Airduo Digihaler Side Effects Center

Last updated on RxList: 7/15/2021
Airduo Digihaler Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Airduo Digihaler?

Airduo Digihaler (fluticasone propionate and salmeterol) is a combination of a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for treatment of asthma in patients aged 12years and older. AirDuo Digihaler should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2-adrenergic agonist (LABA).

What Are Side Effects of Airduo Digihaler?

Common side effects of Airduo Digihaler include:

Dosage for Airduo Digihaler

The dose of Airduo Digihaler is 1 inhalation of AirDuo Digihaler 55/14 mcg, 113/14 mcg, or 232/14 mcg twice daily.

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

Airduo Digihaler may interact with ritonavir, ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, beta-blockers, and diuretics. Tell your doctor all medications and supplements you use.

Airduo Digihaler During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Airduo Digihaler; it may harm a fetus. Other corticosteroids pass into breast milk, but the concentrations of the medications in Airduo Digihaler are likely to be low in breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Airduo Digihaler (fluticasone propionate and salmeterol) Inhalation Powder, for Oral Inhalation 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.

QUESTION

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

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

Call your doctor at once if you have:

  • wheezing, choking, or other breathing problems after using this medicine;
  • fever, chills, cough with mucus, feeling short of breath;
  • chest pain, fast or irregular heartbeats, severe headache, pounding in your neck or ears;
  • tremors, nervousness;
  • blurred vision, tunnel vision, eye pain, or seeing halos around lights;
  • signs of thrush (a fungal infection)--sores or white patches in your mouth or throat, trouble swallowing;
  • high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
  • low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or
  • signs of a hormonal disorder--worsening tiredness or weakness, feeling light-headed, nausea, vomiting.

Fluticasone can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

Common side effects may include:

  • headache, muscle pain, bone pain, back pain;
  • nausea, vomiting;
  • thrush, throat irritation;
  • ongoing cough, hoarseness or deepened voice;
  • cold symptoms such as stuffy nose, sneezing, sore throat; or
  • ear infection (in a child)--fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness.

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 Airduo Digihaler (Fluticasone Propionate and Salmeterol Inhalation Powder)

SLIDESHOW

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

SIDE EFFECTS

Systemic and local corticosteroid use may result in the following:

  • Candida albicans infection [see WARNINGS AND PRECAUTIONS]
  • Immunosuppression and Risk of Infections [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.

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 ARMONAIR RESPICLICK 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 ARMONAIR RESPICLICK 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 ARMONAIR RESPICLICK, and More Common than Placebo in Subjects with Asthma

Adverse Reaction ARMONAIR RESPICLICK
55 mcg
(n=129)
%
ARMONAIR RESPICLICK
113 mcg
(n=274)
%
ARMONAIR RESPICLICK
232 mcg
(n=146)
%
Placebo
(n=273)
%
URTI 5.4 4.7 5.5 4.8
Nasopharyngitis 5.4 5.8 4.8 4.4
Oral candidiasis* 3.1 2.9 4.8 0.7
Headache 1.6 7.3 4.8 4.4
Cough 1.6 1.8 4.8 2.6
* 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 ARMONAIR RESPICLICK) that were reported more frequently by patients with asthma treated with ARMONAIR RESPICLICK 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 ARMONAIR RESPICLICK 113 mcg or 232 mcg; fluticasone propionate/salmeterol multidose dry powder inhaler (AIRDUO RESPICLICK, hereafter referred to as fluticasone propionate/salmeterol MDPI) 113 mcg/14 mcg or 232 mcg/14 mcg; fluticasone propionate aerosol 110 mcg or 220 mcg; or fluticasone propionate and salmeterol inhalation powder 250 mcg/50 mcg, 500 mcg/50 mcg. The types of adverse reactions among ARMONAIR RESPICLICK treatments were similar to those reported above in placebo-controlled 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.

DRUG INTERACTIONS

Inhibitors Of Cytochrome P450 3A4

Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with ARMONAIR RESPICLICK is not recommended because increased systemic corticosteroid adverse effects may occur.

Ritonavir

A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations [see CLINICAL PHARMACOLOGY]. During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression.

Ketoconazole

Coadministration of orally inhaled fluticasone propionate (1,000 mcg) and ketoconazole (200 mg once daily) resulted in a 1.9-fold increase in plasma fluticasone propionate exposure and a 45% decrease in plasma cortisol area under the curve (AUC), but had no effect on urinary excretion of cortisol.

Read the entire FDA prescribing information for Airduo Digihaler (Fluticasone Propionate and Salmeterol Inhalation Powder)

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

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