Indacaterol, Inhalation in-da-KAT-er-oll

What are other names for this medicine?

Type of medicine: long-acting beta-agonist (LABA); bronchodilator

Generic and brand names: indacaterol inhalation; Arcapta Neohaler

What is this medicine used for?

This long-acting medicine is inhaled to treat chronic obstructive pulmonary (lung) disease such as chronic bronchitis or emphysema. It is not used to treat asthma.

This medicine is not usually used alone. It is usually used with steroids or other medicines to improve breathing.

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, or to milk or milk proteins
• diabetes
• heart disease
• high blood pressure
• liver problems
• long QT syndrome (problems with electrical activity in the heart muscle)
• problems with low levels of potassium in your blood
• seizures
• thyroid problems

Tell your healthcare provider about all other medicines you are taking or using for your breathing problem.

Females of childbearing age: Tell 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 discussing with your healthcare provider.

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. Use this medicine exactly as your healthcare provider prescribes. Do not use more or less or use it longer than prescribed. Do not stop using this medicine or any other medicine without your healthcare provider's approval.

Do not swallow these capsules. Keep the capsules in the sealed package until you are ready to use them. Use the capsules only in the Neohaler. Never place the capsules in the mouthpiece of the Neohaler. To use the Neohaler:

1. Open the inhaler by pulling off the cap. Hold the bottom of the inhaler and tilt the mouthpiece to open the chamber.
2. Place one capsule in the chamber. It does not matter which end of the capsule is placed in the chamber.
3. Close the mouthpiece firmly until you hear a click.
4. Hold the Neohaler device with the mouthpiece upwards. Press buttons on both sides of the inhaler in once and then let go. You should hear a click. This makes holes in the capsule and allows the medicine to be released when you breathe in. Do not push the button more than once. Be careful not to get powder from the capsule in your eyes.
5. Turn your head away from the inhaler, and breathe out to the end of a normal breath. Do not breathe into the inhaler.
6. Raise the Neohaler device to your mouth, with the buttons on the sides (not top and bottom). Close your lips tightly around the mouthpiece. Keep your head in an upright position and breathe in rapidly and steadily, and as deeply as you can. You should hear a whirring noise that means the capsule is releasing medicine.
7. Hold your breath and remove the mouthpiece from your mouth. Hold your breath for 5 to 10 seconds, or as long as is comfortable. This gives the medicine time to settle in your airways and lungs.
8. Turn your head away from the inhaler, and breathe out slowly. Do not breathe into the inhaler.
9. Open the inhaler to see if any powder is left in the capsule. If there is powder left, repeat the steps above to make sure you get the full dose.
10. After you have finished taking your daily dose, open the mouthpiece again. Tip out the used capsule and dispose of it. Close the Neohaler and replace the cap.
11. Keep the inhaler dry. Do not wash it. You may use a dry cloth to wipe it clean.

If you have any questions about how to use this medicine, ask your healthcare provider or your pharmacist to explain. If you are using other inhaler medicines, talk with your healthcare provider about which medicine to use first.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and use the next one as directed. Do not use double doses. Do not take more than 1 dose in 24 hours. 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: chest pain, fast irregular heartbeat, tremors, dizziness, dry mouth, headache, nausea, muscle cramps, nervousness, tiredness.

What should I watch out for?

In people with asthma, long-acting beta2-adrenergic agonists (LABAs) increase the risk of 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 healthcare 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.

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.

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.

Your healthcare provider will want to check you regularly too see how this medicine affects you. Keep all appointments.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are using this medicine.

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 are unable to reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives, itching, rash, swelling of your tongue or throat, tightness in your chest, increased trouble breathing).

Serious (report these to your healthcare provider right away): Chest pain, fast or irregular heartbeat, nervousness, trouble breathing or sudden shortness of breath, fainting, severe lightheadedness, unusual weakness or tiredness, muscle spasms or tremor, increased hunger or thirst, severe cough.

Other: Nausea, dizziness, trouble sleeping, headache, sore throat, cough, dry mouth, runny nose.

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:

• antiarrhythmics such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide (Tambocor), propafenone (Rythmol), procainamide, quinidine, and sotalol (Betapace)
• antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (Erythrocin, E.E.S.), levofloxacin (Levaquin), moxifloxacin (Avelox), and pentamidine (NebuPent)
• antidepressants such as amitriptyline, doxepin, fluoxetine (Prozac), imipramine (Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), and sertraline (Zoloft)
• antipsychotic medicines such as chlorpromazine, haloperidol (Haldol), pimozide (Orap), thioridazine, and ziprasidone (Geodon)
• beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), pindolol, propranolol (Inderal LA), and sotalol (Betapace)
• corticosteroids such as prednisone, dexamethasone, and methylprednisolone (Medrol)
• diuretics such as bumetanide, ethacrynic acid (Edecrin), furosemide (Lasix), torsemide (Demadex), chlorothiazide (Diuril), hydrochlorothiazide (Microzide), chlorthalidone (Thalitone), and methyclothiazide
• ketoconazole (Nizoral)
• MAO inhibitor antidepressants such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• medicines to treat breathing or lung problems such as arformoterol (Brovana), oxtriphylline (Choledyl), formoterol (Dulera, Foradil, Symbicort), salmeterol (Serevent, Advair), aminophylline, and theophylline (Theolair, Theo-24, Uniphyl)
• methadone (Dolophine, Methadose)
• ritonavir (Norvir)
• stimulants such as dextroamphetamine (Dexedrine), methamphetamine (Desoxyn), amphetamine sulfate, caffeine, and pseudoephedrine (Sudafed)
• vandetanib (Caprelsa)
• verapamil (Calan, Covera, Isoptin)

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 the medicine at room temperature. Protect the medicine from heat, high humidity, and bright light. Keep the capsules in the blister pack until you use them. Once the blister pack is opened, use the medicine right away.

This advisory includes selected information only and may not include all side effects of this medicine or drug 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.