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Xopenex HFA

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Xopenex HFA

PATIENT INFORMATION

XOPENEX HFA®
(pronounced zo-pen-eks hfa)
(levalbuterol tartrate) Inhalation Aerosol

For Oral Inhalation Only

Read this Patient Information before you start to use XOPENEX HFA and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

What is XOPENEX HFA?

XOPENEX HFA is an inhaled prescription medicine used for the treatment or prevention of asthma in people 4 years of age and older.

It is not known if XOPENEX HFA is safe and effective in children younger than 4 years of age.

Who should not use XOPENEX HFA?

Do not use XOPENEX HFA if you are allergic to levalbuterol, racemic albuterol orany of the ingredients in XOPENEX HFA. See the end of this leaflet for a complete list of ingredients in XOPENEX HFA.

What should I tell my doctor before using XOPENEX HFA?

Before you use XOPENEX HFA, tell your doctor if you have:

  • heart problems
  • high blood pressure
  • seizures
  • diabetes
  • thyroid problems
  • any other medical conditions
  • are pregnant or planning to become pregnant. It is not known if XOPENEX HFA will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if XOPENEX HFA passes into your breast milk. You and your doctor should decide if you will use XOPENEX HFA or breastfeed. You should not do both.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. XOPENEX HFA may affect the way other medicines work, and other medicines may affect how XOPENEX HFA works.

Especially tell your doctor if you take:

Ask your doctor if you are not sure if any of your medicines are the kinds listed above.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

How should I use XOPENEX HFA?

  • Read the step-by-step Instructions for Using XOPENEX HFA at the end of this leaflet.
  • Use XOPENEX HFA exactly as your doctor tells you to. Do not change your dose without talking to your doctor first.
  • Your doctor will tell you how many times and when to use your XOPENEX HFA.
  • An adult should help a child use XOPENEX HFA.
  • Do not use your XOPENEX HFA more often than your doctor tells you to.
  • Get medical help right away if XOPENEX HFA:
    • does not work as well for your asthma symptoms or
    • your asthma symptoms get worse or
    • you need to use your XOPENEX HFA more often than usual
  • If you also use another medicine by inhalation, you should ask your doctor for instructions on when to use it while you are also using XOPENEX HFA.

What are the possible side effects of XOPENEX HFA?

XOPENEX HFA can cause serious side effects including:

  • sudden shortness of breath (bronchospasm). Sudden shortness of breath can happen right away after using XOPENEX HFA.
  • worsening asthma.
  • heart problems.
  • death. If you use too much XOPENEX HFA you can have heart or lung problems that can lead to death.
  • serious allergic reactions. Call your doctor and stop using XOPENEX HFA rightaway if you have any symptoms of an allergic reaction such as:
    • swelling of the face, throat or tongue
    • hives
    • rash
    • breathing problems
  • low potassium levels in your blood

Call your doctor or go to the nearest hospital emergency room right away if you have any of the serious side effects listed above or if you have worsening lung symptoms.

The most common side effects of XOPENEX HFA include:

  • accidental injury
  • bronchitis
  • dizziness
  • pain
  • sore throat
  • runny nose
  • vomiting
  • palpitations
  • chest pain
  • fast heart rate
  • tremors
  • nervousness

Tell your doctor if you have any side effects that bother you or that does not go away.

These are not all the possible side effects of XOPENEX HFA. For more information ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store XOPENEX HFA?

  • Store XOPENEX HFA between 68°F to 77°F (20°C to 25°C).
  • Keep XOPENEX HFA Inhaler away from heat or open flame.
  • Keep XOPENEX HFA Inhaler away from freezing temperatures and direct sunlight.
  • Do not puncture the XOPENEX HFA Inhaler.
  • Store XOPENEX HFA Inhaler with the mouthpiece down.

The XOPENEX HFA Inhaler should be safely thrown away after using:

    • 200 actuations for the 15 gram canister.
    • 80 actuations for the 8.4 gram canister.
  • Do not throw XOPENEX HFA Inhaler into a fire or an incinerator.

Keep XOPENEX HFA and all medicines out of the reach of children.

General information about the safe and effective use of XOPENEX HFA

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use XOPENEX HFA for a condition for which it was not prescribed. Do not give XOPENEX HFA to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about XOPENEX HFA. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about XOPENEX HFA that is written for health professionals.

For more information go to www.XOPENEX.com.

For customer service, call 1-888-394-7377.

