AirDuo RespiClick is a prescription medication used to treat asthma in patients 12 years and older. It is a single product containing 2 medications: fluticasone and salmeterol. Fluticasone belongs to a group of drugs called inhaled steroids. These work by reducing swelling in the airways. Salmeterol belongs to a class of drugs called long-acting beta-agonists (LABAs). These work by relaxing and opening air passages in the lungs, making it easier to breathe.

This medication is an oral inhalation and is typically used twice a day, in the morning and evening, about 12 hours apart.

AirDuo Respicklick is not used to relieve sudden breathing problems.

Common side effects include infection of nose and throat, thrush in the mouth or throat, and headache.

AirDuo RespiClick is a prescription medication used to treat asthma, a disease involving inflammation and swelling of the airways. AirDuo RespiClick is used in patients aged 12 years and older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

AirDuo RespiClick is NOT used to relieve sudden breathing problems.

Serious side effects have been reported with AirDuo RespiClick.  See the "Drug Precautions" section.

Common side effects of AirDuo RespiClick include:

• thrush in the mouth or throat (fungal infection caused by Candida albicans). Rinse your mouth with water without swallowing after use to help prevent this
• respiratory tract infection (inflammation of nasal passages, sore throat, and/or common cold)
• throat irritation
• hoarseness and voice changes
• cough
• headache
• back pain

This is not a complete list of AirDuo RespiClick side effects.  Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects.  You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with AirDuo RespiClick including the following:

• Increased risk of death from asthma problems. People with asthma who take long-acting beta2 adrenergic agonist (LABA) medicines, such as salmeterol (one of the medicines in AirDuo RespiClick), have an increased risk of death from asthma problems.
• Weakened immune system. AirDuo RespiClick may increase the chance of getting infections.
• Adrenal insufficiency. Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones.  This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an inhaled steroid (such as AirDuo RespiClick). When your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include the following: feeling tired, lack of energy, weakness, nausea and vomiting, and low blood pressure.
• Thrush. AirDuo RespiClick can cause a fungal infection in your mouth or throat. It is important to rinse your mouth with water without swallowing after using AirDuo RespiClick to help reduce your chance of getting thrush.
• Sudden breathing problems immediately after inhaling your medicine. Call your healthcare provider if breathing problems worsen over time while using AirDuo RespiClick.
• Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction: rash, hives, swelling of your face, mouth, and tongue, and breathing problems.
• Effects on the heart. AirDuo RespiClick can cause increased blood pressure, a fast or irregular heartbeat, and chest pain.
• Effects on the nervous system. AirDuo RespiClick can cause a tremor and nervousness.
• Osteoporosis. AirDuo RespiClick can cause bone thinning or weakness.
• Slowed growth in children. A child's growth should be checked often.
• Glaucoma and cataracts. AirDuo RespiClick can cause eye problems. It is important to have regular eye exams while using AirDuo RespiClick.
• Changes in laboratory blood values. AirDuo RespiClick can cause changes in your sugar, potassium, and certain types of white blood cells.

Do not take AirDuo RespiClick in the following situations:

• if you are allergic to AirDuo RespiClick or to any of its ingredients
• if you have a severe allergy to milk proteins
• in the treatment of a sudden attack of asthma

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of AirDuo RespiClick, there are no specific foods that you must exclude from your diet when receiving this medication.

You should not use AirDuo RespiClick if you have a severe allergy to milk proteins. See the "Drug Precautions" section.

Before taking AirDuo RespiClick, tell your doctor about all of your medical conditions.  Especially tell your doctor if you:

• are allergic to AirDuo RespiClick or to any of its ingredients
• have heart problems
• have high blood pressure
• have seizures
• have thyroid problems
• have diabetes
• have liver problems
• have osteoporosis (weak bones)
• have an immune system problem
• have eye problems such as glaucoma or cataracts
• have any type of viral, bacterial, or fungal infection
• are exposed to chickenpox or measles
• have any other medical conditions
• are pregnant or plan to become pregnant
• are breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems.  No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

There is an increased risk of preeclampsia (dangerously high blood pressure) in the mother and prematurity (when babies are born earlier than expected) in the newborn when asthma is poorly or moderately controlled in pregnant women. Pregnant women should be closely monitored to make sure that asthma is under optimal control.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if AirDuo RespiClick crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using AirDuo RespiClick.

Take AirDuo RespiClick exactly as prescribed.

AirDuo RespiClick comes in inhalation form and is used twice a day, in the morning and evening, about 12 hours apart.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of AirDuo RespiClick at the same time.

AirDuo RespiClick Inhaler Instructions:

1. If you will be using a new inhaler for the first time, remove it from the foil wrapper.
2. Holding the inhaler upright, with the cap on the bottom and the inhaler pointing upwards, load the dose by opening the protective dust cap at the end of the mouthpiece until it clicks. Do not open the cap unless you are ready to use the inhaler. Every time the protective cap is opened, a dose is ready to inhale. You will see the number in the dose counter go down. Do not waste doses by opening the inhaler unless you are inhaling a dose.
3. Breathe out as completely as possible through your mouth. Do not blow or exhale into the inhaler.
4. Place the mouthpiece between your lips well into your mouth. Close your lips tightly around the mouthpiece. Inhale slowly and deeply through your mouth. Do not breath in through your nose. Make sure that your fingers or lips do not block the vent above the mouthpiece.
5. Remove the inhaler from your mouth and hold your breath for 10 seconds or as long as you comfortably can. Do not blow or exhale through the inhaler.
6. Close the cap firmly over the mouthpiece.
7. Keep the inhaler clean and dry at all times. To clean your inhaler, use a clean, dry tissue or cloth. Do not wash or put any part of your inhaler in water.

Take this medication exactly as prescribed by your doctor.  Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age

The recommended dose of AirDuo RespiClick for the treatment of asthma in people 12 years of age and older is 1 inhalation twice a day, in the morning and evening, about 12 hours apart.

If you take too much AirDuo RespiClick, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.

Do not use other medicines that contain a LABA (Long-acting beta2 adrenergic agonists) for any reason due to overdose risk. Examples of other medicines that contain a LABA include salmeterol, formoterol fumarate, arformoterol tartrate, and indacaterol. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.

• Store AirDuo RespiClick at room temperature between 59ºF and 77ºF (15ºC and 25ºC).
• Avoid exposure to extreme heat, cold, or humidity.
• Store AirDuo RespiClick in the unopened foil pouch and only open when ready for use.
• Keep the yellow cap on the inhaler closed during storage.
• Keep your AirDuo RespiClick inhaler dry and clean at all times.
• Throw away AirDuo RespiClick 30 days after opening the foil pouch, when the dose counter displays 0, or after the expiration date on the product, whichever comes first.
• Keep AirDuo RespiClick and all medicines out of the reach of children.

Warning: asthma-related death

Long‑acting beta2‑adrenergic agonists (LABA), such as salmeterol, one of the active ingredients in AirDuo RespiClick, increase the risk of asthma‑related death.

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. AirDuo RespiClick is not used for patients whose asthma is adequately controlled on low‑ or medium‑dose inhaled corticosteroids.