Fluticasone and Salmeterol Oral Inhalation

Why this is used

The combination of fluticasone and salmeterol is used to prevent wheezing, shortness of breath, and breathing difficulties caused by asthma and chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema). Fluticasone is in a class of medications called steroids. It works by reducing swelling in the airways. Salmeterol is in a class of medications called long-acting beta-agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.

How to take it

The combination of fluticasone and salmeterol comes as a powder to inhale by mouth using a specially designed inhaler. It is usually used twice a day, in the morning and evening, about 12 hours apart. Use fluticasone and salmeterol at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use fluticasone and salmeterol exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor. Talk to your doctor about how you should take your other oral or inhaled medications for asthma during your treatment with salmeterol and fluticasone inhalation. If you were using a short-acting beta agonist inhaler such as albuterol (Proventil, Ventolin) on a regular basis, your doctor will probably tell you to stop using it regularly but to continue to use it to treat sudden attacks of asthma symptoms. Follow these directions carefully. Do not change the way you use any of your medications or stop taking any of your medications without talking to your doctor. Do not use fluticasone and salmeterol during an attack of asthma or COPD. Your doctor will prescribe a short-acting inhaler to use during attacks. Fluticasone and salmeterol inhalation controls asthma and COPD but does not cure these conditions. It may take a week or longer before you feel the full benefit of fluticasone and salmeterol. Continue to use fluticasone and salmeterol even if you feel well. Do not stop using fluticasone and salmeterol without talking to your doctor. If you stop using fluticasone and salmeterol inhalation, your symptoms may return. Before you use fluticasone and salmeterol inhalation for the first time, ask your doctor, pharmacist, or respiratory therapist to show you how to use the inhaler. Practice using your inhaler while he or she watches. To use the inhaler, follow these steps:

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If you will be using a new inhaler for the first time, remove it from the box and the foil wrapper. Fill in the blanks on the inhaler label with the date that you opened the pouch and the date 1 month later when you must replace the inhaler.</li>
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Hold the inhaler in one hand, and put the thumb of your other hand on the thumbgrip. Push your thumb away from you as far as it will go until the mouthpiece appears and snaps into position.</li>
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Hold the inhaler in a level, horizontal position with the mouthpiece toward you. Slide the lever away from you as far as it will go until it clicks.</li>
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Every time the lever is pushed back, a dose is ready to inhale. You will see the number in the dose counter go down. Do not waste doses by closing or tilting the inhaler, playing with the lever, or advancing the lever more than once.</li>
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Hold the inhaler level and away from your mouth, and breathe out as far as you comfortably can.</li>
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Keep the inhaler in a level, flat position. Put the mouthpiece to your lips. Breathe in quickly and deeply though the inhaler, not through your nose.</li>
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Remove the inhaler from your mouth, and hold your breath for 10 seconds or as long as you comfortably can. Breathe out slowly.</li>
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You will probably taste or feel the salmeterol powder released by the inhaler. Even if you do not, do not inhale another dose. If you are not sure you are getting your dose of fluticasone and salmeterol, call your doctor or pharmacist.</li>
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Rinse your mouth with water, but do not swallow.</li>
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Put your thumb on the thumbgrip and slide it back toward you as far as it will go. The inhaler will click shut.</li></ul> Never exhale into the inhaler, take the inhaler apart, or wash the mouthpiece or any part of the inhaler. Keep the inhaler dry. Do not use the inhaler with a spacer.

Side effects

<p></p> <p></p> <p></p> <p>Fluticasone and salmeterol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

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runny nose</li>
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sneezing</li>
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sore throat</li>
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throat irritation</li>
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sinus pain</li>
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headache</li>
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nausea</li>
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vomiting</li>
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diarrhea</li>
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stomach pain</li>
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muscle and bone pain</li>
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dizziness</li>
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weakness</li>
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tiredness</li>
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sweating</li>
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tooth pain</li>
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red or dry eyes</li>
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shaking of a part of your body that you cannot control</li>
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sleep problems</li></ul></p> <p></p> <p>Some side effects can be serious. If you experience any of the following side effects, call your doctor immediately:

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coughing, wheezing, or chest tightness that begins soon after you inhale fluticasone and salmeterol</li>
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hives</li>
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rash</li>
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swelling of the face, throat, tongue, lips, hands, feet, ankles, or lower legs</li>
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choking or difficulty swallowing</li>
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hoarseness</li>
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noisy, high-pitched breathing</li>
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pounding fast, or irregular heartbeat</li>
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fainting</li>
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chest pain</li>
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cough</li>
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burning or tingling in the hands or feet</li>
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blurred vision</li>
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white patches in the mouth</li>
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fever, chills, and other signs of infection</li></ul>Fluticasone and salmeterol may cause children to grow more slowly. Your child's doctor will monitor your child's growth carefully. Talk to your child's doctor about the risks of giving this medication to your child.Fluticasone and salmeterol may increase the risk that you will develop glaucoma, cataracts, or osteoporosis. You will probably need to have regular eye exams and bone tests during your treatment with fluticasone and salmeterol. Talk to your doctor about the risks of using this medication.Fluticasone and salmeterol may cause other side effects. Call your doctor if you have any unusual problems while using this medication.If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at <a href='http://www.fda.gov/Safety/MedWatch'>http://www.fda.gov/Safety/MedWatch</a>] or by phone [1-800-332-1088].</p>

Precautions

Before using fluticasone and salmeterol, tell your doctor and pharmacist if you are allergic to fluticasone (Flonase, Flovent), salmeterol (Serevent), any other medications, milk protein, or any foods. tell your doctor if you use another LABA such as formoterol (Foradil) or salmeterol (Serevent). These medications should not be used with fluticasone and salmeterol inhalation. Your doctor will tell you which medication you should use and which medication you should stop using. tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); beta-blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); cimetidine (Tagamet); clarithromycin (Biaxin); cyclosporine (Neoral, Sandimmune); danazol (Danocrine); delavirdine (Rescriptor); diltiazem (Cardizem, Dilacor, Tiazac); diuretics ('water pills'); fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); HIV protease inhibitors such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase); isoniazid (INH, Nydrazid); other medications for asthma or COPD; medications for seizures; metronidazole (Flagyl); nefazodone; oral contraceptives (birth control pills); telithromycin (Ketek); troleandomycin (TAO); verapamil (Calan, Covera, Isoptin, Verelan); and zafirlukast (Accolate). Also tell your doctor and pharmacist if you are taking the following medications or have stopped taking them during the past 2 weeks: antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); and monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl), and tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. tell your doctor if you or anyone in your family has or has ever had osteoporosis (a condition in which the bones become weak and fragile), and if you have or have ever had high blood pressure, irregular heartbeat, seizures, hyperthyroidism (overactive thyroid), diabetes, tuberculosis (TB), glaucoma (an eye disease), any condition that affects your immune system, liver disease, or heart disease. Also tell your doctor if you have a herpes eye infection or any other type of infection and if you smoke or use tobacco products, if you do not eat a healthy diet, or if you do not exercise very often. if you are having surgery, including dental surgery, tell your doctor or dentist that you are using fluticasone and salmeterol. tell your doctor if you have never had chickenpox or measles and have not been vaccinated against these infections. Stay away from people who are sick, especially people who have chickenpox or measles. If you are exposed to these infections or if you develop symptoms of these infections, call your doctor immediately. You may need to get a vaccine (shot) to protect you from these infections.

Overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911. Symptoms of overdose may include:

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seizures</li>
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chest pain</li>
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dizziness</li>
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fainting</li>
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blurred vision</li>
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fast, pounding, or irregular heartbeat</li>
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nervousness</li>
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headache</li>
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shaking of a part of your body that you cannot control</li>
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muscle cramps or weakness</li>
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dry mouth</li>
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nausea</li>
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excessive tiredness</li>
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lack of energy</li>
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difficulty falling asleep or staying asleep</li></ul>
Educational reference only — talk to a pharmacist or prescriber about Fluticasone and Salmeterol Oral Inhalation.