To report adverse events, call 1-877-737-7226.

For medical information, call 1-800-739-0565

What are the ingredients in XOPENEX HFA?

Active ingredient: levalbuterol tartrateInactive ingredient: propellant HFA-134a, Dehydrated Alcohol USP, Oleic Acid NF

Instructions for Using XOPENEX HFA

The parts of your XOPENEX HFA inhaler (See Figure 1):

Figure 1

The parts of XOPENEX HFA inhaler - Illustration

Using your XOPENEX HFA inhaler

  • XOPENEX HFA should be at room temperature before you use it.
  • Priming the inhaler:

Before you use XOPENEX HFA for the first time, you must prime the inhaler so that you will get the right amount of medicine when you use it.

    • To prime the inhaler, take the cap off the mouthpiece and shake the inhaler well. Then spray the inhaler into the air away from your face. Avoid spraying in your eyes. Shake and spray the inhaler like this 3 more times to finish priming it.
    • You must prime the inhaler again if you have not used it in more than3 days.
    • An adult should help a child use XOPENEX HFA.

Read the following 6 steps before using XOPENEX HFA and follow them before each use. If you have any questions, ask your doctor or pharmacist.

1. Take the cap off the mouthpiece of the actuator (See Figure 2). Look inside the mouthpiece for foreign objects, and remove any that you see. Make sure the canister fits firmly in the actuator. Shake the inhaler well for 5 seconds.

Figure 2

Take the cap off the mouthpiece of the actuator - Illustration

2. Hold the inhaler with the mouthpiece down (See Figure 2). Before you put the mouthpiece in your mouth, breathe out through your mouth and push out as much air from your lungs as you can. Put the mouthpiece in your mouth and close your lips around it.

Figure 3

Hold the inhaler with the mouthpiece down - Illustration

3. Push the top of the canister all the way down while you breathe in deeply and slowly through your mouth (See Figure 3).Right after the spray comes out, take your finger off the canister. After you have breathed in all the way, take the inhaler out of your mouth and close your mouth.

4. Hold your breath for 10 seconds if possible. Then breathe normally.

5. Wait about 1 minute, then shake the inhaler well. Repeat steps 2 through 4.

6. Put the cap back on the mouthpiece after each time you use the XOPENEX HFA. Make sure the cap snaps firmly into place.

Cleaning your XOPENEX HFA inhaler:

Figure 4

Properly clean the blue plastic actuator - Illustration

  • The inhaler may stop working if you do not properly clean the blue plastic actuator (mouthpiece) at least one time a week. See Figure 4.
    To clean the actuator:
    • Remove the canister and red mouthpiece cap. Do not clean the metal canister or allow the metal canister to become wet.
    • Wash the actuator through the top and bottom with warm running water for at least 30 seconds.
    • Shake the actuator to remove excess water
    • Air-dry the actuator completely. Blockage from medicine build-up is more likely to happen if the actuator is not allowed to air-dry thoroughly.
  • When the actuator is dry, replace the canister and the mouthpiece cap.
  • Make sure the canister is fully and firmly inserted into the actuator.
  • If your actuator becomes blocked, it means that little or no medicine is coming out of the mouthpiece. See Figure 5. Wash your actuator and air-dry completely as described above.

Figure 5

Clogged and unclogged actuator -  Illustration

  • If you need to use your inhaler before the plastic actuator is completely dry:
    • Shake the excess water off the actuator.
    • Replace the canister and shake well.
    • Test-spray twice into the air, away from your face, to remove most of the water remaining in the actuator.
    • Take your dose as prescribed.
    • Rewash the actuator and air-dry it thoroughly as described above.

How should I store XOPENEX HFA?

  • Store XOPENEX HFA between 68°F to 77°F (20°C to 25°C).
  • Keep XOPENEX HFA Inhaler away from heat or open flame.
  • Keep XOPENEX HFA Inhaler away from freezing temperatures and direct sunlight.
  • Do not puncture the XOPENEX HFA Inhaler.
  • Store XOPENEX HFA with the mouthpiece down.
  • The XOPENEX HFA inhaler should be safely thrown away after using:
    • 200 actuations for the 15 gram canister.
    • 80 actuations or the 8.4 gram canister.
  • Do not throw your XOPENEX HFA inhaler into a fire or incinerator.

Keep XOPENEX HFA and all medicines out of the reach of children.

Last reviewed on RxList: 8/8/2012
This monograph has been modified to include the generic and brand name in many instances.

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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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