Pronunciation:

see-voe-FLOO-rane

Brand Names:

• Sojourn
• Ultane
• Ultane Amerinet
• Ultane Novation

Dosage Forms:

• Liquid

Classifications:

Therapeutic—

Volatile Liquid

Chemical—

Haloalkane

Uses of This Medicine:

Inhaled sevoflurane is used to cause general anesthesia (loss of consciousness) before and during surgery. It belongs to the group of medicines known as general anesthetics.

This medicine is to be given only by or under the direct supervision of a doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of inhaled sevoflurane in children. However, children are more likely to have unwanted side effects, including brain or nerve problems or heart problems, which may require caution in patients receiving this medicine.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of inhaled sevoflurane in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Cisapride
• Dronedarone
• Levoketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adagrasib
• Alfentanil
• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Buprenorphine
• Bupropion
• Buserelin
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Dexmethylphenidate
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Etrasimod
• Famotidine
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Lumefantrine
• Macimorelin
• Mefloquine
• Methadone
• Methylphenidate
• Metronidazole
• Mifepristone
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moxifloxacin
• Nafarelin
• Nilotinib
• Nitrous Oxide
• Norepinephrine
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Phenobarbital
• Pimavanserin
• Pitolisant
• Ponesimod
• Posaconazole
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Ribociclib
• Rilpivirine
• Risperidone
• Ritonavir
• Selpercatinib
• Serdexmethylphenidate
• Sertindole
• Sertraline
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• St John's Wort
• Sulpiride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tolterodine
• Toremifene
• Trazodone
• Triclabendazole
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alcuronium
• Atracurium
• Doxacurium
• Metocurine
• Mivacurium
• Pancuronium
• Pipecuronium
• Rocuronium
• Tubocurarine
• Vecuronium

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Down syndrome—Use with caution. May cause serious heart problems (eg, slow heartbeat, cardiac arrest) in patients with this condition.

• Heart or blood vessel disease or
• Heart rhythm problems or
• Hyperkalemia (high potassium in the blood) or
• Hypotension (low blood pressure) or
• Hypovolemia (low blood volume) or
• Kidney disease or
• Liver disease or
• Lung or breathing problems (eg, respiratory depression)—Use with caution. May make these conditions worse.

• Hereditary problems (eg, high risk for malignant hyperthermia)—Should not be used in patients with these conditions.

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine in a hospital. You will inhale the medicine through a mask placed over your mouth and nose.

Precautions While Using This Medicine:

Your doctor will check you closely after receiving this medicine. This will allow your doctor to see if the medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Hyperkalemia may occur rarely after receiving this medicine. Tell your doctor right away if you have confusion, irregular heartbeat, nausea or vomiting, numbness or tingling in the hands, feet, or legs, or trouble breathing after receiving this medicine.

This medicine may cause malignant hyperthermia (high body temperature). Check with your doctor right away if you have fast heartbeat, high fever, or rigid muscles.

Check with your doctor right away if you have black, tarry stools, chills, dark urine, dizziness, fever, general tiredness or weakness, headache, itching, light-colored stools, loss of appetite, nausea and vomiting, upper right stomach pain, vomiting of blood, or yellow eyes and skin. These may be symptoms of a serious liver problem.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, including QT prolongation.

This medicine may cause severe bradycardia (slow heartbeat) in patients with Down syndrome. Check with your doctor right away if you or your child has chest pain or discomfort, lightheadedness, dizziness, or fainting, slow or irregular heartbeat, trouble breathing, or unusual tiredness.

General anesthetics may cause some people to feel drowsy, tired, or weak. They may also cause problems with coordination and one's ability to think. Therefore, after receiving a general anesthetic, do not drive, use machines, or do anything else that could be dangerous if you are not alert.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Blurred vision

chest pain, tightness, or discomfort

choking

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast, pounding, or irregular heartbeat or pulse

lightheadedness, dizziness, or fainting

slow or irregular heartbeat

sweating

trouble breathing

unable to speak

unusual tiredness or weakness

Less common

Low body temperature

not breathing

pale or blue lips, fingernails, or skin

weak or feeble pulse

Rare

Bleeding gums

blood in the urine or stools

body aches or pain

chills

cough

coughing up blood

decrease in frequency of urination

decrease in urine volume

difficulty in swallowing

difficulty in passing urine (dribbling)

extremely shallow or slow breathing

eye pain

fainting

general feeling of illness

headache

hoarseness

increased menstrual flow or vaginal bleeding

nausea

noisy breathing

nosebleeds

painful urination

paralysis

pinpoint red spots on skin

prolonged bleeding from cuts

red or dark brown urine

red or black, tarry stools

sore throat

stuffy or runny nose

tender, swollen glands in the neck

trouble in swallowing

unusual bleeding or bruising

voice changes

Incidence not known

Confusion as to time, place, or person

dark urine

hallucinations

high fever

hives, itching, or skin rash

holding false beliefs that cannot be changed by fact

increased blood pressure

increased thirst

light-colored stools

lower back or side pain

no blood pressure or pulse

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

restlessness

rigid muscles

seizures

shakiness

sleepiness

slow to respond

slurred speech

stomach pain, continuing

stopping of the heart

swelling of the face, fingers, lower legs

unconsciousness

unpleasant breath odor

unusual excitement, nervousness, or restlessness

upper right abdominal or stomach pain

vomiting of blood

yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Shivering

sleepiness or unusual drowsiness

Less common

Clumsiness

problems with movement

watering of the mouth

Incidence not known

Burning, dry, or itching eyes

change in vision

discharge, excessive tearing

hiccups

impaired vision

lack or loss of strength

redness, pain, swelling of the eye, eyelid, or inner lining of eyelid

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.