AirDuo RespiClick

Name: AirDuo RespiClick

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include dizziness, vomiting, weakness, chest pain, tremors, feeling nervous, fast or pounding heartbeats, or seizure.

What should I avoid while using AirDuo RespiClick (fluticasone and salmeterol)?

Do not use a second inhaled bronchodilator unless your doctor tells you to. This includes formoterol (Foradil, Perforomist, Symbicort, Dulera), arformoterol (Brovana), indacaterol (Arcapta), olodaterol (Striverdi, Stiolto Respimat), salmeterol (Serevent), or vilanterol (Bree Ellipta, Anoro Ellipta).

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medicine.

Indications and Usage for Airduo Respiclick

AIRDUO™ RESPICLICK® is indicated for the treatment of asthma in patients aged 12 years and older.

LABAs, such as salmeterol, one of the active ingredients in Airduo Respiclick, increase the risk of asthma related death. Available data from controlled clinical trials suggest that LABAs increase the risk of asthma related hospitalization in pediatric and adolescent patients [see Warnings and Precautions (5.1)]. Therefore, when treating patients with asthma, physicians should only prescribe Airduo Respiclick for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue Airduo Respiclick) if possible without loss of asthma control and maintain the patient on a long term asthma control medication, such as an inhaled corticosteroid. Do not use Airduo Respiclick for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

Important Limitation of Use: Airduo Respiclick is NOT indicated for the relief of acute bronchospasm.

How Supplied/Storage and Handling

How Supplied

Airduo Respiclick is supplied in the following three strengths as a white dry-powder inhaler. Each inhaler has a yellow cap and is packaged individually in a foil pouch in a carton. Each inhaler contains 0.45g of the formulation and provides 60 actuations:

STRENGTH NDC CODE

Airduo Respiclick 55/14 mcg

NDC 59310-805-06

Airduo Respiclick 113/14 mcg

NDC 59310-812-06

Airduo Respiclick 232/14 mcg

NDC 59310-822-06

Each Airduo Respiclick inhaler has a dose counter attached to the actuator. Patients should never try to alter the numbers for the dose counter. Discard the inhaler when the counter displays 0, 30 days after opening the foil pouch or after the expiration date on the product, whichever comes first. The labeled amount of medication in each actuation cannot be assured after the counter displays 0, even though the inhaler is not completely empty and will continue to operate [see Patient Counseling Information (17)].

Storage and Handling

Store at room temperature (between 15º and 25ºC; 59º and 77ºF) in a dry place; excursions permitted from 59º F to 86º F (15ºC to 30ºC). Avoid exposure to extreme heat, cold, or humidity.

Keep out of reach of children.

Airduo Respiclick should be stored inside the unopened moisture‑protective foil pouch and only removed from the pouch immediately before initial use. Discard Airduo Respiclick 30 days after opening the foil pouch or when the counter reads 0, whichever comes first. The inhaler is not reusable. Do not attempt to take the inhaler apart.

Package/Label Display Panel

AirDuo™ RespiClick® (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, 60 Metered Inhalations Carton Text

TEVA

NDC 59310-805-06

Rx Only

AirDuo™

RespiClick® 55/14

(fluticasone propionate 55 mcg

and salmeterol 14 mcg)

Inhalation Powder

55 mcg/14 mcg

With Dose Counter

FOR ORAL INHALATION ONLY

60 METERED INHALATIONS

0.45 g NET CONTENTS

Refer to enclosed Medication Guide and

Instructions for Use for detailed

information on product use and handling.

ATTENTION: Dispense with enclosed Medication Guide.

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