Sevoflurane

Sevoflurane
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

Sevoflurane is a general anesthetic that is FDA approved for the {{{indicationType}}} of general anesthesia. Common adverse reactions include cardiovascular: bradyarrhythmia (3% to 5% ), hypotension (4% to 11% ), gastrointestinal: nausea (25% ), vomiting (18% ), neurologic: somnolence (9% ), psychiatric: agitation (6% to 15%), respiratory: cough (5% to 11% ), interrupted breathing (2% to 6% ), other: shivering (6% ).

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• General anesthesia: 0.5% to 3% concentration with or without concomitant use of nitrous oxide

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• General anesthesia: 0.5% to 3% concentration with or without concomitant use of nitrous oxide

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

Sevoflurane can cause malignant hyperthermia. It should not be used in patients with known sensitivity to sevoflurane or to other halogenated agents nor in patients with known or suspected susceptibility to malignant hyperthermia.

Warnings

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. Per study defined criteria (Hou et al.) one patient in the sevoflurane group developed elevations of creatinine, in addition to glycosuria and proteinuria. This patient received sevoflurane at fresh gas flow rates of ≤ 800 mL/minute. Using these same criteria, there were no patients in the active control group who developed treatment emergent elevations in serum creatinine.

Sevoflurane may present an increased risk in patients with known sensitivity to volatile halogenated anesthetic agents. KOH containing CO2 absorbents are not recommended for use with sevoflurane.

Reports of QT prolongation, associated with torsade de pointes (in exceptional cases, fatal), have been received. Caution should be exercised when administering sevoflurane to susceptible patients (e.g. patients with congenital Long QT Syndrome or patients taking drugs that can prolong the QT interval).

Malignant Hyperthermia

In susceptible individuals, potent inhalation anesthetic agents, including sevoflurane, may trigger a skeletal muscle hypermetabolic state leading to high oxygen demand and the clinical syndrome known as malignant hyperthermia. Sevoflurane can induce malignant hyperthermia in genetically susceptible individuals, such as those with certain inherited ryanodine receptor mutations. 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.

In clinical trials, one case of malignant hyperthermia was reported. In addition, there have been postmarketing reports of malignant hyperthermia. Some of these cases have been fatal.

Treatment of malignant hyperthermia includes discontinuation of triggering agents (e.g., sevoflurane), administration of intravenous dantrolene sodium (consult prescribing information for intravenous dantrolene sodium for additional information on patient management), and application of supportive therapy. Supportive therapy may include efforts to restore body temperature, respiratory and circulatory support as indicated, and management of electrolyte-fluid-acid-base abnormalities. Renal failure may appear later, and urine flow should be monitored and sustained if possible.

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 creatine 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.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Sevoflurane Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Sevoflurane Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Sevoflurane Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

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

Monitoring

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

IV Compatibility

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

Overdosage

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

Pharmacology

Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

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

Storage

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

Precautions with Alcohol

Alcohol-Sevoflurane 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 Sevoflurane Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Sevoflurane 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.