Generic Name: levalbuterol (LEV-al-BUE-ter-ol)
Brand Name: Xopenex HFA
Levalbuterol aerosol is used for:
Treating and preventing breathing problems in patients who have asthma or certain airway diseases. It may also be used for other conditions as determined by your doctor.
Levalbuterol aerosol is a sympathomimetic (beta-agonist) bronchodilator. It works by widening the airways in the lungs, which helps you breathe more easily.
Do NOT use levalbuterol aerosol if:
- you are allergic to any ingredient in levalbuterol aerosol or to albuterol
- you are using another short-acting sympathomimetic bronchodilator (eg, pirbuterol) or inhaled epinephrine
Contact your doctor or health care provider right away if any of these apply to you.
Before using levalbuterol aerosol:
Some medical conditions may interact with levalbuterol aerosol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of heart problems (eg, fast or irregular heartbeat), blood vessel problems, high blood pressure, or low blood potassium levels
- if you have a history of seizures, diabetes, thyroid problems, kidney problems, or adrenal gland tumor (pheochromocytoma)
- if you have ever had an unusual reaction to another sympathomimetic medicine (eg, pseudoephedrine), such as fast or irregular heartbeat, overexcitement, or severe trouble sleeping
- if you have taken linezolid, a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or a tricyclic antidepressant (eg, amitriptyline) within the last 14 days
Some MEDICINES MAY INTERACT with levalbuterol aerosol. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood potassium levels may be increased
- Epinephrine, linezolid, MAOIs (eg, phenelzine), methylxanthines (eg, theophylline), other short-acting sympathomimetic bronchodilators (eg, pirbuterol), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of levalbuterol aerosol's side effects
- Beta-blockers (eg, propranolol) because they may decrease levalbuterol aerosol's effectiveness or worsen your condition
- Digoxin because its effectiveness may be decreased by levalbuterol aerosol
This may not be a complete list of all interactions that may occur. Ask your health care provider if levalbuterol aerosol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use levalbuterol aerosol:
Use levalbuterol aerosol as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with levalbuterol aerosol. Talk to your pharmacist if you have questions about this information.
- Levalbuterol aerosol is for oral inhalation only. Do not spray in the eyes. If you get levalbuterol aerosol in the eyes, rinse immediately with cool tap water.
- Prime the inhaler before you use it for the first time. To prime it, point it away from yourself and others. Spray 4 test sprays into the air, shaking well before each spray. You will need to reprime the inhaler any time it has not been used for longer than 3 days.
- Before using levalbuterol aerosol, be sure that the canister is properly placed in the inhaler unit. Remove the protective cap from the mouthpiece and check to make sure there are no hidden foreign objects.
- Shake well before each use. Breathe out slowly and completely through the mouth. Place the mouthpiece fully into the mouth in its upright position and close the lips around it, unless your doctor has told you otherwise. Your doctor may have told you to hold the inhaler 1 to 2 inches (2 or 3 centimeters) away from the open mouth or to use a special spacing device. As you start to take a slow, deep breath through the mouth, press the canister and mouthpiece together at exactly the same time. This will release a dose of levalbuterol aerosol. Continue breathing in slowly and deeply. After you have breathed all the way in, remove the inhaler from your mouth. Hold your breath for 10 seconds or as long as comfortable; then breathe out slowly through pursed lips or your nose. If more than 1 inhalation is to be used, wait about 1 minute and repeat the above steps.
- Replace the protective cap on the mouthpiece after each use.
- If the patient is a child, an adult should help the child use levalbuterol aerosol.
- Clean the plastic mouthpiece and cap at least once a week to prevent blockage. Remove the metal canister. Rinse the mouthpiece through the top and bottom with warm running water for at least 30 seconds. Shake off excess water, and then allow the mouthpiece to air dry completely (eg, overnight). After the plastic case and cap dry, replace the canister. Place the cap back on the mouthpiece. Do NOT allow the metal canister to become wet.
- If you must use the inhaler before it is completely dry, shake the excess water off of the plastic mouthpiece. Insert the canister into the plastic mouthpiece, shake well, and spray 2 times into the air, away from yourself and others. You may then use a dose. After your dose, rewash the plastic case and air dry completely.
