Salmeterol, Inhalation

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KEY POINTS

• This medicine is inhaled through the mouth to prevent asthma attacks or to treat symptoms of COPD. Use it exactly as directed.
• Do not use this medicine for sudden breathing problems. Your healthcare provider can prescribe a short-acting inhaled medicine to use when you have a sudden breathing problem.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: long-acting beta-agonist; bronchodilator

Generic and brand names: salmeterol, inhalation; Serevent Diskus

What is this medicine used for?

This medicine is inhaled through the mouth to:

• Prevent asthma attacks (It does not stop asthma attacks that have already started.)
• Prevent wheezing caused by exercise in people who have lung problems
• Treat symptoms of COPD

This medicine must be used along with another long-term asthma control medicine, such as an inhaled corticosteroid.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine, lactose, or milk protein
• Diabetes
• Heart disease, heart failure, or heart rhythm problems
• High blood pressure
• Liver disease
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Problems with potassium levels in the blood
• Seizures
• Thyroid problems

Do not take this medicine if you have taken an MAO inhibitor within the last 14 days. This can cause very serious side effects.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Be sure you know when to take the medicine and how much medicine you should take. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Use this medicine exactly as your healthcare provider prescribes. Do not use this medicine more often than prescribed. Using too much can cause serious side effects. Try to use it the same times each day. Do not stop taking this medicine without your healthcare provider's approval. Suddenly stopping this medicine may be life-threatening.

Check with your healthcare provider before using this medicine in children under age 4 years. An adult should supervise the use of this medicine by a child.

If you are using this medicine to prevent exercise-induced bronchospasm, use this medicine 30 minutes before you exercise. Do not use this medicine again for 12 hours. Do not use extra medicine before exercise if you are already taking this medicine twice a day.

If you are using other inhaled medicines, ask your healthcare provider or pharmacist which you should use first, and how long you should wait before using the second inhaler. Do not use this medicine with a spacer device.

What if I miss a dose?

If you miss a dose, skip the missed dose and use the next one as directed. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: muscle cramps or weakness, tremors, nervousness, headache, dry mouth, nausea, vomiting, dizziness, chest pain, fast or irregular heartbeat, lightheadedness, fainting, seizures.

What should I watch out for?

This medicine must not be the only medicine you use to treat asthma or COPD. Do not use this medicine for sudden breathing problems. Your healthcare provider may also prescribe a short-acting inhaled medicine to use when you have a sudden breathing problem. Use all medicines as directed by your healthcare provider. Talk with your healthcare provider if you have any questions.

In people with asthma, long-acting beta2-adrenergic agonists (LABAs) increase the risk of asthma-related hospitalization or death. It is not known if LABAs increase the risk of death in people with COPD. Talk with your healthcare provider about this.

If you have any of these symptoms, call your provider right away:

• You need to use more puffs than usual of your short-acting inhaler or use it more often.
• You have severe breathing trouble that does not improve, such as persistent wheezing, coughing, or shortness of breath.
• You have a bluish color in your lips or fingernails or cannot speak.
• You have any breathing symptoms that are getting worse.

If you have severe coughing, trouble breathing, shortness of breath, or wheezing right after using this medicine, contact your healthcare provider right away. This may be life-threatening. If your symptoms get worse over time, do not increase your dose of this medicine. Instead, contact your healthcare provider about what you should do.

You may need to have lung function tests or other tests to see how the medicine affects you. Keep all appointments.

This medicine may increase your heart rate or blood pressure. Talk with your healthcare provider about this.

This medicine may make you dizzy. Do not drive or operate machinery unless you are fully alert.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine. Always carry a form of identification stating that you take this medicine, such as a medical alert bracelet or ID card.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; tightness in your chest; swelling of your lips, tongue, and throat); choking; trouble swallowing; persistent wheezing, coughing, or shortness of breath; bluish color in the lips or fingernails; being unable to speak.

Serious (Report these to your healthcare provider right away.): Increased trouble breathing, wheezing, or coughing; chest pain; fast or irregular heartbeat; severe headache; severe drowsiness; confusion, unexplained increased hunger or thirst; changes in urination; itching over the whole body; unexplained fever or sore throat; seizures; severe dizziness or fainting; severe nervousness; tremors; severe muscle cramps or weakness.

Other: Headache, joint or muscle pain, mild rash, runny or stuffy nose, mild dizziness, diarrhea, mild nausea, throat irritation, dry mouth, trouble sleeping.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Allergy, cold, or cough medicines such as oxymetazoline (Afrin, Dristan), phenylephrine (Neo-Synephrine, Sudafed PE), and pseudoephedrine (Sudafed)
• Anagrelide (Agrylin)
• Antibiotics such as azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), linezolid (Zyvox), moxifloxacin (Avelox), ofloxacin, pentamidine (NebuPent, Pentam), tedizolid (Sivextro), and telithromycin (Ketek)
• Antidepressants such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), nefazodone, and sertraline (Zoloft)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), olanzapine (Zyprexa), paliperidone (Invega), pimavanserin (Nuplazid), pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, and ziprasidone (Geodon)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and ombitasvir/paritaprevir/ritonavir (Technivie)
• Atomoxetine (Strattera)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), bisoprolol (Zebeta), carteolol, carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, sotalol (Betapace, Sorine), and timolol
• Caffeine in food, drinks, or medicines
• Cancer medicines such as arsenic trioxide (Trisenox), ceritinib (Zykadia), crizotinib (Xalkori), dasatinib (Sprycel), idelalisib (Zydelig), imatinib (Gleevec), nilotinib (Tasigna), panobinostat (Farydak), pazopanib (Votrient), procarbazine (Matulane), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cisapride
• Conivaptan (Vaprisol)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Diet pills such as diethylpropion (Tenuate), phendimetrazine, and phentermine (Adipex-P, Suprenza)
• Diuretics (water pills) such as bumetanide, furosemide (Lasix), chlorothiazide (Diuril), chlorthalidone, hydrochlorothiazide (Microzide), and torsemide (Demadex)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Ephedrine
• Epinephrine (Adrenalin, Asthmanefrin, Auvi-Q, EpiPen)
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, procainamide, propafenone (Rythmol), quinidine, and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Midodrine
• Mifepristone (Korlym, Mifeprex)
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), droperidol (Inapsine), netupitant/palonosetron (Akynzeo), and ondansetron (Zofran)
• Other medicines to treat breathing or lung problems such as arformoterol (Brovana), budesonide/formoterol (Symbicort), fluticasone/vilanterol (Breo Ellipta), formoterol (Perforomist), fluticasone/salmeterol (Advair), indacaterol (Arcapta), mometasone/formoterol (Dulera), and olodaterol (Striverdi Respimat)
• Pain medicines such as buprenorphine (Buprenex, Butrans) and methadone (Dolophine, Methadose)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Rasagiline (Azilect)
• Stimulants such as armodafinil (Nuvigil), dexmethylphenidate (Focalin), dextroamphetamine (Dexedrine), methamphetamine (Desoxyn), methylphenidate (Concerta, Daytrana, Metadate, Ritalin), and modafinil (Provigil)
• Tetrabenazine (Xenazine)
• Tricyclic antidepressants such as amitriptyline, desipramine (Norpramin), imipramine (Tofranil), and nortriptyline (Pamelor) (Do not take this medicine and a tricyclic antidepressant within 14 days of each other.)

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, and tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store at room temperature in a dry place away from direct heat or sunlight. Do not open the foil pouch until you are ready to use it. The Diskus should be discarded in 6 weeks after removal from the foil pouch, or after all blisters have been used, whichever comes first. The Diskus is not reusable.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.