Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

SALMETEROL/FLUTICASONE INHALATION DISK - ORAL

(flew-TICK-uh-sone/sal-MET-er-all)

COMMON BRAND NAME(S): Advair Diskus

WARNING: Rare (sometimes fatal) asthma-related problems have occurred with the use of products containing salmeterol. While this problem is rare, when it does occur it has affected black people more than other races. Do not stop using your medications for asthma or other breathing problems (emphysema or bronchitis) without doctor approval, since your condition will worsen if you suddenly stop your treatment. Consult your doctor or pharmacist for more details.

Uses

This product is a combination "controller" medication used as long-term (maintenance) treatment to prevent or decrease the symptoms of asthma (e.g., wheezing, trouble breathing), and also chronic lung disease (emphysema/bronchitis-COPD). It works by opening the airways in the lungs (decreases bronchiolar swelling and causes muscle relaxation). This medication does not work immediately and should not be used for acute asthma attacks. Use other quick-relief medicines/inhalers for sudden shortness of breath or asthma attacks.

How To Use

Learn all preparation and usage instructions in the product package. Refer to the illustrated directions provided by the manufacturer for instructions on the correct use of this device. If any of the information is unclear, consult your doctor or pharmacist. Always activate and use this device in a level, horizontal position. Inhale this medication by mouth usually twice daily, in the morning and the evening (12 hours apart); or use as directed by your doctor. Your dosage is based on your condition and response to treatment. This medication should be used regularly to receive the most benefit from it. Never exhale into the device. Do not use with a spacer. Never wash the mouthpiece or any part of the device. Do not take the inhaler apart. Gargle and rinse your mouth after using this medication to help prevent dryness, relieve throat irritation, and to prevent mouth infections (e.g., thrush). Do not swallow the rinse solution. Use this medication exactly as prescribed; do not use it more frequently or use more inhalations than prescribed. Doing so would decrease the effectiveness of the drug and increase the risk of side effects. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased. If you find that your fast-acting inhaler is not working as well or if you need to use it more often than usual (i.e., using 4 or more puffs daily, or using more than 1 inhaler every 8 weeks), tell your doctor or pharmacist promptly. It may be a sign of worsening asthma which is a serious condition.

Side Effects

Hoarseness (dysphonia), throat irritation, headache, cough, dry mouth or throat may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these serious side effects occur: white patches on tongue or mouth, swollen/painful mouth or tongue. Tell your doctor immediately if any of these unlikely but serious side effects occur: weight gain, vision changes, trouble sleeping, tremors. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: seizures, severe muscle weakness or cramping, fast/irregular heartbeat, numbness/tingling of the hands or feet, chest pain, worsening of breathing symptoms (e.g., wheezing, coughing). An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. Rarely, your wheezing might actually increase immediately after using this medication (paradoxical bronchospasm). If this occurs, use your "quick relief" inhaler (such as albuterol). Seek immediate medical attention if your breathing does not improve at that time. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: irregular/fast heartbeat (cardiac tachyarrhythmias), untreated lung infection (bacterial, fungal, tuberculosis), certain lung diseases (bronchiectasis). Before using this medication, tell your doctor your medical history, especially of: heart disease (angina, arrhythmias), liver problems, diabetes, high blood pressure, low potassium levels (hypokalemia), eye problems (e.g., cataracts, glaucoma), depression, recent infection, seizures, thyroid problems (e.g., hyperthyroid), any allergies you may have. This product may make you dizzy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. If you have switched from an oral corticosteroid (e.g., prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses and suddenly stop using it, your body may not produce enough natural steroids. You may need to start taking additional corticosteroids, especially if you body is stressed due to a major infection, surgery, or injury. Consult your doctor or pharmacist for more details, and inform them that you use (or have used) any type of corticosteroid. Carry a warning card stating that you may need supplemental corticosteroids (e.g., prednisone) during stress periods (such as trauma or major surgery). Contact your doctor if you experience any of the following signs of low steroid levels: unusual weakness, weight loss, fainting, dizziness. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the effects on the heart (cardiovascular) Caution is advised when using this drug in children. Though it is very unlikely to occur with inhaled steroids (fluticasone), this medication may decrease a child's growth rate, but not necessarily their final adult height. Though it is very unlikely with inhaled steroid use, children might be prone to serious cases of common infections, such as chickenpox or measles. Avoid exposing the child to such diseases. Consult the doctor or pharmacist for more details. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. One of the medications in this product (salmeterol) passes into breast milk; it is unknown if the other product (fluticasone) passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Drug Interactions

Before using this medication, tell your doctor of all prescription and nonprescription medication you may use, especially: other asthma drugs (e.g., quick-relief inhalers), oral corticosteroids (e.g., dexamethasone, prednisone), beta-blockers (e.g., metoprolol, propranolol), MAO inhibitors (e.g., furazolidone, linezolid, moclobemide, phenelzine, procarbazine, selegiline, isocarboxazid, tranylcypromine), tricyclic antidepressants (e.g., amitriptyline, nortriptyline), "water pills" (diuretics such as furosemide, hydrochlorothiazide), HIV protease inhibitors (e.g., lopinavir, ritonavir), azole antifungals (e.g., itraconazole, ketoconazole), "adrenaline-like" stimulants (e.g., pseudoephedrine, ephedra). Use of this inhaler within 2 weeks after stopping MAO inhibitors or tricyclic antidepressants is not recommended, since these medications may increase the serious side effects of salmeterol. Check the labels on all your medicines (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could increase your heart rate or blood pressure. Ask your pharmacist about the safe use of those products. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include seizures, chest pain, unusually fast/irregular heartbeat, severe muscle weakness/cramping, or fainting .

Notes

Do not share this medication with others. Laboratory and/or medical tests (e.g., IOP, children's rate of growth) should be performed to monitor your progress or check for side effects. Consult your doctor for more details. Learn to use a peak flow meter, use it daily, and promptly report worsening asthma (such as readings in the yellow or red range or increased use of quick-relief inhalers). Try to avoid irritants that may trigger an asthma attack such as smoke, pollen, pet dander, dust, or molds.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store this medication exactly as directed on the package. The inhaler must be kept dry at all times. Keep all medicines away from children and pets.

Medical Alert

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).