. Therefore, the lack of significant color change should not be taken as an assurance of adequate hydration. CO2 absorbents should be replaced routinely regardless of the state of the color indicator.
As with other inhalational anesthetic agents, the use of CO2 absorbents without strong bases is preferable. DESFLURANE is not recommended for mask induction as it causes a high incidence of laryngospasm, coughing, breath holding, apnea, increase in secretions and oxyhemoglobin desaturation (see ADVERSE REACTIONS).
As with any inhalation agent, the use of DESFLURANE proportionately decreases the concentration of all other gases administered concurrently, including oxygen (O2). For example, the addition of 10% DESFLURANE to 70% nitrous oxide (N2O) and 30% O2 reduces the O2 concentration to 27%.
Nitrous oxide diminishes the inspired concentration of DESFLURANE required to reach a desired level of anesthesia (see DOSAGE AND ADMINISTRATION, Table 6). Cardiovascular Caution should be exercised when administering DESFLURANE to susceptible patients.
DESFLURANE, like other inhalation anesthetic agents, may prolong the QT interval in adults and children. , patients with congenital Long QT Syndrome or patients taking drugs that can prolong the QT interval). DESFLURANE (desflurane, USP) Page 6 of 47 In healthy volunteers, in the absence of concomitant N2O and/or opioid administration, sudden step increases in the end-tidal concentration of desflurane may cause transient increases in sympathetic activity with associated increases in heart rate and blood pressure.
The hemodynamic changes are more common at concentrations ≥ 6% and more severe with large (≥ 1%), sudden increments. Without treatment, and without further increases in desflurane concentration, these increases in heart rate and blood pressure resolve in approximately 4 minutes.
At the new, higher end-tidal desflurane concentration blood pressure is likely to be lower and heart rate higher than at the previous, lower steady-state desflurane concentration. The transient increases of heart rate and blood pressure are less if the end-tidal concentration of desflurane is increased in increments of 1% or less.
However, if during the transiently increased heart rate and blood pressure the end-tidal concentration of desflurane is again rapidly increased, further increase of heart rate and blood pressure may result. Administration of sympatholytic drugs (fentanyl, alfentanil, esmolol, clonidine) prior to a sudden step increase of desflurane blunts or blocks the increase in heart rate and blood pressure.
The sympathetic response is not obtunded by intravenous or endotracheal lidocaine or by intravenous propofol (see ACTION AND CLINICAL PHARMACOLOGY). When DESFLURANE is used in the […]