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AirDuo RespiClick

Last reviewed on RxList: 2/18/2020
AirDuo RespiClick Side Effects Center

What Is Airduo Respiclick?

Airduo Respiclick (fluticasone propionate and salmeterol) inhalation powder is a fixed dose combination product containing a corticosteroid and a LABA indicated for treatment of asthma in patients aged 12 years and older.

What Are Side Effects of Airduo Respiclick?

Common side effects of Airduo Respiclick include:

Dosage for Airduo Respiclick

The starting dosage of Airduo Respiclick is based on prior asthma therapy and disease severity. To treat asthma in patients 12 years and older the dose is 1 inhalation of Airduo Respiclick 55/14 mcg, 113/14 mcg, or 232/14 mcg twice daily.

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

Airduo Respiclick may interact with ritonavir, ketoconazole, monoamine oxidase inhibitors, tricyclic antidepressants, beta-blockers, and diuretics. Tell your doctor all medications and supplements you use.

Airduo Respiclick During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Airduo Respiclick; it is unknown how it will affect a fetus. It is unknown if Airduo Respiclick passes into breast milk. Other corticosteroids have been detected in human milk. However, fluticasone propionate and salmeterol 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 Airduo Respiclick (fluticasone propionate and salmeterol) Inhalation Powder 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.

SLIDESHOW

What Is Asthma? Symptoms, Causes, and Treatments See Slideshow
AirDuo RespiClick Professional Information

SIDE EFFECTS

Use Of LABA May Result In The Following
  • Serious asthma-related events – hospitalizations, intubations, death [see WARNINGS AND PRECAUTIONS]
  • Cardiovascular and central nervous system effects [see WARNINGS AND PRECAUTIONS]
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 In Asthma

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 incidence of adverse reactions associated with AIRDUO RESPICLICK in Table 2 is based upon two placebo-controlled, 12-week, clinical studies (Study 1 and 2). A total of 1,364 adolescent and adult patients previously treated with inhaled corticosteroids were treated twice daily ARMONAIR RESPICLICK 55 mcg, 113 mcg, 232 mcg or AIRDUO RESPICLICK 55/14 mcg, 113/14 mcg, 232/14 mcg, or placebo. Sixty percent of patients were female and 80% of patients were white. The average duration of exposure was 82 to 84 days in the active treatment groups compared with 75 days in the placebo group.

Table 2: Adverse Reactions with ≥3% Incidence with AIRDUO 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)
%
AIRDUO RESPICLICK
55/14 mcg
(n=128)
%
AIRDUO RESPICLICK
113/14 mcg
(n=269)
%
AIRDUO RESPICLICK
232/14 mcg
(n=145)
%
Placebo
(n=273)
%
Infections and infestations
Nasopharyngitis 5.4 5.8 4.8 8.6 4.8 6.9 4.4
Oral candidiasis* 3.1 2.9 4.8 1.6 2.2 3.4 0.7
Musculoskeletal and connective tissue disorders
Back pain 0 1.5 1.4 3.1 0.7 0 1.8
Nervous system disorders
Headache 1.6 7.3 4.8 5.5 4.8 2.8 4.4
Respiratory disorders
Cough 1.6 1.8 3.4 2.3 3.7 0.7 2.6
*Oral candidiasis includes oropharyngeal candidiasis, oral fungal infection, and oropharyngitis fungal

Other adverse reactions not previously listed (and occurring in <3% of patients and in three or more patients on AIRDUO RESPICLICK), whether considered drug-related or not by the investigators, that were reported more frequently by patients with asthma treated with AIRDUO RESPICLICK compared with patients treated with placebo include the following:

Sinusitis, oropharyngeal pain, pharyngitis, dizziness, influenza, rhinitis allergic, respiratory tract infection, rhinitis, nasal congestion, abdominal pain upper, myalgia, pain in extremity, dyspepsia, laceration, dermatitis contact, and palpitations.

Long Term Safety Study

This was a 26-week, open labeled study of 674 patients previously treated with inhaled corticosteroids who were treated twice daily with ARMONAIR RESPICLICK 113 mcg, 232 mcg, AIRDUO RESPICLICK 113/14 mcg, 232/14 mcg, fluticasone propionate inhalation aerosol 110 mcg and 220 mcg, and fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder, and fluticasone propionate 500 mcg and salmeterol 50 mcg inhalation powder. The types of adverse reactions 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 and/or salmeterol regardless of indication. 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 and/or salmeterol or a combination of these factors.

Cardiac Disorders: Arrhythmias (including atrial fibrillation, extrasystoles, supraventricular tachycardia), ventricular tachycardia.

Endocrine Disorders: Cushing’s syndrome, Cushingoid features, growth velocity reduction in children/adolescents, hypercorticism.

Eye Disorders: Glaucoma.

Gastrointestinal Disorders: Abdominal pain, dyspepsia, xerostomia.

Immune System Disorders: Immediate and delayed hypersensitivity reaction (including very rare anaphylactic reaction). Very rare anaphylactic reaction in patients with severe milk protein allergy.

Infections and Infestations: Esophageal candidiasis.

Metabolic and Nutrition Disorders: Hyperglycemia, weight gain.

Musculoskeletal, Connective Tissue, and Bone Disorders: Arthralgia, cramps, myositis, osteoporosis.

Nervous System Disorders: Paresthesia, restlessness.

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

Reproductive System and Breast Disorders: Dysmenorrhea.

Respiratory, Thoracic, and Mediastinal Disorders: Chest congestion; chest tightness, dyspnea; facial and oropharyngeal edema, immediate bronchospasm; paradoxical bronchospasm; tracheitis; wheezing; reports of upper respiratory symptoms of laryngeal spasm, irritation, or swelling such as stridor or choking.

Skin and Subcutaneous Tissue Disorders: Ecchymoses, photodermatitis.

Vascular Disorders: Pallor.

Read the entire FDA prescribing information for AirDuo RespiClick (Fluticasone Propionate and Salmeterol)

QUESTION

Asthma is a chronic respiratory disease. See Answer
Related Resources for AirDuo RespiClick

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

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