Sojourn250 mg/250 ml

Sojourn is a volatile halogenated inhalational anesthetic agent used exclusively in the hospital/operating-room setting under the care of qualified anesthesia personnel.

Established / FDA-approved uses

• Induction of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery, either alone or in combination with other anesthetic agents.
• Maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery.

Guideline-supported / adjunct uses

• Preferred agent for inhalational (mask) induction in pediatric patients because of its non-pungent odor and low airway irritability.
• Used as part of balanced anesthesia together with nitrous oxide, oxygen, opioids, and neuromuscular blocking agents.

Sojourn is not indicated for any use outside the perioperative/procedural anesthesia setting and is never self-administered by patients.

Each bottle contains 100% Sevoflurane as a clear, colorless, non-flammable liquid intended for administration by vaporization through a vaporizer specifically calibrated for Sevoflurane. It contains no additives or preservatives.

Sojourn is a fluorinated methyl isopropyl ether, a halogenated volatile liquid general anesthetic that is vaporized and inhaled to induce and maintain general anesthesia. It has a low blood/gas solubility coefficient, which allows rapid changes in the depth of anesthesia and rapid emergence after discontinuation.

It is supplied as a liquid for use only with a vaporizer specifically calibrated for Sojourn; it is not given by injection or by mouth.

Sojourn belongs to the class of general anesthetics — inhalational (volatile halogenated ether anesthetics).

Mechanism of action

The precise mechanism by which Sevoflurane produces general anesthesia, like other volatile anesthetics, is not fully established. It is believed to enhance inhibitory neurotransmission (potentiating GABA-A receptor-mediated chloride currents and glycine receptor activity) while inhibiting excitatory neurotransmission (including NMDA and nicotinic acetylcholine receptors) in the central nervous system, producing dose-dependent depression of CNS activity that results in loss of consciousness, amnesia, and immobility to noxious stimuli.

Pharmacokinetics

• Low blood/gas partition coefficient (~0.65–0.69) gives rapid onset of and emergence from anesthesia.
• Approximately 5% is metabolized in the liver via cytochrome P450 2E1, producing hexafluoroisopropanol and inorganic fluoride; the rest is eliminated unchanged through the lungs.
• Minimum alveolar concentration (MAC) required decreases with increasing age and with concurrent use of nitrous oxide or opioids.

Sojourn is administered by inhalation only, via a vaporizer specifically calibrated for Sojourn, connected to an anesthesia breathing circuit with oxygen or an oxygen/nitrous oxide mixture. It must never be given by any other route.

Use with a fresh gas flow adequate to avoid excessive accumulation of degradation products in the breathing circuit (see Precautions and Warnings regarding Compound A).

• Nitrous oxide and opioids: reduce the MAC (dose requirement) of Sojourn; concentrations must be reduced accordingly to avoid excessive anesthetic depth.
• Neuromuscular blocking agents: Sojourn potentiates and prolongs the effect of non-depolarizing neuromuscular blockers; doses of these agents should be reduced.
• CO2 absorbents (especially desiccated barium hydroxide lime): can degrade Sojourn, forming Compound A and, rarely, carbon monoxide; risk increases with low fresh-gas flow and desiccated absorbent (see Precautions and Warnings).
• Other CNS/cardiac depressants (e.g., benzodiazepines, other anesthetics): additive CNS and cardiorespiratory depression.
• QT-prolonging drugs: additive risk of QT interval prolongation; use with caution in combination.

Common

• Nausea and vomiting
• Emergence agitation/delirium (particularly in young children)
• Hypotension or, less often, bradycardia/tachycardia
• Cough, breath-holding, or laryngospasm during induction
• Shivering, headache, dizziness on emergence

Serious (less common)

• Malignant hyperthermia — see Contraindications and Precautions and Warnings.
• Dose-dependent respiratory depression and cardiovascular depression (hypotension, arrhythmia).
• Rare hepatic dysfunction, including isolated reports of hepatitis/hepatic failure.
• QT interval prolongation, rarely associated with arrhythmia.

