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Q: What is XOPENEX Inhalation Solution?
A: XOPENEX Inhalation Solution is a liquid medicine that is used with a machine called a nebulizer. The nebulizer turns the liquid medicine into a vapor-like mist so it can be inhaled. Health care providers may often prescribe nebulized medicine instead of an inhaler for young children or older adults, to help them take their medicine properly, and easily.
Q: How often is XOPENEX Inhalation Solution taken?
A: XOPENEX Inhalation Solution is commonly used to relax the airways in the lungs when bronchospasm (airway narrowing) occurs. It is also commonly used as a fast-acting “reliever” medicine, used to quickly relieve symptoms. It is important to take XOPENEX Inhalation Solution exactly as your health care provider prescribes it. Your health care provider also may prescribe other medicines, called “controllers,” which are taken every day at a regular time. It is important not to confuse reliever and controller medicines. Ask your health care provider if you are not sure how each medicine should be taken.
Q: How is XOPENEX Inhalation Solution different?
A: XOPENEX Inhalation Solution is the only nebulized medication for the treatment of bronchospasm associated with asthma and COPD, that contains only levalbuterol.
Q: How is XOPENEX Inhalation Solution used?
 A: 1. Open the package by tearing the serrated edge along the seam of the foil pouch. Remove 1 unit-dose vial for immediate use. Keep the rest of the unused unit-dose vials in the foil pouch to protect them from light.
2. Twist open the top of 1 unit-dose vial and squeeze the entire contents into the nebulizer reservoir.
3. Connect the nebulizer reservoir to the mouthpiece or face mask (Figure 2).
4. Connect the nebulizer to the compressor.
 5. Sit in a comfortable, upright position. Place the mouthpiece in your mouth or put on the face mask and turn on the compressor.
6. Breathe as calmly, deeply, and evenly as possible until no more mist is formed in the nebulizer reservoir (about 5 to 15 minutes).
7. Do not mix other medicines or liquids with XOPENEX Inhalation Solution unless instructed to do so by your health care provider.
Q: How is the nebulizer machine cleaned?
A: Follow the manufacturer’s instructions for cleaning your nebulizer. The nebulizer machine should be cleaned regularly to sanitize surfaces. Cleaning the machine can also help it last longer. Generally, the directions will tell you to do the following after each use:
1. Remove the mask/mouthpiece and T-shaped part. Remove the tubing and set it aside.
2. ONCE EVERY DAY—wash the mask/mouthpiece and T-shaped part with mild dishwashing soap and warm water.
3. Rinse the mask/mouthpiece and T-shaped part in warm running water for 30 seconds.
4. ONCE OR TWICE PER WEEK—soak the tubing, mask/mouthpiece, and cup for 30 minutes in a solution that is one part distilled white vinegar and two parts distilled water. Throw out the vinegar/water solution after use—do not reuse it. Rinse the nebulizer parts under warm running water for one minute.
5. Shake off excess water. Air-dry on a clean cloth or paper towel.
6. Put the mask/mouthpiece, T-shaped part, cup, and tubing back together, and connect the device to the compressor. Run the machine for 10 to 20 seconds to dry the inside of the nebulizer.
7. Disconnect the tubing from the compressor. Store the nebulizer in a resealable plastic bag.
8. Place the cover over the compressor. Finally, remember—NEVER put the compressor in water.
Adapted from the National Asthma Education Program, Office of Prevention, Education, and Control. Teach Your Patients About Asthma: A Clinician’s Guide. Bethesda, MD: National Heart, Lung, and Blood Institute; October 1992. US Dept of Health and Human Services publication 92-2737.
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©2007 Sepracor Inc. All rights reserved |
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Patient Prescribing Information
XOPENEX® (levalbuterol HCl) Inhalation Solution
0.31 mg,* 0.63 mg,* 1.25 mg*
*Potency expressed as levalbuterol
CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION
Patient Information about XOPENEX
What is XOPENEX used for?
XOPENEX (Zō–pen-eks) is used to treat or prevent narrowing of airways (bronchospasm) in patients 6 years of age and older with reversible obstructive airway disease, such as asthma.
