AirDuo Digihaler

AirDuo Digihaler is a prescription medicine used to control symptoms of asthma and to prevent symptoms such as wheezing in people 12 years of age and older. AirDuo Digihaler contains a built-in electronic module that records and stores information about inhaler events. AirDuo Digihaler may be used with, and transmits information to, an App through Bluetooth® wireless technology.

AirDuo Digihaler combines two medications: the inhaled corticosteroid (ICS) medicine fluticasone propionate and the LABA medicine salmeterol. Fluticasone propionate helps to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems. Salmeterol helps the muscles around the airways in your lungs stay relaxed to prevent symptoms, such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe.

This medication comes in an inhaler. Use 1 inhalation of AirDuo Digihaler 2 times each day. Use AirDuo Digihaler at the same time each day, about 12 hours apart.

Common side effects include upper respiratory tract infection, and thrush in the mouth or throat.

AirDuo Digihaler is a prescription medicine used to control symptoms of asthma and to prevent symptoms such as wheezing in people 12 years of age and older.

AirDuo Digihaler is not for people 12 years of age and older with asthma who are well controlled with an asthma control medicine, such as a low or medium dose of an inhaled corticosteroid medicine. AirDuo Digihaler is for people 12 years of age and older with asthma who need both an ICS and LABA medicine.

AirDuo Digihaler is not used to relieve sudden breathing problems and will not replace a rescue inhaler.

It is not known if AirDuo Digihaler is safe and effective in children younger than 12 years of age.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescibed by your doctor. Follow the directions on your prescription label carefully. 

Administer AirDuo Digihaler as 1 inhalation twice daily (approximately 12 hours apart at the same time every day) by the orally inhaled route. Rinse your mouth with water without swallowing after each inhalation.

• AirDuo Digihaler does not require priming.

• Do not use AirDuo Digihaler with a spacer or volume holding chamber.

• Do not use AirDuo Digihaler by other routes.

• Do not use more than two times every 24 hours. More frequent administration or a greater number of daily inhalations (more than one inhalation twice daily) is not recommended.

The recommended starting dosage for AirDuo Digihaler is based on asthma severity and current inhaled corticosteroid use and strength. For example:

• For patients not taking inhaled corticosteroids (ICS) (with less severe asthma): the usual starting dose is 55/14 mcg (55 mcg of fluticasone propionate and 14 mcg of salmeterol), administered twice daily.

• For patients with greater asthma severity, the usual starting dose is either:

  • 113/14 mcg (113 mcg of fluticasone propionate and 14 mcg of salmeterol), administered twice daily; or

  • 232/14 mcg (232 mcg of fluticasone propionate and 14 mcg of salmeterol), administered twice daily.

• For patients switching to AirDuo Digihaler from another inhaled corticosteroid or combination product, the low (55/14 mcg), medium (113/14 mcg) or high (232/14 mcg) dose strength of AirDuo Digihaler will be selected based on the strength of the previous inhaled corticosteroid product, or the strength of the inhaled corticosteroid from a combination product, and disease severity.

Serious side effects have been reported with AirDuo Digihaler including:

• thrush. AirDuo Digihaler can cause a fungal infection in your mouth or throat.  It is important to rinse your mouth with water without swallowing after using this medication to help reduce your chance of getting thrush.

• weakened immune system and increased chance of getting infections (immunosuppression).

• reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an inhaled steroid (such as AirDuo Digihaler). When your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include:

  • feeling tired
  • lack of energy
  • weakness
  • nausea and vomiting
  • low blood pressure

• sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using AirDuo Digihaler and call your healthcare provider right away.

• serious allergic reactions. Stop using AirDuo Digihaler and call your healthcare provider or get emergency medical help if you get any of the following symptoms of a serious allergic reaction:

  • rash
  • hives
  • swelling of face, mouth and tongue
  • breathing problems

• effects on heart. 

  • increased blood pressure
  • a fast or irregular heartbeat
  • chest pain

• effects on nervous system.

  • tremor
  • nervousness

• bone thinning or weakness (osteoporosis).

• slowed growth in children. The growth of a child should be checked often.

• eye problems including glaucoma and cataracts. You should have regular eye exams while using AirDuo Digihaler.

• changes in laboratory blood values (sugar, potassium, certain types of white blood cells).

Do not use AirDuo Digihaler:

• to treat sudden, severe symptoms of asthma.
• if you have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.
• if you are allergic to fluticasone propionate or any of the inactive ingredients in AirDuo Digihaler.

Serious side effects have been reported with AirDuo Digihaler.  See the "AirDuo Digihaler Precautions" section.

Common side effects include:

• infection of nose and throat (nasopharyngitis)
• thrush (fungal infection) in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
• back pain
• headache
• cough

This is not a complete list of AirDuo Digihaler side effects.  Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects.  You may report side effects to the FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. AirDuo Digihaler and certain other medicines may interact with each other. This may cause serious side effects.

Especially, tell your healthcare provider if you take:

Antifungal or anti-HIV medicines or other medications that inhibit cytochrome P450 3A4 (CYP3A4) such as:

• ritonavir
• atazanavir
• clarithromycin 
• indinavir
• itraconazole
• nefazodone
• nelfinavir
• saquinavir
• ketoconazole
• telithromycin

Monoamine oxidase inhibitors such as:

• tranylcypromine (Parnate)
• phenelzine (Nardil)
• selegiline (Eldepryl, Zelapar)
• isocarboxazid (Marplan)
• rasagiline (Azilect)

Tricyclic antidepressants such as:

• trimipramine (Surmontil)
• amitriptyline (Elavil)
• nortriptyline (Pamelor, Aventyl)
• protriptyline (Vivactil)
• clomipramine (Anafranil)

Beta blockers such as:

• metoprolol (Toprol XL, Lopressor
• carvedilol (Coreg)
• bisoprolol (Zebeta)
• betaxolol (Kerlone)
• nebivolol (Bystolic)
• propranolol (Inderal)

Non-potassium-sparing diuretics such as:

• bumetanide (Bumex)
• chlorothiazide (Diuril)
• chlorthalidone (Thalitone)
• ethacrynic acid (Edecrin)
• furosemide (Lasix)
• hydrochlorothiazide (Microzide, HCTZ)
• metolazone (Zaroxolyn)
• torsemide (Demadex)

This is not a complete list of AirDuo Digihaler drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in humans with AirDuo Digihaler. 

In animal studies, pregnant animals were given the medicines in AirDuo Digihaler and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if the medicines in AirDuo Digihaler pass into your breast milk and if they can harm your baby. Because many medications can cross into human milk and because the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using AirDuo Digihaler.