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ADVAIR HFA- fluticasone propionate and salmeterol xinafoate aerosol, metered


  1. Patient Information
  2. Advair Hfa Is Used For Asthma As Follows:
  3. Do Not Use Advair Hfa:
  4. Call Your Healthcare Provider Or Get Medical Care Right Away If:
  5. Advair Hfa Can Cause Serious Side Effects, Including:
  6. Symptoms Of Adrenal Insufficiency Include:
  7. Common Side Effects Of Advair Hfa Include:
  8. How Should I Store Advair Hfa?
  9. Active Ingredients:
  10. Inactive Ingredient:
  11. For Correct Use Of Your Advair Hfa Inhaler, Remember:
  12. Revised: 2/2019document Id:

Patient Information 

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

Serious Asthma-Related Events

Inform patients with asthma that LABA when used alone increases the risk of asthma-related hospitalization or asthma-related death. Available data show that when ICS and LABA are used together, such as with ADVAIR HFA, there is not a significant increase in the risk of these events.

Not for Acute Symptoms

Inform patients that ADVAIR HFA is not meant to relieve acute asthma symptoms and extra doses should not be used for that purpose. Advise patients to treat acute asthma symptoms with an inhaled, short-acting beta2-agonist such as albuterol. Provide patients with such medication and instruct them in how it should be used.

Instruct patients to

ADVAIR HFA combines the inhaled corticosteroid (ICS) medicine fluticasone propionate and the long-acting beta2-adrenergic agonist (LABA) medicine salmeterol.
ICS medicines such as fluticasone propionate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.
LABA medicines such as salmeterol help the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe.
ADVAIR HFA is not used to relieve sudden breathing problemsand will not replace a rescue inhaler.
It is not known if ADVAIR HFA is safe and effective in children younger than 12 years of age.

Advair Hfa Is Used For Asthma As Follows: 

ADVAIR HFA is a prescription medicine used to control symptoms of asthma and to prevent symptoms such as wheezing in adults and adolescents aged 12 years and older.
ADVAIR HFA contains salmeterol, the same medicine found in SEREVENT DISKUS (salmeterol xinafoate inhalation powder). LABA medicines such as salmeterol when used alone increase the risk of hospitalizations and death from asthma problems. ADVAIR HFA contains an ICS and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.
ADVAIR HFA is not for adults and adolescents with asthma who are well controlled with an asthma control medicine, such as a low to medium dose of an ICS medicine. ADVAIR HFA is for adults and adolescents with asthma who need both an ICS and LABA medicine.

Do Not Use Advair Hfa: 

to relieve sudden breathing problems.
as a rescue inhaler.
if you are allergic to fluticasone propionate, salmeterol, or any of the ingredients in ADVAIR HFA.

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

Do notuse ADVAIR HFA unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
ADVAIR HFA comes in 3 different strengths. Your healthcare provider prescribed the strength that is best for you.
Use ADVAIR HFA exactly as your healthcare provider tells you to use it.Do notuse ADVAIR HFA more often than prescribed.
Use 2 inhalations of ADVAIR HFA 2 times each day. Use ADVAIR HFA at the same time each day, about 12 hours apart.
If you miss a dose of ADVAIR HFA, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at 1 time.
If you take too much ADVAIR HFA, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.
Do not use other medicines that contain a LABA for any reason.Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.
Do notstop using ADVAIR HFA, even if you are feeling better, unless your healthcare provider tells you to.
ADVAIR HFA does not relieve sudden breathing problems.Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
Rinse your mouth with waterwithout swallowingafter each dose of ADVAIR HFA. This will help lessen the chance of getting a yeast infection (thrush) in your mouth and throat.

Call Your Healthcare Provider Or Get Medical Care Right Away If: 

your breathing problems get worse.
you need to use your rescue inhaler more often than usual.
your rescue inhaler does not work as well to relieve your symptoms.
you need to use 4 or more inhalations of your rescue inhaler in 24 hours for 2 or more days in a row.
you use 1 whole canister of your rescue inhaler in 8 weeks.
your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.
you have asthma and your symptoms do not improve after using ADVAIR HFA regularly for 1 week.

