Important Safety Information for ADVAIR DISKUS 250/50 for COPD
People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as salmeterol (one of the medicines in ADVAIR DISKUS), have an increased risk of death from asthma problems (see Bolded Warning). CONTINUED BELOW
Acute Symptoms: Symptoms that come on abruptly or over a short period of time. Acute is the opposite of chronic.
Alveoli: Tiny saclike air spaces in the lungs, where there's a transfer of carbon dioxide from the blood into the lungs, and of oxygen from the lungs into the blood.
Arterial blood gas (ABG) test: Blood is withdrawn from a small artery and then analyzed by a special machine that records the amount of carbon dioxide (waste gas), oxygen, and acidity (pH) in the blood.
Artery: A blood vessel that carries blood from the heart to the organs and other parts of the body; in health, arteries carry blood rich in oxygen, except the Pulmonary Artery which carries blood to the lung.
Biopsy: Surgical removal of a small amount of tissue for examination and diagnosis.
Bronchi: These are the large hollow air passages of the lungs.
Bronchial tubes: Hollow air passages that branch out from the trachea, or windpipe, into the lungs. Oxygenated air passes into the lungs through these tubes, while waste gases like carbon dioxide pass out.
Bronchioles: Air passages that are so small they can be seen only through a microscope. They serve the same purpose as the bronchi.
Bronchodilation: The increase in diameter of the bronchi and bronchioles.
Bronchoscope: A tubular instrument, with lenses and lights, which is inserted through the upper airway into the bronchial tubes.
Bronchoscopy: A procedure in which a bronchoscope is inserted into the upper airway through the trachea and branching segments of the bronchi. Fluid or tissue may be removed and examined. The scope is usually made of fiberoptics and is flexible.
Carbon dioxide (CO2): A colorless, odorless, nonflammable gas produced as a waste product by living tissues. CO2 is eliminated by the tissues into the blood, to be exhaled by the lungs in exchange for oxygen (O2).
Chest X-ray: A chest x-ray helps medical professionals see parts of the lungs and diagnose pneumonia and emphysema, as well as other lung diseases.
Chronic Bronchitis: Increased coughing and mucus production caused by inflammation of the airways. Bronchitis is considered chronic (or long-term) if a person coughs and produces excess mucus most days during three months in a year, for two years in a row.
Chronic symptoms: Those that are prolonged. The opposite of acute symptoms.
Cilia: Tiny, hairlike structures that line the airways. In healthy lungs, cilia propel bacteria, pollutants, and other irritants upwards so they can be expelled. Cigarette smoking prevents cilia from working properly. In patients with COPD, the cilia may be injured and unable to perform optimally, if at all.
Diaphragm: The curved muscle that separates the chest from the abdomen. When we inhale, it flattens, then sinks, to help draw air into the lungs.
Dilate: To widen a circular opening, like the inside of a tube, the airways in the lungs, or the pupil of the eye.
Dyspnea: Difficult or labored breathing; shortness of breath.
Emphysema: A type of chronic obstructive pulmonary disease (COPD) associated with damage of the air sacs and/or the smallest breathing tubes in the lungs.
Exacerbations: An exacerbation is when your COPD symptoms (including cough, increased mucus production, and shortness of breath) are worse than usual. This can last for a few days or longer and often requires treatment with antibiotics, oral steroids, and in some cases, hospitalization.
Hypersensitivity: A reaction to a particular food, drug, or chemical. It may occur on the skin or throughout the body and may become life-threatening.
Mucus: A thick liquid that moistens and lubricates body tissues, including those in the airways of the lungs.
Nebulizer: A device that sprays liquid medicine in aerosol form into the air one breathes.
Oxygen (O2): Colorless, odorless gas essential for all human life processes. It's the most important component of air.
Pharyngitis: Inflammation of the pharynx that causes a sore throat.
Phlegm: Thick, sticky, stringy mucus produced by the respiratory tract, usually as a result of irritation, inflammation, or infection of the airways.
