IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
SALMETEROL DISK INHALER - ORAL
COMMON BRAND NAME(S): Serevent Diskus
WARNING: Rarely, when treating asthma, serious (sometimes fatal) asthma-related breathing problems have occurred with the use of long-acting inhaled beta agonists (such as salmeterol). Therefore, in patients with asthma, this drug should only be prescribed when one long-term medication (such as inhaled corticosteroids) does not control breathing problems or when more than one long-term medication is clearly needed to control breathing problems. Salmeterol must not be used alone to treat asthma. 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. Once asthma symptoms are controlled, if possible, your doctor may stop treatment with salmeterol and continue only your other asthma medications (such as inhaled corticosteroids). Follow your doctor's directions carefully.
USES: Salmeterol 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 should only be used long-term if your asthma symptoms are not controlled by your other asthma medications (such as inhaled corticosteroids). Salmeterol must not be used alone to treat asthma. (See also Warning section.) It is also used to prevent asthma brought on by exercise (bronchospasm). Salmeterol works in the airways by relaxing muscles and opening air passages to improve breathing. 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. This medication should be used in combination with other medications such as long-acting inhaled corticosteroids. However, it should not be used with other long-acting inhaled beta agonists (e.g., formoterol, combination salmeterol/fluticasone) since this may increase your risk for side effects. It is recommended that children and teenagers, who need to use salmeterol to treat their asthma, should use a combination salmeterol/fluticasone product. Check with your child's doctor to see if this product is the right product for your child. 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 for taking the corticosteroids by mouth.
HOW TO USE: Read the Medication Guide available from your pharmacist before you start using salmeterol 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 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. 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 often 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 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 you are only using this medication occasionally to prevent asthma brought on by exercise (bronchospasm), use it at least 30 minutes before exercise, and do not use another dose for at least 12 hours. If you have sudden asthma/shortness of breath, use a quick-relief inhaler (e.g., albuterol). 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 daily 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. Learn which of your inhalers you should use every day and which you should use if your breathing suddenly worsens. Ask your doctor what to do if you have worsening cough or shortness of breath, wheezing, increased sputum, or worsening peak flow meter readings. Learn when you can self-medicate and when you should get medical help right away. Inform your doctor if your condition persists or worsens.
SIDE EFFECTS: 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. 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.
PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this drug, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., angina, irregular heartbeat), high blood pressure, diabetes, liver problems, seizures, thyroid problems (e.g., overactive thyroid). 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 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 salmeterol safely. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This drug should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Many drugs besides salmeterol may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others. Therefore, before using salmeterol, report all medications you are currently using to your doctor or pharmacist. Other medications can affect the removal of salmeterol from your body, thereby affecting how salmeterol 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.
OVERDOSE: 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 chest pain, fast/irregular heartbeat, headache, fainting.
NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., pulmonary function 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, or 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.
MISSED DOSE: If you are on a prescribed schedule and miss a dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store the US product at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Store the Canadian product at room temperature below 77 degrees F (25 degrees C) away from light and moisture. Do not store in the bathroom. 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 July 2012. Copyright(c) 2012 First Databank, Inc.