Fluticasone and salmeterol

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

For people with COPD, fluticasone and salmeterol is for long-term treatment. For people with asthma, fluticasone and salmeterol is for short-term treatment until symptoms are well controlled 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 other purposes not listed in this medication guide.

Fluticasone and salmeterol is not a rescue medicine. It will not work quickly enough to treat an asthma or bronchospasm attack.

Seek medical attention if you have worsening breathing problems, or if you think your medications are not working as well.

You should not use fluticasone and salmeterol 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, which makes it easier for you to get an infection or worsen an infection that you already have or have recently had. Tell your doctor about any illness or infection you have had in 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, do not exercise, do not get enough vitamin D or calcium in your diet, or have a family history of osteoporosis. Talk with your doctor about your risk.

Tell your doctor if you are pregnant. It is not known if this medicine will harm an unborn baby. However, untreated or uncontrolled asthma during pregnancy may cause complications like low birth weight, premature birth, or eclampsia (dangerously high blood pressure that can lead to medical problems for 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.

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

Fluticasone and salmeterol may cause serious side effects. Call your doctor right away 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—more thirst, more urination, dry mouth, fruity breath odor;
• low potassium level—leg cramps, constipation, irregular heartbeats, fluttering in your chest, more thirst or urination, numbness or tingling, muscle weakness or feeling limp; 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 of fluticasone and salmeterol 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 feeling full in the ear, 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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Using too much of this medicine can cause life-threatening side effects.

Fluticasone and salmeterol is not a rescue medicine for asthma or bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

Advair Diskus is a powder form of fluticasone and salmeterol that comes with a special inhaler device pre-loaded with blister packs containing measured doses of the medicine. Advair HFA and AirDuo Respiclick each come in a canister that is used with an actuator inhaler device.

Use the medicine at the same time each day. Use only the inhaler device provided with your medication.

Shake the Advair HFA inhaler for at least 5 seconds before each spray.

Do not allow a young child to use this medicine without help from an adult.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Rinse your mouth with water without swallowing after each use of your inhaler.

Your dose needs may change due to surgery, illness, stress, or a recent asthma attack. Do not change your medication dose or schedule without your doctor's advice.

If you also use an oral steroid medication, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose.

If you use a peak flow meter at home, tell your doctor if your numbers are lower than normal.

Your vision and your bone mineral density may need to be checked often.

Store your medicine at room temperature, away from moisture, heat, and sunlight. Avoid high heat, such as open flame or in a car on a hot day. Carefully follow all storage and disposal directions provided with your medicine.

Once your asthma is under control, your doctor may want you to stop using this medicine. Do not stop using the medicine unless your doctor tells you to.

Skip the missed dose and take your next dose at the usual time. Do not take two doses at once.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Signs of an overdose may include chest pain, a rapid heartbeat, and feeling shaky or short of breath.

Using an inhaled steroid for a long time can cause glaucoma, cataracts, thinning skin, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual issues, impotence, or a loss of interest in sex.

Avoid close contact with people who are sick or have infections. Contact your doctor for preventive treatment if you come into contact with chickenpox or measles. These illnesses can be serious or even life-threatening for people using a steroid like fluticasone.

Do not use a second inhaled bronchodilator unless your doctor instructs 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).

Sometimes it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or reduce how well the medications work.

Tell your doctor about all your other medicines, especially:

• antifungal medicine; or
• medicine to treat HIV or AIDS.

This list is not complete, and many other drugs may affect fluticasone and salmeterol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.