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levalbuterol (cont.)

What should I discuss with my healthcare provider before using levalbuterol inhalation (Xopenex, Xopenex Concentrate)?

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

To make sure you can safely use levalbuterol, tell your doctor if you have any of these other conditions:

  • heart disease, high blood pressure, or congestive heart failure;
  • a heart rhythm disorder;
  • a seizure disorder;
  • diabetes; or
  • overactive thyroid.

FDA pregnancy category C. It is not known whether levalbuterol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether levalbuterol passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using levalbuterol.

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

How should I use levalbuterol inhalation (Xopenex, Xopenex Concentrate)?

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

Use only the prescribed dose of this medicine and follow all patient instructions for safe use. Talk with your doctor about your individual risks and benefits of using levalbuterol.

When using the inhaler device for the first time, prime it by spraying 4 test sprays into the air, away from your face. Shake well before priming. Also prime the inhaler if you have not used it for 3 days or longer, or if you have dropped the inhaler.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

The instructions below are for standard use of the inhaler and nebulizer devices. Your doctor may want you to use your device differently. Use only the inhaler device provided with your medicine or you may not get the correct dose.

To use the 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.

To use the solution with a nebulizer:

  • Open the foil pouch and remove one vial of levalbuterol solution. Do not use the medication if it does not appear clear and colorless.
  • Gently twist open the vial and squeeze all of the medicine out into the chamber of the nebulizer. The medicine must be used right away after opening the vial. Throw away any medicine in the vial if it is opened and not used right away.
  • Attach the mouthpiece or face mask to the drug chamber. Then, attach the drug chamber to the compressor.
  • Sit upright in a comfortable position. Place the mouthpiece into your mouth or put the face mask on, covering your nose and mouth. Turn on the compressor.
  • Breathe in slowly and evenly until you have inhaled all of the medicine (usually 5 to 15 minutes). The treatment is complete when 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.

Each single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after inhaling your dose.

If you also use a steroid inhaler, use your levalbuterol nebulization solution first to open up your airways, then use the steroid inhaler as directed.

Do not mix other medicines for nebulization with a dose of levalbuterol unless specifically directed to do so by your doctor.

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

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.

Store levalbuterol vials in the protective foil pouch at room temperature, away from moisture and heat. Protect from light.

Keep each vial in the foil pouch until you are ready to prepare a dose in the nebulizer. If you do not use a vial right away, protect the vial from light and use it within 1 week after removing it from the foil pouch. Once you have opened the foil pouch, all of the vials should be used within 2 weeks.

Keep the levalbuterol inhaler 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.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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