ProAir HFA

The active ingredient in the ProAir HFA inhaler is albuterol sulfate. This albuterol inhaler is a short-acting beta-adrenergic agonist (SABA), which relaxes the smooth muscle in the lungs to open up the airways and help you breathe easier. It is indicated for adults and children over 4 years old for treating and preventing bronchospasm due to asthma or COPD, including exercise-induced bronchospasm.

The propellant in this inhaler is HFA, unlike other inhalers containing chlorofluorocarbons (CFCs), which are more harmful to the environment.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using ProAir HFA. However, the following is a synopsis of the general guidelines for the use of ProAir HFA:

1. To assemble the inhaler, insert the metal canister into the red plastic piece. The dose counter through the window at the base of the red plastic piece should show a black dot.

2. To open the inhaler, remove the mouthpiece by squeezing the sides of the cap and pulling it straight out.

3. Before using ProAir HFA for the first time, prime the inhaler by shaking it for 5 seconds and spraying a few test sprays away from your face. Repeat twice before first use, or if you haven’t used the inhaler for 2 weeks or more. After the first three primes, the dose counter should now read 200.

4. To use, shake well for five seconds, and breathe out through your mouth.

5. Place the mouthpiece in your mouth and close your mouth around it.

6. Press down on the top of the canister while inhaling slowly and deeply through your mouth.

7. Hold your breath for as long as is comfortable, try for at least 10 seconds, then breathe out slowly.

8. Wait about one minute, then repeat steps 4-7 if needed for another dose. Use 2 inhalations every 4-6 hours as needed. For exercise-induced bronchospasm, use 2 inhalations 15-30 minutes before exercise.

9. Always rinse your mouth (swish and spit) after using this inhaler, and replace the mouthpiece for storage.

10. You should clean the mouthpiece of your inhaler once a week to prevent medicine buildup. To do so, remove the canister and rinse the plastic actuator in warm water for about 30 seconds. Then shake off the excess water, and allow the mouthpiece to air-dry overnight.

11. Keep an eye on the dose counter, the number will be red when you have 20 or fewer doses remaining.

The most common side effects of ProAir HFA include:

• Sore throat, throat irritation, runny nose.
• Chest pain.
• Shakiness or nervousness.
• Headache, dizziness, or insomnia.
• High blood pressure.
• Muscle cramps.
• Hypokalemia (low potassium).

Some individuals may experience serious side effects while using ProAir HFA. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Irregular heartbeat/ heart rate, weakness, or worsening of an existing heart condition.
• Hypersensitivity or allergic reactions (rash, hives, swelling of the tongue, lips, or throat, anaphylaxis), which can be life-threatening.
• Sudden paradoxical bronchospasm (trouble breathing, wheezing, chest pain or tightness, cough).

These are not all of the possible side effects of ProAir HFA. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting ProAir HFA, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether you have:

• Heart problems such as coronary insufficiency, cardiac arrhythmia, and hypertension.
• Convulsive disorders such as epilepsy.
• Hyperthyroidism.
• Diabetes mellitus (Type 2 diabetes).

A history of hypersensitivity to albuterol sulfate.

This inhaler works very quickly, within 10-15 minutes.

When ProAir HFA is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Beta-blockers like atenolol and propranolol, which can prevent ProAir HFA from working, and cause severe bronchospasm.
• Non-potassium sparing diuretics, which when combined with ProAir HFA can worsen/ cause severe cardiovascular effects, or a reduction in your potassium levels (hypokalemia).
• Digoxin, when combined with ProAir HFA, can lead to lower blood levels of digoxin.
• Antidepressants such as monoamine oxidase inhibitors or tricyclic antidepressants, as there may be additive cardiovascular effects when combined with ProAir HFA.

Each actuation of the metered-dose inhaler delivers 108 mcg of albuterol sulfate (90 mcg of albuterol base).

This inhaler should be stored at room temperature with the mouthpiece facing down and out of the reach of children.

This inhaler is manufactured by IVAX Pharmaceuticals, but marketed/ sold by Teva Respiratory.

Yes, there is a generic version available. Albuterol is also sold under the brand names Proventil HFA, ProAir RespiClick, ProAir Digihaler, and Ventolin HFA.

If your breathing worsens or albuterol does not seem to be working for you, contact your physician. If you find yourself using this inhaler more than usual, let your doctor know, as this may mean you require a different treatment plan.

Albuterol is considered safe in pregnancy, with no increased risk of harm to a growing fetus. Further, uncontrolled asthma is associated with higher-risk pregnancies, and albuterol is the preferred bronchodilator for treating asthma in pregnancy. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

When used in usual doses, albuterol is considered safe with breastfeeding, as it is inhaled and does not reach significant levels in the blood. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.