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Q: What is XOPENEX HFA?
A: XOPENEX (pronounced zō-pen-eks) HFA is a medicine that helps relieve tightening of the airways in the lungs. This tightening of the airways is often caused by asthma or chronic obstructive pulmonary disease (COPD), which can cause symptoms like coughing, wheezing, chest tightness, and shortness of breath.
XOPENEX HFA comes in an inhaler/puffer, which is a handheld device that delivers a puff of medicine into the airways. The inhaler/puffer releases just the right amount of medicine with every puff.
Q: What does “HFA” mean?
A:“HFA” refers to the ingredient in the inhaler that causes the puff of medicine come out when you press the top of the canister. For more information please see the Patient’s Instructions for Use.
Many other inhalers that you may have used in the past used an ingredient called “CFC.” CFCs are being phased out due to environmental concerns. The XOPENEX inhaler has always contained the environmentally friendly HFA ingredient.
Q: How often is XOPENEX HFA taken?
A: XOPENEX HFA is most often used as a fast-acting “reliever” medicine, which means it is taken only when needed to quickly relieve symptoms. However, this is not the only possible use, so it is important to take XOPENEX HFA 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 HFA different?
A: XOPENEX HFA is the only inhaler/puffer medication for the treatment of bronchospasm associated with asthma and COPD, that contains only levalbuterol.
Q: How is XOPENEX HFA stored?
A: PROPER STORAGE OF YOUR INHALER IS IMPORTANT TO MAKE SURE IT KEEPS WORKING. SEE STORAGE INSTRUCTIONS BELOW. Store XOPENEX HFA at room temperature (68°F-77°F). Protect from freezing temperatures and direct sunlight. Store with the mouthpiece (actuator) 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.
As with all HFA inhalers, XOPENEX HFA should be stored at room temperature and cleaned weekly, according to the patient’s instructions. HFA inhalers require more frequent cleaning and are sensitive to temperatures above 120°F.
Q: How is the XOPENEX HFA Inhaler used?
A: 1. Shake the inhaler well before each use.
 2. Remove the cap from the plastic mouthpiece. Make sure that the canister is properly seated and that there are no foreign objects in the mouthpiece. Note: You will need to prime the inhaler by releasing 4 test sprays into the air, away from your face, before using it for the first time and when the inhaler has not been used for more than 3 days.
3. Breathe out fully through your mouth, letting as much air out of your lungs as possible. Place the mouthpiece fully into your mouth, holding the inhaler in the mouthpiece-down position, and close your lips around it.
 4. While breathing in deeply and slowly through your mouth, fully depress the top of the metal canister with your middle finger. Release your finger from the canister and remove the inhaler from your mouth after you receive the puff.
5. Hold your breath for 10 seconds, if possible. If your health care provider prescribed more than 1 puff, wait 1 minute before your next puff. Then, shake the inhaler well, and repeat Steps 3 through 5. Replace the cap on the mouthpiece after each use.
Q: How is the XOPENEX HFA inhaler cleaned?
A: KEEPING THE BLUE PLASTIC MOUTHPIECE (ACTUATOR) CLEAN IS VERY IMPORTANT TO KEEP THE MEDICINE FROM CLOGGING. THE MOUTHPIECE SHOULD BE WASHED, SHAKEN TO REMOVE EXCESS WATER, AND AIR-DRIED FULLY AT LEAST ONCE A WEEK. THE INHALER MAY STOP WORKING IF IT IS NOT WELL CLEANED.
ROUTINE CLEANING INSTRUCTIONS:
 Step 1. To clean the blue plastic mouthpiece (actuator), remove the metal canister and red mouthpiece cap.
Step 2. Wash the mouthpiece through the top and bottom with warm running water for 30 seconds at least once a week. Do not clean the metal canister or allow the metal canister to become wet.
Never put the metal canister in water.
 Step 3. To dry, shake off excess water and let the mouthpiece air-dry fully. This can be done overnight.
Step 4. When the mouthpiece is dry, replace the canister and the mouthpiece cap. Make sure the canister is firmly placed into the mouthpiece. Blockage from medicine buildup is more likely to occur if the mouthpiece is not allowed to air-dry fully.
 IF YOUR MOUTHPIECE BECOMES BLOCKED (little or no medicine coming out of the mouthpiece), wash your mouthpiece as described in Steps 1 and 2 and air-dry fully as described in Step 3.
Step 5. IF YOU NEED TO USE YOUR INHALER BEFORE THE PLASTIC MOUTHPIECE IS FULLY DRY, shake excess water off the mouthpiece, replace the canister, shake well, and test-spray twice into the air (away from your face) to remove most of the water left in the mouthpiece. Then take your dose as prescribed. After such use, rewash the mouthpiece and air-dry it fully as described in Steps 1 through 3.
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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
