ArmonAir RespiClick
- Generic Name: fluticasone propionate multidose dry powder inhaler for oral inhalation
- Brand Name: ArmonAir RespiClick
ArmonAir RespiClick (Fluticasone Propionate Multidose Dry Powder Inhaler for Oral Inhalation) side effects drug center
ArmonAir RespiClick Side Effects Center
What Is ArmonAir RespiClick?
Armonair Respiclick (fluticasone propionate) inhalation powder is a corticosteroid indicated for maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older.
What Are Side Effects of ArmonAir RespiClick?
Common side effects of Armonair Respiclick include:
- runny and stuffy nose,
- upper respiratory tract infection,
- oral thrush (oral candidiasis),
- headache, and
- cough.
Dosage for ArmonAir RespiClick
The starting dosage of Armonair Respiclick is based on prior asthma therapy and disease severity. The dose to treat asthma in patients 12 years and older the dose is 1 inhalation of Armonair Respiclick 55 mcg, 113 mcg, or 232 mcg twice daily.
What Drugs, Substances, or Supplements Interact with ArmonAir RespiClick?
Armonair Respiclick may interact with ritonavir and ketoconazole. Tell your doctor all medications and supplements you use.
ArmonAir RespiClick During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Armonair Respiclick; it is unknown if it will affect a fetus. It is unknown if 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 Respiclick (fluticasone propionate) Inhalation Powder Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
ArmonAir RespiClick 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 RespiClick (Fluticasone Propionate Multidose Dry Powder Inhaler for Oral Inhalation)
ArmonAir RespiClick 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 | 3.4 | 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.
Read the entire FDA prescribing information for ArmonAir RespiClick (Fluticasone Propionate Multidose Dry Powder Inhaler for Oral Inhalation)
&Copy; ArmonAir RespiClick Patient Information is supplied by Cerner Multum, Inc. and ArmonAir RespiClick Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.