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Salmeterol

Pronunciation

Generic Name: salmeterol (sal-MEE-ter-ol)
Brand Name: Serevent Diskus

Long-acting beta-agonists such as salmeterol have been rarely associated with an increased risk of asthma-related death. They may also increase the risk of asthma-related hospitalizations in CHILDREN and TEENAGERS. When used to treat asthma, salmeterol must be used along with another asthma-control medicine (eg, inhaled corticosteroids). It should only be used to treat asthma patients who are not controlled by using other long-term asthma-control medicine. Salmeterol should not be used in patients whose asthma is well controlled by inhaled corticosteroids.


Salmeterol is used for:

Treating asthma in combination with another long-term asthma-control medicine (eg, inhaled corticosteroids). It may also be used to prevent breathing problems in certain patients, including patients with nighttime asthma, or breathing problems caused by exercise. It may be used for long-term treatment of chronic obstructive pulmonary disease (COPD). It may also be used for other conditions as determined by your doctor.

Salmeterol is a long-acting beta-agonist bronchodilator. It works by widening the airways in the lungs, which helps you breathe more easily.

Do NOT use salmeterol if:

  • you are allergic to any ingredient in salmeterol
  • you are using another medicine that has a long-acting beta-agonist (eg, formoterol, arformoterol, indacaterol) in it
  • you are taking an azole antifungal (eg, itraconazole, ketoconazole), an HIV protease inhibitor (eg, atazanavir, nelfinavir, ritonavir), a macrolide antibiotic (eg, clarithromycin), nefazodone, or telithromycin
  • you are having an asthma attack (eg, sudden, severe onset or worsening of asthma or COPD symptoms, such as chest tightness, cough, shortness of breath, wheezing)
  • you have asthma and you are not currently using a long-term asthma-control medicine (eg, inhaled corticosteroids)
  • you have asthma that is already well controlled with the use of a long-term asthma-control medicine

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using salmeterol:

Some medical conditions may interact with salmeterol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have had a severe allergic reaction to milk protein
  • if you have a history of liver problems, diabetes, heart problems (eg, fast or irregular heartbeat, heart blood vessel problems), high blood pressure, low blood potassium levels, seizures, an adrenal gland tumor (pheochromocytoma), or an overactive thyroid
  • if you have recently been to an emergency room for asthma, have a history of frequent hospitalizations for asthma, or have ever had a life-threatening asthma attack
  • if you have had an unusual reaction to a sympathomimetic medicine (eg, albuterol, pseudoephedrine), such as fast or irregular heartbeat, overexcitement, or severe trouble sleeping
  • if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or a tricyclic antidepressant (eg, amitriptyline), or you have taken any of these medicines within the last 14 days

Some MEDICINES MAY INTERACT with salmeterol. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Azole antifungals (eg, itraconazole, ketoconazole), HIV protease inhibitors (eg, atazanavir, nelfinavir, ritonavir), macrolide antibiotics (eg, clarithromycin), nefazodone, or telithromycin because the risk of fast or irregular heartbeat may be increased
  • Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood potassium or irregular heartbeat may be increased
  • Catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), other long-acting beta-agonists (eg, formoterol, arformoterol, indacaterol), MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of salmeterol's side effects
  • Beta-blockers (eg, propranolol) because they may decrease salmeterol's effectiveness or worsen your condition

This may not be a complete list of all interactions that may occur. Ask your health care provider if salmeterol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use salmeterol:

Use salmeterol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Salmeterol comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get salmeterol refilled.
  • Always activate and use this device in a level, horizontal position. Do NOT try to use a spacer device with salmeterol.
  • To prepare the device for use, open the protective foil pouch and remove the inhaler device. Hold the device in one hand. Use the thumb of the opposite hand to push the thumbgrip as far away from you as it will go. The mouthpiece will appear and snap into position.
  • Hold the device in a level, flat position with the mouthpiece toward you. Use your thumb to slide the lever away from you as far as it will go. You should hear a click. The device is now ready for use.
  • Do NOT close or tilt the device, play with the lever, or move the lever more than once. You may accidentally release or waste a dose.
  • To use a dose of salmeterol, hold the inhaler level and away from your mouth. Breathe out fully. Do NOT exhale into the device for any reason. Put the mouthpiece to your lips. Breathe in quickly and deeply through your mouth and hold your breath. Remove the inhaler from your mouth. Continue to hold your breath for 10 seconds or as long as possible. Then, breathe out slowly.
  • Close the device when you are finished taking a dose. Slide the thumbgrip back toward you as far as it will go. The device will click shut, and the lever will return to its original position.
  • Salmeterol delivers your dose as a very fine powder. Most, but not all, patients can taste or feel it. Even if you cannot feel it, do not use more than the recommended dose. If you are not sure if you are receiving your dose, contact your doctor or pharmacist.
  • If you are using salmeterol to prevent breathing problems caused by exercise, use it at least 30 minutes before you start to exercise. Do not use another dose for at least 12 hours. If you already use salmeterol twice daily on a regular basis, do NOT take an extra dose before you exercise.
  • Discard the inhaler 6 weeks after removing it from the protective foil pouch or after all the blisters have been used, whichever comes first.
  • The dose indicator on the device will tell you how many doses are left. The dose indicator will read "0" when all the blisters have been used.
  • Never wash the mouthpiece or any other part of the inhaler. Keep it dry and always store it in a dry place.
  • Do NOT try to take the unit apart.
  • Continue to use salmeterol even if you feel well. Do not miss any doses.
  • If you miss a dose of salmeterol, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use salmeterol.

