Patient information: uses, side effects, how to take - Airsupra

What is AIRSUPRA?

AIRSUPRA combines 2 medicines, a short/rapid-acting beta₂-adrenergic agonist (SABA) medicine (albuterol sulfate) and an inhaled corticosteroid (ICS) medicine (budesonide), in 1 inhaler, delivered as a propelled spray.

SABA medicines such as albuterol help to relax the smooth muscles of the airways, causing the airways to widen, leading to easier breathing.
ICS medicines such as budesonide help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing difficulties.
AIRSUPRA is a prescription medicine used:
- as needed as a rescue inhaler to treat or prevent symptoms of asthma (tightening of the airways, wheezing, cough, and shortness of breath).
- to help prevent sudden severe breathing problems (asthma attacks).
AIRSUPRA is used as 2 inhalations (puffs) as needed. Do not use more than 12 inhalations (puffs) in a 24-hour period.
AIRSUPRA is not to be used as maintenance treatment for asthma. If you are currently taking medicine long-term to maintain control of asthma symptoms, you should continue to take that medicine as directed by your healthcare provider.
It is not known if AIRSUPRA is safe and effective in children.

Do not use AIRSUPRA if you:

are allergic to albuterol sulfate, budesonide, or any of the other ingredients in AIRSUPRA. See the end of this Patient Information leaflet for a complete list of ingredients in AIRSUPRA.

Before using AIRSUPRA, tell your healthcare provider about all your medical conditions, including if you:

have heart problems.
have high blood pressure (hypertension).
have convulsions (seizures).
have thyroid problems.
have diabetes.
have low potassium levels in your blood.
have an immune system problem.
have or had tuberculosis of your respiratory tract.
have had any type of viral, bacterial, parasitic, fungal infection, or herpes simplex infection of the eye (ocular herpes simplex) that has not been treated.
have been exposed to chickenpox or measles or you have not received vaccines against these diseases.
have or are at risk for weak bones. You are at risk for weak bones if you:
- are inactive for a long period of time.
- have a family history of osteoporosis.
- are a woman going through menopause (“the change of life”) or are past menopause.
- smoke or use tobacco.
- are elderly.
- do not eat well (poor nutrition).
- use medicines that cause bone thinning (such as seizure medicines or corticosteroids) for a long time.
have eye problems such as increased pressure in the eye, glaucoma, or cataracts.
have liver problems.
are pregnant or plan to become pregnant. It is not known if AIRSUPRA may harm your unborn baby.
- Pregnancy Registry. There is a pregnancy registry for women who use asthma medicines during pregnancy. If you become pregnant, contact the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists at 1-877-311-8972 or visit http://mothertobaby.org/pregnancy-studies/.
are breastfeeding. It is not known if the medicines in AIRSUPRA pass into your breast milk and if they can harm your baby. You and your healthcare provider should decide if you will take AIRSUPRA while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. AIRSUPRA and certain other medicines may affect each other causing side effects.

Especially, tell your healthcare provider if you take:

medicines known as strong CYP3A4 inhibitors
other inhaled medicines or asthma medicines
beta blockers

diuretics
digoxin
monoamine oxidase inhibitors
tricyclic antidepressants

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines that you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

How should I use AIRSUPRA?

Read the step-by-step instructions for using AIRSUPRA at the end of this Patient Information leaflet.

Before using AIRSUPRA, make sure your healthcare provider has taught you how to use the inhaler and that you understand how to use it correctly.
Use AIRSUPRA exactly as your healthcare provider tells you to use it. Do not use AIRSUPRA more often than prescribed (no more than 12 puffs which equals 6 doses) within a 24-hour period.
Do not change or stop other inhaled medicines or asthma medicines (oral or inhaled) without first talking to your healthcare provider.
Call your healthcare provider or get emergency medical care right away if:
- your breathing problems get worse.
- you need to use AIRSUPRA more often than usual.
- AIRSUPRA does not work as well to relieve your asthma.

What are the possible side effects of AIRSUPRA?

