Salmeterol

Long-acting beta-agonists such as Salmeterol have been rarely associated with an increased risk of asthma-related death. Salmeterol should only be used by certain patients with severe asthma or by patients who cannot get adequate control of asthma symptoms by using other asthma-controller medicines (eg, inhaled corticosteroids).

Salmeterol is used for:

Long-term treatment of asthma. It may 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 widens 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, fluticasone/salmeterol, formoterol) in it

* you are taking an azole antifungal (eg, ketoconazole), an HIV protease inhibitor (eg, ritonavir), a macrolide antibiotic (eg, clarithromycin), nefazodone, or telithromycin

* you are having an asthma attack (eg, sudden severe onset or worsening of asthma symptoms such as chest tightness, cough, shortness of breath, wheezing)

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, ketoconazole), HIV protease inhibitors (eg, 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), long-acting beta-agonists (eg, fluticasone/salmeterol, formoterol), 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

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 towards 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 towards 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.

* Salmeterol may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Salmeterol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

* Salmeterol will not stop an asthma attack once it has already started. Be sure to carry a short-acting bronchodilator 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, check with your doctor or pharmacist.

* If you have been regularly using a short-acting bronchodilator inhaler (eg, albuterol), talk with your doctor about how to use it with Salmeterol . Short-acting bronchodilators are normally only used with Salmeterol to treat breathing problems that may occur between doses.

* 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 short-acting bronchodilator 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 short-acting bronchodilator 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. 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 short-acting bronchodilator. 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.

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 nose; throat irritation; tremor.

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 symptoms (eg, coughing, increased chest tightness, shortness of breath, or wheezing); overexcitement; severe or persistent headache or dizziness; severe or persistent muscle pain or cramps.

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.