Armonair Digihaler

(Fluticasone Propionate)

The active ingredient in Armonair Digihaler is fluticasone propionate, an inhaled corticosteroid. It works by targeting swelling in the lungs, preventing the release of inflammatory chemicals that cause the symptoms of asthma.

This inhaler is used for long-term asthma control. It is not intended for sudden breathing problems (bronchospasm) and will not replace your rescue inhaler like albuterol sulfate.

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 Armonair Digihaler. However, the following is a synopsis of the general guidelines for the use of Armonair Digihaler:

1. Remove the inhaler from the foil pouch. Hold the inhaler upright, and open the green cap until you hear a click.

2. Breathe out away from the inhaler, then seal your lips around the mouthpiece. Make sure not to block the vent above the mouthpiece with your lips or fingers.

3. Breathe in quickly and deeply, then hold your breath for about 10 seconds. Breathe out away from the inhaler.

4. Close the green cap after each dose.

5. Always rinse your mouth and spit the water out after using an inhaled corticosteroid.

6. Watch the dose counter on the back of the inhaler; the number will turn red when 20 doses are remaining.

7. The inhaler has a built-in electronic module, which you can connect to a mobile app that records information about inhaler events, including peak expiratory flow rate. This is not required to use the inhaler.

The most common side effects of Armonair Digihaler include:

• Upper respiratory tract infection.
• Headache.
• Throat irritation or sore throat.
• Dry mouth.
• Infections of the ear, nose, and throat.

Some individuals may experience serious side effects while using Armonair Digihaler. 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) - 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 - cough, fever, chills, and increased breathing problems.
• Adrenal gland insufficiency - fatigue, weakness, nausea, vomiting, and low blood pressure. This can be brought on by discontinuation of an oral corticosteroid such as prednisone.
• Serious allergic reactions - rash, hives, swelling of the face, mouth, or tongue, anaphylaxis, and trouble breathing.
• Thinning or weakness of the bones (osteoporosis).
• Growth suppression in pediatric populations.
• Eye problems such as glaucoma or cataracts.
• Immunosuppression - potential worsening of existing tuberculosis, fungal, bacterial, viral, parasitic infection, or ocular herpes simplex. While taking this drug, you should avoid contact with anyone who has been exposed to or is currently diagnosed with measles or chickenpox.
• Eosinophilic conditions are rare and mostly associated with withdrawal from oral corticosteroids.

This medication also has the potential to cause an initial worsening of your asthma symptoms (increased wheezing), 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 Armonair Digihaler. 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 Armonair Digihaler, 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:

• 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.
• Allergy to milk proteins (lactose).

With the first dose of Armonair Digihaler, 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 Armonair Digihaler 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), may increase the levels of the drug and induce heart-related side effects.
• Oral corticosteroids - inhaled fluticasone may increase the side effects of systemic corticosteroids.

Brand name Armonair Digihaler is available as 30 mcg, 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate per actuation.

Armonair Digihaler should be stored at room temperature and protected from extreme heat, cold, or humidity. It should be kept out of reach of children and pets. Once the foil pouch has been opened, the inhaler must be discarded 30 days after. The inhaler contains a battery - follow all local regulations for battery disposal.

Armonair Digihaler is manufactured by Teva Pharmaceuticals.

No, there is no generic version of this product, but it is available from other brands such as Armonair Respiclick or in combination inhalers such as the AirDuo Digihaler.

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.

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.

Fluticasone 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.

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 nursing infant.

There is no human data on fluticasone exposure to a nursing infant, but the properties of the drug suggest it poses minimal risk.

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.