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Clinical Trials Experience
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 (desflurane) in clinical trials, 370 adults and 152 children were induced with SUPRANE (desflurane) alone and 987 patients were maintained principally with SUPRANE (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*, laryngospasm*, oxyhemoglobin desaturation (SpO2 < 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)|
|*Incidence of events 3% - 10%|
Frequency of Events Occurring in Less Than 1% of Patient (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|
|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 infarct|
|Metabolic and Nutrition||Increased creatinine phosphokinase|
|Skin and Appendages||Pruritus|
Post Marketing Experience
The following adverse reactions have been identified during post-approval use of SUPRANE (desflurane) . 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
Nervous System Disorders: Convulsion
Eye Disorders: Ocular icterus
Cardiac Disorders: Cardiac arrest, Torsade de pointes, ventricular failure, ventricular hypokinesia
Hepatobiliary Disorders: Hepatic failure, hepatic necrosis, cytolytic hepatitis, cholestasis, jaundice, hepatic function abnormal, liver disorder
Musculoskeletal, Connective Tissue and Bone Disorders: Rhabdomyolysis
Investigations: Electrocardiogram ST-T change, electrocardiogram T-wave inversion, tranaminases increased, alanine aminotransferase increased, aspartate aminotransferase 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
*All of reactions categorized within this SOC were accidental exposures to non-patients.
Read the Suprane (desflurane) Side Effects Center for a complete guide to possible side effects »
No clinically significant adverse interactions with commonly used preanesthetic drugs, or drugs used during anesthesia (muscle relaxants, intravenous agents, and local anesthetic agents) were reported in clinical trials. The effect of SUPRANE (desflurane) on the disposition of other drugs has not been determined. Similar to isoflurane, SUPRANE (desflurane) does not predispose to premature ventricular arrhythmias in the presence of exogenously infused epinephrine in swine.
Benzodiazepines and Opioids (MAC Reduction)
Benzodiazepines and opioids decrease the amount of desflurane (MAC) needed to produce anesthesia. This effect is shown in Table 3 for intravenous midazolam (25-50 µg/kg) and intravenous fentanyl (3-6 µg/kg) in patients of two different age groups.
Table 3: SUPRANE (desflurane) MAC with Fentanyl or Midazolam Mean ±
SD (percent reduction)
|Dose||18-30 years||31-65 years|
|No fentanyl||6.4 ± 0.0||6.3 ± 0.4|
|3 µg/kg fentanyl||3.5 ± 1.9 (46%)||3.1 ± 0.6 (51%)|
|6 µg/kg fentanyl||3.0 ± 1.2 (53%)||2.3 ± 1.0 (64%)|
|No midazolam||6.9 ± 0.1||5.9 ± 0.6|
|25 µg/kg midazolam||-||4.9 ± 0.9 (16%)|
|50 µg/kg midazolam||-||4.9 ± 0.5 (17%)|
Neuromuscular Blocking Agents
Anesthetic concentrations of SUPRANE (desflurane) at equilibrium (administered for 15 or more minutes before testing) reduced the ED95 of succinylcholine by approximately 30% and that of atracurium and pancuronium by approximately 50% compared to N2O/opioid anesthesia (see Table 4). The effect of desflurane on duration of nondepolarizing neuromuscular blockade has not been studied.
Table 4: DOSAGE OF MUSCLE RELAXANT CAUSING 95% DEPRESSION
IN NEUROMUSCULAR BLOCKADE
|SUPRANE Concentration||Mean ED95 (µg/kg)|
|0.65 MAC 60% N2O/O2||26||123||-||-|
|1.25 MAC 60% N2O/O2||18||91||-||-|
|1.25 MAC O2||22||120||362||19|
Dosage reduction of neuromuscular blocking agents during induction of anesthesia may result in delayed onset of conditions suitable for endotracheal intubation or inadequate muscle relaxation, because potentiation of neuromuscular blocking agents requires equilibration of muscle with the delivered partial pressure of SUPRANE (desflurane) .
Among nondepolarizing drugs, pancuronium, atracurium, and vecuronium interactions have been studied. In the absence of specific guidelines:
- For endotracheal intubation, do not reduce the dose of nondepolarizing muscle relaxants or succinylcholine.
- During maintenance of anesthesia, the dose of nondepolarizing muscle relaxants is likely to be reduced compared to that during N2O/opioid anesthesia. Administration of supplemental doses of muscle relaxants should be guided by the response to nerve stimulation.
Concomitant Use with N2O
Concomitant administration of N2O reduces the MAC of SUPRANE [see DOSAGE AND ADMINISTRATION, Table 1] .
Last reviewed on RxList: 4/27/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional Suprane Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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