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AIRDUO RESPICLICK- fluticasone propionate and salmeterol powder, metered


  1. Patient Information
  2. Patients Should Be Given The Following Information:
  3. Instruct Patients To Seek Medical Attention If They Experience Any Of The Following:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Patients Should Be Given The Following Information: 

Serious Asthma Events

Inform patients with asthma that LABA when used alone increases the risk of asthma-related

hospitalization and asthma-related death. Available data show that when ICS and LABA are

used together, such as with AIRDUO RESPICLICK, there is not a significant increase in the risk of these events.

Not for Acute Symptoms

Inform patients that AIRDUO RESPICLICK is not meant to relieve acute asthma symptoms and extra doses should not be used for that purpose. Advise patients to treat acute asthma symptoms with an inhaled, short acting beta2agonist such as albuterol. Provide patients with such medication and instruct them in how it should be used.

Instruct Patients To Seek Medical Attention If They Experience Any Of The Following: 

  • Decreasing effectiveness of inhaled, short acting beta2agonists
  • Need for more inhalations than usual of inhaled, short acting beta2agonists
  • Significant decrease in lung function as outlined by the physician

Tell patients they should not stop therapy with AIRDUO RESPICLICK without physician/provider guidance since symptoms may recur after discontinuation.

Do Not Use Additional Long-Acting Beta2Agonists

Instruct patients not to use other LABA for asthma.

Local Effects

Inform patients that localized infections withCandida albicansoccurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, treat it with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing therapy with AIRDUO RESPICLICK, but at times therapy with AIRDUO RESPICLICK may need to be temporarily interrupted under close medical supervision. Rinsing the mouth with water without swallowing after inhalation is advised to help reduce the risk of thrush.

Immunosuppression

Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and, if exposed, to consult their physicians without delay. Inform patients of potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

Hypercorticism and Adrenal Suppression

Advise patients that AIRDUO RESPICLICK may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, inform patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to AIRDUO RESPICLICK.

Immediate Hypersensitivity Reactions

Advise patients that immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of AIRDUO RESPICLICK. Patients should discontinue AIRDUO RESPICLICK if such reactions occur and contact their healthcare provider or get emergency medical help. There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of powder products containing lactose; therefore, patients with severe milk protein allergy should not take AIRDUO RESPICLICK.

Reduction in Bone Mineral Density

Advise patients who are at an increased risk for decreased BMD that the use of corticosteroids may pose an additional risk.

Reduced Growth Velocity

Inform patients that orally inhaled corticosteroids, including fluticasone propionate, may cause a reduction in growth velocity when administered to adolescent patients. Physicians should closely follow the growth of adolescents taking corticosteroids by any route.

Ocular Effects

Long-term use of inhaled corticosteroids may increase the risk of some eye problems (cataracts or glaucoma); consider regular eye examinations.

Risks Associated with Beta Agonist Therapy

Inform patients of adverse effects associated with beta2agonists, such as palpitations, chest pain, rapid heart rate, tremor, or nervousness.

Pregnancy

Inform patients who are pregnant or nursing that they should contact their physician about the use of AIRDUO RESPICLICK.

Use Daily for Best Effect

Patients should use AIRDUO RESPICLICK at regular intervals as directed. The daily dosage of AIRDUO RESPICLICK should not exceed 1 inhalation twice a day. Advise patients, if they miss a dose, to take their next dose at the same time they normally do and to not take 2 doses at one time. Individual patients will experience a variable time to onset and degree of symptom relief and full benefit may not be achieved until treatment has been administered for 1 to 2 weeks or longer. Patients should not increase the prescribed dosage but should contact their physicians if symptoms do not improve or if the condition worsens. Instruct patients not to stop use of AIRDUO RESPICLICK abruptly. Patients should contact their physicians immediately if they discontinue use of AIRDUO RESPICLICK.

Caring for and Storing the Inhaler

Instruct patients to not open their inhaler unless they are taking a dose.Repeated opening and closing the cover without taking medication will waste medication and may damage the inhaler.

Advise patients to keep their inhaler dry and clean at all times.Never wash or put any part of the inhaler in water.Patient should replace inhaler if washed or placed in water.Advise patients to immediately replace inhaler if mouthpiece cover is damaged or broken.

Gently wipe the mouthpiece with a dry cloth or tissue as needed.

Instruct patients to store the inhaler at room temperature and to avoid exposure to extreme heat, cold, or humidity.

Instruct patients to never take the inhaler apart.

Inform patients that AIRDUO RESPICLICK has a dose counter. When the patient receives the inhaler, the number 60 will be displayed. The dose counter will count down each time the mouthpiece cap is opened and closed. The dose-counter window displays the number of actuations left in the inhaler in units of two (e.g., 60, 58, 56, etc.). When the counter displays 20, the color of the numbers will change to red to remind the patient to contact their pharmacist for a refill of medication or consult their physician for a prescription refill. When the dose counter reaches 0, the background will change to solid red. Inform patients to discard AIRDUO RESPICLICK when the dose counter displays 0, 30 days after opening the foil pouch or after the expiration date on the product, whichever comes first.

Rx only

Marketed by: Teva Respiratory, LLC
Frazer, PA 19355

Manufactured by: Teva Pharmaceutical Industries Ltd.
Jerusalem, Israel

Copyright 2018 Teva Respiratory, LLC

All rights reserved.

United States Patent Nos. 6701917, 6718972, 6748947, 6871646, 7540282, 8006690, 8651103, 8714149, 8978966, 9066957, 9216260, 9415008, 9463288, 9616024, 9731087.

AIRDPI-003

Rev. March 2018

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