ArmonAir RespiClick and AirDuo RespiClick Asthma Inhalers Approved
January 27, 2017 - The U.S. FDA approved two new dry-powder inhalers, ArmonAirTM RespiClick® (fluticasone propionate) and AirDuoTM RespiClick® (fluticasone propionate/salmeterol), manufactured by Teva Pharmaceutical Industries Ltd.. Both medications are indicated for maintenance treatment of asthma for patients who are at least 12 years old. Patients using either ArmonAir RespiClick or AirDuo RespiClick are advised to rinse out their mouths with plain water after each inhalation because they contain the corticosteroid, fluticasone propionate which can lead to oropharyngeal candidiasis (fungal infections of the mouth and throat). Recommended dosing for each is one inhalation two times a day. Neither is intended for relief of acute asthma attacks. Patients with serious reactions to milk should not use them.
AirDuo RespiClick also contains the long-acting beta2 agonist (LABA), salmeterol, therefore it’s labeling has boxed warnings that it increases the risk of death due to asthma and that using it may also raise the chance of hospitalization for children and teens. It should be reserved for patients whose asthma is not well managed by another maintenance medication for asthma.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.