Advair Hfa Can Cause Serious Side Effects, Including: 

fungal infection in your mouth or throat (thrush).Rinse your mouth with water without swallowing after using ADVAIR HFA to help reduce your chance of getting thrush.
pneumonia.ADVAIR HFA contains the same medicine found in ADVAIR DISKUS (fluticasone propionate and salmeterol inhalation powder). ADVAIR DISKUS is used to treat people with asthma and people with chronic obstructive pulmonary disease (COPD). People with COPD have a higher chance of getting pneumonia. ADVAIR DISKUS may increase the chance of you getting pneumonia. It is not known if ADVAIR HFA is safe and effective in people with COPD. Call your healthcare provider right away if you have any of the following symptoms:

increase in mucus (sputum) production chills

change in mucus color increased cough

fever increased breathing problems

weakened immune system and increased chance of getting infections (immunosuppression).
reduced adrenal function (adrenal insufficiency).Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an inhaled steroid (such as ADVAIR HFA). During this transition period, when your body is under stress such as from fever, trauma (such as a car accident), infection, surgery, or worse COPD symptoms, adrenal insufficiency can get worse and may cause death.

Symptoms Of Adrenal Insufficiency Include: 

feeling tired nausea and vomiting

lack of energy low blood pressure (hypotension)

weakness

sudden breathing problems immediately after inhaling your medicine.If you have sudden breathing problems immediately after inhaling your medicine, stop using ADVAIR HFA and call your healthcare provider right away.
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 swelling of your face, mouth, and tongue

hives breathing problems

effects on heart.

increased blood pressure chest pain

a fast or irregular heartbeat

effects on nervous system.

tremor nervousness

bone thinning or weakness (osteoporosis).
slowed growth in children.Your child s growth should be checked regularly by the healthcare provider while using ADVAIR HFA.
eye problemsincluding glaucoma, increased pressure in your eye, cataracts, or other changes in vision. You should have regular eye exams while using ADVAIR HFA.
changes in laboratory blood levels (sugar, potassium, certain types of white blood cells).

Common Side Effects Of Advair Hfa Include: 

upper respiratory tract infection headache

throat irritation dizziness

hoarseness and voice changes nausea and vomiting

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

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 Advair Hfa? 

Store ADVAIR HFA at room temperature between 68 F and 77 F (20 C and 25 C) with the mouthpiece down.
The contents of your ADVAIR HFA are under pressure: Do notpuncture.Do notuse or store near heat or open flame. Temperatures above 120 F may cause the canister to burst.
Do notthrow into fire or an incinerator.
Safely throw away ADVAIR HFA in the trash when the counter reads000.

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

General information about the safe and effective use of ADVAIR HFA.

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

You can ask your healthcare provider or pharmacist for information about ADVAIR HFA that was written for health professionals.

Active Ingredients: 

fluticasone propionate, salmeterol xinafoate

Inactive Ingredient: 

propellant HFA-134a

For more information about ADVAIR HFA, call 1-888-825-5249 or visit our website at www.advair.com.

Trademarks are owned by or licensed to the GSK group of companies.

GlaxoSmithKline, Research Triangle Park, NC 27709

2019 GSK group of companies or its licensor.

ADH:13PIL

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: January 2019

INSTRUCTIONS FOR USE

ADVAIR (AD vair) HFA

(fluticasone propionate and salmeterol inhalation aerosol)

for oral inhalation use

Your ADVAIR HFA inhaler

Figure A

Figure A

Figure B

Figure B

The metal canister holds the medicine.See Figure A.
The metal 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 plastic actuator.See Figure B.
The counter starts at either124or064, depending on which size inhaler you have. 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 metal canister.
The purple plastic actuator sprays the medicine from the metal canister. The plastic actuator has a protective cap that covers the mouthpiece.See Figure A.Keep the protective cap on the mouthpiece when the metal canister is not in use. The strap keeps the cap attached to the plastic actuator.
Do notuse the plastic actuator with a canister of medicine from any other inhaler.
Do notuse an ADVAIR HFA metal canister with an actuator from any other inhaler.

