Desflurane

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Desflurane
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

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Overview

Desflurane is a general anesthetics that is FDA approved for the {{{indicationType}}} of General anesthesia. Common adverse reactions include gastrointestinal: nausea (27% ), vomiting (16% ), respiratory: cough ( adult induction, 22% to 34% ), interrupted breathing (adult induction, 30% to 39%; adult and intubated pediatric maintenance, greater than 1% ).

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

General anesthesia: induction, initial INHALED concentration of 3% in oxygen or nitrous oxide/oxygen, increased by 0.5% to 1% increments every 2 to 3 breaths or as tolerated (end tidal concentrations 4% to 11%) inspired concentrations greater than 12% have been safely administered during induction and may require a reduction of nitrous oxide or air General anesthesia: maintenance, INHALED concentrations of 2.5% to 8.5% with or without concomitant nitrous oxide; dosage must be individualized based on patient response

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Desflurane in adult patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Desflurane in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

General anesthesia: maintenance, INHALED in concentrations of 5.2% to 10% with or without concomitant nitrous oxide; dosage must be individualized based on patient response

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Desflurane in pediatric patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Desflurane in pediatric patients.

Contraindications

The use of SUPRANE (desflurane, USP) is contraindicated in the following conditions:

   Known or suspected genetic susceptibility to malignant hyperthermia.
   Patients in whom general anesthesia is contraindicated.
   Induction of anesthesia in pediatric patients.
   Patients with known sensitivity to SUPRANE (desflurane, USP) or to other halogenated agents [see Warnings and Precautions (5.5)].
   Patients with a history of confirmed hepatitis or with a history of unexplained moderate to severe hepatic dysfunction (e.g., jaundice associated with fever and/or eosinophilia) after anesthesia with SUPRANE (desflurane, USP) or other halogenated agents [see Warnings and Precautions].

Warnings

Malignant Hyperthermia

In susceptible individuals, potent inhalation anesthetic agents may trigger a skeletal muscle hypermetabolic state leading to high oxygen demand and the clinical syndrome known as malignant hyperthermia. In genetically susceptible pigs, desflurane induced malignant hyperthermia. The clinical syndrome is signaled by hypercapnia, and may include muscle rigidity, tachycardia, tachypnea, cyanosis, arrhythmias, and/or unstable blood pressure. Some of these nonspecific signs may also appear during light anesthesia: acute hypoxia, hypercapnia, and hypovolemia.

Treatment of malignant hyperthermia includes discontinuation of triggering agents, administration of intravenous dantrolene sodium, and application of supportive therapy. (Consult prescribing information for dantrolene sodium intravenous for additional information on patient management.) Renal failure may appear later, and urine flow should be monitored and sustained if possible.

Fatal outcome of malignant hyperthermia has been reported with desflurane.

Perioperative Hyperkalemia

Use of inhaled anesthetic agents has been associated with rare increases in serum potassium levels that have resulted in cardiac arrhythmias and death in pediatric patients during the postoperative period. Patients with latent as well as overt neuromuscular disease, particularly Duchenne muscular dystrophy, appear to be most vulnerable. Concomitant use of succinylcholine has been associated with most, but not all, of these cases. These patients also experienced significant elevations in serum creatinine kinase levels and, in some cases, changes in urine consistent with myoglobinuria. Despite the similarity in presentation to malignant hyperthermia, none of these patients exhibited signs or symptoms of muscle rigidity or hypermetabolic state. Early and aggressive intervention to treat the hyperkalemia and resistant arrhythmias is recommended, as is subsequent evaluation for latent neuromuscular disease.

Respiratory Adverse Reactions in Pediatric Patients

Due to the limited data available in non-intubated pediatric patients, 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 Clinical Studies ].

Caution should be exercised should SUPRANE (desflurane, USP) be used for maintenance of anesthesia with laryngeal mask airway (LMA™ mask) in children, in particular for children 6 years old or younger because of the increased potential for adverse respiratory reactions, e.g. coughing and laryngospasm, especially with removal of the LMA™ mask under deep anesthesia [see Clinical Studies].

Caution should be exercised when SUPRANE (desflurane, USP) is used for maintenance of anesthesia in children with asthma or a history of recent upper airway infection due to the potential for airway narrowing and increases in airway resistance.

Interactions with Desiccated Carbon Dioxide Absorbents

Desflurane like some other inhalation anesthetics, can react with desiccated carbon dioxide (CO2) absorbents to produce carbon monoxide that may result in elevated levels of carboxyhemoglobin in some patients. Case reports suggest that barium hydroxide lime and soda lime become desiccated when fresh gases are passed through the CO2 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 SUPRANE (desflurane, USP).

Hepatobiliary Disorders

With the use of halogenated anesthetics, disruption of hepatic function, icterus and fatal liver necrosis have been reported; such reactions appear to indicate hypersensitivity. As with other halogenated anesthetic agents, SUPRANE (desflurane, USP) may cause sensitivity hepatitis in patients who have been sensitized by previous exposure to halogenated anesthetics [see Contraindications (4)]. Cirrhosis, viral hepatitis or other pre-existing hepatic disease may be a reason to select an anesthetic other than a halogenated anesthetic. As with all halogenated anesthetics, repeated anesthesia within a short period of time should be approached with caution.

Laboratory Findings

Transient elevations in glucose and white blood cell count may occur as with use of other anesthetic agents.

Adverse Reactions

Clinical Trials Experience

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, USP) 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.

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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.

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Postmarketing Experience

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of SUPRANE (desflurane, USP). 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

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, 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

  • All of reactions categorized within this SOC were accidental exposures to non-patients.

Drug Interactions

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, USP) on the disposition of other drugs has not been determined. Similar to isoflurane, SUPRANE (desflurane, USP) does not predispose to premature ventricular arrhythmias in the presence of exogenously infused epinephrine in swine.

7.1 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

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Neuromuscular Blocking Agents

Anesthetic concentrations of 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.

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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, USP).

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.

7.3 Concomitant use with N2O

Concomitant administration of N2O reduces the MAC of SUPRANE (desflurane, USP) [see Dosage and Administration (2), Table 1].

7.4 Beta Blockers

Concomitant use of beta blockers may exaggerate the cardiovascular effects of inhalational anesthetics, including hypotension and negative inotropic effects.

7.5 Monoamine Oxidase Inhibitors (MAO)

Concomitant use of MAO inhibitors and inhalational anesthetics may increase the risk of hemodynamic instability during surgery or medical procedures.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Desflurane in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Desflurane in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Desflurane during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Desflurane in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Desflurane in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Desflurane in geriatric settings.

Gender

There is no FDA guidance on the use of Desflurane with respect to specific gender populations.

Race

There is no FDA guidance on the use of Desflurane with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Desflurane in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Desflurane in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Desflurane in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Desflurane in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Desflurane Administration in the drug label.

Monitoring

There is limited information regarding Desflurane Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Desflurane and IV administrations.

Overdosage

There is limited information regarding Desflurane overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Desflurane Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Desflurane Mechanism of Action in the drug label.

Structure

There is limited information regarding Desflurane Structure in the drug label.

Pharmacodynamics

There is limited information regarding Desflurane Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Desflurane Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Desflurane Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Desflurane Clinical Studies in the drug label.

How Supplied

There is limited information regarding Desflurane How Supplied in the drug label.

Storage

There is limited information regarding Desflurane Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Desflurane Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Desflurane interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Desflurane Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Desflurane Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.