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|Xopenex HFA Aerosol

Xopenex HFA Aerosol

Xopenex HFA Aerosol is used for:

Treating and preventing breathing problems in patients who have asthma or certain airway diseases. It may also be used for other conditions as determined by your doctor.

Xopenex HFA Aerosol is a sympathomimetic (beta-agonist) bronchodilator. It works by relaxing the smooth muscle in the airway, which allows air to flow in and out of the lungs more easily.

Do NOT use Xopenex HFA Aerosol if:

• you are allergic to any ingredient in Xopenex HFA Aerosol or to albuterol

Contact your doctor or health care provider right away if any of these apply to you.

Before using Xopenex HFA Aerosol:

Some medical conditions may interact with Xopenex HFA Aerosol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of heart problems (eg, fast or irregular heartbeat, low blood output), blood vessel problems, high blood pressure, or low blood potassium levels
• if you have a history of seizures, diabetes, overactive thyroid, kidney problems, or adrenal gland tumor (pheochromocytoma)
• if you have ever had an unusual reaction to another sympathomimetic medicine (eg, pseudoephedrine)
• if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or tricyclic antidepressant (eg, amitriptyline), or if you have taken either of these within the last 14 days

Some MEDICINES MAY INTERACT with Xopenex HFA Aerosol. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood potassium levels may be increased
• Catechol-O-methyltransferase (COMT) inhibitors (eg, entracapone), epinephrine, MAOIs (eg, phenelzine), short-acting sympathomimetic bronchodilators (eg, metaproterenol), stimulants (eg, amphetamine), sympathomimetics (eg, pseudoephedrine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Xopenex HFA Aerosol"s side effects
• Beta-blockers (eg, propranolol) because they may decrease Xopenex HFA Aerosol"s effectiveness
• Digoxin because its effectiveness may be decreased by Xopenex HFA Aerosol

This may not be a complete list of all interactions that may occur. Ask your health care provider if Xopenex HFA Aerosol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Xopenex HFA Aerosol:

Use Xopenex HFA Aerosol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Xopenex HFA Aerosol. Talk to your pharmacist if you have questions about this information.
• Prime the inhaler before you use it for the first time. To prime it, spray 4 test sprays into the air, away from your face. You will need to reprime the inhaler any time it has not been used for longer than 3 days.
• Before using Xopenex HFA Aerosol, be sure that the canister is properly placed in the inhaler unit. Shake well before each dose. Breathe out slowly and completely. Place the mouthpiece between your lips and try to rest your tongue flat, unless your doctor has told you otherwise. Your doctor may have told you to hold the inhaler 1 to 2 inches (2 or 3 centimeters) away from the open mouth or to use a special spacing device. As you start to take a slow, deep breath, press the canister and mouthpiece together at exactly the same time. This will release a dose of Xopenex HFA Aerosol. Continue breathing in slowly and deeply and hold for 10 seconds or as long as comfortable, then breathe out slowly through pursed lips or your nose. If more than 1 inhalation is to be used, wait a few minutes and repeat the above steps. Keep the spray away from your eyes.
• Replace the cap on the mouthpiece after each use
• Clean the plastic mouthpiece and cap at least once a week to prevent blockage. Remove the metal canister. Rinse in warm running water for at least 30 seconds. Shake off excess water, and then allow the mouthpiece to air dry completely (eg, overnight). After the plastic case and cap dry, replace the canister. Place the cap back on the mouthpiece. Do NOT allow the metal canister to become wet.
• If you must use the inhaler before it is completely dry, shake the excess water off of the plastic mouthpiece. Insert the canister into the plastic case, shake well, and spray 2 times into the air, away from yourself and others. You may then use a dose. After your dose, rewash the plastic case and air dry completely.
• If the inhaler becomes blocked, wash the plastic case as directed.
• This inhaler contains 200 sprays. Do not use this inhaler after 200 sprays have been used. It may not give the correct amount of medicine with each spray.
• Do not use Xopenex HFA Aerosol with any other mouthpiece. Do not use this mouthpiece with any other medicine.
• If you miss a dose of Xopenex HFA Aerosol and you are using it regularly, use it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Xopenex HFA Aerosol.

Important safety information:

• Xopenex HFA Aerosol may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Xopenex HFA Aerosol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Xopenex HFA Aerosol may sometimes cause severe breathing problems right after you use a dose. When this problem occurs, it is often after the first use of a new canister. If this happens, seek medical care at once.
• If your usual dose does not work well, your symptoms become worse, or you need to use it more often than normal, contact your doctor at once. This may be a sign of seriously worsening asthma. Your doctor may need to change your dose or medicine.
• Xopenex HFA Aerosol should work for up to 4 to 6 hours. Do NOT use more than the recommended dose or use more often than prescribed without checking with your doctor. The risk of severe heart problems and sometimes death may be increased with overuse of Xopenex HFA Aerosol.
• Talk with your doctor or pharmacist about all of your asthma medicines and how to use them. Do not start, stop, or change the dose of any asthma medicine unless your doctor tells you to.
• Xopenex HFA Aerosol may cause dry mouth or an unpleasant taste in your mouth. Rinsing your mouth with water after each dose may help relieve these effects.
• Tell your doctor or dentist that you take Xopenex HFA Aerosol before you receive any medical or dental care, emergency care, or surgery.
• Keep track of how many inhalations you use. When your medicine supply begins to run low, call your doctor or pharmacy as soon as possible for a refill.
• Do NOT place the canister in water to try to determine how much medicine you have left.
• The contents of this canister are under pressure. Do NOT store or use Xopenex HFA Aerosol near an open flame. Do NOT puncture, break, or burn the container, even if it appears empty.
• Diabetes patients - Xopenex HFA Aerosol may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests, including lung function, may be performed while you use Xopenex HFA Aerosol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Xopenex HFA Aerosol with caution in the ELDERLY; they may be more sensitive to its effects.
• Caution is advised when using Xopenex HFA Aerosol in CHILDREN; they may experience vomiting with use of Xopenex HFA Aerosol. Safety and effectiveness in children younger than 4 years old have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Xopenex HFA Aerosol while you are pregnant. It is not known if Xopenex HFA Aerosol is found in breast milk. If you are or will be breast-feeding while you use Xopenex HFA Aerosol, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Xopenex HFA Aerosol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; dry mouth; nervousness; runny or stuffy nose; sore or dry throat; tremor.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fast or irregular heartbeat; new or worsening wheezing, coughing, or trouble breathing; severe headache or dizziness; severe or persistent trouble sleeping; sudden shortness of breath; unusual hoarseness.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include chest pain; dizziness; fast or irregular heartbeat; seizures; severe or persistent dizziness or headache; severe or persistent nervousness, tremor, or trouble sleeping.

Store Xopenex HFA Aerosol upright between 68 and 77 degrees F (20 and 25 degrees C). Store with the mouthpiece down. Do not freeze. Avoid temperatures above 120 degrees F (48 degrees C). Store away from heat and direct sunlight. Keep Xopenex HFA Aerosol out of the reach of children and away from pets.

General information:

• If you have any questions about Xopenex HFA Aerosol, please talk with your doctor, pharmacist, or other health care provider.
• Xopenex HFA Aerosol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Xopenex HFA Aerosol. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.