Before using your ADVAIR HFA inhaler

Take ADVAIR 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.

Priming your ADVAIR HFA inhaler

Figure C

Figure C

Figure F

Figure D

Before you use ADVAIR 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 for 5 seconds. Then spray the inhaler 1 time into the air away from your face.See Figure C. Avoid spraying in eyes.
Shake and spray the inhaler like this 3 more times to finish priming it. The counter should now read120or060, depending on which size inhaler you have.See Figure D.
You must prime your inhaler again if you have not used it in more than 4 weeks or if you drop it. Take the cap off the mouthpiece and shake the inhaler well for 5 seconds. Then spray it 1 time into the air away from your face. Shake and spray the inhaler like this 1 more time to finish priming it.

How to use your ADVAIR HFA inhaler

Follow these steps every time you use ADVAIR HFA.

Figure F

Figure E

Figure F

Figure F

Figure G

Figure G

Step 1.Make sure the metal canister fits firmly in the plastic actuator. The counter should show through the window in the actuator.
Shake the inhaler wellfor 5 seconds before each spray.
Take the cap off the mouthpiece of the plastic 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.
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 metal 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 metal 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.
Wait about 30 seconds and shake the inhaler well for 5 seconds. Repeat steps 2 through 6.
Step 7. Rinse your mouth with water after breathing in the medicine.Spit out the water. Do not swallow it.See Figure G.
Step 8.Put the cap back on the mouthpiece after every time you use the inhaler. Make sure it snaps firmly into place.
Cleaning your ADVAIR HFA inhaler
Figure H

Figure H

Figure I

Figure I

Clean your inhaler at least 1 time each week after your evening dose.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 H.

Step 9.Take the cap off the mouthpiece. The strap on the cap will stay attached to the actuator. Do not take the metal canister out of the plastic actuator.
Step 10.Use a dry cotton swab to clean the small circular opening where the medicine sprays out of the canister. Carefully twist the swab in a circular motion to take off any medicine.See Figure I.
Step 11.Wipe the inside of the mouthpiece with a clean tissue dampened with water. Let the actuator air-dry overnight.
Step 12.Put the cap back on the mouthpiece after the actuator has dried.

Replacing your ADVAIR HFA inhaler

When the counter reads 020, you should refill your prescription or ask your healthcare provider if you need another prescription for ADVAIR HFA.
When the counter reads 000, throw the inhaler away.You should not keep using the inhaler when the counter reads000because you may 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 Advair Hfa Inhaler, Remember: 

The metal canister should always fit firmly in the plastic 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.
After each dose, rinse your mouth with water and spit it out.Do notswallow the water.
Do nottake the inhaler apart.
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.

For more information about ADVAIR HFA or how to use your inhaler, call 1-888-825-5249 or visit our website at www.advair.com.

Trademarks are owned by or licensed to the GSK group of companies.

GlaxoSmithKline, Research Triangle Park, NC 27709

2019 GSK group of companies or its licensor.

ADH:3IFU

This Instructions for Use has been approved by the U.S. Food and Drug Administration Revised: January 2019

PRINCIPAL DISPLAY PANEL

NDC 0173-0715-20

ADVAIR HFA 45/21

(fluticasone propionate 45 mcg and salmeterol 21 mcg*inhalation aerosol)

12 g

For oral inhalation with ADVAIR HFA actuator only.

*Contents:Each canister contains a microcrystalline suspension of fluticasone propionate and salmeterol xinafoate in propellant HFA-134a(1,1,1,2,-tetrafluoroethane).

Each actuation delivers 45 mcg of fluticasone propionate and 30.45 mcg of salmeterol xinafoate equivalent to 21 mcg of salmeterol base from the mouthpiece.

See prescribing information for dosage information.

RXonly

With Counter

120 Metered Actuations

2019 GSK group of companies or its licensor.

62000000035722 Rev. 3/19
Advair HFA 45mcg 120 dose carton

PRINCIPAL DISPLAY PANEL

NDC 0173-0716-20

ADVAIR HFA 115/21

(fluticasone propionate 115 mcg and salmeterol 21 mcg*inhalation aerosol)

12 g

For oral inhalation with ADVAIR HFA actuator only.

