Advair HFA

The active ingredients in Advair HFA are fluticasone propionate, an inhaled corticosteroid and salmeterol, an LABA. Inhaled corticosteroids work by targeting swelling in the lungs, preventing the release of inflammatory elements that cause the symptoms of asthma. Inhaled LABA medications are bronchodilators, which work by opening up the airways to relieve shortness of breath and cough caused by asthma.

This inhaler is not intended for sudden breathing problems and will not replace your rescue inhaler like albuterol (Ventolin HFA, ProAir HFA). It is also not recommended for people with chronic obstructive pulmonary disease (COPD), as they may benefit more from Advair Diskus.

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 Advair HFA. However, the following is a synopsis of the general guidelines for the use of Advair HFA:

1. To assemble the HFA inhaler, insert the metal canister into the purple plastic actuator. Check the back of the plastic actuator to ensure you can see the counter on the canister through the window (should read either 124 or 064).

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

3. Before using Advair HFA for the first time, prime the inhaler by shaking it for 5 seconds and spraying into the air away from your face. Repeat four times before first use, twice if you haven’t used the inhaler for 4 weeks or more, or dropped it.

3. To use, shake the inhaler well for five seconds, and breathe out through your mouth.

4. Put the mouthpiece in your mouth and close your lips around it.

5. Push the top of the canister down while breathing in slowly and deeply through your mouth.

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

7. Wait about 30 seconds, then repeat steps 4-7 if needed for another dose.

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

9. You should clean the mouthpiece of your HFA inhaler once a week, after your evening dose, to prevent medicine build-up. To do so, remove the cap and use a dry cotton swab to wipe the small circular opening. Then use a clean, damp tissue to wipe the inside of the mouthpiece, and let it air-dry overnight.

10. Watch the dose counter, and refill your prescription when it reads 020. When the counter reads 000, there are no doses left, and you should dispose of the inhaler.

The most common side effects of Advair HFA include:

• Upper respiratory tract infection.
• Headache.
• Throat irritation or sore throat.
• Dry mouth.
• Muscle pain.
• Bone pain.
• Hoarseness/ voice changes.
• Nausea/ vomiting.
• Dizziness.

Some individuals may experience serious side effects while using Advair 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:

• Fungal infections of the mouth/ throat (thrush), which may present as white patches on the roof of your mouth - to avoid/ reduce this risk, always rinse your mouth after using this inhaler, and spit out the water (don’t swallow).
• Pneumonia, which may present with symptoms of cough, fever, chills, and increased breathing problems.
• Adrenal gland insufficiency, which may present with symptoms of fatigue, weakness, nausea, vomiting, and low blood pressure.
• Serious allergic reactions which may present as rash, hives, swelling of the face, mouth, or tongue, and/ or trouble breathing.
• Effects on the heart (increased blood pressure, irregular heartbeat, heart rate or heart rhythm, chest pain) or nervous system (tremor or nervousness).
• Thinning or weakness of the bones (osteoporosis).
• Eye problems such as glaucoma or cataracts - to manage this risk, you should have regular eye exams while using this medication.
• Infections - while taking this drug, you should avoid contact with anyone who has been exposed to or is currently diagnosed with measles or chickenpox.

This medication also has the potential to cause an initial worsening of your asthma symptoms, requiring you to use your rescue inhaler more often, experience nighttime awakenings due to your symptoms, or have acute asthma attacks. Contact your physician if this occurs at any time.

These are not all of the possible side effects of Advair 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 Advair 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 artery disease or heart failure.
• High blood pressure.
• Seizures, or a seizure disorder.
• Thyroid disorder.
• Type 2 diabetes.
• Weak bones (osteoporosis).
• Medical conditions affecting the immune system.
• Eye conditions such as glaucoma or cataracts.
• Liver dysfunction.

• Treatment of a sudden or severe asthma attack (rescue use).
• Allergy to fluticasone or salmeterol.
• Chronic obstructive pulmonary disease (COPD).

With the first dose of Advair HFA, you may notice improvements in your breathing within 30 minutes, but the maximum benefits from this medication are seen after a week of regular use.

When Advair 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:

• Strong CYP3A4 inhibitors, such as azole antifungals (ketoconazole, posaconazole, voriconazole), antibiotics (clarithromycin), and antivirals (ritonavir), which may increase the levels of the drug and induce heart-related side effects.
• Monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants, such as amitriptyline, which may increase the effects of the medication on the heart.
• Beta-blockers (labetalol, nadolol, propanolol, sotalol), which may induce bronchospasm (wheezing).
• Diuretics, or “water pills”, when used in combination with Advair HFA, may reduce potassium levels.

• Fluticasone/ salmeterol 45 mcg/21 mcg
• Fluticasone/ salmeterol 115 mcg/21 mcg
• Fluticasone/ salmeterol 230 mcg/21 mcg

Advair HFA should be stored at room temperature with the mouthpiece facing down, out of reach of children.

Advair HFA is manufactured by GSK.

Yes, there is a generic version of Advair HFA currently available. There are also similar products containing an inhaled corticosteroid (mometasone, budesonide) in combination with a LABA (formoterol, arformoterol, or vilanterol).

This medication should not be discontinued abruptly, as you will have an increased risk of asthma symptoms. If, after a two-week trial, you feel this medication is not effective or you are experiencing significant side effects, talk with your physician to discuss next steps for managing your condition.

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.

Overall, as this drug is inhaled, it is expected that it does not reach high enough concentrations in the blood to cause harm to a growing fetus.

Regarding fluticasone, it is reported to be compatible with pregnancy, and experts suggest that there is a minimal risk of exposure to a growing fetus when the parent uses inhaled fluticasone. There were also no reports of effects of pre-term labour, low birth weight, or malformations.

For salmeterol, there is limited data on the risk during pregnancy, but what experts have found suggests that the risk to a growing fetus is minimal.

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.

Overall, as this drug is inhaled, it is expected that it does not reach high enough concentrations in the blood to cause harm to a nursing infant.

For both fluticasone and salmeterol, there is no human data on the exposure to a nursing infant, but the properties of both drugs suggest they pose minimal risk.