facebook
Subscribe50$/product give away!


Submit an Article to Pharmacy HQ     
Please include the author's name, title, and citations.     

ALBUTEROL SULATE HFA- albuterol sulfate aerosol, metered


  1. Patient Information
  2. Frequency Of Use:
  3. Albuterol Sulfate Hfa Is A Prescription Inhaled Medicine Used In People Aged 4 Years And Older To:
  4. Who Should Not Use Albuterol Sulfate Hfa?
  5. Tell Your Healthcare Provider About All Of Your Health Conditions, Including If You:
  6. Albuterol Sulfate Hfa Can Cause Serious Side Effects, Including:
  7. Common Side Effects Of Albuterol Sulfate Hfa Include:
  8. How Should I Store Albuterol Sulfate Hfa?
  9. The Contents Of Your Albuterol Sulfate Hfa Are Under Pressure:
  10. What Are The Ingredients In Albuterol Sulfate Hfa?
  11. If You Need To Use Your Inhaler Before The Actuator Is Completely Dry:
  12. Replacing Your Albuterol Sulfate Hfa Inhaler:
  13. For Correct Use Of Your Albuterol Sulfate Hfa Inhaler, Remember:
  14. Manufactured By:
  15. Manufactured For:
  16. Contents:
  17. Important:
  18. Contents Under Pressure:
  19. Revised: 2/2019document Id:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Frequency Of Use: 

Inform patients that the action of Albuterol Sulfate HFA should last up to 4 to 6 hours. Do not use Albuterol Sulfate HFA more frequently than recommended. Instruct patients not to increase the dose or frequency of doses of Albuterol Sulfate HFA without consulting the physician. Instruct patients to

Albuterol Sulfate Hfa Is A Prescription Inhaled Medicine Used In People Aged 4 Years And Older To: 

treat or prevent bronchospasm in people who have reversible obstructive airway disease
prevent exercise-induced bronchospasm

It is not known if Albuterol Sulfate HFA is safe and effective in children younger than 4 years of age.

Who Should Not Use Albuterol Sulfate Hfa? 

Do not use Albuterol Sulfate HFAif you are allergic to albuterol sulfate or any of the ingredients in Albuterol Sulfate HFA.

Tell Your Healthcare Provider About All Of Your Health Conditions, Including If You: 

have heart problems.
have high blood pressure.
have seizures.
have thyroid problems.
have diabetes.
have low potassium levels in your blood.
are allergic to any of the ingredients in Albuterol Sulfate HFA or any other medicines.

Read the step-by-step instructions for using Albuterol Sulfate HFA at the end of this Patient Information.

Do notuse Albuterol Sulfate HFA unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
Children should use Albuterol Sulfate HFA with an adult s help, as instructed by the child s healthcare provider.
Use Albuterol Sulfate HFA exactly as your healthcare provider tells you to use it.Do notuse Albuterol Sulfate HFA more often than prescribed.
Do notincrease your dose or take extra doses of Albuterol Sulfate HFA without first talking to your healthcare provider.
Each dose of Albuterol Sulfate HFA should last up to 4 hours to 6 hours.
Get medical help right away if Albuterol Sulfate 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 Albuterol Sulfate HFA, use other inhaled medicines and asthma medicines only as directed by your healthcare provider.
Call your healthcare provider if your asthma symptoms like wheezing and trouble breathing become worse over a few hours or days. Your healthcare provider may need to give you another medicine to treat your symptoms.

Albuterol Sulfate Hfa Can Cause Serious Side Effects, Including: 

worsening trouble breathing, coughing, and wheezing (paradoxical bronchospasm).If this happens, stop using Albuterol Sulfate HFA and call your healthcare provider 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 Albuterol Sulfate HFA
serious allergic reactions.Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
rash
hives
swelling of your face, mouth, and tongue
breathing problems
changes in laboratory blood levels (sugar, potassium)

Common Side Effects Of Albuterol Sulfate Hfa Include: 

sore throat
upper respiratory tract infection, including viral infection
cough
muscle pain
your heart feels like it is pounding or racing (palpitations)
chest pain
fast heart rate
shakiness
nervousness
dizziness

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the side effects with Albuterol Sulfate HFA. Ask your healthcare provider or pharmacist for more information.

