What is the most important information I should know about fluticasone and salmeterol?
You should not use this medicine if you are allergic to fluticasone, salmeterol, or milk proteins.
Fluticasone and salmeterol is not a rescue medicine. It will not work fast enough to treat an asthma or bronchospasm attack.
Salmeterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known.
What is fluticasone and salmeterol inhalation?
Fluticasone is a steroid that prevents the release of substances in the body that cause inflammation. Salmeterol is a bronchodilator. It works by relaxing muscles in the airways to improve breathing.
Fluticasone and salmeterol inhalation is a combination medicine 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?
You should not use this medicine if you are allergic to fluticasone or salmeterol (Serevent), or:
- if you have a severe allergy to milk proteins; or
- if you are having an asthma attack or severe COPD symptoms.
Salmeterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Talk with your doctor about your individual risks and benefits of using this medicine.
To make sure this medicine is safe for you, tell your doctor if you have:
- a food or drug allergy;
- heart disease or high blood pressure;
- epilepsy or other seizure disorder;
- any type of infection;
- a weak immune system;
- diabetes;
- glaucoma;
- tuberculosis;
- osteoporosis;
- a thyroid disorder; or
- liver 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.
It is not known whether fluticasone and salmeterol is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.
It is not known whether this medicine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
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.
This medicine is not approved for use by anyone younger than 4 years old.
How should I use fluticasone and salmeterol?
Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Using too much of this medicine can cause life-threatening side effects.
Fluticasone and salmeterol is not a rescue medicine. It will not work fast enough to treat an asthma attack. Use only a fast-acting inhalation medicine for an asthma attack.
Seek medical attention if you think your 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. The device opens and loads a blister each time you use the inhaler.
Advair HFA and AirDuo Respiclick each come in a canister that is used with an actuator inhaler device.
Use only the inhaler device provided with your medication.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Shake the Advair HFA inhaler for at least 5 seconds before each spray.
Rinse your mouth with water after each use of your inhaler.
Your dose needs may change if you have surgery, are ill, are under stress, or have recently had an 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.
While using fluticasone and salmeterol, your vision and your bone mineral density may need to be checked often.
Seek medical attention if your breathing problems do not improve, or if your symptoms get worse quickly. If you use a peak flow meter at home, call your doctor if your numbers are lower than normal.
Store your medicine at room temperature away from moisture, light, and heat (especially high heat, such as open flame or in a car on a hot day).
Throw the inhaler device away 1 month after you took it out of the foil pouch, or if the dose indicator shows a zero (even if it feels like there is still medicine inside).
Once your asthma is under control, your doctor may want you to stop using this medicine. Keep all follow-up appointments and do not stop using the medicine unless your doctor tells you to.
What happens if I miss a dose?
Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
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 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.
What are the possible side effects of fluticasone and salmeterol?
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;
- chest pain, fast or uneven heart beats, restless feeling, tremors;
- severe headache, pounding in your neck or ears, nosebleed;
- fever, chills, swollen glands, mouth sores, skin sores, flu symptoms, cough with yellow or green mucus;
- blurred vision, tunnel vision, eye pain, or seeing halos around lights;
-
high blood sugar --increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin;
-
low potassium --confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling; or
-
signs of a hormonal disorder --worsening tiredness or muscle weakness, feeling light-headed, anxiety, feeling irritable, nausea, vomiting, loss of appetite, diarrhea, weight loss, weight gain, slow wound healing.
Common side effects may include:
- headache, muscle pain, bone pain, back pain;
- nausea, vomiting;
- throat irritation, white patches in the mouth or throat;
- cold symptoms such as stuffy nose, sneezing, sore throat; or
- ongoing cough, hoarseness or deepened voice.
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?
Many drugs can interact with this medicine. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:
- an antidepressant, heart or blood pressure medicine, a diuretic or "water pill";
- antifungal medicine such as ketoconazole; or
- ritonavir (Norvir) or lopinavir/ritonavir (Kaletra).
This list is not complete and many other drugs can interact with fluticasone and salmeterol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
Where can I get more information?
Your pharmacist can provide more information about fluticasone and salmeterol inhalation.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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