Rarely, serious (sometimes fatal) asthma-related breathing problems have occurred with the use of long-acting inhaled beta agonists (e.g., salmeterol). This product contains salmeterol in combination with fluticasone (a corticosteroid). It is not known if adding a corticosteroid changes this risk. Therefore, in patients with asthma, this drug should only be prescribed when one long-term medication (e.g., inhaled corticosteroids) does not control breathing problems or when more than one long-term medication is clearly needed to control breathing problems. Before using this medication, it is important to learn how to use it properly. Discuss the risks and benefits of treatment with this medication with your doctor.

This product is a combination medication (salmeterol and fluticasone). It is used as a long-term (maintenance) treatment to prevent or decrease wheezing and trouble breathing caused by asthma or ongoing lung disease (e.g., COPD, emphysema). It works in the airways by decreasing swelling and relaxing muscles. Controlling symptoms of breathing problems can decrease time lost from work or school.

This medication does not work immediately and should not be used for sudden attacks of breathing trouble. Your doctor must prescribe a quick-relief medicine/inhaler (e.g., albuterol) for sudden shortness of breath/asthma attacks while you are on this medication. You should always have a quick-relief inhaler with you. Consult your doctor or pharmacist for more details.

Do not use other long-acting inhaled beta agonists (e.g., formoterol) with this product since this may increase your risk for side effects.

In patients with asthma, this medication should not be used when breathing problems can be controlled with inhaled corticosteroids (e.g., flunisolide, fluticasone) and occasional use of quick-relief inhalers. (See also Warning section.)

If you are regularly taking corticosteroids by mouth (e.g., prednisone), you should not stop using them or use this inhaled medication instead. Continue to follow your doctor's instructions on taking the corticosteroids by mouth.

Read the Medication Guide available from your pharmacist before you start using salmeterol/fluticasone and each time you get a refill. Refer to the illustrated directions provided by the manufacturer for directions on how to use 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. You may or may not taste/feel the drug when you inhale. Either is normal. 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 with water after using this medication to help prevent dryness and mouth infections (e.g., thrush) and relieve throat irritation. Do not swallow the rinse water.

The dosage is based on your medical condition and response to therapy. Use this medication regularly to receive the most benefit from it. To help you remember, use it at the same times each day. Do not use it more than prescribed or use more than 1 inhalation twice daily since this may increase the risk of side effects.

Do not stop taking this medication or change your dose without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.

If you have been using a quick-relief inhaler (e.g., albuterol) on a regular daily schedule (such as 4 times daily), you must stop this schedule and only use it as needed for sudden shortness of breath/asthma attacks. Consult your doctor for details.

If this medication stops working well, or you need to use your quick-relief inhaler more often than usual (4 or more puffs for 2 or more days in a row, or use of more than 1 inhaler every 8 weeks), seek immediate medical attention. It may be a sign of worsening asthma, which is a serious condition.

It may take 1 week or longer before the full benefit of this drug takes effect. Inform your doctor if your condition persists or worsens.

See also Precautions.

Hoarseness, throat irritation, headache, rapid heartbeat, nervousness, cough, dry mouth/throat, or upset stomach may occur.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: white patches on tongue/in mouth, increased thirst/urination, persistent weight gain, vision problems (e.g., blurred vision), shaking, severe muscle cramping.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, fast/slow/irregular heartbeat, severe dizziness, fainting, seizures.

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 (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Rarely, this medication has caused severe (rarely fatal), sudden worsening of breathing problems/asthma (paradoxical bronchospasm). If you have trouble breathing or experience sudden wheezing, use your quick-relief inhaler and seek immediate medical attention.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have a severe allergy (anaphylaxis) to lactose or milk proteins (not lactose intolerance); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, bone loss (osteoporosis), depression, diabetes, eye problems (e.g., cataracts, glaucoma), heart problems (e.g., angina, irregular heartbeat), any recent infection, liver problems, seizures, smoking, thyroid problems (e.g., overactive thyroid).

Fluticasone/salmeterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using fluticasone/salmeterol, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using fluticasone/salmeterol safely.

