Sevorane Solution for Inhalation

Sevorane is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. Each ml inhalation liquid contains Sevorane USP 100% V/V.

Sevoflurane is a preparation of Sevoflurane, a volatile liquid for inhalation. Sevoflurane is an inhalational anesthetic agent for use in induction and maintenance of general anesthesia. The minimum alveolar concentration (MAC) of Sevoflurane decreases with age. Sevoflurane is weakly soluble in blood and tissue, resulting in the rapid achievement of a sufficient alveolar concentration to produce anesthesia and a subsequent rapid elimination until cessation of anesthesia. Sevoflurane produces loss of consciousness, reversible abolition of pain and motor activity, diminution of autonomic reflexes, respiratory and cardiovascular depression. These effects are dose-dependent. Sevoflurane has a low blood/gas partition coefficient (0.65) leading to a rapid 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 anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment and circulatory resuscitation must be immediately available. Since level of anesthesia may be altered rapidly, only vaporizers producing predictable concentrations of Sevoflurane should be used. The administration of general anesthesia must be individualized based on the patient's response.

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.

Use in children and adolescents: The safety and efficacy of induction and maintenance of general anesthesia with sevoflurane have been established in pediatric patients aged 1 to 18 years

Epinephrine administered with Sevorane may increase the risk of ventricular arrhythmias. Sevorane may lead to marked hypotension in patients treated with calcium antagonists. Impairment of atrioventricular conduction may be observed when verapamil and Sevorane are administered concomitantly. Concomitant use of MAO inhibitors and inhalational anesthetics may increase the risk of hemodynamic instability during surgery or medical procedures. Sevorane administration is compatible with barbiturates, propofol and other commonly used intravenous anesthetics. Sevorane administration is compatible with benzodiazepines and opioids as commonly used in surgical practice. The anesthetic requirement for Sevorane is decreased when administered in combination with nitrous oxide. The risk of developing malignant hyperthermia increases with the concomitant administration of succinylcholine and volatile anesthetic agents. Sevorane increases both the intensity and duration of neuromuscular blockade induced by nondepolarizing muscle relaxants. Reduced doses of neuromuscular blocking agents during induction of anesthesia may result in delayed onset of conditions suitable for endotracheal intubation or inadequate muscle relaxation. Among available nondepolarizing agents, only vecuronium, pancuronium and atracurium interactions have been studied during Sevorane anesthesia. Cases of mild, moderate and severe hepatic dysfunction or hepatitis after anesthesia with Sevorane have been reported. An exothermic reaction occurs when Sevorane is exposed to CO2 absorbents. KOFI containing CO2 absorbents are not recommended for use with Sevorane.

It is contraindicated in patients with known hypersensitivity to sevoflurane or other halogenated inhalational anesthetics or any other components of this product. It is also contraindicated in patients with known or suspected genetic susceptibility to malignant hyperthermia.

The most common side effects are bradycardia, hypotension, agitation, laryngospasm, airway obstruction, breathholding, cough increased, tachycardia, shivering, somnolence, increased salivation, nausea and vomiting.

Pregnancy: There are no adequate and well-controlled studies in pregnant women. The safety of sevoflurane in labor and delivery has not been demonstrated. Sevoflurane can cause uterine smooth muscle relaxation and may contribute to uterine atony.

Lactation: It is not known whether sevoflurane or its metabolites are present in human milk. To minimize infant exposure to sevoflurane or its metabolites, a nursing mother may temporarily pump and discard breast milk produced during the first 24 hours after administration of sevoflurane. Exercise caution when administering sevoflurane to a nursing mother.

Because clinical experience in administering Sevorane to patients with renal insufficiency (creatinine >1.5 mg/dl) is limited, its safety in these patients has not been established. Sevorane may be associated with glycosuria and proteinuria when used for long procedures at low flow rates. Sevorane may present an increased risk in patients with known sensitivity to volatile halogenated anesthetic agents. Sevorane may cause respiratory depression, which may be augmented by opioid premedication or other agents causing respiratory depression. Reports of QT prolongation have been received. Fatal outcomes of malignant hyperthermia have been reported. 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. Episodes of severe bradycardia and cardiac arrest, not related to underlying congenital heart disease, have been reported during anesthesia induction with Sevorane in pediatric patients with Down syndrome. During induction, closely monitor heart rate and consider incrementally increasing the inspired Sevorane concentration until a suitable level of anesthesia is achieved. Consider having an anticholinergic and epinephrine available when administering Sevorane for induction in this patient population. During the maintenance of anesthesia, increasing the concentration of Sevorane produces dose dependent decreases in blood pressure. Excessive decreases in blood pressure or respiratory depression may be related to depth of anesthesia and may be corrected by decreasing the inspired concentration of Sevorane. The recovery from general anesthesia should be assessed carefully before a patient is discharged from the post-anesthesia care unit.

In the event of overdosage, discontinue administration of Sevorane, maintain a patent airway, initiate assisted or controlled ventilation with oxygen and maintain adequate cardiovascular function.

General (Inhalation) anesthetics

Store below 25°C in a dry place, protected from light. Keep away from the reach of children.