Ultane Novation (Inhalation)

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.

Your doctor will monitor you closely after receiving this medicine. This will help your doctor determine if the medicine is working correctly. Blood and urine tests may be needed to check for side effects.

Hyperkalemia may occur rarely after receiving this medicine. Tell your doctor immediately if you experience 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). Contact your doctor right away if you have a fast heartbeat, high fever, or stiff muscles.

Seek medical attention 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 yellowing of the eyes and skin. These may be signs of a serious liver issue.

Contact your doctor immediately if you notice any changes in your heart rhythm. You may feel dizzy or faint, or you may experience a fast, pounding, or uneven heartbeat. Make sure your doctor is aware if you have a history of heart rhythm issues, 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 experiences chest pain or discomfort, lightheadedness, dizziness, fainting, slow or irregular heartbeat, trouble breathing, or unusual tiredness.

General anesthetics may cause some individuals to feel drowsy, tired, or weak. They may also lead to coordination issues and affect thinking ability. Therefore, after receiving a general anesthetic, do not drive, operate machinery, or engage in any activities that could be dangerous if you are not alert.

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

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine versus the benefits it will provide. For this medicine, the following should be taken into account:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know if you have any other types of allergies, like to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Research has not shown any specific problems in children that would limit the use of inhaled sevoflurane. However, children might be more likely to experience unwanted side effects, including issues with the brain, nerves, or heart, which may require careful monitoring.

Geriatric

Research has not shown any specific problems in the elderly that would limit the use of inhaled sevoflurane.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with caution. If you are receiving this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen because of their potential importance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or adjust other medicines you are taking.

• 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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both 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 increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both medicines.

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around meal times or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Down syndrome—Use with caution. It may cause serious heart problems (e.g., 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 (e.g., respiratory depression)—Use with caution. It may worsen these conditions.

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

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.

In the U.S.

• Sojourn
• Ultane
• Ultane Amerinet
• Ultane Novation

Available Dosage Forms:

• Liquid

Therapeutic Class: Volatile Liquid

Chemical Class: Haloalkane

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.