fluticasone and salmeterol

What is the most important information I should know about fluticasone and salmeterol?

What is fluticasone and salmeterol inhalation?

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.

What should I discuss with my healthcare provider before using fluticasone and salmeterol?

• 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.

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

How should I use fluticasone and salmeterol?

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.

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.

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.

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.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Overdose symptoms may include chest pain, fast heart rate, and feeling shaky or short of breath.

Long term use of an inhaled steroid can lead to glaucoma, cataracts, thinning skin, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using fluticasone and salmeterol?

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).

What are the possible side effects of fluticasone and salmeterol?

• 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.

What other drugs will affect fluticasone and salmeterol?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

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.

Where can I get more information?

Your pharmacist can provide more information about fluticasone and salmeterol inhalation.