Pregnancy: Sojourn should be used in pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; it is widely used for general anesthesia during cesarean delivery under direct medical supervision, but a physician should always weigh the indication carefully. Consult a physician before use in pregnancy.

Lactation: Data on transfer of Sojourn into breast milk are limited. Because of its rapid pulmonary elimination and short half-life, clinically significant exposure of the infant through milk is considered unlikely once the mother has recovered from anesthesia, but a physician should be consulted regarding timing of breastfeeding resumption after anesthesia with Sojourn.

• Specialist administration only: Sojourn must be given only by persons trained in general anesthesia, with immediate availability of airway management, artificial ventilation, oxygen enrichment, and circulatory resuscitation equipment.
• Malignant hyperthermia: be prepared to treat with dantrolene sodium and to discontinue the anesthetic immediately if signs (unexplained tachycardia, tachypnea, muscle rigidity, rising temperature, hypercarbia) occur.
• Respiratory and cardiovascular depression: dose-dependent; monitor ventilation, oxygenation, and hemodynamics continuously.
• Compound A formation: use of low fresh-gas flow (<2 L/min) with CO2 absorbents, particularly desiccated absorbents, can generate Compound A, which has caused nephrotoxicity in animal studies; a theoretical/debated concern in humans. Use adequate fresh gas flow and avoid prolonged low-flow anesthesia, especially in patients with pre-existing renal impairment.
• QT prolongation: use caution in patients with or at risk of QT prolongation, or receiving other QT-prolonging drugs.
• Hepatic impairment: rare hepatotoxicity reported; use caution, particularly with repeated exposure.
• Emergence agitation: more frequent in pediatric patients; monitor closely during recovery.
• Not for use outside the anesthesia setting and never for self-administration.

Overdose (excessive anesthetic depth) with Sojourn presents as profound respiratory depression and/or circulatory depression (severe hypotension, bradycardia, or cardiac arrest). This is a medical emergency requiring immediate action by the anesthesia team: discontinue Sojourn administration immediately, secure and maintain the airway, institute assisted or controlled ventilation with 100% oxygen, and support the circulation as needed. Because Sojourn is administered only in a monitored clinical setting, any suspected overdose should prompt immediate medical intervention/emergency response rather than any home management.

Store at room temperature (below 30°C) in the tightly closed original container, protected from light and excessive heat. No special preservative or refrigeration is required. Keep out of reach of children and unauthorized personnel; use only in a properly equipped anesthesia facility.

Pediatric patients

Sojourn is approved for induction and maintenance of general anesthesia in pediatric patients and is a preferred agent for mask induction because of its non-pungent odor. MAC requirement is age-dependent (higher in infants and young children than in adults) and must be titrated accordingly; emergence agitation is more common in this group.

Elderly patients

MAC requirement decreases with age; lower concentrations are typically needed to achieve the desired anesthetic depth in elderly patients.

Hepatic impairment

Use with caution because of rare reports of hepatotoxicity; monitor accordingly, particularly with repeated exposures.

Renal impairment

Use with caution regarding Compound A formation; avoid prolonged low fresh-gas-flow techniques (see Precautions and Warnings).

Sojourn is used only for the duration of the surgical, obstetric, or diagnostic procedure requiring general anesthesia, as determined and continuously titrated by the anesthesia provider. It is not intended for continuous or repeated administration outside the perioperative setting.

General anesthetics (inhalational); halogenated ether anesthetics.

Sevoflurane is believed to produce general anesthesia by enhancing inhibitory neurotransmission (via GABA-A and glycine receptors) and inhibiting excitatory neurotransmission (via NMDA and nicotinic acetylcholine receptors) in the central nervous system. This results in dose-dependent, reversible depression of CNS activity, producing unconsciousness, amnesia, and immobility in response to noxious (surgical) stimuli.

B

Sojourn is approved for induction and maintenance of general anesthesia in pediatric patients (inpatient and outpatient surgery) and is commonly preferred for inhalational mask induction because of its low airway irritability and non-pungent odor. Age-appropriate MAC concentrations must be used, as pediatric patients — especially infants — require higher concentrations than adults. Emergence agitation/delirium is more frequent in young children and should be anticipated and monitored during recovery.