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). |
| Molecular Weight | 200.05 |
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 | Sevoflurane is generally avoided in the first trimester unless necessary. It is not known to be a major teratogen, but elective surgery should be deferred. There is limited human data; animal studies show no consistent teratogenic effects at subanesthetic doses. |
| 2nd trimester | Use with caution. Sevoflurane is not considered a significant teratogen, but non-urgent procedures are often postponed. There is a risk of spontaneous abortion with any anesthetic. |
| 3rd trimester | Use with caution near term. Sevoflurane may cause uterine relaxation and potential fetal depression. There is a risk of neonatal respiratory depression if administered just before delivery. Consider neonatal resuscitation availability. |
Clinical note
Comprehensive clinical and safety monograph for ULTANE (ULTANE).
| Placental transfer | Sevoflurane crosses the placenta rapidly due to its low molecular weight and high lipid solubility. Fetal concentrations approach maternal levels within 10-15 minutes of induction. The umbilical vein/maternal artery ratio ranges from 0.5 to 0.8. |
■ FDA Black Box Warning
None
| Serious Effects |
Known or suspected susceptibility to malignant hyperthermiaKnown or suspected history of malignant hyperthermiaHypersensitivity to sevoflurane or other halogenated anesthetics
| 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 |
| Food/Dietary | No specific food interactions with sevoflurane. However, patients should adhere to preoperative fasting guidelines (typically 6-8 hours for solids, 2 hours for clear liquids) to reduce aspiration risk during anesthesia. |
Loading safety data…
| Breastfeeding |
| Sevoflurane is rapidly eliminated from the body after anesthesia; levels in breast milk are minimal and not expected to cause adverse effects in the infant. The American Academy of Pediatrics considers it compatible with breastfeeding, but it is advisable to wait until the mother is fully awake and has cleared the drug (typically 12-24 hours after anesthesia) before resuming breastfeeding to minimize any potential exposure. Clinical judgment is advised. |
| Lactation Rating | L2 (Probably Compatible) |
| 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. |
| 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. |
| Clinical Pearls | ULTANE (sevoflurane) is a volatile anesthetic with low blood-gas solubility, facilitating rapid induction and emergence. It is associated with a risk of malignant hyperthermia; have dantrolene available. Sevoflurane can degrade in carbon dioxide absorbents to compound A, which may cause renal injury; use fresh gas flows ≥2 L/min to minimize this risk. Monitor end-tidal sevoflurane concentration closely, as hypotension and respiratory depression are dose-dependent. |
| Patient Advice | You will receive this medication only under the supervision of an anesthesia professional · Do not eat or drink before surgery as instructed by your doctor · You may experience dizziness or drowsiness after waking; do not drive for 24 hours · Report any history of kidney disease or adverse reactions to anesthesia · Inform your doctor if you are pregnant or breastfeeding · You will be monitored throughout the procedure for vital signs and safety |