Sevoflurane is indicated for the induction and maintenance of general anesthesia in both adult and pediatric patients undergoing inpatient and outpatient surgical procedures. Each mL of inhalation liquid contains Sevoflurane USP 100% v/v.

Sevoflurane is a volatile liquid anesthetic administered via inhalation. It is used for both the induction and maintenance of general anesthesia. The minimum alveolar concentration (MAC) of Sevoflurane decreases with increasing age. Sevoflurane has low solubility in blood and tissues, allowing rapid attainment of effective alveolar concentrations for anesthesia and quick elimination after discontinuation. It produces reversible loss of consciousness, analgesia, suppression of motor activity, and reduction of autonomic reflexes, along with respiratory and cardiovascular depression. These effects are dose-dependent. Due to its low blood/gas partition coefficient (approximately 0.65), Sevoflurane enables rapid onset and recovery from anesthesia.

Route of administration: It should be administered by inhalation delivered from a vaporizer. The concentration of Sevoflurane being delivered from a vaporizer should be known. This may be accomplished by using a vaporizer calibrated specifically for Sevoflurane. Sevoflurane should be administered only by persons trained in the administration of general anaesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment and circulatory resuscitation must be immediately available. Since level of anaesthesia may be altered rapidly, only vaporizers producing predictable concentrations of Sevoflurane should be used. The administration of general anaesthesia must be individualized based on the patient’s response.

Pre-anaesthetic 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 anaesthesia 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 anaesthetic circuit.

Use in children and adolescents: The safety and efficacy of induction and maintenance of general anaesthesia with sevoflurane have been established in pediatric patients aged 0 to 18 years.

The use of epinephrine with sevoflurane may increase the risk of ventricular arrhythmias. In patients receiving calcium channel blockers, sevoflurane may cause significant hypotension. Co-administration with verapamil may impair atrioventricular conduction. The combined use of MAO inhibitors and inhalational anesthetics may increase the likelihood of hemodynamic instability during surgical procedures. Sevoflurane is compatible with intravenous anesthetics such as barbiturates and propofol, as well as with benzodiazepines and opioids commonly used in clinical practice. The anesthetic requirement of sevoflurane is reduced when used with nitrous oxide. Concurrent use with succinylcholine and other volatile anesthetics may increase the risk of malignant hyperthermia. Sevoflurane enhances both the intensity and duration of neuromuscular blockade caused by non-depolarizing muscle relaxants. Lower doses of these agents during induction may delay adequate muscle relaxation or intubation conditions. Interactions have been studied with vecuronium, pancuronium, and atracurium. Cases of hepatic dysfunction or hepatitis following sevoflurane anesthesia have also been reported. An exothermic reaction may occur when sevoflurane comes into contact with CO₂ absorbents; therefore, certain absorbents are not recommended.

Sevoflurane is contraindicated in patients with known hypersensitivity to sevoflurane, other halogenated anesthetics, or any component of the formulation. It is also contraindicated in patients with known or suspected susceptibility to malignant hyperthermia.

Common adverse effects include bradycardia, hypotension, agitation, laryngospasm, airway obstruction, breath-holding, cough, tachycardia, shivering, drowsiness, increased salivation, nausea, and vomiting.

Pregnancy: Adequate and well-controlled studies in pregnant women are lacking. The safety of sevoflurane during labor and delivery has not been established. It may cause relaxation of uterine muscles, potentially leading to uterine atony.

Lactation: It is unknown whether sevoflurane is excreted in human milk. To reduce infant exposure, breastfeeding mothers may consider discarding breast milk for 24 hours after administration. Caution is advised when used in nursing women.

Due to limited clinical experience with sevoflurane in patients with renal impairment (creatinine >1.5 mg/dL), its safety in this population has not been fully established. Prolonged use of sevoflurane at low flow rates may be associated with glycosuria and proteinuria. Patients with known sensitivity to volatile halogenated anaesthetic agents may have an increased risk of adverse reactions. Sevoflurane may cause respiratory depression, which can be enhanced by opioid premedication or other respiratory depressant agents. Cases of QT interval prolongation have been reported, and fatal cases of malignant hyperthermia have occurred. The use of inhalational anaesthetic agents has been associated with rare increases in serum potassium levels, which may lead to cardiac arrhythmias and, in some cases, death in paediatric patients during the postoperative period. Severe bradycardia and cardiac arrest, not related to underlying congenital heart disease, have been reported during induction with sevoflurane in paediatric patients with Down syndrome. During induction, heart rate should be closely monitored, and the inspired concentration of sevoflurane should be increased gradually until an adequate level of anaesthesia is achieved. Consideration should be given to the availability of anticholinergic agents and epinephrine during induction in this patient group. During maintenance of anaesthesia, increasing concentrations of sevoflurane may cause dose-dependent reductions in blood pressure. Marked hypotension or respiratory depression may be related to excessive depth of anaesthesia and can be corrected by reducing the inspired concentration of sevoflurane. Recovery from general anaesthesia should be carefully evaluated before the patient is discharged from the post-anaesthesia care unit.

In case of overdose, discontinue sevoflurane immediately, ensure airway patency, provide assisted ventilation with oxygen, and maintain cardiovascular stability.

General inhalational anesthetic

Store below 25°C in a dry place, protected from light, and keep out of reach of children.