patient counseling information
See FDA-Approved Patient Labeling (17.9)
Patients should be given the following information:
17.1 Frequency of Use
The action of PROAIR HFA Inhalation Aerosol should last for 4 to 6 hours. Do not use PROAIR HFA Inhalation Aerosol more frequently than recommended. Instruct patients to not increase the dose or frequency of doses of PROAIR HFA Inhalation Aerosol without consulting the physician. If patients find that treatment with PROAIR HFA Inhalation Aerosol becomes less effective for symptomatic relief, symptoms become worse, and/or they need to use the product more frequently than usual, they should seek medical attention immediately.
17.2 Priming and Cleaning
Priming: Priming is essential to ensure appropriate albuterol content in each actuation. Instruct patients to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face.
Cleaning: To ensure proper dosing and prevent actuator orifice blockage, instruct patients to wash the red plastic actuator mouthpiece and dry thoroughly at least once a week. Instruct patients that if they have more than one PROAIR HFA inhaler, they should wash each one at separate times to prevent attaching the wrong canister to the wrong plastic actuator. In this way, they can be sure they will always know the correct number of remaining doses. Patients should be instructed to never attach a canister of medicine from any other inhaler to the PROAIR HFA actuator and never attach the PROAIR HFA canister to an actuator from any other inhaler. Patients should not remove the canister from the actuator except during cleaning because reattachment may release a dose into the air and the dose counter will count down each time a spray is released. Detailed cleaning instructions are included in the illustrated Information for the Patient leaflet.
17.3 Dose Counter
Patients should be informed that PROAIR HFA has a dose counter attached to the actuator. When the patient receives the inhaler, a black dot will appear in the viewing window until it has been primed 3 times, at which point the number 200 will be displayed. The dose counter will count down each time a spray is released. The dose-counter window displays the number of sprays left in the inhaler in units of two (e.g., 200, 198, 196, etc). When the counter displays 20, the color of the numbers will change to red to remind the patient to contact their pharmacist for a refill of medication or consult their physician for a prescription refill. When the dose counter reaches 0, the background will change to solid red. Patients should be informed to discard PROAIR HFA inhaler when the dose counter displays 0 or after the expiration date on the product, whichever comes first.
17.4 Paradoxical Bronchospasm
Inform patients that PROAIR HFA Inhalation Aerosol can produce paradoxical bronchospasm. Instruct patients to discontinue PROAIR HFA Inhalation Aerosol if paradoxical bronchospasm occurs.
17.5 Concomitant Drug Use
While patients are taking PROAIR HFA Inhalation Aerosol, other inhaled drugs and asthma medications should be taken only as directed by a physician.
17.6 Common Adverse Events
Common adverse effects of treatment with inhaled albuterol include palpitations, chest pain, rapid heart rate, tremor, or nervousness.
Patients who are pregnant or nursing should contact their physician about the use of PROAIR HFA Inhalation Aerosol.
17.8 General Information on Use
Effective and safe use of PROAIR HFA Inhalation Aerosol includes an understanding of the way that it should be administered.
Shake well before each spray.
Use PROAIR HFA Inhalation Aerosol only with the actuator supplied with the product. Discard the PROAIR HFA inhaler when the dose counter displays 0 or after the expiration date on the product, whichever comes first. Never immerse the canister in water to determine how full the canister is ("float test").
In general, the technique for administering PROAIR HFA Inhalation Aerosol to children is similar to that for adults. Children should use PROAIR HFA Inhalation Aerosol under adult supervision, as instructed by the patient's physician.
17.9 FDA-Approved Patient Labeling
See tear-off illustrated Information for the Patient leaflet.
Mktd by: Teva Respiratory, LLC
Frazer, PA 19355
Mfd by: IVAX Pharmaceuticals Ireland
Copyright ©2012, Teva Respiratory, LLC
All rights reserved.
PROAIR® is a registered trademark of Teva Respiratory, LLC
The color red as used on the ProAir® HFA inhaler is a registered trademark of Teva Respiratory, LLC
Manufactured In Ireland
PE 3378 06/2016
Detach Patient's Instructions for use from package insert and dispense with the product.
PROAIR® HFA (prō' ār)
Read this Patient Information before you start using PROAIR HFA and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
What is PROAIR HFA?
PROAIR HFA is a prescription medicine used in people 4 years of age and older to:
treat or prevent bronchospasm in people who have reversible obstructive airway disease
prevent exercise induced bronchospasm
It is not known if PROAIR HFA is safe and effective in children under 4 years of age.
Who should not use PROAIR HFA?