AIRSUPRA can cause serious side effects, including:

worsening trouble breathing, coughing, and wheezing (paradoxical bronchospasm). If this happens, stop using AIRSUPRA and call your healthcare provider or get emergency medical care 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 who use too much AIRSUPRA.
serious allergic reactions. Tell your healthcare provider or get emergency medical care right away if you have:
- skin rash, redness, or swelling
- severe itching
- swelling of the face, mouth, and tongue
- trouble breathing or swallowing
- chest pain
changes in laboratory blood levels. Low levels of potassium (hypokalemia) may cause abnormal heart rhythms. Your healthcare provider may do blood tests to check your potassium levels during treatment with AIRSUPRA.
weakened immune system and increased chance of getting infections. Tell your healthcare provider about any signs and symptoms of infection including:

fever
pain

aches
chills

feeling tired
nausea and vomiting

fungal infection in your mouth and throat (thrush). This is a common side effect. Rinse your mouth with water, if available, without swallowing after using AIRSUPRA to help reduce your chance of getting thrush.
reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. This can happen when you start taking a medicine containing an ICS (such as AIRSUPRA). When your body is under stress from fever, trauma (such as a car accident), infection or surgery, adrenal insufficiency can get worse.
Symptoms of adrenal insufficiency include:

feeling tired
lack of energy

weakness
nausea and vomiting

low blood pressure

bone thinning or weakness (osteoporosis). Your healthcare provider should check you for this during treatment with AIRSUPRA.
eye problems, including glaucoma and cataracts. You should have regular eye exams while using AIRSUPRA.

Call your healthcare provider or get medical help right away if you have symptoms of any of the serious side effects listed above.

Common side effects of AIRSUPRA include:

headache
cough
hoarseness

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

These are not all the side effects of AIRSUPRA. For more information, ask your healthcare provider or pharmacist.

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 AstraZeneca at 1-800-236-9933.

How should I store AIRSUPRA?

Store AIRSUPRA at room temperature between 68ºF to 77ºF (20ºC to 25ºC). Keep in a dry place away from heat and sunlight.
Store AIRSUPRA in the unopened foil pouch and only open when ready for use.
Do not put a hole in the AIRSUPRA canister.
Do not use or store AIRSUPRA near heat or a flame. Temperatures above 120ºF (49ºC) may cause the canister to burst.
Do not throw the AIRSUPRA canister into a fire or an incinerator.
Throw away AIRSUPRA 12 months after you open the foil pouch or when the puff indicator reaches zero “0”, whichever comes first.

Keep AIRSUPRA and all medicines out of the reach of children.

General information about the safe and effective use of AIRSUPRA

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

You can ask your pharmacist or healthcare provider for information about AIRSUPRA that is written for healthcare professionals.

What are the ingredients in AIRSUPRA?

Active ingredients: micronized albuterol sulfate and micronized budesonide.

Inactive ingredients: hydrofluoroalkane (HFA-134a) and porous particles 1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC) and calcium chloride.

AIRSUPRA is a registered trademark of the AstraZeneca group of companies ©AstraZeneca 2025

Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850; Manufactured by: AstraZeneca Dunkerque Production (AZDP), Dunkerque, France

For more information, go to www.AIRSUPRA.com or call 1-800-236-9933.

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: September 2025

Instructions for Use

AIRSUPRA^®(ayr soo' prah)

(albuterol and budesonide)

inhalation aerosol, for oral inhalation use

120-inhalation canister

Read this Instructions for Use before you start using AIRSUPRA and each time you get a new refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Important information

For oral inhalation use only.
Use AIRSUPRA exactly as your healthcare provider tells you to.
Before you use AIRSUPRA for the first time, you will need to prime it.
Rinse the white actuator 1-time each week so that the medicine does not build up and block the spray through the mouthpiece.
2 puffs of medicine is 1-dose. Do not use more than 6 doses (12 puffs) in a 24-hour period.
Rinse your mouth with water, if available, after using AIRSUPRA to decrease the chance of getting a fungal infection (thrush) in your mouth and throat.