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 Albuterol Sulfate Hfa? 

Store Albuterol Sulfate HFA at room temperature between 68 F and 77 F (20 C and 25 C) with the mouthpiece down.

The Contents Of Your Albuterol Sulfate Hfa Are Under Pressure: 

Do not puncture. Do not use or store near heat or open flame. Temperatures above 120 F may cause the canister to burst.
Do not throw into fire or an incinerator.
Store Albuterol Sulfate HFA in the unopened foil pouch and only open when ready for use.
Keep Albuterol Sulfate HFA and all medicines out of the reach of children.

General information about the safe and effective use of Albuterol Sulfate HFA

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

This Patient Information leaflet summarizes the most important information about Albuterol Sulfate HFA. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information about Albuterol Sulfate HFA that was written for healthcare professionals.

For more information about Albuterol Sulfate HFA, call 1-888-825-5249.

What Are The Ingredients In Albuterol Sulfate Hfa? 

Active ingredient: albuterol sulfate

Inactive ingredient: propellant HFA-134a

Instructions for Use

For Oral Inhalation Only

Your Albuterol Sulfate HFA inhaler

The metal canister holds the medicine.See Figure A.
Figure A

Figure A

The canister has a counter to show how many sprays of medicine you have left. The number shows through a window in the back of the actuator.See Figure B.
Figure B

Figure B

The counter starts at204. The number will count down by 1 each time you spray the inhaler. The counter will stop counting at000.
Do not try to change the numbers or take the counter off the metal canister.The counter cannot be reset, and it is permanently attached to the canister.
The blue plastic actuator sprays the medicine from the canister. The actuator has a protective cap that covers the mouthpiece.See Figure A.Keep the protective cap on the mouthpiece when the canister is not in use. The strap keeps the cap attached to the actuator.
Do notuse the actuator with a canister of medicine from any other inhaler.
Do notuse an Albuterol Sulfate HFA canister with an actuator from any other inhaler.

Before using your Albuterol Sulfate HFA inhaler

Take Albuterol Sulfate HFA out of the foil pouch just before you use it for the first time. Safely throw away the pouch and the drying packet that comes inside the pouch.
The inhaler should be at room temperature before you use it.
If your child needs to use Albuterol Sulfate HFA, watch your child closely to make sure your child uses the inhaler correctly. Your healthcare provider will show you how your child should use Albuterol Sulfate HFA.

Priming your Albuterol Sulfate HFA inhaler

Before you use Albuterol Sulfate 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 1 time into the air away from your face.See Figure C. Avoid spraying in eyes.
Figure C

Figure C

Shake and spray the inhaler like this 3 more times to finish priming it. The counter should now read200.See Figure D.
Figure D

Figure D

You must prime your inhaler again if you have not used it in more than 14 days or if you drop it. Take the cap off the mouthpiece and shake and spray the inhaler 4 times into the air away from your face.

How to use your Albuterol Sulfate HFA inhaler

Follow these steps every time you use Albuterol Sulfate HFA.

Step 1.Make sure the canister fits firmly in the actuator. The counter should show through the window in the actuator.

Shake the inhaler wellbefore each spray.

Take the cap off the mouthpiece of the actuator. Look inside the mouthpiece for foreign objects, and take out any you see.

Step 2.Hold the inhaler with the mouthpiece down.See Figure E.

Figure E

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.

Figure F

Figure F

Step 4.Push the top of the canisterall the way downwhile you breathe in deeply and slowly through your mouth.See Figure F.

Step 5.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 for about 10 seconds,or for as long as is comfortable.Breathe out slowly as long as you can.

If your healthcare provider 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 it snaps firmly into place.

Cleaning your Albuterol Sulfate HFA inhaler

Clean your inhaler at least 1 time each week. You may not see any medicine build-up on the inhaler, but it is important to keep it clean so medicine build-up will not block the spray.See Figure G.

Figure G

Figure G

Step 8.Take the canister out of the actuator, and take the cap off the mouthpiece. The strap on the cap will stay attached to the actuator.

Step 9.Hold the actuator under the faucet and run warm water through it for about 30 seconds.See Figure H.

