ArmonAir Digihaler

Last reviewed on RxList: 9/25/2020
ArmonAir Digihaler Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is ArmonAir Digihaler?

ArmonAir Digihaler (fluticasone propionate powder, metered) contains a corticosteroid, and is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older.

What Are Side Effects of ArmonAir Digihaler?

Side effects of include:

  • upper respiratory tract infection,
  • runny or stuffy nose,
  • oral thrush,
  • headache, and
  • cough

Dosage for ArmonAir Digihaler

The dose of ArmonAir Digihaler for treatment of asthma in patients 12 years and older is 1 inhalation of ArmonAir Digihaler 55 mcg, 113 mcg, or 232 mcg twice daily.

ArmonAir Digihaler In Children

The safety and effectiveness of ArmonAir Digihaler in the maintenance treatment of asthma as prophylactic therapy in pediatric patients 12 years of age and older has been established.

The safety and effectiveness of ArmonAir Digihaler in pediatric patients below the age of 12 years have not been established.

Inhaled corticosteroids, including fluticasone propionate, may cause a reduction in growth velocity when administered to pediatric patients. A reduction of growth velocity in children or teenagers may occur as a result of poorly controlled asthma or from use of corticosteroids, including inhaled corticosteroids. The effects of long-term treatment of children and adolescents with inhaled corticosteroids, including fluticasone propionate, on final adult height are not known.

What Drugs, Substances, or Supplements Interact with ArmonAir Digihaler?

ArmonAir Digihaler may interact with other medicines such as:

  • strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin)

Tell your doctor all medications and supplements you use.

ArmonAir Digihaler During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using ArmonAir Digihaler; it is unknown how it would affect a fetus. In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes. Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control. It is unknown if the medication in ArmonAir Digihaler passes into breast milk. Other corticosteroids have been detected in human milk. However, fluticasone propionate concentrations in plasma after inhaled therapeutic doses are low and therefore concentrations in human breast milk are likely to be correspondingly low. Consult your doctor before breastfeeding.

Additional Information

Our ArmonAir Digihaler (fluticasone propionate powder, metered) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Asthma is a chronic respiratory disease. See Answer
ArmonAir Digihaler Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • weakness, tired feeling, nausea, vomiting, feeling like you might pass out;
  • wheezing, choking, or other breathing problems after using this medicine;
  • blurred vision, tunnel vision, eye pain, or seeing halos around lights;
  • worsening of your asthma symptoms;
  • blood vessel inflammation--fever, cough, stomach pain, weight loss, skin rash, severe tingling, numbness, chest pain; or
  • liver problems--upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Fluticasone can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

  • cold symptoms such as stuffy nose, sneezing, sore throat, sinus pain;
  • low fever, cough, wheezing, chest tightness;
  • hoarseness or deepened voice;
  • white patches or sores inside your mouth or on your lips;
  • headache; or
  • nausea, vomiting, upset stomach.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for ArmonAir Digihaler (Fluticasone Propionate Powder for Inhalation)

SLIDESHOW

What Is Asthma? Symptoms, Causes, and Treatments See Slideshow
ArmonAir Digihaler Professional Information

SIDE EFFECTS

Systemic and local corticosteroid use may result in the following:

  • Candida albicans infection [see WARNINGS AND PRECAUTIONS]
  • Immunosuppression [see WARNINGS AND PRECAUTIONS]
  • Hypercorticism and adrenal suppression [see WARNINGS AND PRECAUTIONS]
  • Reduction in bone mineral density [see WARNINGS AND PRECAUTIONS]
  • Growth effects in pediatrics [see WARNINGS AND PRECAUTIONS]
  • Glaucoma and cataracts [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of ArmonAir Digihaler has been established from adequate and well-controlled studies of fluticasone propionate inhalation powder [ARMONAIR RESPICLICK, hereafter referred to as fluticasone propionate multidose dry powder inhaler (MDPI)].

In two placebo-controlled, 12-week, clinical studies (Trial 1 and Trial 2) [see Clinical Studies] a total of 822 adolescent and adult patients with persistent symptomatic asthma despite ICS or ICS/LABA therapy were treated twice daily with either placebo; or fluticasone propionate MDPI 55 mcg, 113 mcg, or 232 mcg. Sixty percent of patients were female and 80% of patients were white. The average duration of exposure was 82 days in the fluticasone propionate MDPI groups compared with 75 days in the placebo group. Table 1 displays the incidence of most common adverse reactions in pooled Trials 1 and 2.

Table 1: Adverse Reactions with ≥ 3% Incidence with Fluticasone Propionate MDPI, and More Common than Placebo in Subjects with Asthma

Adverse ReactionFluticasone Propionate MDPI 55 meg
(n=129) %
Fluticasone Propionate MDPI 113 meg
(n=274) %
Fluticasone Propionate MDPI 232 meg
(n=146) %
Placebo
(n=273) %
URTI5.44.75.54.8
Nasopharyngitis5.45.84.84.4
Oral candidiasis*3.12.94.80.7
Headache1.67.34.84.4
Cough1.61.83.42.6
* Oral candidiasis includes oropharyngeal candidiasis, oral fungal infection, oropharyngitis fungal
URTI = upper respiratory tract infection

Other adverse reactions not previously listed (and occurring in <3% of patients and in three or more patients on fluticasone propionate MDPI) that were reported more frequently by patients with asthma treated with fluticasone propionate MDPI compared with patients treated with placebo include the following:

Oropharyngeal pain, hypertension, rhinitis allergic, influenza, pyrexia, dizziness, respiratory tract infection, muscle spasms, rhinitis, epistaxis, ligament sprain, musculoskeletal pain, pain in extremity, throat irritation, and vomiting.

Long Term Safety Study

This was a 26-week, open label study of 674 patients previously treated with inhaled corticosteroids who were treated twice daily with fluticasone propionate MDPI 113 mcg or 232 mcg; fluticasone propionate/salmeterol MDPI (AIRDUO RESPICLICK hereafter referred to as fluticasone propionate/salmeterol MDPI) 113/14 mcg or 232/14 mcg; fluticasone propionate aerosol 110 mcg or 220 mcg; or fluticasone propionate and salmeterol inhalation powder 250/50 mcg or 500/50 mcg. The types of adverse reactions among fluticasone propionate MDPI treatments were similar to those reported above in placebocontrolled studies.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during post-approval use of fluticasone propionate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to fluticasone propionate or a combination of these factors.

Ear, Nose, and Throat: Aphonia, facial and oropharyngeal edema, and throat soreness.

Endocrine and Metabolic: Cushingoid features, growth velocity reduction in children/adolescents, hyperglycemia, and osteoporosis.

Eye: Cataracts, blurred vision, and central serous chorioretinopathy.

Immune System Disorders: Immediate and delayed hypersensitivity reactions, including anaphylaxis, rash, angioedema, and bronchospasm, have been reported. Anaphylactic reactions in patients with severe milk protein allergy have been reported.

Infections and Infestations: Esophageal candidiasis.

Psychiatry: Agitation, aggression, anxiety, depression, and restlessness. Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children.

Respiratory: Asthma exacerbation, bronchospasm, chest tightness, dyspnea, immediate bronchospasm, pneumonia, and wheeze.

Skin: Contusions and ecchymoses.

Read the entire FDA prescribing information for ArmonAir Digihaler (Fluticasone Propionate Powder for Inhalation)

© ArmonAir Digihaler Patient Information is supplied by Cerner Multum, Inc. and ArmonAir Digihaler Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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