Parts of your AIRSUPRA inhaler

Reading the puff indicator

The puff indicator will count down by 1 each time you spray a puff of medicine.

Do not try to take a puff of medicine when the pointer is at 0 because you will not receive a full dose.

Before using your AIRSUPRA inhaler

1. Write the Use by date
Write the Use By Date (the date 12 months after you open the foil pouch) on the actuator label using permanent ink. For example, if you open the foil pouch on March 1, you will write March 1 on the actuator label.
	Write the Use By Date on the actuator label.

2. Prime your AIRSUPRA inhaler before first use
Take the cover off the mouthpiece by squeezing both sides of the cover while pulling it down.	Shake the inhaler well. Hold your AIRSUPRA inhaler facing away from you and press down firmly on the top of the puff indicator to spray 1 test-puff into the air. Repeat the priming steps for a total of 4 test-puffs. Shake your AIRSUPRA inhaler before each test-puff.

Extra puffs are provided for priming. Do not skip priming.

When and how to re-prime your AIRSUPRA inhaler
Re-prime your inhaler: if it is not used for more than 7 days. if it is dropped after rinsing white actuator	To re-prime your inhaler: Take the cover off the mouthpiece and spray 2 test-puffs into the air. Shake your AIRSUPRA inhaler before each test-puff.


Extra puffs are provided for priming. Do not skip priming.

Inhaling your medicine

1. Check
Take the cover off the mouthpiece. Check the mouthpiece for foreign objects and remove objects before use.
	Check inside mouthpiece.

2. Shake and Inhale

Shake well

Breathe out fully

Place the mouthpiece into your mouth and close your lips around the mouthpiece.

Start to breathe in

deeply and slowly

while spraying 1 puff.

Continue breathing in

until you cannot anymore.

Remove the mouthpiece from your mouth. Hold your breath for as long as you can or up to 10 seconds.

3. Repeat	4. Place the mouthpiece cover back on	5. Rinse
Immediately repeat the shake and inhale step to take a second puff.	Place the mouthpiece cover back on the mouthpiece.	Rinse your mouth with water, if available (Do not swallow the water).

2 puffs equals 1 dose.

Rinsing your actuator 1 time each week

1. Remove canister

Remove the canister and set it aside. Take the cover off the mouthpiece. Do not allow the canister to get wet.

2. Rinse through both ends
Rinse each end of the actuator with warm water for 30 seconds. Shake off as much water as you can. Do not use soap. Do not dry with a towel or tissue.

Look into the mouthpiece and actuator to make sure any medicine build-up has been completely washed away. If there is any build-up, repeat the weekly rinse step 2 again.
	Check inside mouthpiece and actuator.

3. Air-dry

Let the actuator air-dry, such as overnight.

4. Re-assemble and re-prime

Re-assemble AIRSUPRA when the actuator is fully dry.

First, place the mouthpiece cover back on. After the mouthpiece cover is on, gently press the canister down into actuator. Do not insert the canister while the mouthpiece cover is off.

Re-prime the inhaler by following the Re-prime steps above.

Emergency inhaler use when wet

If you need to use the inhaler before it is dry:

shake off as much excess water as you can
insert the canister into the actuator
shake and spray 2-test puffs into the air away from your face
take the prescribed dose
rinse the actuator again following the Weekly Rinse steps

Storing your inhaler

Store your inhaler at room temperature between 68°F to 77°F (20°C to 25°C).
Do not store in a humid environment, such as a bathroom.
Keep your inhaler and all medicines out of the reach of children.

Throwing away your AIRSUPRA inhaler

Throw away your AIRSUPRA inhaler in the household trash:

when the puff indicator reaches zero “0” or 12 months after you open the foil pouch, whichever comes first.

Do not reuse or use the actuator with medicine canisters from other inhalers.

Do not puncture or throw the canister into a fire or incinerator.

Ordering a new AIRSUPRA inhaler

Order a new AIRSUPRA inhaler when the pointer on the puff indicator is in the yellow zone.

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

Revised: September 2025