Do not use PROAIR HFA if you are allergic to albuterol sulfate or any of the ingredients in PROAIR HFA. See the end of this leaflet for a complete list of ingredients in PROAIR HFA.
What should I tell my doctor before I use PROAIR HFA?
Before you use PROAIR HFA, tell your doctor if you:
have heart problems
have high blood pressure (hypertension)
have convulsions (seizures)
have thyroid problems
have low potassium levels in your blood
are pregnant or plan to become pregnant. It is not known if PROAIR 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 PROAIR HFA passes into your breast milk. Talk to your doctor about the best way to feed your baby if you are using PROAIR HFA.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
PROAIR HFA and other medicines may affect each other and cause side effects. PROAIR HFA may affect the way other medicines work, and other medicines may affect the way PROAIR HFA works.
Especially tell your doctor if you take:
other inhaled medicines or asthma medicines
beta blocker medicines
monoamine oxidase inhibitors
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 PROAIR HFA?
For detailed instructions, see "Instructions for Use" at the end of this Patient Information.
Use PROAIR HFA exactly as your doctor tells you to use it.
If your child needs to use PROAIR HFA, watch your child closely to make sure your child uses the inhaler correctly. Your doctor will show you how your child should use PROAIR HFA.
Each dose of PROAIR HFA should last up to 4 hours to 6 hours.
Do not increase your dose or take extra doses of PROAIR HFA without first talking to your doctor.
Get medical help right away if PROAIR HFA no longer helps your symptoms.
Get medical help right away if your symptoms get worse or if you need to use your inhaler more often.
While you are using PROAIR HFA, do not use other inhaled rescue medicines and asthma medicines unless your doctor tells you to do so.
Call your doctor if your asthma symptoms like wheezing and trouble breathing become worse over a few hours or days. Your doctor may need to give you another medicine (for example, corticosteroids) to treat your symptoms.
What are the possible side effects of PROAIR HFA?
PROAIR HFA may cause serious side effects, including:
worsening trouble breathing, coughing and wheezing (paradoxical bronchospasm). If this happens stop using PROAIR HFA and call your doctor or get emergency help right away. Paradoxical bronchospasm is more likely to happen with your first use of a new canister of medicine.
heart problems including faster heart rate and higher blood pressure
possible death in people with asthma who use too much PROAIR HFA
allergic reactions. Call your doctor right away if you have the following symptoms of an allergic reaction:
swelling beneath your skin or in your throat
worsening trouble breathing
low potassium levels in your blood
worsening of other medical problems in people who also use PROAIR HFA including increases in blood sugar
The most common side effects of PROAIR HFA include:
your heart feels like it is pounding or racing (palpitations)
fast heart rate
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of PROAIR HFA. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store PROAIR HFA?
Store PROAIR HFA at room temperature between 59° F and 77° F (15° C and 25° C).
Avoid exposure to extreme heat and cold.
Shake the PROAIR HFA canister well before use.
Do not puncture the PROAIR HFA canister.
Do not store the PROAIR HFA canister near heat or a flame. Temperatures above 120° F may cause the canister to burst.
Do not throw the PROAIR HFA canister into a fire or an incinerator.
Avoid spraying PROAIR HFA in your eyes.
Keep PROAIR HFA and all medicines out of the reach of children.
General Information about the safe and effective use of PROAIR HFA
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PROAIR HFA for a condition for which it was not prescribed. Do not give PROAIR HFA to other people, even if they have the same symptoms that you have. It may harm them.
This Patient Information summarizes the most important information about PROAIR HFA. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about PROAIR HFA that is written for health professionals.
For more information, go to www.ProAirHFA.com or call 1-888-482-9522.
What are the ingredients in PROAIR HFA?
Active ingredient: albuterol sulfate
Inactive ingredients: propellant HFA-134a and ethanol.
Instructions for Use
PROAIR® HFA (prō' ār)
Read this Instructions for Use before you start using PROAIR HFA and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
The Parts of Your PROAIR HFA Inhaler Device:
There are 2 main parts of your PROAIR HFA inhaler device including a:
red plastic actuator that sprays the medicine from the canister. See Figure A.
protective dust cap that covers the mouthpiece of the actuator. See Figure A.
There is also a metal canister that holds the medicine. See Figure A.
There is also a dose counter attached to the back of the actuator with a viewing window that shows you how many sprays of medicine you have left. See Figure B.
You will see a black dot in the viewing window on the actuator until the device has been primed 3 times. See Figure B and "Priming Your PROAIR HFA Device" below.
Do not use the PROAIR HFA actuator with a canister of medicine from any other inhaler.
Do not use a PROAIR HFA canister with an actuator from any other inhaler, including another PROAIR HFA inhaler.
