Xopenex HFA: Uses, Side Effects and Dosage

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

Do not use XOPENEX HFA if you:

• are allergic to levalbuterol, racemic albuterol or any of the ingredients in XOPENEX HFA. See the end of this Patient Information leaflet for a complete list of ingredients in XOPENEX HFA.

Before you use XOPENEX HFA, tell your doctor about all of your medical conditions, including if you:

• have heart problems.
• have high blood pressure.
• have seizures.
• have diabetes.
• have thyroid problems.

• are pregnant or plan to become pregnant. It is not known if XOPENEX HFA will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.

• are breastfeeding or plan to breastfeed. It is not known if XOPENEX HFA passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use XOPENEX HFA.

Tell your doctor about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. XOPENEX HFA may affect the way other medicines work, and other medicines may affect how XOPENEX HFA works.

Especially tell your doctor if you take:

• other inhaled medicines or asthma medicines
• heart medicines
• medicines that increase urination (diuretics)
• antidepressants
• medicine to treat chronic obstructive pulmonary disease (COPD). Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I use XOPENEX HFA?

• Read the step-by-step Instructions for use for XOPENEX HFA at the end of this Patient Information leaflet.
• XOPENEX HFA is for oral inhalation use only.
• 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. Your doctor should show you how your child should 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
• your asthma symptoms get worse
• you need to use XOPENEX HFA more often than usual

• While you are using XOPENEX HFA, do not use other inhaled medicines and asthma medicines unless your doctor tells you to.

What are the possible side effects of XOPENEX HFA?

XOPENEX HFA can cause serious side effects including:

• 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.

The most common side effects of XOPENEX HFA include:

• accidental injury
• bronchitis
• dizziness
• pain

• sore throat
• runny nose
• vomiting
• palpitations

• chest pain
• fast heart rate
• tremors
• nervousness

These are not all the possible side effects of XOPENEX HFA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Lupin Pharmaceuticals, Inc. at 1-800-399-2561.

How should I store XOPENEX HFA?

• Store XOPENEX HFA at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not use or store XOPENEX HFA inhaler near heat or open flame. Temperatures above 120°F may cause the canister to burst.
• Do not freeze XOPENEX HFA.
• Keep XOPENEX HFA out of direct sunlight.
• Do not put a hole in the XOPENEX HFA canister.
• Store XOPENEX HFA with the mouthpiece down.
• Throw away XOPENEX HFA when the dose indicator display window reaches zero "0", showing that all 200 sprays (actuations) have been used.
• Do not throw XOPENEX HFA into a fire or an incinerator.

Keep XOPENEX HFA and all medicines out of the reach of children.

General information about the safe and effective use of XOPENEX HFA

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use XOPENEX HFA for a condition for which it was not prescribed. Do not give XOPENEX HFA to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or doctor for information about XOPENEX HFA that is written for health professionals.

What are the ingredients in XOPENEX HFA?

Active ingredient : levalbuterol tartrate

Inactive ingredients : propellant HFA-134a, Dehydrated Alcohol USP, Oleic Acid NF

INSTRUCTIONS FOR USE

XOPENEX HFA^®

(zō-pen-eks hfa)

(levalbuterol tartrate)

inhalation aerosol, for oral inhalation use

Important Information:

• For oral inhalation use only
• Use XOPENEX HFA exactly as your doctor tells you to.
• If you have any questions about the use of your inhaler, ask your doctor or pharmacist.

The parts of your XOPENEX HFA inhaler (See Figure 1):

Figure 1

• XOPENEX HFA comes as a canister that fits into an actuator with a dose indicator.

  • Do not use the XOPENEX HFA actuator with a canister of medicine from any other inhaler.
  • Do not use the XOPENEX HFA canister with an actuator from any other inhaler.
• The dose indicator display window will show you how many sprays of medicine you have left in your inhaler. A spray of medicine is released each time you press down on the center of the dose indicator.
• It is important that you pay attention to the number of sprays left in your XOPENEX HFA inhaler by reading the dose indicator. You should also keep track of the number of sprays used from your inhaler.

Each canister of XOPENEX HFA contains enough medicine for you to spray your medicine 200 times (See Figure 2a).

• The pointer will be pointing between 180 and 200 after you take 10 sprays. This means that there are 190 sprays of medicine left in the canister (See Figure 2b).
• The pointer will be pointing to 180 after you take 10 more sprays. This means that there are 180 sprays of medicine left in the canister (See Figure 2c).

Figure 2a	Figure 2b	Figure 2c
200 sprays	190 sprays	180 sprays

• The dose indicator display window will continue to move after every 10 sprays. The number on the dose indicator display window will continue to change after every 20 sprays.

Figure 2d

• The dose indicator display window will change to red, as shown in the shaded area, when there are only 20 sprays of medicine left in your inhaler (See Figure 2d). You should refill your prescription or ask your doctor if you need another prescription for XOPENEX HFA.
• When the number in the dose indicator display window reaches zero "0", this means that 200 sprays of medicine have been used. Throw away your XOPENEX HFA inhaler.

Note: Do not place the canister under water to find out the amount of medicine left in the canister.

