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Xopenex

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Xopenex

PATIENT INFORMATION

XOPENEX®
(pronounced zo-pen-eks)
(levalbuterol hydrochloride) Inhalation Solution 0.31 mg, 0.63 mg, 1.25 mg 3 mL Unit-Dose Vials

For Oral Inhalation Only
XOPENEX Inhalation Solution is only for use with a nebulizer.

Read this Patient Information before you start to use XOPENEX Inhalation Solution 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 Inhalation Solution?

XOPENEX Inhalation Solution is an inhaled prescription medicine used for the treatment or prevention of bronchospasm in people 6 years of age and older.

It is not known if XOPENEX Inhalation Solution is safe and effective in children younger than 6 years of age.

XOPENEX Inhalation Solution is supplied in 3 mL unit-dose vials in three different strengths of levalbulterol (0.31 mg, 0.63 mg, 1.25 mg). The vials do not require dilution before use.

Who should not use XOPENEX Inhalation Solution?

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

What should I tell my doctor before using XOPENEX Inhalation Solution?

Before you use XOPENEX Inhalation Solution, tell your doctor if you have:

  • had an allergic reaction to levalbuterol or racemic albuterol
  • 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 Inhalation Solution 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 Inhalation Solution passes into your breast milk. You and your doctor should decide if you will use XOPENEX Inhalation Solution or breastfeed. You should not do both.

Tell your doctor about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. XOPENEX Inhalation Solution may affect the way other medicines work, and other medicines may affect how XOPENEX Inhalation Solution 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 Inhalation Solution?

  • Read the step-by-step Instructions for Using XOPENEX Inhalation Solution at the end of this leaflet.
  • Use XOPENEX Inhalation Solution 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 Inhalation Solution.
  • An adult should help a child use XOPENEX Inhalation Solution.
  • Do not use your XOPENEX Inhalation Solution more often than your doctor tells you to.
  • Get medical help right away if XOPENEX Inhalation Solution:
    • does not work as well for your asthma symptoms or
    • your asthma symptoms get worse or
    • you need to use your XOPENEX Inhalation Solution 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 Inhalation Solution.
  • Do not mix XOPENEX Inhalation Solution with other medicines in your nebulizer.
  • Only use XOPENEX Inhalation Solution if it is colorless. Throw away the XOPENEX Inhalation Solution vial if the liquid medicine is not colorless.
  • Do not use XOPENEX Inhalation Solution after the expiration date on the vial.

What are the possible side effects of XOPENEX Inhalation Solution?

XOPENEX Inhalation Solution can cause serious side effects including:

  • sudden shortness of breath (bronchospasm). Sudden shortness of breath can happen right away after using XOPENEX Inhalation Solution.
  • worsening asthma
  • heart problems
  • death. If you use too much XOPENEX Inhalation Solution you can have heart or lung problems that can lead to death.
  • serious allergic reactions. Call your doctor and stop using XOPENEX Inhalation Solution right away 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 Inhalation Solution include:

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

These are not all the possible side effects of XOPENEX Inhalation Solution. 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 Inhalation Solution?

  • Store unopened XOPENEX Inhalation Solution vials in the protective foil pouch they come in between 68°F and 77°F (20°C and 25°C).
  • Keep XOPENEX Inhalation Solution away from light and heat.
  • When a XOPENEX Inhalation Solution foil pouch is opened, use the vials within 2 weeks.
  • When XOPENEX Inhalation Solution vials are removed from the foil pouch, use them right away or within 1 week.

Keep XOPENEX Inhalation Solution and all medicines out of the reach of children.

General information about the safe and effective use of XOPENEX Inhalation Solution.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use XOPENEX Inhalation Solution for a condition for which it was not prescribed. Do not give XOPENEX Inhalation Solution 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 Inhalation Solution. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about XOPENEX Inhalation Solution that is written for health professionals.

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 Inhalation Solution?

Active ingredient: levalbuterol hydrochloride

Inactive ingredients: sodium chloride, sulfuric acid, water and nitrogen

Instructions for Using XOPENEX Inhalation Solution

XOPENEX Inhalation Solution vial (see Figure A):

Figure A

Inhalation Solution vial - Illustration

Using your XOPENEX Inhalation Solution:

Read the following Steps before using your XOPENEX Inhalation Solution. If you have any questions, ask your doctor or pharmacist.

Step 1. Open the foil pouch by tearing the notched edge along the seam of the pouch (See Figure B). Remove 1 vial to be used right away. Keep the rest of the unused vials in the foil pouch to protect them from light and heat.

Figure B

Open the foil pouch - Illustration

Step 2. Hold the vial in your hands. Make sure your thumb and finger cover the twist-off tabs below the X-top (See Figure C).

Figure C

Make sure your thumb and finger cover the twist-off tabs - Illustration

Step 3. While holding the top firmly between your thumb and finger, twist the body of the vial to open the vial (See Figure C).

Step 4. Throw away the top of the vial and squeeze the entire contents of the vial into the nebulizer reservoir (See Figure D).

Figure D

Squeeze the entire contents of the vial into the nebulizer reservoir - Illustration

Step 5. Connect the nebulizer reservoir to the mouthpiece (See Figure E.1) or face mask (See Figure E.2).

Figure E.1

Connect the nebulizer reservoir to the mouthpiece - Illustration

Figure E.2

Connect the nebulizer reservoir to the face mask - Illustration

Step 6. Connect the nebulizer to the compressor (See Figure F).

Figure F

Connect the nebulizer to the compressor - Illustration

Step 7. Sit in a comfortable, upright position. Place the mouthpiece in your mouth (See Figure G.1) or put on your face mask (See Figure G.2). Turn on the compressor.

Figure G.1

Place the mouthpiece in your mouth - Illustration

Figure G.2

Place the mouthpiece on your face mask - Illustration

Step 8. Breathe as calmly, deeply, and evenly as possible until no more mist is seen in the nebulizer reservoir. Your treatment will take about 5 to 15 minutes. When you do not see any mist in the nebulizer reservoir, your treatment is finished.

Step 9. Clean and store your nebulizer. See the manufacturer's instructions that come with your nebulizer for how to clean and store your nebulizer.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 4/11/2014
This monograph has been modified to include the generic and brand name in many instances.

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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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