Fluticasone and salmeterol inhalation is a steroid and bronchodilator combination medicine that is used to prevent asthma attacks. It is also used to prevent flare-ups or worsening of chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and/or emphysema.

In people with COPD, fluticasone and salmeterol is for long-term treatment. In people with asthma, this medicine is for short-term treatment until symptoms are well controlled with with other medicines.

Advair Diskus is for use in adults and children who are at least 4 years old. Advair HFA and AirDuo Respiclick are for use in adults and children who are at least 12 years old.

Fluticasone and salmeterol may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to fluticasone or salmeterol, or:

• if you have a severe allergy to milk proteins; or
• if you are having an asthma attack or severe COPD symptoms.

Fluticasone can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

Tell your doctor if you have ever had:

• glaucoma or cataracts;
• heart disease or high blood pressure;
• a seizure;
• diabetes;
• a food or drug allergy;
• a weak immune system;
• any type of infection (bacterial, fungal, viral, or parasitic);
• osteoporosis;
• a thyroid disorder; or
• liver or kidney disease.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk.

Tell your doctor if you are pregnant. It is not known whether this medicine will harm an unborn baby. However, having untreated or uncontrolled asthma during pregnancy may cause complications such as low birth weight, premature birth, or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating asthma may outweigh any risks to the baby.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Do not give this medicine to a child without medical advice.

Use Wixela Inhub (Inhalation) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medicine;
• fever, chills, cough with mucus, feeling short of breath;
• chest pain, fast or irregular heartbeats, severe headache, pounding in your neck or ears;
• tremors, nervousness;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• signs of thrush (a fungal infection)--sores or white patches in your mouth or throat, trouble swallowing;
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or
• signs of a hormonal disorder--worsening tiredness or weakness, feeling light-headed, nausea, vomiting.

Fluticasone can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

Common side effects may include:

• headache, muscle pain, bone pain, back pain;
• nausea, vomiting;
• thrush, throat irritation;
• ongoing cough, hoarseness or deepened voice;
• cold symptoms such as stuffy nose, sneezing, sore throat; or
• ear infection (in a child)--fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

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