Important safety information:

  • Salmeterol will not stop an asthma attack or other sudden, severe breathing problems once they have already started. Be sure to carry a rescue inhaler (eg, albuterol) with you at all times to treat any breathing problems that may occur between doses of salmeterol (eg, severe or sudden onset of wheezing or shortness of breath). If you have any questions about which medicines stop asthma attacks or other sudden, severe breathing problems, check with your doctor or pharmacist.
  • If you have been regularly using a rescue inhaler (eg, albuterol), talk with your doctor about how to use it with salmeterol. Rescue inhalers are normally only used with salmeterol to treat breathing problems that may occur between doses.
  • Salmeterol should be used to treat asthma only if you are currently taking a long-term asthma-control medicine (eg, inhaled corticosteroids) and your asthma is not well controlled. Using salmeterol as your only asthma-control medicine has been rarely associated with an increased risk of asthma-related death. Contact your doctor if you have questions about this information.
  • The risk of serious heart problems (eg, irregular heartbeat) may be greater if you use salmeterol in high doses. Do NOT use more than the recommended dose or use more often than prescribed.
  • If your symptoms do not get better within 1 week of starting salmeterol, or if they get worse, contact your doctor right away.
  • Tell your doctor at once if you notice that your rescue inhaler does not work as well, if you need to use it often (eg, 4 or more times a day for more than 2 days in a row; more than 1 canister in 8 weeks), or if you have a decrease in your peak flow meter results.
  • Contact your doctor or seek medical care right away if you have breathing problems that worsen quickly, or if you use your rescue inhaler and do not get relief.
  • Salmeterol is not to be used in place of a corticosteroid. If you are using a corticosteroid medicine for asthma, do not stop or reduce the dose unless your doctor tells you to.
  • Talk with your doctor or pharmacist about all of your asthma medicines and how to use them. Your doctor may make changes to your asthma-control medicines once your asthma is well controlled. Do not start, stop, or change the dose of any asthma medicine unless your doctor tells you to.
  • Salmeterol may sometimes cause severe breathing problems right after you use a dose. If this happens, use your rescue inhaler. Contact your doctor or seek other medical care at once.
  • Diabetes patients - Salmeterol may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Lab tests, including lung function tests and blood pressure, may be performed while you use salmeterol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use salmeterol with caution in the ELDERLY; they may be more sensitive to its effects, especially effects on the heart.
  • Salmeterol should be used with extreme caution in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using salmeterol while you are pregnant. It is not known if salmeterol is found in breast milk. If you are or will be breast-feeding while you use salmeterol, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of salmeterol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; nasal or sinus congestion; nervousness; stuffy or runny nose; throat irritation.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness); chest pain; choking; fast or irregular heartbeat; fever; new or worsening asthma or COPD symptoms (eg, coughing, increased chest tightness, shortness of breath, wheezing); overexcitement; severe or persistent headache, dizziness, or nervousness; severe or persistent muscle pain or cramps; symptoms of high blood sugar (eg, increased thirst, urination, or hunger; unusual weakness or drowsiness; confusion); tremor.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of salmeterol:

Store salmeterol at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store salmeterol away from heat, moisture, and direct sunlight. Throw salmeterol away 6 weeks after it is removed from the foil pouch. Keep salmeterol out of the reach of children and away from pets.

General information:

  • If you have any questions about salmeterol, please talk with your doctor, pharmacist, or other health care provider.
  • Salmeterol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take salmeterol or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about salmeterol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to salmeterol. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using salmeterol.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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