Uses of Levalbuterol Inhalation Solution:

• It is used to open the airways in lung diseases where spasm may cause breathing problems.

What do I need to tell my doctor BEFORE I take Levalbuterol Inhalation Solution?

• If you have an allergy to levalbuterol, albuterol, or any other part of levalbuterol inhalation solution.
• If you are allergic to levalbuterol inhalation solution; any part of levalbuterol inhalation solution; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are using another drug like this one. If you are not sure, ask your doctor or pharmacist.
• If you are taking inhaled epinephrine.

This is not a list of all drugs or health problems that interact with levalbuterol inhalation solution.

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 levalbuterol inhalation solution 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 Levalbuterol Inhalation Solution?

• Tell all of your health care providers that you take levalbuterol inhalation solution. This includes your doctors, nurses, pharmacists, and dentists.
• Do not run out of levalbuterol inhalation solution.
• Do not take more of levalbuterol inhalation solution or use it more often than you have been told. Deaths have happened when too much of levalbuterol inhalation solution was taken. Talk with your doctor.
• Call your doctor right away if your normal dose does not work well, if your signs get worse, or if you need to use levalbuterol inhalation solution more often than normal.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• If you are 65 or older, use levalbuterol inhalation solution with care. You could have more side effects.
• This medicine is not approved for use in children younger than 6 years of age. The chance of side effects may be raised in children younger than 6 years of age. Talk with the doctor.
• 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.

How is this medicine (Levalbuterol Inhalation Solution) best taken?

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

• Keep out of your eyes.
• If you are using more than 1 inhaled drug, ask the doctor which drug to use first.
• For breathing in only as a liquid (solution) by a special machine (nebulizer) into the lungs.
• Only use the type of nebulizer that you have been told to use. If you are not sure what type of nebulizer to use, talk with the doctor.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Some of these products must be mixed with saline before use. Check with your doctor or pharmacist to see if your product needs to be mixed.
• Do not mix other drugs in nebulizer.

What do I do if I miss a dose?

• If you use levalbuterol inhalation solution on a regular basis, use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.
• Many times levalbuterol inhalation solution is used on an as needed basis. Do not use more often than told by the doctor.

What are some side effects that I need to call my doctor about right away?

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 high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• Chest pain or pressure or a fast heartbeat.
• Very nervous and excitable.
• This medicine may sometimes cause severe breathing problems. This may be life-threatening. When this happens with an inhaler or with liquid for breathing in, most of the time it happens right after a dose and after the first use of a new canister or vial of levalbuterol inhalation solution. If you have trouble breathing, breathing that is worse, wheezing, or coughing, get medical help right away.

What are some other side effects of Levalbuterol Inhalation Solution?

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:

• Feeling nervous and excitable.
• Headache.
• Dizziness.
• Runny nose.
• Shakiness.
• Throat irritation.
• Diarrhea.

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 Levalbuterol Inhalation Solution?

• Store at room temperature. Do not freeze.
• Protect from heat and light.
• Store unused containers in foil pouch until use.
• After opening the foil pouch, be sure you know how long the product is good and how to store it. Ask the doctor or pharmacist if you are not sure.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about levalbuterol inhalation solution, please talk with your doctor, nurse, pharmacist, or other health care provider.
• 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.