What are the symptoms of bronchospasm?
Symptoms of bronchospasm include: coughing, wheezing, chest tightness, and shortness of breath.
Who should not take XOPENEX?
You should not take XOPENEX if you have had any type of reaction (hypersensitivity) to levalbuterol or albuterol.
Special Warnings Concerning XOPENEX:
Like other inhaled beta-agonists, XOPENEX Inhalation Solution can produce a narrowing of the airways called paradoxical bronchospasm, which may be life-threatening.
Your health care provider may need to prescribe other medications in addition to XOPENEX to help control your asthma. Do not stop taking other asthma medications unless advised by your health care provider.
XOPENEX can cause significant heart-related side effects, such as an increase in pulse, blood pressure and/or related symptoms. If you have a heart condition, your doctor will determine if XOPENEX is right for you.
Use as directed by your doctor or health care provider. Deaths have been reported with similar inhaled medications in asthma patients who use too much medication.
Hypersensitivity reactions (severe allergic reactions) may occur immediately after taking XOPENEX. If you experience itching, areas of skin swelling (angioedema), skin rash, or narrowing of the airways, these may be signs of a hypersensitivity reaction. Seek immediate medical attention if this happens.
If you find that treatment becomes less effective, your symptoms become worse and/or you need to use the product more frequently than usual, you should seek medical attention immediately.
General Precautions with XOPENEX:
If you currently have, or have had, a history of the following conditions, your health care provider will evaluate you to decide if XOPENEX is right for you:
- heart disease (e.g., reduced heart circulation, high blood pressure, and irregular heartbeat)
- seizures
- high levels of thyroid hormone
- diabetes
- reactions to medications similar to XOPENEX
What should I tell my doctor or health care provider?
Review all medications that you are taking with your health care provider, including those that you take without prescription. Because of the potential to interact with XOPENEX and cause side effects, tell your doctor if you are taking other medications such as:
- diuretics, such as furosemide and HCTZ (hydrochlorothiazide)
- antidepressants such as monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants
- drugs known to affect the heart’s regular rhythm
- drugs used for high blood pressure or after a heart attack, such as metoprolol or atenolol
Tell your doctor if you are trying to become pregnant, are already pregnant, or are nursing.
What are some possible side effects of XOPENEX? (This is not a complete list of side effects reported with XOPENEX. Your health care provider can discuss with you a more complete list of side effects.)
Side effects of XOPENEX may depend on dose. XOPENEX may result in a temporary increase in heart rate, tremors, or nervousness.
How is XOPENEX taken?
XOPENEX Inhalation Solution is administered by the use of a nebulizer (NEB-yoo-ly-zer). A nebulizer is a device that converts XOPENEX Inhalation Solution into a fine mist that can be inhaled. Your doctor will instruct you on the correct use of your nebulizer and also give you written instructions. It is very important that you take your XOPENEX as directed by your physician.
Xopenex Inhalation Solution Patient's Instructions for Use
How is XOPENEX stored?
Store XOPENEX in the protective foil pouch at room temperature (68°F - 77°F). Protect from light and excessive heat. Keep unopened vials in the foil pouch. Once the pouch is opened, the vials should be used within two weeks. Vials removed from the pouch, if not used immediately, should be protected from light and used within one week. Discard any vial if the solution is not colorless.
What are the inactive ingredients in XOPENEX Inhalation Solution?
The inactive ingredients are water, sodium chloride, and sulfuric acid.
How can I find out more about XOPENEX?
Talk to your doctor. Your doctor is the best source of information, or you can call the Sepracor Customer Assistance Center at 1-888-394-7377.
Ask your doctor for the complete prescribing information and the attached Patient's Instructions for Use. This information is also available at www.xopenex.com.
September 2007
Sepracor Inc.
Marlborough, MA 01752
XOPENEX HFA® (levalbuterol tartrate) Inhalation Aerosol
CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION
Patient Information about XOPENEX HFA
For Oral Inhalation Only
What is XOPENEX HFA used for?
XOPENEX (Zō–pen-eks) HFA is used to treat or prevent narrowing of airways (bronchospasm) in patients 4 years of age and older with reversible obstructive airway disease, such as asthma.
