levalbuterol 0.31 mg/3 mL solution for nebulization

Generic name:
Levalbuterol pre-mixed solution - inhalation

Pronunciation
(LEV-al-BUE-ter-ol)

Brand name(s)
Xopenex

Levalbuterol is used to treat wheezing and shortness of breath that commonly occur with lung problems (such as asthma, chronic obstructive pulmonary disease). It is a quick-relief drug. Controlling these symptoms can decrease time lost from work or school. Levalbuterol belongs to a class of drugs known as bronchodilators. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily.

Read the Patient Information Leaflet available from your pharmacist before you start using this medication and each time you get a refill. This product is used with a special machine called a nebulizer that changes the solution to a fine mist that you breathe in. Consult your doctor, pharmacist, or respiratory therapist on how to inhale this medication properly with this equipment. If a child is using this equipment, a parent or other responsible adult should supervise the child.

This product should be clear and colorless. Before using, check this product for particles or discoloration. If either is present, do not use the liquid.

This product does not require any mixing before use unless your doctor instructs you otherwise. This medication is inhaled into the lungs using a nebulizer as directed by your doctor, usually 3 times a day. Each treatment usually takes about 5 to 15 minutes. Use this medication only through a nebulizer. Do not swallow or inject the solution. Do not mix with other medications in the nebulizer. To prevent infections, clean the nebulizer and mouthpiece/face mask according to the manufacturer's directions.

Dosage is based on your medical condition, age, and response to treatment. Do not increase your dose or use this drug more often than prescribed without your doctor's approval. Using too much of this medication will increase your risk of serious (possibly fatal) side effects.

Learn which of your inhalers/medications you should use every day (controller drugs) and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, worsening peak flow meter readings, waking up at night with trouble breathing, if you use your quick-relief inhaler/medication more often (more than 2 days a week), or if your quick-relief inhaler/medication does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.

Tell your doctor if your symptoms do not get better or if they get worse.

Headache, nervousness, shaking (tremor), dizziness, trouble sleeping, dry mouth, nausea, stomach upset, diarrhea, or runny nose may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including:

• fast/pounding heartbeat
• anxiety
• swollen glands

Get medical help right away if you have any very serious side effects, including:

• irregular heartbeat
• chest pain
• rapid breathing
• confusion

Rarely, this medication has caused severe (rarely fatal), sudden worsening of breathing problems/asthma (paradoxical bronchospasm). If you experience sudden wheezing, get medical help right away.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using levalbuterol, tell your doctor or pharmacist if you are allergic to it; or to similar bronchodilators (such as albuterol, metaproterenol, salmeterol); or to sympathomimetic drugs (such as epinephrine, pseudoephedrine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• heart disease (such as irregular heartbeat, angina, heart attack)
• high blood pressure
• seizures
• diabetes

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Levalbuterol is very similar to albuterol. Do not use inhaled medications containing albuterol while using levalbuterol.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: chest pain, fast/pounding/irregular heartbeat, headache, shaking (tremors), nervousness, weakness, severe dizziness, seizures.

Do not share this medication with others.

Avoid allergens, irritants, smoking and other factors that make asthma worse.

Lab and/or medical tests (such as blood pressure, heart rate, EKG) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Learn to use a peak flow meter, use it daily, and promptly report worsening asthma (such as readings in the yellow/red range or increased use of quick-relief inhalers).

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and heat. Keep vials in the foil pouch until ready to use. Once the foil pouch is opened, this medication expires after 2 weeks. If the vials are removed from the foil pouch and not used right away, protect it from light and use within 1 week. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.