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XOPENEX HFA

XOPENEX HFA Inhalation Aerosol: Ready-when-needed relief...


XOPENEX HFA is a handheld inhaler that is sometimes called a "puffer." It is a convenient treatment option for those who need quick relief from symptoms, are unable to use a nebulizer, and/or prefer taking medicine through an inhaler. The XOPENEX HFA inhaler/puffer is designed to release a measured amount of medicine with every puff, and is indicated for children four years and older. XOPENEX HFA is most often used as a fast-acting "reliever" or rescue medicine. It is taken when needed to quickly relieve symptoms like wheezing, coughing, chest tightness, and shortness of breath associated with asthma or chronic obstructive pulmonary disease (COPD).

Refill before you reach 80 or 200 sprays.

Discard your XOPENEX HFA inhaler after you have used either 200 inhalations from the 15g canister or 80 inhalations from the 8.4g canister. The correct amount of medicine in each inhalation cannot be assured after 200 sprays from the 15g canister or 80 sprays from the 8.4g canister, even though the canister is not completely empty. Never immerse the canister in water to determine how full the canister is. Before you reach 80 or 200 sprays, you should consult your healthcare provider to determine if a refill is needed. Do not stop taking your XOPENEX HFA inhaler without consulting with your healthcare provider.

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IMPORTANT SAFETY INFORMATION & full PRESCRIBING INFORMATION

XOPENEX® (levalbuterol HCl) Inhalation Solution
0.31 mg,* 0.63 mg,* 1.25 mg*
*Potency expressed as levalbuterol

For more information please refer to full prescribing information

Patient Information about XOPENEX Inhalation Solution

What is XOPENEX Inhalation Solution used for?
XOPENEX (zō-pen-eks) Inhalation Solution 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 occurs in asthma or chronic obstructive pulmonary disease (COPD).

What are the symptoms of bronchospasm?
Symptoms of bronchospasm include: coughing, wheezing, chest tightness, and shortness of breath.

Important Safety Information:
Like other inhaled beta-agonists, XOPENEX Inhalation Solution can produce a narrowing of the airways called paradoxical bronchospasm, which may be
life-threatening.

Your healthcare provider may need to prescribe other medications in addition to XOPENEX Inhalation Solution to help control your asthma. Do not stop taking other asthma medications unless advised by your healthcare provider.

XOPENEX Inhalation Solution 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 healthcare provider will determine if XOPENEX is right for you.

Use as directed by your healthcare 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 Inhalation Solution. 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.

If you currently have, or have had, a history of the following conditions, your healthcare provider will evaluate you to decide if XOPENEX Inhalation Solution 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 Inhalation Solution

What should I tell my healthcare provider?
Review all medications that you are taking with your healthcare provider, including those that you take without prescription. Because of the potential to interact with XOPENEX Inhalation Solution and cause side effects, tell your healthcare provider 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 healthcare provider if you are trying to become pregnant, are already pregnant, or are nursing.

What are some possible side effects of XOPENEX Inhalation Solution?
(This is not a complete list of side effects reported with XOPENEX Inhalation Solution. Your healthcare provider can discuss with you a more complete list of
side effects.)

Side effects of XOPENEX Inhalation Solution may depend on dose. XOPENEX Inhalation Solution may result in a temporary increase in heart rate, tremors, or
nervousness.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

How is XOPENEX Inhalation Solution 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 healthcare provider 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 Inhalation Solution as directed by your healthcare provider.

How is XOPENEX Inhalation Solution stored?
Store XOPENEX Inhalation Solution 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 Inhalation Solution?
Talk to your healthcare provider. Your healthcare provider is the best source of information, or you can call the Sunovion Customer Assistance Center at
1-888-394-7377.

Please refer to the attached Patient's Instructions for Use.

April 2009
Sunovion Pharmaceuticals Inc.
Marlborough, MA 01752


XOPENEX HFA® (levalbuterol tartrate) Inhalation Aerosol

For more information please refer to 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 occurs in asthma or chronic obstructive pulmonary disease (COPD).

What are the symptoms of bronchospasm?
Symptoms of bronchospasm may include: coughing, wheezing, chest tightness, and shortness of breath.

Important Safety Information:
Like other inhaled beta-agonists, XOPENEX HFA can produce a narrowing of the airways called paradoxical bronchospasm, which may be life-threatening.

While you are using XOPENEX HFA Inhalation Aerosol, other inhaled drugs and asthma medications should be taken only as directed by your healthcare 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 healthcare provider will determine if XOPENEX HFA is right for you.

Use as directed by your healthcare 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.

If you currently have, or have had, a history of the following conditions, your healthcare 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 healthcare provider?
Review all medications that you are taking with your healthcare provider, including those that you take without prescription. Because of the potential to interact with XOPENEX HFA and cause side effects, tell your healthcare provider 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 healthcare provider 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 healthcare provider can discuss with you a more complete list of side effects.)

Common adverse effects include palpitations, chest pain, rapid heart rate, tremor, and nervousness.

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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 healthcare provider 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
healthcare provider.

How is XOPENEX HFA stored?
Store XOPENEX HFA at room temperature (68-77°F). Protect from freezing temperatures and direct sunlight. Store with the actuator (or 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 healthcare provider. Your healthcare provider is the best source of information, or you can call the Sunovion Customer Assistance Center at
1-888-394-7377.

April 2009
Sunovion Pharmaceuticals Inc.
Marlborough, MA 01752

 

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