This product may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Avoid contact with people who have chickenpox or measles unless you have previously had these diseases (e.g., in childhood). If you are exposed to one of these infections and you have not previously had it, seek immediate medical attention.

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 for an extended time and suddenly stop using it, your body may not produce enough natural steroids. You may need to start taking additional corticosteroids, especially if your body is stressed due to a major infection, surgery, or injury. Deaths have sometimes occurred during such stresses due to low steroid levels. Tell your doctor immediately if any of the following side effects occur: unusual weakness, sudden weight loss, dizziness. Consult your doctor or pharmacist for more details, and inform them that you use (or have used) any type of corticosteroid. Consult your doctor or pharmacist now for advice regarding future stress situations. You may need to carry a supply of corticosteroid tablets as a precaution. Carry a warning card or medical ID bracelet that identifies your need for oral corticosteroids during times of stress as noted. (See also Medical Alert section.)

This medication may make it harder to notice the signs of an infection or put you at greater risk of developing an infection. If you have COPD, your risk of developing pneumonia is higher. Tell your doctor immediately if you have any signs of pneumonia or other infection (such as persistent sore throat, fever, chills, increased cough, an increase in the amount of mucus/sputum or a change in its color, increased trouble breathing).

Older adults may be more sensitive to the effects of this drug, especially dizziness, increased risk of pneumonia, and effects on the heart.

Caution is advised when using this drug in children. Though it is unlikely to occur with inhaled steroids, this medication may temporarily slow down a child's rate of growth, but it will probably not affect final adult height. Monitor your child's height periodically.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if salmeterol or fluticasone pass into breast milk. Based on information for similar drugs, fluticasone may pass into breast milk. Consult your doctor before breast-feeding.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medication because very serious interactions may occur: natalizumab.

Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) within 2 weeks before, during, and after treatment with this medication. In some cases a serious, possibly fatal drug interaction may occur.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this product.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: aldesleukin, amphotericin B, other asthma drugs (e.g., quick-relief inhalers), beta blockers (e.g., metoprolol, propranolol), corticosteroids taken by mouth (e.g., dexamethasone, prednisone), inhaled anesthetics (e.g., halothane), mifepristone, tricyclic antidepressants (e.g., amitriptyline, nortriptyline).

Many drugs besides this product may affect the heart rhythm (QT prolongation) including dofetilide, pimozide, procainamide, amiodarone, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others. Therefore, before using fluticasone/salmeterol, report all medications you are currently using to your doctor or pharmacist.

Other medications can affect the removal of fluticasone and salmeterol from your body, thereby affecting how this medication works. These drugs include nefazodone, telithromycin, azole antifungals (such as ketoconazole, itraconazole), macrolide antibiotics (such as clarithromycin), HIV protease inhibitors (such as ritonavir, saquinavir). This is not a complete list.

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 these products.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include seizures, chest pain, fast/irregular heartbeat, severe muscle cramping, fainting.

Do not share this medication with others.

Laboratory and/or medical tests (e.g., morning cortisol levels, pulmonary function tests, regular eye exams, bone density tests) may 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/red range, increased use of quick-relief inhalers).

Avoid allergens/irritants such as smoke, pollen, pet dander, dust, or molds that may worsen asthma and other breathing problems.

Ask your doctor or pharmacist if you should have an annual flu shot.

In adults, this medication can increase the risk of bone loss (osteoporosis) if used for a long time. Talk with your doctor about your risk, and about available treatments for osteoporosis. Lifestyle changes that reduce the risk of bone loss include doing weight-bearing exercise, getting enough calcium and vitamin D, stopping smoking, and limiting alcohol. To help prevent osteoporosis later in life, encourage children to exercise and eat a healthy diet (including calcium).

If you miss a dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Store the U.S. product at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Do not remove the device from its original foil package until ready to use. Discard the device 1 month after you remove it from the original foil package or after the dose indicator reads "0," whichever comes first.

For the Canadian product, the manufacturer recommends not storing it above 86 degrees F (30 degrees C). Keep away from light and moisture. Do not store in the bathroom. Keep the device closed when not in use.

Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

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).

Information last revised May 2009 Copyright(c) 2009 First DataBank, Inc.