ULTANE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ULTANE (ULTANE).
Sevoflurane is a volatile general anesthetic that enhances inhibitory neurotransmission via GABA-A and glycine receptors, and inhibits excitatory neurotransmission via NMDA and nicotinic acetylcholine receptors, producing anesthesia, amnesia, and muscle relaxation.
| Metabolism | Approximately 5% of sevoflurane is metabolized by cytochrome P450 (CYP2E1) to hexafluoroisopropanol (HFIP), carbon dioxide, and inorganic fluoride. |
| Excretion | Renal excretion of inorganic fluoride metabolites accounts for >95% of elimination; <5% excreted unchanged in urine. |
| Half-life | Terminal elimination half-life of inorganic fluoride is approximately 2-5 hours (mean 3.0 h) in adults; context: prolonged with obesity or renal impairment. |
| Protein binding | Minimal binding to plasma proteins; <5% bound. |
| Volume of Distribution | Volume of distribution at steady state: 0.5-1.5 L/kg (mean 1.0 L/kg); large Vd indicates extensive tissue distribution. |
| Bioavailability | Inhalation: ~100% bioavailable; no oral route. |
| Onset of Action | Inhalation: onset within 30-60 seconds; peak effect in 2-5 minutes. |
| Duration of Action | Duration of anesthesia: 5-10 minutes after discontinuation of inspired concentration; rapid recovery due to low blood-gas partition coefficient (0.65). |
Inhalation: Induction, 0.5-3% sevoflurane in oxygen or oxygen/nitrous oxide; maintenance, 1.5-3% sevoflurane with or without nitrous oxide.
| Dosage form | LIQUID |
| Renal impairment | No dose adjustment required for GFR ≥30 mL/min; use with caution in GFR <30 mL/min due to potential for elevated fluoride concentrations, but no specific dose adjustment recommended. |
| Liver impairment | No dose adjustment required for Child-Pugh A or B; use with caution in Child-Pugh C, but no specific dose adjustment recommended. |
| Pediatric use | Induction: 2-4% sevoflurane in oxygen or oxygen/nitrous oxide, up to 8% for mask induction; maintenance: 1.5-3% with or without nitrous oxide. |
| Geriatric use | Elderly patients are more sensitive to sevoflurane; use lower doses for induction and maintenance, typical maintenance 0.5-2% sevoflurane. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ULTANE (ULTANE).
| Breastfeeding | Sevoflurane is excreted into breast milk in low quantities. The milk-to-plasma (M/P) ratio has not been specifically determined for sevoflurane, but based on physicochemical properties, it is expected to be low. Due to rapid clearance and low oral bioavailability, the risk to a nursing infant is considered minimal after a single anesthetic dose. However, it is recommended to express and discard breast milk for 24 hours after anesthesia to minimize infant exposure. |
| Teratogenic Risk | Sevoflurane (ULTANE) is classified as FDA Pregnancy Category B. Animal studies have not demonstrated teratogenic or fetotoxic effects at clinically relevant doses. In humans, limited data do not indicate an increased risk of major malformations with first-trimester exposure. However, use during the second and third trimesters may cause transient neonatal depression, including hypotonia and respiratory depression, due to placental transfer. Prolonged or repeated exposure should be avoided, especially during organogenesis, as with all volatile anesthetics. |
■ FDA Black Box Warning
None
| Serious Effects |
["Known or suspected susceptibility to malignant hyperthermia","Known sensitivity to sevoflurane or other halogenated agents"]
| Precautions | ["Risk of malignant hyperthermia; may cause respiratory depression; caution in patients with preexisting respiratory or cardiovascular disease; monitor for hepatotoxicity; use with caution in patients with renal impairment (elevated fluoride levels); sevoflurane may cause QT prolongation"] |
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| Fetal Monitoring | Continuous fetal heart rate monitoring during maternal anesthesia is recommended when gestational age >20 weeks, particularly during non-obstetric surgery. Maternal vital signs, including blood pressure, heart rate, oxygen saturation, and end-tidal CO2, must be monitored closely. Inhaled anesthetic agents, including sevoflurane, can cause uterine relaxation and increase the risk of maternal hypotension, which may compromise placental perfusion. Therefore, careful attention to maternal fluid balance and avoidance of excessive doses is essential. |
| Fertility Effects | There is no evidence that sevoflurane, when administered at standard anesthetic doses, adversely affects human fertility. Animal studies have not shown impaired fertility or reproductive performance. Occupational exposure to volatile anesthetics, including sevoflurane, has been associated with increased risks of spontaneous abortion in female healthcare personnel, but this risk is not considered significant with proper scavenging and low-level exposure. |