What are the symptoms of bronchospasm?
Symptoms of bronchospasm include: coughing, wheezing, chest tightness, and shortness of breath.
Who should not take XOPENEX HFA?
You should not take XOPENEX HFA if you have had any type of reaction (hypersensitivity) to levalbuterol, albuterol, or any other component of XOPENEX HFA.
Special Warnings Concerning XOPENEX HFA:
Like other inhaled beta-agonists, XOPENEX HFA can produce a narrowing of the airways called paradoxical bronchospasm, which may be life-threatening.
Your health care provider may need to prescribe other medications in addition to XOPENEX HFA to help control your asthma. Do not stop taking other asthma medications unless advised by your health care provider.
XOPENEX HFA can cause significant heart-related side effects, such as an increase in pulse, blood pressure and/or related symptoms. If you have a heart condition, your doctor will determine if XOPENEX HFA is right for you.
Use as directed by your doctor or health care provider. Deaths have been reported with similar inhaled medications in asthma patients who use too much medication.
Hypersensitivity reactions (severe allergic reactions) may occur immediately after taking XOPENEX HFA. If you experience itching, areas of skin swelling (angioedema), skin rash, or narrowing of the airways, these may be signs of a hypersensitivity reaction. Seek immediate medical attention if this happens.
If you find that treatment becomes less effective, your symptoms become worse and/or you need to use the product more frequently than usual, you should seek medical attention immediately.
General Precautions with XOPENEX HFA:
If you currently have, or have had, a history of the following conditions, your health care provider will evaluate you to decide if XOPENEX HFA is right for you:
- heart disease (e.g., reduced heart circulation, high blood pressure, and irregular heartbeat)
- seizures
- high levels of thyroid hormone
- diabetes
- reactions to medications similar to XOPENEX HFA
What should I tell my doctor or health care provider?
Review all medications that you are taking with your health care provider, including those that you take without prescription. Because of the potential to interact with XOPENEX HFA and cause side effects, tell your doctor if you are taking other medications such as:
- diuretics, such as furosemide and HCTZ (hydrochlorothiazide)
- antidepressants such as monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants
- drugs known to affect the heart’s regular rhythm
- drugs used for high blood pressure or after a heart attack, such as metoprolol or atenolol
Tell your doctor if you are trying to become pregnant, are already pregnant, or are nursing.
What are some possible side effects of XOPENEX HFA? (This is not a complete list of side effects reported with XOPENEX HFA. Your health care provider can discuss with you a more complete list of side effects.)
Side effects of XOPENEX HFA may depend on the number of actuations used within a given time period. XOPENEX HFA may result in a temporary increase in heart rate, tremors, or nervousness.
How is XOPENEX HFA taken?
XOPENEX HFA is administered by the use of a pressurized metered-dose inhaler, which produces a fine mist that can be inhaled. Your doctor will instruct you on the correct use of your metered-dose inhaler and also give you written instructions. The usual dose of XOPENEX HFA is 2 inhalations repeated every 4 to 6 hours. One inhalation every four hours may be sufficient in some patients. It is very important that you use XOPENEX HFA as directed by your doctor.
Xopenex HFA Patient's Instructions for Use
How is XOPENEX HFA stored?
Store XOPENEX HFA at room temperature (68°F - 77°F). Protect from freezing temperatures and direct sunlight. Store with the actuator (mouthpiece) down. The contents are under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Avoid spraying in eyes. Keep out of reach of children.
What are the inactive ingredients in XOPENEX HFA?
The inactive ingredients are propellant HFA-134a (1,1,1,2-tetrafluoroethane), dehydrated alcohol USP, and oleic acid NF.
How can I find out more about XOPENEX HFA?
Talk to your doctor. Your doctor is the best source of information, or you can call the Sepracor Customer Assistance Center at 1-888-394-7377.
Ask your doctor for the complete prescribing information and the attached Patient’s Instructions for Use. This information is also available at www.xopenex.com.
September 2007
Sepracor Inc.
Marlborough, MA 01752
