Airsupra 90 mcg-80 mcg/actuation HFA aerosol inhaler

Generic name:
Albuterol/ budesonide hfa inhaler - oral inhalation

Pronunciation
(al-BUE-ter-ol/bue-DES-oh-nide)

Brand name(s)
Airsupra

This product is used to prevent and treat wheezing and shortness of breath caused by asthma. It is a quick-relief product. It contains 2 medications: albuterol and budesonide. Albuterol (also known as salbutamol in some countries) belongs to a class of drugs known as bronchodilators. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Budesonide belongs to a class of drugs known as corticosteroids. It works by reducing swelling (inflammation) of the airways in the lungs to make breathing easier. Controlling symptoms of breathing problems can decrease time lost from work or school.

Read the Patient Information Leaflet and Instructions for Use provided by your pharmacist before you start using this medication and each time you get a refill. Follow the illustrated directions for the proper use of this medication. If you have any questions, ask your doctor or pharmacist.

Shake the canister well before using. Follow the instructions for test sprays in the air if you are using a canister for the first time, if you have not used it for more than a week, if you have cleaned it, or if it was dropped. A fine mist is a sign that the inhaler is working properly. Avoid spraying the medication in your eyes. If you are using other inhalers at the same time, wait at least one minute between the use of each medication.

Inhale this medication by mouth as directed by your doctor, usually as needed. Do not use more than 12 puffs in 24 hours. Do not increase your dose or use this drug more often than prescribed without your doctor's approval. Using too much of this medication will increase your risk of serious (possibly fatal) side effects.

To prevent dry mouth, hoarseness, and oral yeast infections from developing, gargle and rinse your mouth with water after each use. Do not swallow the rinse water.

The dosage is based on your medical condition and response to treatment.

If you are regularly using a different corticosteroid taken by mouth (such as prednisone), you should not stop using it unless directed by your doctor. You may have withdrawal symptoms if the drug is suddenly stopped. Some conditions (such as asthma, allergies) may become worse when the drug is suddenly stopped. To prevent withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness), your doctor may direct you to slowly lower the dose of your old medication after you begin using this product. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away. See also Precautions section.

Always have quick-relief inhalers with you. Keep track of the number of inhalations you use and discard the inhaler after you have used the labeled number of inhalations on the product package. Also count the test sprays used to prime the inhaler.

Learn which of your inhalers you should use every day (controller drugs) and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, worsening peak flow meter readings, waking up at night with trouble breathing, if you use your quick-relief inhaler more often (more than 2 days a week), or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.

Tell your doctor if you do not get better or if you get worse.

See also Precautions section.

Dry/irritated throat, headache, hoarseness, or coughing may occur as your body adjusts to the medication. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including:

• white patches in your mouth or on your tongue
• weakness
• bone pain
• nausea/vomiting
• increased thirst/urination
• vision problems
• signs of infections (such as sore throat that doesn't go away, fever, chills)

Rarely, this medication has caused severe (rarely fatal), sudden worsening of breathing problems/asthma (paradoxical bronchospasm) right after you use it. If you experience sudden wheezing, get medical help right away.

Get medical help right away if you have any very serious side effects, including:

• chest pain
• fast/irregular heartbeat

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this product, tell your doctor or pharmacist if you are allergic to albuterol or budesonide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• current/past infections (such as tuberculosis, herpes)
• bone loss (osteoporosis)
• eye problems (such as cataracts, glaucoma)
• heart problems (such as irregular heartbeat, angina, heart attack)
• high blood pressure
• seizure
• thyroid problems
• diabetes
• liver problems

If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses for a long time, it may be more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used a corticosteroid taken by mouth within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. Carry a warning card or medical ID bracelet that says you use (or have used) corticosteroid medications.

This medication may mask signs of infection. It can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

This drug may make you dizzy or cause blurred vision. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Budesonide passes into breast milk. It is unknown if albuterol passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

• desmopressin

This product contains albuterol. It is very similar to levalbuterol. Do not use other medications containing albuterol or levalbuterol while using this product.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: fast/pounding/irregular heartbeat, severe shaking (tremors), seizures.

Do not share this medication with others.

Lab and/or medical tests (such as cortisol levels, lung function, eye exams, bone density tests, blood pressure) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Avoid substances that can worsen breathing problems by causing irritation or allergic reaction, such as smoke, pollen, pet dander, dust, and mold.

Learn to use a peak flow meter, use it daily, and promptly report worsening breathing problems (such as readings in the yellow/red range, increased use of quick-relief inhalers).

Because the flu virus can worsen breathing problems, ask your doctor or pharmacist if you should have a flu shot every year.

In adults, this medication can increase the risk of bone loss (osteoporosis) if used for a long time. Talk with your doctor about your risk, and about available treatments for osteoporosis. Lifestyle changes that help promote healthy bones include doing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. You may also need to take calcium and vitamin D supplements. Consult your doctor for specific advice. To help prevent osteoporosis later in life, encourage children to exercise and eat a healthy diet (including calcium).

Not applicable.

Store at room temperature away from moisture, heat, and sunlight. Do not store in the bathroom. Do not puncture the canister or expose it to high heat or open flame. Do not open the original foil package until you are ready to use the medication. Once the foil package is opened, this medication expires after 6 to 12 months (depending on your product). Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.