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Prescribing Information
 * AirDuo RespiClick
 * Authorized Generic

Patient Information
 * AirDuo RespiClick
 * Authorized Generic

Patient Site
 * Product Information
 * Dosing
   * Less Medicine
 * Delivery
   * Innovative Delivery
 * Using Airduo Respiclick
   * Device Design
   * Instructions For Use
 * Efficacy & Safety profiles
   * Efficacy Profile
   * Safety Profile

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   * Efficacy Profile
   * Safety Profile


AIRDUO RESPICLICK


THE FIRST ICS/LABA AVAILABLE AS BRANDED AND AUTHORIZED GENERIC

that offers the lowest approved dose of fluticasone propionate
and salmeterol at each strength1-4




INDICATION FOR AIRDUO RESPICLICK/AUTHORIZED GENERIC

AirDuo RespiClick® is indicated for the treatment of asthma in patients aged 12
years and older. AirDuo RespiClick is only for patients uncontrolled on an
inhaled corticosteroid (ICS) or whose disease severity clearly warrants an
ICS/Long-acting beta2-agonist (LABA).

Limitation of Use: AirDuo RespiClick is not indicated for the relief of acute
bronchospasm.


PRODUCT INFORMATION

Discover the features of the authorized generic of AirDuo RespiClick

DOSING

Learn how low AirDuo RespiClick can go

USING AIRDUO RESPICLICK

Get to know the basic steps of using your inhaler

;

 


IMPORTANT SAFETY INFORMATION FOR AIRDUO RESPICLICK/AUTHORIZED GENERIC

Contraindications: AirDuo RespiClick is contraindicated in:

 * Primary treatment of status asthmaticus or other acute episodes of asthma
   requiring intensive measures
 * Patients with known severe hypersensitivity to milk proteins or any
   ingredients of AirDuo RespiClick

Serious Asthma-Related Events—Hospitalizations, Intubations, Death: Use of LABA
as monotherapy (without an ICS) for asthma is associated with an increased risk
of asthma-related death. Available data from controlled clinical trials also
suggest that use of LABA as monotherapy increases the risk of asthma-related
hospitalization in pediatric and adolescent patients. These findings are
considered a class effect of LABA monotherapy. When LABA are used in fixed-dose
combination with ICS (such as AirDuo RespiClick), data from large clinical
trials do not show a significant increase in the risk of serious asthma-related
events (hospitalizations, intubations, death) compared with ICS alone

Deterioration of Disease and Acute Episodes: AirDuo RespiClick should not be
initiated in patients during rapidly deteriorating or potentially
life-threatening episodes of asthma. AirDuo RespiClick is not indicated for the
relief of acute bronchospasm. An inhaled, short-acting beta2-agonist, not AirDuo
RespiClick, should be used to relieve acute symptoms such as shortness of breath

Avoid Excessive Use and Avoid Use with Other Long acting Beta2-Agonists: AirDuo
RespiClick should not be used more often than recommended, at higher doses than
recommended, or in conjunction with other medicines containing LABA, as an
overdose may result. Clinically significant cardiovascular effects and
fatalities have been reported in association with excessive use of inhaled
sympathomimetic drugs. Patients using AirDuo RespiClick should not use another
medicine containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol
tartrate, indacaterol) for any reason

Oropharyngeal Candidiasis has occurred in patients treated with AirDuo
RespiClick. Advise patients to rinse the mouth with water without swallowing
following inhalation

Immunosuppression and Risks of Infections: Patients who use corticosteroids,
such as found in AirDuo RespiClick are at risk for potential worsening of
existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or
ocular herpes simplex. A more serious or even fatal course of chickenpox or
measles may occur in susceptible patients. Use with caution in patients with the
above because of the potential for worsening of these infections

Transferring Patients from Systemic Corticosteroid Therapy: Particular care is
needed for patients who have been transferred from systemically active
corticosteroids to ICS because deaths due to adrenal insufficiency have occurred
in patients with asthma during and after transfer from systemic corticosteroids
to less systemically available ICS. Taper patients slowly from systemic
corticosteroids if transferring to AirDuo RespiClick

Hypercorticism and Adrenal Suppression may occur with high doses of ICS,
including fluticasone propionate, or at the recommended dose in susceptible
individuals. If such changes occur, discontinue AirDuo RespiClick slowly

Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors: The use of strong
cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, ketoconazole) with
AirDuo RespiClick is not recommended because increased systemic corticosteroid
and increased cardiovascular adverse effects may occur

Paradoxical Bronchospasm and Upper Airway Symptoms: Paradoxical bronchospasm may
occur. If bronchospasm occurs treat immediately with an inhaled short-acting
bronchodilator, discontinue AirDuo RespiClick and institute alternative therapy

Hypersensitivity Reactions, Including Anaphylaxis: Immediate hypersensitivity
reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension),
including anaphylaxis, may occur after administration of AirDuo RespiClick.
Discontinue AirDuo RespiClick if such reactions occur

Cardiovascular and Central Nervous System Effects: The salmeterol component of
AirDuo RespiClick, can be associated with excessive beta-adrenergic stimulation
which could present as the following symptoms: seizures, angina, hypertension or
hypotension, tachycardia with rates up to 200 beats/min, arrhythmias,
nervousness, headache, tremor, palpitation, nausea, dizziness, fatigue, malaise,
and insomnia. Use with caution in patients with cardiac arrhythmias,
hypertension, coronary insufficiency. Drug may need to be discontinued in
certain patients.

Reduction in Bone Mineral Density (BMD): Decreases in BMD have been observed
with long-term administration of products containing ICS. Patients with major
risk factors for decreased bone mineral content, such as prolonged
immobilization, family history of osteoporosis, or chronic use of drugs that can
reduce bone mass (e.g., anticonvulsants, oral corticosteroids) should be
monitored and treated with established standards of care when using AirDuo
RespiClick

Effect on Growth: ICS may cause a reduction in growth velocity. Patients should
be maintained on the lowest dose of inhaled corticosteroid that effectively
controls their asthma. Monitor growth of pediatric patients receiving AirDuo
RespiClick.

Glaucoma and Cataracts: Long-term use of ICS, including fluticasone propionate,
a component of AirDuo RespiClick, may increase the risk for cataracts or
glaucoma. Regular eye exams should be considered

Eosinophilic Conditions and Churg-Strauss Syndrome: Systemic eosinophilic
conditions, such as Churg-Strauss syndrome, may occur when using AirDuo
RespiClick. Be alert to eosinophilia, vasculitic rash, worsening pulmonary
symptoms, cardiac complications, and/or neuropathy

Coexisting Conditions: Use AirDuo RespiClick with caution in patients with
convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in
patients who are unusually responsive to sympathomimetic amines

Hypokalemia and Hyperglycemia: Beta-adrenergic agonist medicines may produce
significant hypokalemia in some patients, possibly through intracellular
shunting, which has the potential to produce adverse cardiovascular effects.
Decrease in serum potassium are usually transient, not requiring
supplementation. Be alert to hypokalemia and hyperglycemia in patient using
AirDuo RespiClick

Adverse Reactions with AirDuo RespiClick: Most common adverse reactions (greater
than or equal to 3%) include nasopharyngitis, oral candidiasis, headache, cough
and back pain


INDICATION FOR AIRDUO RESPICLICK/AUTHORIZED GENERIC

AirDuo RespiClick is indicated for the treatment of asthma in patients aged 12
years and older. AirDuo RespiClick is only for patients uncontrolled on an
inhaled corticosteroid (ICS) or whose disease severity clearly warrants an
ICS/Long-acting beta2-agonist (LABA).

Limitation of Use: AirDuo RespiClick is not indicated for the relief of acute
bronchospasm.

Please see full Prescribing Information for AirDuo RespiClick and Fluticasone
Propionate/Salmeterol MDPI.



References: 1. AirDuo RespiClick Prescribing Information. Parsippany, NJ: Teva
Respiratory, LLC. 2. Fluticasone Propionate and Salmeterol Inhalation Powder
Prescribing Information. Parsippany, NJ: Teva Respiratory, LLC. 3. Advair Diskus
Prescribing Information. Research Triangle Park, NC: GlaxoSmithKline; February
2017. 4. AirDuo RespiClick Medication Guide. Parsippany, NJ: Teva Respiratory,
LLC.

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If you would like to contact Teva Respiratory headquarters, you may call:
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©2024 Teva Respiratory, LLC.

This site is intended for US healthcare professionals only.

All rights reserved.   ADR-40342    September 2024



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