Figure H

Figure H

Step 10.Turn the actuator upside down and run warm water through the mouthpiece for about 30 seconds.See Figure I.

Figure I

Figure I

Step 11.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 Steps 9 and 10.

Step 12.Let the actuator air-dry overnight.See Figure J.

Figure J

Figure J

Step 13.When the actuator is dry, put the protective cap on the mouthpiece and then put the canister in the actuator and make sure it fits firmly. Shake the inhaler well, remove the cap, and spray the inhaler once into the air away from your face. (The counter will count down by 1 number.) 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 cap on the mouthpiece and then put the canister in the actuator and make sure it fits firmly.
Shake the inhaler well and spray it 1 time into the air away from your face.
Take your Albuterol Sulfate HFA dose as prescribed.
Follow cleaning Steps 8 through 13 above.

Replacing Your Albuterol Sulfate Hfa Inhaler: 

When the counter reads 020, you should refill your prescription or ask your healthcare provider if you need another prescription for Albuterol Sulfate HFA.
Throw the inhaler awaywhen the counter reads000or 12 months after you opened the foil pouch, whichever comes first. You should not keep using the inhaler when the counter reads000because you will not receive the right amount of medicine.
Do not use the inhalerafter the expiration date, which is on the packaging it comes in.

For Correct Use Of Your Albuterol Sulfate Hfa Inhaler, Remember: 

The canister should always fit firmly in the actuator.
Breathe in deeply and slowly to make sure you get all the medicine.
Hold your breath for about 10 seconds after breathing in the medicine. Then breathe out fully.
Always keep the protective cap on the mouthpiece when your inhaler is not in use.
Always store your inhaler with the mouthpiece pointing down.
Clean your inhaler at least 1 time each week.

If you have questions about Albuterol Sulfate HFA or how to use your inhaler, call 1-888-825-5249.

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

Manufactured By: 

GlaxoSmithKline

Research Triangle Park, NC 27709

December 2015

VNT-PS:1PIL

Relabeled By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL

NDC 68788-7353-2

Albuterol SulfateHFA

Inhalation Aerosol

90 mcg per actuation

200 Metered Inhalations

FOR ORAL INHALATION ONLY

For use with Albuterol Sulfate HFA actuator only.

Discard when the counter reads 000 or 12 months after removal from the moisture-protective foil pouch.

Pouch opened: ____ Use by: ____

Net Wt. 18 g

Manufactured For: 

Prasco Laboratories

Mason, OH 45040 USA

Rxonly

Relabeled By: Preferred Pharmaceuticals Inc.

Contents: 

A microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). Each actuation delivers 108 mcg of albuterol sulfate equivalent to 90 mcg albuterol base from the mouthpiece. See prescribing information for dosage information.

Important: 

Read accompanying directions carefully.

WARNING: Do not exceed the dose prescribed by your doctor.

If difficulty in breathing persists, get immediate medical help.

Contents Under Pressure: 

Do not puncture. Do not use or store near heat or open flame. Keep out of reach of children.

Shake the inhaler well before each spray.

Store at room temperature between 68oF and 77oF (20oC and 25oC). with the mouthpiece down.

10000000139663 Rev. 5/16
Albuterol Sulfate Inhalation Aerosol
ALBUTEROL SULATE HFA
albuterol sulfate aerosol, metered
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68788-7353(NDC:66993-019)
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALBUTEROL SULFATE(UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)ALBUTEROL90 ug
Inactive Ingredients
Ingredient NameStrength
NORFLURANE(UNII: DH9E53K1Y8)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-7353-21 in 1 CARTON02/27/2019
1200 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02098302/27/2019
Labeler -Preferred Pharmaceuticals Inc. (791119022)
Registrant -Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-7353)

Revised: 2/2019document Id: 

1106c156-f70c-46a1-9855-899386ae8341Set id: 1106c156-f70c-46a1-9855-899386ae8341Version: 1Effective Time: 20190227Preferred Pharmaceuticals Inc.



Your use of this website constitutes your agreement to the terms and conditions linked below:
Terms and Conditions | Resources
2017 © Copyright PharmacyHQ.com. Questions?
Please contact: pharmacyhq.mail@gmail.com