Priming Your PROAIR HFA Device:
Your PROAIR device must be primed before you use it for the first time or if your device has not been used for more than 14 days in a row. Do not prime your PROAIR HFA device every day.
Remove your PROAIR HFA device from its package.
Remove the protective dust cap from the mouthpiece.
Shake the inhaler well, and spray it into the air away from your face. See Figure C.
Shake and spray the inhaler like this 2 more times to finish priming it.
The dose counter on the actuator should display the number 200 after you prime the actuator for the first time. See Figure D.
Each Time You Use Your PROAIR HFA Device:
Make sure the canister fits firmly in the plastic actuator.
Look into the mouthpiece to make sure there are no foreign objects there, especially if the cap has not been used to cover the mouthpiece.
Reading the Dose Counter on Your PROAIR HFA Actuator
The dose counter will count down each time a spray is released. The dose counter window shows the number of sprays left in your inhaler in units of 2 sprays. For example, there are 190 sprays left if the arrow is exactly opposite the number 190, or 189 sprays left if the arrow points between 190 and 188. See Figure D.
When the dose counter reaches 0, it will continue to show 0 and you should replace your PROAIR HFA device.
The dose counter cannot be reset and is permanently attached to the actuator. Never change the numbers for the dose counter or touch the pin inside the actuator.
Do not remove the canister from the plastic actuator except during cleaning. Reattaching the canister to the actuator may accidently release a dose of PROAIR HFA into the air. The dose counter will count down each time a spray is released.
Using Your PROAIR HFA Device:
Step 1. Shake the inhaler well before each spray. Take the cap off the mouthpiece of the actuator.
Step 2. Hold the inhaler with the mouthpiece down. See Figure E.
Step 3. Breathe out through your mouth and push as much air from your lungs as you can. Put the mouthpiece in your mouth and close your lips around it. See Figure F.
Step 4. Push the top of the canister all the way down while you breathe in deeply and slowly through your mouth. See Figure F.
Step 5. 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.
Step 6. Hold your breath as long as you can, up to 10 seconds, then breathe normally.
If your doctor has told you to use more sprays, wait 1 minute and shake the inhaler again. Repeat Steps 2 through Step 6.
Step 7. Put the cap back on the mouthpiece after every time you use the inhaler. Make sure the cap snaps firmly into place.
Cleaning Your PROAIR HFA Device:
It is very important to keep the plastic actuator clean so the medicine will not build-up and block the spray. See Figure G and Figure H.
Do not try to clean the metal canister or let it get wet. The inhaler may stop spraying if it is not cleaned correctly.
If you have more than 1 PROAIR HFA inhaler, wash each device at separate times to prevent putting the wrong canister together with the wrong plastic actuator. This way you can be sure you will always know the correct number of remaining doses of PROAIR HFA.
Wash the actuator at least 1 time each week as follows:
Take the canister out of the actuator, and take the cap off the mouthpiece.
Hold the actuator under the faucet and run warm water through it for about 30 seconds. See Figure I.
Turn the actuator upside down and run warm water through the mouthpiece for about 30 seconds. See Figure J.
Shake off as much water from the actuator as you can. Look into the mouthpiece to make sure any medicine build-up has been completely washed away. If there is any build-up, repeat the washing instructions.
Let the actuator air-dry completely, such as overnight. See Figure K.
When the actuator is dry, put the canister in the actuator and make sure it fits firmly. Shake the inhaler well and spray it twice into the air away from your face. Put the cap back on the mouthpiece.
If you need to use your inhaler before the actuator is completely dry:
Shake as much water off the actuator as you can.
Put the canister in the actuator and make sure it fits firmly.
Shake the inhaler well and spray it twice into the air away from your face.
Take your PROAIR HFA dose as prescribed.
Follow the Cleaning Instructions above.
Replacing Your PROAIR HFA Device
When the dose counter on the actuator says the number 20, the color of the numbers will change to red. The red numbers are to remind you to refill your prescription or ask your doctor for another prescription for PROAIR HFA. When the dose counter reaches 0, the background color will change to solid red.
Throw the PROAIR HFA inhaler away as soon as the dose counter says 0 or after the expiration date on the PROAIR HFA packaging, whichever comes first. You should not keep using the inhaler after 200 sprays even though the canister may not be completely empty. You cannot be sure you will receive any medicine after using 200 sprays.
Do not use the inhaler after the expiration date on the PROAIR HFA packaging.
This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
Marketed by Teva Respiratory, LLC
Frazer, PA 19355
Manufactured by IVAX Pharmaceuticals Ireland