pharmacopeia
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/api/v1/drug/sevoflurane

Mechanism of action

Sourced from openFDA

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

GABA AGlycine

Indications

Sourced from openFDA
  • Sevoflurane, USP is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. Sevoflurane, USP should be administered only by persons trained in the administration of general anesthesia.

Contraindications

Sourced from openFDA
  • • Known or suspected genetic susceptibility to malignant hyperthermia. (see WARNINGS - Malignant Hyperthermia , CLINICAL PHARMACOLOGY - Pharmacogenomics ).contraindicated

Dosage & administration

Sourced from openFDA

DOSAGE & ADMINISTRATION The concentration of sevoflurane being delivered from a vaporizer should be known. This may be accomplished by using a vaporizer calibrated specifically for sevoflurane. The administration of general anesthesia must be individualized based on the patient's response. Replacement of Desiccated CO 2 Absorbents When a clinician suspects that the CO 2 absorbent may be desiccated, it should be replaced. The exothermic reaction that occurs with sevoflurane and CO 2 absorbents is increased when the CO 2 absorbent becomes desiccated, such as after an extended period of dry gas flow through the CO 2 absorbent canisters (see PRECAUTIONS ). Pre-anesthetic Medication No specific premedication is either indicated or contraindicated with sevoflurane. The decision as to whether or not to premedicate and the choice of premedication is left to the discretion of the anesthesiologist. Induction Sevoflurane has a nonpungent odor and does not cause respiratory irritability; it is suitable for mask induction in pediatrics and adults. Maintenance Surgical levels of anesthesia can usually be achieved with concentrations of 0.5 - 3% sevoflurane with or without the concomitant use of nitrous oxide. Sevoflurane can be administered with any type of anesthesia circuit. Table 9.

Warnings & precautions

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Risk of Renal Injury Although data from controlled clinical studies at low flow rates are limited, findings taken from patient and animal studies suggest that there is a potential for renal injury which is presumed due to Compound A. Animal and human studies demonstrate that sevoflurane administered for more than 2 MAC·hours and at fresh gas flow rates of < 2 L/min may be associated with proteinuria and glycosuria. While a level of Compound A exposure at which clinical nephrotoxicity might be expected to occur has not been established, it is prudent to consider all of the factors leading to Compound A exposure in humans, especially duration of exposure, fresh gas flow rate, and concentration of sevoflurane. During sevoflurane anesthesia the clinician should adjust inspired concentration and fresh gas flow rate to minimize exposure to Compound A. To minimize exposure to Compound A, sevoflurane exposure should not exceed 2 MAC·hours at flow rates of 1 to < 2 L/min. Fresh gas flow rates < 1 L/min are not recommended. Because clinical experience in administering sevoflurane to patients with renal insufficiency (creatinine >1.5 mg/dL) is limited, its safety in these patients has not been established. Sevoflurane may be associated with glycosuria and proteinuria when used for long procedures at low flow rates. The safety of low flow sevoflurane on renal function was evaluated in patients with normal preoperative renal function. One study compared sevoflurane (N = 98) to an active control (N = 90) administered for ≥ 2 hours at a fresh gas flow rate of ≤ 1 Liter/minute.

Adverse reactions

Sourced from openFDA

Clinical Trials Experience Adverse events are derived from controlled clinical studies conducted in the United States, Canada, and Europe. The reference drugs were isoflurane, enflurane, and propofol in adults and halothane in pediatric patients. 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 5182 patients enrolled in the clinical studies, 2906 were exposed to sevoflurane, including 118 adults and 507 pediatric patients who underwent mask induction. Each patient was counted once for each type of adverse event. Adverse events reported in patients in clinical studies and considered to be possibly or probably related to sevoflurane are presented within each body system in order of decreasing frequency in the following listings. One case of malignant hyperthermia was reported in pre-registration clinical studies.

Use in specific populations

Sourced from openFDA

Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women. In animal reproduction studies, reduced fetal weights were noted following exposure to 1 MAC sevoflurane for three hours a day during organogenesis. Developmental and reproductive toxicity studies of sevoflurane in animals in the presence of strong alkalies (i.e., degradation of sevoflurane and production of Compound A) have not been conducted. 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. 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 2-4% and 15-20%, respectively.

Overdosage

Sourced from openFDA

In the event of overdosage, or what may appear to be overdosage, the following action should be taken: discontinue administration of sevoflurane, maintain a patent airway, initiate assisted or controlled ventilation with oxygen, and maintain adequate cardiovascular function.

Approval history

Sourced from openFDA
  • Jun 7, 1995NDANDA020478Abbvie
  • Jul 2, 2002ANDAANDA075895Baxter Hlthcare
  • May 2, 2007ANDAANDA077867Piramal Critical
  • Nov 19, 2007ANDAANDA078650Halocarbon Prods
  • Nov 3, 2015ANDAANDA203793Shanghai Hengrui
  • Aug 18, 2023ANDAANDA214382Shandong

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.
7,843 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. 1Hypotension5787.4%
  2. 2Drug Interaction4806.1%
  3. 3Cardiac Arrest4175.3%
  4. 4Bradycardia3764.8%
  5. 5Drug Ineffective2893.7%
  6. 6Hyperthermia Malignant2803.6%
  7. 7Anaesthetic Complication Neurological2753.5%
  8. 8Tachycardia2553.3%
  9. 9Serotonin Syndrome2523.2%
  10. 10Anaphylactic Shock2393.0%
  11. 11Anaphylactic Reaction2323.0%
  12. 12Foetal Exposure During Pregnancy2192.8%
  13. 13Oxygen Saturation Decreased2152.7%
  14. 14Acute Kidney Injury2142.7%
  15. 15Off Label Use2122.7%

Literature

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Recent PubMed references pinned to Sevoflurane 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 1,214 ClinicalTrials.gov registrations naming Sevoflurane 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 Sevoflurane. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

Frequently asked questions

How does Sevoflurane work?
Mechanism-of-action classes: GABA A Modulators; Glycine Agonists.
What is Sevoflurane used for?
According to FDA labeling, Sevoflurane carries indications including: Sevoflurane, USP is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. Sevoflurane, USP should be administered only by persons trained in the administration of general anesthesia.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Sevoflurane?
Sevoflurane is classified as Halogenated hydrocarbons, General Anesthetic, GABA A Modulators, Glycine Agonists, Decreased Medullary Respiratory Drive, General Anesthesia, Vasodilation.
What are the brand names for Sevoflurane?
Sevoflurane is marketed under brand names including Petrem, SevoFlo, Sevospire, Sojourn, Ultane.
What are the contraindications for Sevoflurane?
Sevoflurane labeling lists contraindications including: • Known or suspected genetic susceptibility to malignant hyperthermia. (see WARNINGS - Malignant Hyperthermia , CLINICAL PHARMACOLOGY - Pharmacogenomics ).. Always consult the full prescribing information and a clinician.
Note. Data for sevoflurane 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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