- If the inhaler becomes blocked, wash the mouthpiece as directed.
- Do not use levalbuterol aerosol with any other mouthpiece. Do not use this mouthpiece with any other medicine.
- Do NOT place the canister in water to try to determine how much medicine you have left.
- Levalbuterol aerosol contains either 80 or 200 sprays. Be sure you know how many sprays your canister contains. Keep track of the number of sprays you use. Do not continue to use a canister after you have used the appropriate number of sprays; you may not receive the correct amount of medicine with each spray.
- If you miss a dose of levalbuterol aerosol and you are using it regularly, use it as soon as possible. If it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use levalbuterol aerosol.
Important safety information:
- Levalbuterol aerosol may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use levalbuterol aerosol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Levalbuterol aerosol may sometimes cause severe breathing problems right after you use a dose. When this problem occurs, it is often after the first use of a new canister. If this happens, seek medical care at once.
- If your usual dose does not work well, your symptoms become worse, or you need to use it more often than normal, contact your doctor at once. Your asthma could be getting worse, and your doctor may need to change your dose or medicine.
- Levalbuterol aerosol should work for up to 4 to 6 hours. Do NOT use more than the recommended dose or use more often than prescribed without checking with your doctor. The risk of severe heart problems and sometimes death may be increased with overuse of levalbuterol aerosol.
- Talk with your doctor or pharmacist about all of your inhaled and/or asthma medicines and how to use them. Do not start, stop, or change the dose of any medicine unless your doctor tells you to.
- Levalbuterol aerosol may cause dry mouth or an unpleasant taste in your mouth. Rinsing your mouth with water after each dose may help relieve these effects.
- Tell your doctor or dentist that you take levalbuterol aerosol before you receive any medical or dental care, emergency care, or surgery.
- Keep track of how many inhalations you use. When your medicine supply begins to run low, call your doctor or pharmacy as soon as possible for a refill.
- The contents of this canister are under pressure. Do NOT store or use levalbuterol aerosol near an open flame. Do NOT puncture, break, or burn the container, even if it appears empty.
- Diabetes patients - Levalbuterol aerosol may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Use levalbuterol aerosol with caution in the ELDERLY; they may be more sensitive to its effects.
- Levalbuterol aerosol should be used with extreme caution in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.
- Caution is advised when using levalbuterol aerosol in CHILDREN; they may experience vomiting with use of levalbuterol aerosol.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using levalbuterol aerosol while you are pregnant. It is not known if levalbuterol aerosol is found in breast milk. If you are or will be breast-feeding while you use levalbuterol aerosol, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of levalbuterol aerosol:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Dizziness; dry mouth; nausea; nervousness; runny or stuffy nose; sore or dry throat; tremor; trouble sleeping; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); chest pain; decreased coordination; fast breathing; fast or irregular heartbeat; muscle pain, weakness, or cramping; new or worsened cough or breathing problems (eg, shortness of breath, wheezing); pounding in the chest; severe or persistent headache or dizziness; severe or persistent nausea or vomiting; severe or unusual drowsiness; sluggishness.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest pain; fainting; fast or irregular heartbeat; muscle pain, weakness, or cramping; seizures; severe or persistent dizziness, dry mouth, fatigue, headache, light-headedness, nausea, nervousness, or trouble sleeping; severe or unusual drowsiness; tremor.Proper storage of levalbuterol aerosol:
Store levalbuterol aerosol upright between 68 and 77 degrees F (20 and 25 degrees C). Store with the mouthpiece down. Do not freeze. Store away from heat and direct sunlight. Contents are under pressure. Do not puncture, break, or burn the canister even if it appears to be empty. Do not use or store near heat or open flame. Do not expose the container to extreme heat (temperatures above 120 degrees F [48 degrees C]) or cold. Keep levalbuterol aerosol out of the reach of children and away from pets.
- If you have any questions about levalbuterol aerosol, please talk with your doctor, pharmacist, or other health care provider.
- Levalbuterol aerosol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take levalbuterol aerosol or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about levalbuterol aerosol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to levalbuterol aerosol. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using levalbuterol aerosol.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.