Serevent Diskus Oral Inhalator

GENERIC NAME: SALMETEROL (sal-ME-te-role)

COMMON USES: This medicine is a long-acting beta-agonist bronchodilator. This medicine 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.

HOW TO USE THIS MEDICINE: Follow the directions for using this medicine provided by your doctor. This medicine comes with a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully each time you refill this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. THIS MEDICINE DELIVERS YOUR DOSE as a very fine powder. You may or may not taste or feel it. Even if you do not taste or feel it, Do NOT use more than the recommended dose. Ask your doctor or pharmacist if you have questions about your dose. Always activate and use this device in a level, flat position. Do NOT try to use a spacer with this medicine. TO PREPARE THE INHALER FOR USE: Remove the inhaler device from the foil pouch. 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. 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. Do not play with the lever or move it more than once. TO USE A DOSE OF THIS MEDICINE: Hold the inhaler device in a horizontal, level position, away from your mouth. Breathe out slowly and deeply. Do NOT exhale into the device. Put the mouthpiece to your lips. Breathe in forcefully and deeply through your mouth. Hold your breath. Remove the device from your mouth. Continue to hold your breath for 10 seconds or as long as comfortable, then breathe out slowly. CLOSE THE INHALER DEVICE before storing it. IF YOU ARE USING THIS MEDICINE to prevent exercise-induced breathing problems, use it at least 30 minutes before exercise. Do not use another dose for at least 12 hours. If you are using this medicine regularly, twice a day, do NOT use an extra dose before exercise. Do NOT try to take the inhaler device apart. STORE THIS MEDICINE at room temperature between 68 and 77 degrees F (20 to 25 degrees C), away from heat, moisture, and direct sunlight. KEEP THIS MEDICINE out of the reach of children and away from pets. CONTINUE TO USE THIS MEDICINE even if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, skip the missed dose and go back to your regular dosing schedule. Do NOT use 2 doses at once.

CAUTIONS: DO NOT USE THIS MEDICINE if you are allergic to any ingredient in this medicine. BEFORE YOU BEGIN TAKING ANY NEW MEDICINES, either prescription or over-the-counter, check with your doctor or pharmacist. LAB TESTS, including lung function tests and blood pressure, may be performed while you use this medicine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. THIS MEDICINE MAY CAUSE DIZZINESS. This effect may be worse if you take it with alcohol or certain medicines. Do not drive or perform other possibly unsafe tasks until you know how you react to it. THIS MEDICINE WILL NOT STOP AN ASTHMA ATTACK ONCE IT HAS ALREADY STARTED. Be sure to carry a short-acting bronchodilator inhaler (eg, albuterol) with you at all times to treat any breathing problems that may occur between doses of this medicine (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, talk with your doctor about how to use it with this medicine. THIS MEDICINE 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 this medicine as your only asthma-control medicine has been rarely associated with an increased risk of asthma-related death. THE RISK OF SERIOUS HEART PROBLEMS (eg, irregular heartbeat) may be greater if you use this medicine in high doses. Do NOT use more than the recommended dose or use more often than prescribed. 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. THIS MEDICINE 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. THIS MEDICINE 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. Use this medicine with caution in the ELDERLY; they may be more sensitive to its effects, especially effects on the heart. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using this medicine while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use this medicine, check with your doctor. Discuss any possible risks to your baby. DIABETES PATIENTS - This medicine may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

POSSIBLE SIDE EFFECTS: SIDE EFFECTS that may occur while taking this medicine include: headache; nasal or sinus congestion; nervousness; stuffy or runny nose; throat irritation; tremor. If they continue or are bothersome, check with your doctor. SEEK MEDICAL ATTENTION RIGHT AWAY if any of these SEVERE side effects occur: 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 or dizziness; severe or persistent muscle pain or cramps; symptoms of high blood sugar (eg, increased thirst, urination, or hunger; unusual weakness or drowsiness; confusion). AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness. 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. You may report side effects to FDA at 1-800-FDA-1088.

BEFORE USING THIS MEDICINE: WARNING: LONG-ACTING BETA-AGONISTS SUCH AS THIS MEDICINE 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, this medicine 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. This medicine should not be used in patients whose asthma is well controlled by inhaled corticosteroids. SOME MEDICINES MAY INTERACT with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT USE THIS MEDICINE if you are using another medicine that has a long-acting beta-agonist (eg, fluticasone/salmeterol, formoterol) in it or if 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. TELL YOUR HEALTH CARE PROVIDER if you are taking any other medicines, especially any of the following: diuretics (eg, furosemide, hydrochlorothiazide), catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), MAOIs (eg, phenelzine), tricyclic antidepressants (eg, amitriptyline), or beta-blockers (eg, propranolol). This may not be a complete list of all interactions that may occur. Ask your health care provider if this medicine may interact with other medicines you take. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including 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); an overactive thyroid; allergies, including a severe allergic reaction to milk protein; pregnancy; or breast-feeding. Tell your doctor if you have recently been to an emergency room for asthma; have a history of frequent hospitalizations for asthma; have ever had a life-threatening asthma attack; or have had an unusual reaction to a sympathomimetic medicine (eg, albuterol, pseudoephedrine), such as fast or irregular heartbeat, overexcitement, or severe trouble sleeping. Tell your doctor if you have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or a tricyclic antidepressant (eg, amitriptyline) within the last 14 days. USE OF THIS MEDICINE IS NOT RECOMMENDED if 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); or you have asthma that is already well controlled with the use of a long-term asthma-control medicine. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.

OVERDOSE: IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms may include chest pain; dry mouth; fast or irregular heartbeat; seizures; severe or persistent dizziness, fatigue, headache, muscle pain or cramps, nausea, nervousness, trouble sleeping, tremors, or weakness.

ADDITIONAL INFORMATION: IF YOUR SYMPTOMS DO NOT IMPROVE within 1 week of starting this medicine, or if they become worse, check with your doctor. ALWAYS HAVE A SPARE INHALATION DEVICE available in case the unit does not work or is empty. Discard this inhalation device 6 weeks after removing it from the moisture-protective foil overwrap pouch or after all 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. KEEP THIS DEVICE DRY and always store it in a dry place. Never wash the device or the mouthpiece. 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). DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.

The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.