Xopenex is a short-acting bronchodilator that relaxes muscles in the airways and increases air flow to the lungs.

Xopenex inhalation is used to treat or prevent bronchospasm in people with reversible obstructive airway disease.

Xopenex solution is for use in adults and children 6 years of age and older. Xopenex HFA aerosol is for use in adults and children 4 years of age and older.

You should not use Xopenex if you are allergic to levalbuterol or albuterol (Accuneb, ProAir, Proventil, Ventolin).

Before using Xopenex, tell your doctor if you have heart disease, high blood pressure, congestive heart failure, a heart rhythm disorder, a seizure disorder, diabetes, or overactive thyroid.

Tell your doctor about all other medicines you use, especially heart or blood pressure medication, diuretics (water pills), antidepressants, or other inhaled bronchodilators.

Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks. If it seems like you need to use more of any of your medications in a 24-hour period, talk with your doctor. An increased need for medication could be an early sign of a serious asthma attack.

It is very important that you use nebulized Xopenex properly, so that the medicine gets into the lungs. Talk to your doctor about proper nebulizer use.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of levalbuterol can be fatal.

Use Xopenex exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Any child using Xopenex should be supervised by an adult while using this medicine.

Prime the Xopenex inhaler device before your first use. Pump 4 test sprays into the air, away from your face. Shake the inhaler for at least 5 seconds before each spray. Prime again whenever the inhaler has not been used in longer than 3 days.

To use the Xopenex inhaler:

• Shake the canister well just before each spray.

• Uncap the mouthpiece of the inhaler. Breathe out fully. Put the mouthpiece into your mouth and close your lips. Breathe in slowly while pushing down on the canister. Hold your breath for 10 seconds, then breathe out slowly.

• If you use more than one inhalation at a time, wait at least 1 minute before using the second inhalation and shake the inhaler again.

• Keep your inhaler clean and dry, and store it with the cap on the mouthpiece. Clean your inhaler once a week by removing the canister and placing the mouthpiece under warm running water for at least 30 seconds. Shake out the excess water and allow the parts to air dry completely before putting the inhaler back together.

Store the Xopenex inhaler with the mouthpiece down. Keep the inhaler at room temperature away from heat, sunlight, or freezing temperatures.

If your inhaler has a dose number indicator on it, throw away the inhaler when the number displays "0" to show that all sprays have been used.

Keep the inhaler canister away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture or burn an empty inhaler canister.

Xopenex concentrate solution is given with a nebulizer. The concentrate must be mixed with a liquid (diluent) before using it. Ask your pharmacist about which diluent to use and where you can buy it. Be sure you understand how to properly mix the medicine and place it into the nebulizer.

To use the Xopenex solution with a nebulizer:

• Open the foil pouch and empty the medicine into the chamber of the nebulizer. Add the correct amount of diluent as directed by your doctor.

• Attach the mouthpiece or face mask, then attach the drug chamber to the compressor.

• Sit upright in a comfortable position. Place the mouthpiece into your mouth or put on the face mask, covering your nose and mouth. Turn on the compressor.

• Breathe in slowly and evenly until no more mist is formed by the nebulizer and the drug chamber is empty.

• Clean the nebulizer after each use. Follow the cleaning directions that came with your nebulizer.

Do not use the nebulizer solution if it does not appear clear and colorless.

Store the Xopenex concentrate vials in the protective foil pouch at room temperature, away from moisture, heat, and light. Keep each vial in the foil pouch until you are ready to prepare a dose in the nebulizer.

Each single-use plastic vial of Xopenex concentrate is for one use only. Throw away after one use, even if there is still some medicine left in it after inhaling your dose.

Asthma is often treated with a combination of drugs. Use all medications as directed by your doctor. Do not change your doses or medication schedule without your doctor's advice.

Using too much Xopenex or using it too often can cause life-threatening side effects. Seek medical attention if you think your asthma medications are not working as well. An increased need for medication could be an early sign of a serious asthma attack.

You should not use Xopenex if you are allergic to levalbuterol or albuterol (Accuneb, ProAir, Proventil, Ventolin).

To make sure Xopenex is safe for you, tell your doctor if you have:

• heart disease, high blood pressure, or congestive heart failure;

• a seizure disorder;

• diabetes; or

• a thyroid disorder.

It is not known whether Xopenex will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether levalbuterol passes into breast milk or if it could affect a nursing baby. Tell your doctor if you are breast-feeding.

A Xopenex inhaler should not be given to a child younger than 4 years old. Xopenex solution in a nebulizer should not be given to a child younger than 6 years old.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of levalbuterol can be fatal.

Avoid situations that may make your condition worse such as exercising in cold, dry air; smoking; breathing in dust; and exposure to allergens such as pet fur.

Get emergency medical help if you have signs of an allergic reaction to Xopenex: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medicine;

• pounding heartbeats or fluttering in your chest;

• worsening asthma symptoms; or

• low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, extreme thirst, increased urination, numbness or tingling, muscle weakness or limp feeling.

Common Xopenex side effects may include:

• dizziness, nervousness, tremors;

• runny nose, sore throat;

• chest pain or tightness, irregular heartbeats;

• pain; or

• vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor if you have used an MAO inhibitor in the past 14 days. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• any other inhaled medicines to treat asthma or COPD (chronic obstructive pulmonary disease);

• an antidepressant;

• a diuretic or "water pill"; or

• medicine to treat a heart condition.

This list is not complete. Other drugs may interact with levalbuterol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.