Preparing your XOPENEX HFA inhaler for use:

• Your XOPENEX HFA inhaler should be at room temperature before you use it.
• Shake the inhaler well before each use.

Priming your XOPENEX HFA inhaler:

Before you use XOPENEX HFA for the first time or if you have not taken your medicine for 3 days in a row, you must prime the inhaler.

• Look at the dose indicator on top of the inhaler. Make sure that the pointer on the dose indicator is pointing to the "200" inhalation mark before you use your XOPENEX HFA inhaler for the first time.
• Take the cap off the mouthpiece of the actuator (See Figure 3). Check inside the mouthpiece for objects before use.

Figure 3

• Hold the inhaler in the upright position away from the face and shake the inhaler well (See Figure 4).

Figure 4

• Press down fully on the center of the dose indicator to release a spray of medicine from the mouthpiece (See Figure 5). You may hear a soft click from the dose indicator as it counts down during use.

Figure 5

• Avoid spraying in your eyes.
• Repeat the priming steps 3 more times (See Figure 4 and Figure 5) to finish priming the inhaler.
• After priming 4 times the first time you use your XOPENEX HFA inhaler, the dose indicator should be pointing to "200" and your inhaler is now ready to use.

If you do not use your XOPENEX HFA inhaler for more than 3 days, you will need to prime the inhaler again before use.

Using your XOPENEX HFA inhaler:

Step 1: Take the cap off the mouthpiece of the actuator (See Figure 3). Check inside the mouthpiece for objects. Make sure the canister fits firmly in the actuator.

Step 2: Shake the inhaler well for 5 seconds before use.

Step 3: Hold the inhaler upright with the mouthpiece pointing towards you. 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 (See Figure 6).

Figure 6

Step 4: Put the mouthpiece in your mouth and close your lips around it.

Figure 7

Step 5: While breathing in deeply and slowly, press down on the center of the targeting rings (See Figure 7) until a spray of medicine has been released. Then stop pressing the dose indicator.

Step 6: When you have finished breathing in, remove the mouthpiece from your mouth. Close your mouth and hold your breath for 10 seconds if possible. Then breathe out gently.

.

Step 7: Wait about 1 minute, then shake the inhaler well. Repeat steps 3 through 6 to take your second spray of XOPENEX HFA.

Step 8: Put the cap back on the mouthpiece right away after use.

Make sure the cap snaps firmly into place.

Cleaning your XOPENEX HFA inhaler:

Figure 8

Clean the inhaler 1 time each week. It is very important to keep the actuator clean so that medicine will not build up and block the spray from the mouthpiece (See Figure 8).

To clean the actuator:

Step 1: Take the canister out of the actuator (See Figure 9). Do not clean the canister or let it get wet.

Figure 9

Step 2: Take the cap off the mouthpiece.

Step 3: Hold the actuator under the faucet and run warm water through it for at least 30 seconds. Turn the actuator upside down and rinse the actuator again through the mouthpiece for at least 30 seconds (See Figure 10).

Figure 10

Step 4: Shake off as much water from the actuator as you can.

Step 5: Look inside the actuator and mouthpiece to make sure any medicine build-up has been completely washed away. Medicine build-up is more likely to happen if the actuator is not allowed to air-dry completely.

Step 6: Let the actuator air-dry overnight. Do not put the canister back into the actuator if it is still wet.

Step 7: When the actuator is dry, put the canister back in the actuator and put the cap back on the mouthpiece. Make sure to firmly press the canister down in the actuator.

Note: If your actuator becomes blocked, it means that little or no medicine is coming out of the mouthpiece (See Figure 11). Repeat Steps 1 through 7 above in the section "To clean the actuator".

Figure 11

If you need to use your inhaler before the plastic actuator is completely dry:

• Shake off as much water from the actuator as you can.
• Put the canister back into the actuator and shake the inhaler well.
• To remove most of the water from your inhaler, press down on the center of the targeting rings 2 times to release a total of 2 sprays into the air away from your face.
• Take your prescribed dose of medicine.
• Repeat Steps 1 through 7above in the section "To clean the actuator".

How should I store XOPENEX HFA?

• Store XOPENEX HFA at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not use or store XOPENEX HFA inhaler near heat or open flame. Temperatures above 120°F may cause the canister to burst.
• Do not freeze XOPENEX HFA.
• Keep XOPENEX HFA out of direct sunlight.
• Do not put a hole in the XOPENEX HFA canister.
• Store XOPENEX HFA with the mouthpiece down.
• Throw away XOPENEX HFA when the dose indicator display window reaches zero "0", showing that all 200 sprays (actuations) have been used.
• Do not throw XOPENEX HFA into a fire or incinerator.

Keep XOPENEX HFA and all medicines out of the reach of children.

© 2005, 2012, 2024 Lupin Inc. All rights reserved

XOPENEX HFA is a registered trademark of Lupin Inc.

and LUPIN is a registered trademark of Lupin Pharmaceuticals, Inc.

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

LUPIN^®

Manufactured for and Distributed by:

Lupin Pharmaceuticals, Inc.

Naples, FL 34108

To report adverse events, call 1-800-399-2561.

For patent information: https://www.lupin.com/US/specialty/patent-information/

Revised August 2024

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