*Contents:Each canister contains a microcrystalline suspension of fluticasone propionate and salmeterol xinafoate in propellant HFA-134a(1,1,1,2,-tetrafluoroethane).

Each actuation delivers 115 mcg of fluticasone propionate and 30.45 mcg of salmeterol xinafoate equivalent to 21 mcg of salmeterol base from the mouthpiece.

See prescribing information for dosage information.

RXonly

With Counter

120 Metered Actuations

2019 GSK group of companies or its licensor.

62000000035756 Rev. 3/19
Advair HFA 115mcg 120 dose carton

PRINCIPAL DISPLAY PANEL

NDC 0173-0717-20

ADVAIR HFA 230/21

(fluticasone propionate 230 mcg and salmeterol 21 mcg*inhalation aerosol)

12 g

For oral inhalation with ADVAIR HFA actuator only.

*Contents:Each canister contains a microcrystalline suspension of fluticasone propionate and salmeterol xinafoate in propellant HFA-134a(1,1,1,2,-tetrafluoroethane).

Each actuation delivers 230 mcg of fluticasone propionate and 30.45 mcg of salmeterol xinafoate equivalent to 21 mcg of salmeterol base from the mouthpiece.

See prescribing information for dosage information.

RXonly

With Counter

120 Metered Actuations

2019 GSK group of companies or its licensor.

62000000035708 Rev. 3/19
Advair HFA 230mcg 120 dose carton
ADVAIR HFA
fluticasone propionate and salmeterol xinafoate aerosol, metered
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0173-0715
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FLUTICASONE PROPIONATE(UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)FLUTICASONE PROPIONATE45 ug
SALMETEROL XINAFOATE(UNII: 6EW8Q962A5) (SALMETEROL - UNII:2I4BC502BT)SALMETEROL21 ug
Inactive Ingredients
Ingredient NameStrength
NORFLURANE(UNII: DH9E53K1Y8)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0173-0715-201 in 1 CARTON09/29/2008
1120 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0173-0715-221 in 1 CARTON09/29/2008
260 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:0173-0715-611 in 1 CARTON09/29/200808/31/2019
360 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
NDANDA02125409/29/2008
ADVAIR HFA
fluticasone propionate and salmeterol xinafoate aerosol, metered
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0173-0716
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FLUTICASONE PROPIONATE(UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)FLUTICASONE PROPIONATE115 ug
SALMETEROL XINAFOATE(UNII: 6EW8Q962A5) (SALMETEROL - UNII:2I4BC502BT)SALMETEROL21 ug
Inactive Ingredients
Ingredient NameStrength
NORFLURANE(UNII: DH9E53K1Y8)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0173-0716-201 in 1 CARTON09/29/2008
1120 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0173-0716-221 in 1 CARTON09/29/2008
260 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:0173-0716-611 in 1 CARTON09/29/200808/31/2019
360 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
NDANDA02125409/29/2008
ADVAIR HFA
fluticasone propionate and salmeterol xinafoate aerosol, metered
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0173-0717
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FLUTICASONE PROPIONATE(UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)FLUTICASONE PROPIONATE230 ug
SALMETEROL XINAFOATE(UNII: 6EW8Q962A5) (SALMETEROL - UNII:2I4BC502BT)SALMETEROL21 ug
Inactive Ingredients
Ingredient NameStrength
NORFLURANE(UNII: DH9E53K1Y8)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0173-0717-201 in 1 CARTON03/06/2009
1120 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:0173-0717-221 in 1 CARTON03/06/2009
260 in 1 INHALER; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:0173-0717-611 in 1 CARTON03/06/200911/30/2019
360 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
NDANDA02125403/06/2009
Labeler -GlaxoSmithKline LLC (167380711)

Revised: 2/2019document Id: 

44a38383-be21-41e3-b216-0dadce0eca94Set id: dfaca6f9-3277-47b2-319d-1377917cb54cVersion: 27Effective Time: 20190225GlaxoSmithKline LLC



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