Ultane Amerinet (Inhalation)

Inhaled sevoflurane is used to cause general anesthesia (loss of consciousness) before and during surgery. It is part of the group of medicines called 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 you receive this medicine. This will help your doctor determine if the medicine is working correctly. Blood and urine tests may be required to check for any unwanted effects.

Hyperkalemia may rarely happen after receiving this medicine. Inform your doctor immediately if you experience confusion, irregular heartbeat, nausea or vomiting, numbness or tingling in your hands, feet, or legs, or trouble breathing after receiving this medicine.

This medicine may lead to malignant hyperthermia (high body temperature). Contact your doctor right away if you have a fast heartbeat, high fever, or stiff muscles.

Notify your doctor immediately if you experience 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 blood, or yellowing of your eyes and skin. These could be signs of a serious liver issue.

Reach out to your doctor right away if you notice any changes in your heart rhythm. You may feel dizzy or faint, or you may have 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. Contact your doctor immediately 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 make some people feel drowsy, tired, or weak. They can also affect coordination and thinking ability. Therefore, after receiving a general anesthetic, do not drive, operate machinery, or do anything else that could be unsafe 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 weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not shown any specific problems in children that would limit the usefulness of inhaled sevoflurane. However, children may experience more unwanted side effects, including brain or nerve issues or heart problems, which may require caution when using this medicine.

Geriatric

Studies have not shown any specific problems in the elderly that would limit the usefulness of inhaled sevoflurane.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh 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 might be used together even if an interaction could happen. In such cases, your doctor may want to adjust the dose, or other precautions might be needed. When you are receiving this medicine, it is crucial that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are selected for their potential significance and are not an exhaustive list.

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

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around mealtime or with specific foods because interactions may occur. Mixing alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine is used. Make sure to inform your doctor if you have any other medical problems, especially:

• Down syndrome—Use with caution. 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. May worsen these conditions.

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

Along with its necessary effects, a medicine may also cause some unwanted effects. Not all of these side effects may happen, but if they do, they might require medical attention.

Check with your doctor or nurse right away if any of the following side effects happen:

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 happen 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 lessen some of these side effects. Check with your health care professional if any of the following side effects continue, 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 happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for 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.