Airduo Digihaler

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:

• stuffy or runny nose,
• oral thrush,
• headache,
• cough, and
• back pain

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.

 

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)

 

Airduo Digihaler 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 safety of AirDuo Digihaler has been established from adequate and well-controlled studies of fluticasone propionate and salmeterol MDPI .

In two placebo-controlled, 12-week, clinical studies (Trials 1 and 2) [see Clinical Studies], a total of 1,364 adolescent and adult patients with persistent symptomatic asthma despite ICS or ICS/LABA therapy were treated twice daily with either placebo; fluticasone propionate MDPI 55 mcg, 113 mcg, or 232 mcg (ARMONAIR RESPICLICK, hereafter referred to as fluticasone propionate MDPI); or fluticasone propionate/salmeterol MDPI 55/14 mcg, 113/14 mcg, or 232/14 mcg. Sixty percent of patients were female and 80% of patients were white. The average duration of exposure was 82 to 84 days in the fluticasone propionate MDPI and fluticasone propionate/salmeterol MDPI treatment groups compared with 75 days in the placebo group. Table 2 displays the incidence of most common adverse reactions in pooled Trials 1 and 2.

Table 2: Adverse Reactions with ≥3% Incidence with Fluticasone Propionate/Salmeterol MDPI, and More Common than Placebo in Subjects with Asthma (Trials 1 and 2)

Adverse Reaction	fluticasone propionate MDPI 55 mcg (n=129) %	fluticasone propionate MDPI 113 mcg (n=274) %	fluticasone propionate MDPI 232 mcg (n=146) %	fluticasone propionate /salmeterol MDPI 55/14 mcg (n=128) %	fluticasone propionate /salmeterol MDPI 113/14 mcg (n=269) %	fluticasone propionate /salmeterol MDPI 232/14 mcg (n=145) %	Placebo (n=273) %
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
Headache	1.6	7.3	4.8	5.5	4.8	2.8	4.4
Cough	1.6	1.8	3.4	2.3	3.7	0.7	2.6
Back pain	0	1.5	1.4	3.1	0.7	0	1.8
*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 fluticasone propionate/salmeterol MDPI) that were reported more frequently by patients with asthma treated with fluticasone propionate/salmeterol MDPI 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 ICS who were treated twice daily with fluticasone propionate MDPI 113 mcg or 232 mcg; fluticasone propionate/salmeterol MDPI 113/14 mcg or 232/14 mcg; fluticasone propionate inhalation aerosol 110 mcg or 220 mcg; fluticasone propionate and salmeterol inhalation powder (250/50 mcg), or fluticasone propionate and salmeterol inhalation powder (500/50 mcg). 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, blurred vision and central serous chorioretinopathy.

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 Digihaler (Fluticasone Propionate and Salmeterol Inhalation Powder)