Productive cough: A cough in which mucus or phlegm is released, enabling a person to clear his or her lungs.
Pulmonary: Referring to the lungs.
Pulse oximetry: A test performed by placing a special light clip on your finger, earlobe, or forehead. The pulse oximeter uses light waves to indirectly measure the amount of oxygen in your blood. Pulse oximetry can measure oxygen levels continuously and can be performed while the patient is resting, walking, or even sleeping.
Respiratory Tract: The entire system of air passages involved in breathing, especially the trachea, bronchial tubes, bronchioles, and alveoli.
Rhinitis: Inflammation of the lining of the nose.
Spirometer: A machine for measuring air flow, an index of how well the lungs allow a person to breathe.
Sputum: Mucus, phlegm, or other substances coughed up from the respiratory tract.
Trachea: The windpipe. The trachea is the main air passageway from the mouth and nose to the lungs. The trachea ends when it divides into the right and left main bronchi.
Ventilation: The movement of air into and out of the lungs to remove carbon dioxide.
Wheezing: The sound made by air moving through partially narrowed airways.
Approved Uses for ADVAIR DISKUS 250/50 for COPD
ADVAIR DISKUS 250/50 is approved for adults with chronic obstructive pulmonary disease (COPD),
including chronic bronchitis, emphysema, or both.
ADVAIR DISKUS is not for, and should not be used to treat, sudden, severe symptoms of COPD. ADVAIR DISKUS won’t replace a rescue inhaler. You should only take 1 inhalation of ADVAIR DISKUS twice a day. Higher doses will not provide additional benefits.
Important Safety Information for ADVAIR DISKUS® 250/50 (fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder)
- People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as salmeterol (one of the medicines in ADVAIR DISKUS), have an increased risk of death from asthma problems. It is not known whether fluticasone propionate, the other medicine in ADVAIR DISKUS, reduces the risk of death from asthma problems seen with salmeterol.
- Call your healthcare provider if breathing problems worsen over time while using ADVAIR DISKUS. You may need different treatment.
- Get emergency medical care if:
- breathing problems worsen quickly and
- you use your rescue inhaler medicine, but it does not relieve your breathing problems.
- Do not use ADVAIR DISKUS to treat sudden, severe symptoms of asthma or COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms.
- Do not use ADVAIR DISKUS if you have a severe allergy to milk proteins. Ask your doctor if you are not sure.
- Do not use ADVAIR DISKUS more often than prescribed. Do not take ADVAIR DISKUS with other medicines that contain long-acting beta2-agonists for any reason. Tell your doctor about medicines you take and about all of your medical conditions.
- ADVAIR DISKUS can cause serious side effects, including:
- 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:
- swelling of the face, mouth, and tongue
- breathing problems
- sudden breathing problems immediately after inhaling your medicine
- effects on heart
- increased blood pressure
- a fast and irregular heartbeat
- chest pain
- effects on nervous system
- reduced adrenal function (may result in loss of energy)
- changes in blood (sugar, potassium, certain types of white blood cells)
- weakened immune system and a higher chance of infections. You should avoid exposure to chickenpox and measles, and, if exposed, consult your healthcare provider without delay. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex may occur.
- lower bone mineral density. This may be a problem for people who already have a higher chance of low bone density (osteoporosis).
- eye problems including glaucoma and cataracts. You should have regular eye exams while using ADVAIR DISKUS.
- pneumonia. People with COPD have a higher chance of getting pneumonia. ADVAIR DISKUS may increase the chance of getting pneumonia. Call your doctor if you notice any of the following symptoms:
- increase in mucus (sputum) production
- change in mucus color
- increased cough
- increased breathing problems
- Common side effects of ADVAIR DISKUS 250/50 for COPD include:
- thrush in the mouth and throat
- throat irritation
- hoarseness and voice changes
- viral respiratory infections
- muscle and bone pain
- After each dose, rinse your mouth with water and spit the water out. Do not swallow.