pharmacopeia
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Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: GABA A Modulators; Glycine Agonists.

GABA AGlycine

Indications

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  • Desflurane, USP, Liquid for Inhalation, 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 Desflurane, USP, Liquid for Inhalation and intubation. 1.1 Induction of Anesthesia Desflurane, USP, Liquid for Inhalation is indicated as an inhalation agent for induction of anesthesia for inpatient and outpatient surgery in adults.

Contraindications

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  • The use of Desflurane, USP, Liquid for Inhalation is contraindicated in the following conditions: Known or suspected genetic susceptibility to malignant hyperthermia [See Warnings and Precautions (5.1), Clinical Pharmacology (12.5)] . Patients in whom general anesthesia is contraindicated.contraindicated

Dosage & administration

Sourced from openFDA

Only persons trained in the administration of general anesthesia should administer Desflurane, USP, Liquid for Inhalation. 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. Desflurane, USP, Liquid for Inhalation 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, USP, Liquid for Inhalation is deepened. The minimum alveolar concentration (MAC) of Desflurane, USP, Liquid for Inhalation decreases with increasing patient age. The MAC for Desflurane, USP, Liquid for Inhalation is also reduced by concomitant N 2 O administration (See Table 1 ) . The dose should be adjusted accordingly. The following table provides mean relative potency based upon age and effect of N 2 O in predominately ASA physical status I or II patients. Benzodiazepines and opioids decrease the MAC of Desflurane, USP, Liquid for Inhalation [See Drug Interactions (7.1, Table 3) ] . Desflurane, USP, Liquid for Inhalation also decreases the doses of neuromuscular blocking agents required [See Drug Interactions (7.2, Table 4) ] . The dose should be adjusted accordingly.

Warnings & precautions

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Malignant Hyperthermia: Malignant hyperthermia may occur, especially in individuals with known or suspected susceptibility based on genetic factors or family history. Discontinue triggering agents, administer intravenous dantrolene sodium, and apply supportive therapies. ( 5.1 ) Perioperative Hyperkalemia: Perioperative hyperkalemia may occur. Patients with latent or overt neuromuscular disease, particularly with Duchenne muscular dystrophy, appear to be most vulnerable. Early, aggressive intervention is recommended. ( 5.2 ) Respiratory Adverse Reactions in Pediatric Patients: - Not approved for maintenance of anesthesia in non-intubated children due to an increased incidence of respiratory adverse reactions. Monitor and treat accordingly. ( 5.3 ) - May cause airway narrowing and increased airway resistance in children with asthma or a history of recent upper airway infection. Monitor and treat accordingly.( 5.3 ) QTc Prolongation: Carefully monitor cardiac rhythm when administering desflurane to susceptible patients. ( 5.4 ) Interactions with Desiccated Carbon Dioxide (CO 2 ) Absorbents: May react with desiccated CO 2 absorbents to produce carbon monoxide. Replace desiccated CO 2 absorbent before administration of desflurane. ( 5.5 ) Hepatobiliary Disorders: May cause sensitivity hepatitis in patients sensitized by previous exposure to halogenated anesthetics. Approach repeated anesthesia with caution ( 5.6 ) Pediatric Neurotoxicity: In developing animals, exposures greater than 3 hours cause neurotoxicity.

Adverse reactions

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Most common adverse reactions (incidence>10%) are coughing, breath holding, apnea, nausea, vomiting. (6) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 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 desflurane 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.

Use in specific populations

Sourced from openFDA

Geriatric Use: The minimum alveolar concentration (MAC) of desflurane decreases with increasing patient age. ( 8.5 ) 8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women. In animal reproduction studies, embryo-fetal toxicity (reduced viable fetuses and/or increased post-implantation loss) was noted in pregnant rats and rabbits administered 1 MAC desflurane for 4 hours a day (4 MAC-hours/day) during organogenesis. Published studies in pregnant primates demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity during the period of peak brain development increases neuronal apoptosis in the developing brain of the offspring when used for longer than 3 hours. There are no data on pregnancy exposures in primates corresponding to periods prior to the third trimester in humans [See Data] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Pharmacokinetics

Sourced from openFDA
Metabolism
Due to the volatile nature of desflurane in plasma samples, the washin-washout profile of desflurane was used as a surrogate of plasma pharmacokinetics. Desflurane is a volatile liquid inhalation anesthetic minimally biotransformed in the liver in humans.

Overdosage

Sourced from openFDA

The symptoms of overdosage of desflurane can present as a deepening of anesthesia, cardiac and/or respiratory depression in spontaneously breathing patients, and cardiac depression in ventilated patients in whom hypercapnia and hypoxia may occur only at a late stage. In the event of overdosage, or suspected overdosage, take the following actions: discontinue administration of desflurane, maintain a patent airway, initiate assisted or controlled ventilation with oxygen, and maintain adequate cardiovascular function.

Approval history

Sourced from openFDA
  • Sep 18, 1992NDANDA020118Baxter Hlthcare
  • Feb 26, 2018ANDAANDA208234Shanghai Hengrui

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,684 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Hypotension1176.9%
  2. 2Bradycardia1026.1%
  3. 3Cardiac Arrest975.8%
  4. 4Drug Interaction975.8%
  5. 5Anaphylactic Shock925.5%
  6. 6Serotonin Syndrome744.4%
  7. 7Hyperthermia Malignant603.6%
  8. 8Anaphylactic Reaction583.4%
  9. 9Bronchospasm573.4%
  10. 10Drug Ineffective573.4%
  11. 11Tachycardia563.3%
  12. 12Foetal Exposure During Pregnancy472.8%
  13. 13Post Procedural Complication422.5%
  14. 14Blood Pressure Decreased412.4%
  15. 15Circulatory Collapse372.2%

Literature

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Recent PubMed references pinned to Desflurane as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 322 ClinicalTrials.gov registrations naming Desflurane as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Desflurane. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

Frequently asked questions

How does Desflurane work?
Mechanism-of-action classes: GABA A Modulators; Glycine Agonists.
What is Desflurane used for?
According to FDA labeling, Desflurane carries indications including: Desflurane, USP, Liquid for Inhalation, 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 Desflurane, USP, Liquid for Inhalation and intubation. 1.1 Induction of Anesthesia Desflurane, USP, Liquid for Inhalation is indicated as an inhalation agent for induction of anesthesia for inpatient and outpatient surgery in adults.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Desflurane?
Desflurane is classified as Halogenated hydrocarbons, General Anesthetic, GABA A Modulators, Glycine Agonists, Cerebral Arterial Vasoconstriction, Decreased Medullary Respiratory Drive, General Anesthesia, Vasodilation.
What are the brand names for Desflurane?
Desflurane is marketed under brand names including Suprane.
What are the contraindications for Desflurane?
Desflurane labeling lists contraindications including: The use of Desflurane, USP, Liquid for Inhalation is contraindicated in the following conditions: Known or suspected genetic susceptibility to malignant hyperthermia [See Warnings and Precautions (5.1), Clinical Pharmacology (12.5)] . Patients in whom general anesthesia is contraindicated.. Always consult the full prescribing information and a clinician.
Note. Data for desflurane is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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