Xopenex HFA

Xopenex HFA is an inhaled prescription medicine used for the treatment or prevention of asthma in people 4 years of age and older. Xopenex HFA belongs to a group of drugs called beta agonists, or bronchodilators, which work by relaxing and opening air passages to the lungs to make breathing easier.

Xopenex HFA comes as an inhaler and is usually inhaled every 4 to 6 hours. 

Common side effects of Xopenex HFA include accidental injury, inflammation of the tubes which carry air to and from the lungs (bronchitis), and dizziness. 

See "Xopenex" for information about the nebulizer form of Xopenex. 

Xopenex HFA is an inhaled prescription medicine used for the treatment or prevention of asthma in people 4 years of age and older.

Xopenex HFA has not been shown to be safe and effective in children younger than 4 years of age.

• Sunovion

Xopenex HFA can cause serious side effects. See "Xopenex HFA Precautions" section.

The most common side effects of Xopenex HFA include:

• accidental injury
• inflammation of the tubes which carry air to and from the lungs (bronchitis)
• dizziness
• pain
• sore throat
• runny nose
• vomiting
• palpitations
• chest pain
• fast heart rate
• tremors
• nervousness

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other asthma medicines
• beta blockers such as metoprolol (Toprol XL, Lopressor), carvedilol (Coreg), bisoprolol (Zebeta), betaxolol (Kerlone), nebivolol (Bystolic), propranolol (Inderal)
• heart medicines
• medicines that increase urination (diuretics) such as acetazolamide (Diamox), amiloride (Midamor), bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide, HCTZ), metolazone (Zaroxolyn), torsemide (Demadex), triamterene (Dyrenium, Dyazide, Maxzide)
• digoxin (Lanoxin)
• Monoamine Oxidase Inhibitors such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)
• Tricyclic Antidepressants such as trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)
• medicine to treat chronic obstructive pulmonary disease (COPD)

This is not a complete list of Xopenex HFA drug interactions. Ask your pharmacist or doctor for more information.

Serious side effects have been reported with Xopenex HFA including the following:

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

Do not use Xopenex if you are allergice to Xoponex HFA, levalbuterol, racemic albuterol, or any of the ingredients in Xopenex HFA. 

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Xopenex HFA there are no specific foods that you must exclude from your diet when receiving this medication. 

Before you use Xopenex HFA, tell your doctor if you have:

• had an allergic reaction to levalbuterol or racemic albuterol or Xopenex HFA
• heart problems
• high blood pressure
• seizures
• diabetes
• thyroid problems
• any other medical conditions
• are pregnant or planning to become pregnant 
• are breastfeeding or plan to breastfeed

Xopenex HFA may affect the way other medicines work, and other medicines may affect how  Xopenex HFA works.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Xopenex HFA falls into category C. There are no good studies that have been done in humans with Xopenex HFA. Because animal reproduction studies are not always predictive of human response, Xopenex HFA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Tell your doctor if you are breastfeeding or plan to breastfeed. 

It is not known if Xopenex HFA crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Xopenex HFA.

Use Xopenex HFA 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 HFA.
• An adult should help a child use Xopenex HFA.
• Do not use your Xopenex HFA more often than your doctor tells you to.
• Get medical help right away if Xopenex HFA:
  • does not work as well for your asthma symptoms or
  • your asthma symptoms get worse or
  • you need to use your Xopenex HFA 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 HFA.

Using your Xopenex HFA inhaler

• Xopenex HFA should be at room temperature before you use it.

Priming the inhaler:

Before you use Xopenex HFA for the first time, you must prime the inhaler so that you will get the right amount of medicine when you use it.

• To prime the inhaler, take the cap off the mouthpiece and shake the inhaler well. Then spray the inhaler into the air away from your face. Avoid spraying in your eyes. Shake and spray the inhaler like this 3 more times to finish priming it.
• You must prime the inhaler again if you have not used it in more than 3 days.
• An adult should help a child use Xopenex HFA.

Read the following 6 steps before using Xopenex HFA and follow them before each use. If you have any questions, ask your doctor or pharmacist.

1. Take the cap off the mouthpiece of the actuator. Look inside the mouthpiece for foreign objects, and remove any that you see. Make sure the canister fits firmly in the actuator. Shake the inhaler well for 5 seconds.

2. Hold the inhaler with the mouthpiece down. Before you put the mouthpiece in your mouth, breathe out through your mouth and push out as much air from your lungs as you can. Put the mouthpiece in your mouth and close your lips around it.

3. Push the top of the canister all the way down while you breathe in deeply and slowly through your mouth. Right after the spray comes out, take your finger off the canister. After you have breathed in all the way, take the inhaler out of your mouth and close your mouth.

4. Hold your breath for 10 seconds if possible. Then breathe normally.
5. Wait about 1 minute, then shake the inhaler well. Repeat steps 2 through 4.
6. Put the cap back on the mouthpiece after each time you use the Xopenex HFA. Make sure the cap snaps firmly into place.

Cleaning your ​Xopenex HFA inhaler:

Make sure to regularly clean your inhaler.

• The inhaler may stop working if you do not properly clean the blue plastic actuator mouthpiece at least one time a week.
  To clean the actuator:
  • Remove the canister and red mouthpiece cap. Do not clean the metal canister or allow the metal canister to become wet.
  • Wash the actuator through the top and bottom with warm running water for at least 30 seconds.
  • Shake the actuator to remove excess water.
  • Air-dry the actuator completely. Blockage from medicine build-up is more likely to happen if the actuator is not allowed to air-dry thoroughly.
• When the actuator is dry, replace the canister and the mouthpiece cap.
• Make sure the canister is fully and firmly inserted into the actuator.
• If your actuator becomes blocked, it means that little or no medicine is coming out of the mouthpiece. Wash your actuator and air-dry completely as described above.
• If you need to use your inhaler before the plastic actuator is completely dry:
  • ​Shake the excess water off the actuator.
  • Replace the canister and shake well.
  • Test-spray twice into the air, away from your face, to remove most of the water remaining in the actuator.
  • Take your dose as prescribed.
  • Rewash the actuator and air-dry it thoroughly as described above.

The dose your doctor recommends may be based on the following:

• the severity of the condition being treated

The recommended dose of Xopenex HFA for adults and children 4 years of age and older is 2 inhalations repeated every 4 to 6 hours. In some patients, 1 inhalation every 4 hours may work. 

If you take too much Xopenex HFA, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Xopenex HFA between 68°F to 77°F (20°C to 25°C).
• Keep Xopenex HFA inhaler away from heat or open flame.
• Keep Xopenex HFA inhaler away from freezing temperatures and direct sunlight.
• Do not puncture the Xopenex HFA inhaler.
• Store Xopenex HFA inhaler with the mouthpiece down.
• The Xopenex HFA inhaler should be safely thrown away after using:
  • 200 actuations for the 15 gram canister.
  • 80 actuations for the 8.4 gram canister.
• Do not throw Xopenex HFA inhaler into a fire or an incinerator.
• Keep this and all medicines out of the reach of children.