Suprane

What is Suprane used for?

Suprane is a prescription medicine that is used to put you to sleep for surgery. It is used to cause sleep during a procedure.

Description

SUPRANE (desflurane, USP), a nonflammable liquid administered via vaporizer, is a general inhalation anesthetic. It is (±)1,2,2,2-tetrafluoroethyl difluoromethyl ether:

Some physical constants are:

Partition coefficients at 37°C:

Mean Component/Gas Partition Coefficients:

SUPRANE is nonflammable as defined by the requirements of International Electrotechnical Commission 601-2-13.

SUPRANE is a colorless, volatile liquid below 22.8°C. Data indicate that SUPRANE is stable when stored under normal room lighting conditions according to instructions.

SUPRANE is chemically stable. The only known degradation reaction is through prolonged direct contact with soda lime producing low levels of fluoroform (CHF3). The amount of CHF3 obtained is similar to that produced with MAC-equivalent doses of isoflurane. No discernible degradation occurs in the presence of strong acids.

SUPRANE does not corrode stainless steel, brass, aluminum, anodized aluminum, nickel plated brass, copper, or beryllium.

Before taking Suprane, tell your doctor:

• If you are allergic to Suprane; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you or a family member have had muscle problems or a certain health problem called malignant hyperthermia. Signs of malignant hyperthermia include a very high fever, a fast heartbeat, muscle stiffness, and trouble breathing.
• If you have had liver problems after getting an anesthetic.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Suprane with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Suprane?

For all patients taking Suprane:

• Tell all of your health care providers that you take Suprane. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until the effects of Suprane wear off and you feel fully awake.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• High potassium levels have rarely happened with inhaled anesthesia drugs. This has led to abnormal heartbeats and death in some children after surgery. The chance may be raised in people with certain muscle problems. Talk with the doctor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Studies in young animals and children have shown that frequent or long-term use of anesthesia drugs or drugs used for sleep in children younger than 3 years of age may lead to long-term brain problems. This may also happen in unborn babies if the mother uses Suprane during the third trimester of pregnancy. Talk with the doctor.
• If you are 65 or older, use Suprane with care. You could have more side effects.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

Children:

• Use with care in children. Talk with the doctor.

How is Suprane best taken?

Use Suprane as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a liquid for breathing into the lungs by a doctor.
• Other drugs may be given before Suprane to help avoid side effects.

What do I do if I miss a dose?

• This medicine will be given on an as needed basis in a healthcare setting.

What are the side effects of Suprane that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a high potassium level like a heartbeat that does not feel normal; change in thinking clearly and with logic; feeling weak, lightheaded, or dizzy; feel like passing out; numbness or tingling; or shortness of breath.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Trouble breathing, slow breathing, or shallow breathing.
• Slow heartbeat.
• Muscle stiffness.
• Change in color of skin to a bluish color like on the lips, nail beds, fingers, or toes.
• Not able to pass urine or change in how much urine is passed.
• Feeling agitated.
• This medicine may cause a very bad and sometimes deadly problem called malignant hyperthermia. Call your doctor right away if you have a fast heartbeat, fast breathing, fever, or spasm or stiffness of the jaw muscles.
• A type of abnormal heartbeat (prolonged QT interval) has happened with Suprane. Sometimes, this has led to another type of unsafe abnormal heartbeat (torsades de pointes). Call your doctor right away if you have a fast or abnormal heartbeat, or if you pass out.
• Very bad and sometimes deadly liver problems have happened with Suprane. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

What are some other side effects of Suprane?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Headache.
• Cough.
• Drooling.
• Throat irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Suprane?

• If you need to store Suprane at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL