Salmeterol Oral Inhalation

IMPORTANT WARNING:

In a large clinical study, more patients with asthma who used salmeterol experienced severe episodes of asthma that had to be treated in a hospital or caused death than patients with asthma who did not use salmeterol. If you have asthma, use of salmeterol may increase the chance that you will experience serious or fatal asthma problems.

Your doctor will only prescribe salmeterol if your asthma is so severe that two medications are needed to control it. You should never use salmeterol alone; you must always use it along with an inhaled steroid medication. Children and teenagers who need to be treated with salmeterol will probably be treated with a product that combines salmeterol and an inhaled steroid medication in a single inhaler to make it easier for them to use both medications as prescribed.

Because of the risks of using salmeterol, you should only use salmeterol as long as it is needed to bring your asthma symptoms under control. Once your asthma is controlled, your doctor will probably tell you to stop using salmeterol but continue using the other asthma medication.

Talk to your doctor about the risks of using this medication.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with salmeterol and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

WHY is this medicine prescribed?

Salmeterol is used to control wheezing, shortness of breath, coughing, and chest tightness in people with chronic obstructive pulmonary disease (COPD; a group of lung diseases that includes chronic bronchitis and emphysema). It is also used along with an inhaled steroid medication to control wheezing, shortness of breath, coughing, and chest tightness and in adults and children 4 years of age and older with asthma. It is also is used to prevent bronchospasm (breathing difficulties) during exercise in adults and children 4 years of age and older. 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.

Are there OTHER USES for this medicine?

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.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Salmeterol comes as a dry powder to inhale by mouth using a specially designed inhaler. When salmeterol is used to treat asthma or COPD, it is usually used twice a day, in the morning and evening, about 12 hours apart. Use salmeterol at around the same times every day. When salmeterol is used to prevent breathing difficulties during exercise, it is usually used at least 30 minutes before exercise but not more often than once every 12 hours. If you are using salmeterol twice a day on a regular basis, do not use another dose before exercising. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use salmeterol exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Do not use salmeterol to treat sudden attacks of asthma or COPD. Your doctor will prescribe a short-acting beta agonist medication such as albuterol (Accuneb, Proair, Proventil, Ventolin) to use during attacks. If you were using this type of medication on a regular basis before you began treatment with salmeterol, 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 without talking to your doctor.

Do not use salmeterol if you have asthma or COPD that is quickly getting worse. If you have any of the following signs of worsening asthma or COPD, call your doctor immediately:

• your breathing gets worse
• your short-acting inhaler does not work as well as it did in the past
• you need to use more puffs than usual of your short-acting inhaler or use it more often
• you need to use four or more puffs per day of your short-acting inhaler for two or more days in a row
• you use more than one canister (200 inhalations) of your short-acting inhaler during an 8-week period
• your peak-flow meter (home device used to test breathing) results show your breathing problems are worsening
• you have asthma and your symptoms do not improve after you use salmeterol regularly for one week

Salmeterol controls the symptoms of asthma and other lung diseases but does not cure these conditions. Do not stop using salmeterol without talking to your doctor. If you suddenly stop using salmeterol, your symptoms may worsen.

Before you use the salmeterol inhaler the first time, ask your doctor, pharmacist, or respiratory therapist to show you how to use it. Practice using the inhaler while he or she watches.

To use the inhaler, follow these steps:

1. 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 6 weeks later when you must replace the inhaler.
2. 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.
3. 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.
4. 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.
5. Hold the inhaler level and away from your mouth, and breathe out as far as you comfortably can.
6. 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.
7. Remove the inhaler from your mouth, and hold your breath for 10 seconds or as long as you comfortably can. Breathe out slowly.
8. 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 salmeterol, call your doctor or pharmacist.
9. Put your thumb on the thumbgrip and slide it back toward you as far as it will go. The device will click shut.

What SPECIAL PRECAUTIONS should I follow?

Before using salmeterol,

• tell your doctor and pharmacist if you are allergic to salmeterol, any other medications, milk protein, or any foods.

• tell your doctor if you use another LABA such as arformoterol (Brovana), fluticasone and salmeterol combination (Advair), formoterol (Perforomist, in Bevespi Aerosphere, Duaklir Pressair, Dulera, Symbicort), indacaterol (Arcapta), olodaterol (Striverdi Respimat, in Stiolto Respimat), or vilanterol (in Anoro Ellipta, Breo Ellipta, Trelegy Ellipta). These medications should not be used with salmeterol. Your doctor will tell you which medication you should use and which medication you should stop using.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: antifungals such as itraconazole (Onmel, Sporanox, Tolsura) and ketoconazole; beta blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Kapspargo, Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal, Innopran); clarithromycin; diuretics ('water pills'); HIV protease inhibitors such as atazanavir (Reyataz, in Evotaz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra, Viekira Pak), and saquinavir (Invirase); nefazodone; and telithromycin (Ketek). Also tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past 2 weeks: antidepressants such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor, Zonalon), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); and monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), linezolid (Zyvox), phenelzine (Nardil), rasagiline (Azilect), selegiline (Emsam, Zelapar), 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 have or have ever had an irregular heartbeat, high blood pressure, QT prolongation (an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures, or sudden death), diabetes, seizures, or liver, thyroid, or heart disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using salmeterol, call your doctor.

• you should know that salmeterol inhalation sometimes causes wheezing and difficulty breathing immediately after it is inhaled. If this happens, call your doctor right away. Do not use salmeterol inhalation again unless your doctor tells you that you should.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Skip the missed dose and continue your regular dosing schedule. Do not inhale a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Salmeterol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• shaking of a part of your body that you cannot control
• headache
• nervousness
• dizziness
• cough
• stuffed nose
• runny nose
• ear pain
• muscle pain, stiffness, or cramps
• joint pain
• sore, irritated throat

• flu-like symptoms
• nausea
• heartburn
• tooth pain
• dry mouth
• sores or white patches in the mouth
• red or irritated eyes
• difficulty falling asleep or staying asleep
• burning or tingling of the hands or feet

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

• fast or pounding heartbeat
• chest pain
• rash
• hives
• swelling of the face, throat, tongue, lips, or eyes
• hoarseness
• choking or difficulty swallowing
• loud, high-pitched breathing

Salmeterol may cause other side effects. Call your doctor if you have any unusual problems while you are taking 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from direct sunlight, and excess heat and moisture (not in the bathroom). Dispose of the inhaler 6 weeks after you remove it from the foil overwrap or after every blister has been used (when the dose indicator reads 0), whichever comes first.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• seizures
• chest pain
• dizziness
• fainting
• blurred vision
• fast, pounding, or irregular heartbeat
• nervousness
• headache
• shaking of a part of your body that you cannot control
• muscle cramps or weakness
• dry mouth
• nausea
• dizziness
• excessive tiredness
• lack of energy
• difficulty falling asleep or staying asleep

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are using salmeterol.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.