Arcapta (indacaterol) Neohaler - formerly QAB149

Arcapta Neohaler

Generic Name: indacaterol (inhalation) (In da KA ter ol)
Brand Names: Arcapta Neohaler

Arcapta (indacaterol) is a bronchodilator. It works by relaxing muscles in the airways to improve breathing.

Arcapta is used as an inhaled medication to prevent bronchospasm in people with chronic obstructive pulmonary disease (COPD), including bronchitis or emphysema. Arcapta is not for use in treating asthma.

Arcapta may also be used for purposes not listed in this medication guide.

Important information about Arcapta

Arcapta may increase the risk of asthma-related death. It is critical that you use only the prescribed dose of this medicine and follow all patient instructions for safe use of the medication.

Before you use Arcapta, tell your doctor if you have heart disease, high blood pressure, coronary artery disease, a heart rhythm disorder, seizures, diabetes, a thyroid disorder, or lactose intolerance.

Do not take an Arcapta capsule by mouth. It is for use only in the Neohaler device. Call your doctor right away if your symptoms do not improve, or if they get worse while using Arcapta. Tell your doctor if any of your medications do not seem to work as well in preventing attacks. Do not stop using Arcapta without your doctor's advice. Your asthma symptoms may get worse after you stop using the medication.

Before taking Arcapta

You should not use Arcapta if you are allergic to indacaterol or any food products, or if you have asthma.

Arcapta Neohaler capsules may contain lactose. Before taking this medication, tell your doctor if you have a hereditary form of galactose intolerance, severe lactase deficiency, or glucose galactose malabsorption.

To make sure you can safely use Arcapta, tell your doctor if you have any of these other conditions:

• heart disease, high blood pressure, coronary artery disease;
• a heart rhythm disorder;
• a seizure disorder such as epilepsy;
• diabetes; or
• a thyroid disorder.

FDA pregnancy category C. It is not known whether Arcapta will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Do not give Arcapta to anyone under 18 years old without medical advice. It is not known whether indacaterol passes into breast milk or if it could harm a nursing baby. Do not use Arcapta without telling your doctor if you are breast-feeding a baby.

How should I take Arcapta?

Use Arcapta Neohaler capsules exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Arcapta may increase the risk of asthma-related death. It is critical that you use only the prescribed dose of this medicine and follow all patient instructions for safe use of the medication.

Arcapta is usually given once per day. Use the medicine at the same time each day. Follow your doctor's dosing instructions very carefully.

Do not use Arcapta to treat an attack that has already begun. It will not work fast enough. Use only a fast-acting inhalation medication.

Arcapta Neohaler is a powder form of indacaterol that comes with a special inhaler device and blister packs containing capsules of the medicine. You will load one capsule into the inhaler device each time you using the medicine. Pushing the buttons on the side of the Neohaler device will pierce the capsule and release the medicine into the inhaler chamber.

Arcapta comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

You may have a mild cough for about 15 seconds after using the inhaler.

Do not stop using Arcapta without your doctor's advice. Your asthma symptoms may get worse after you stop using the medication.

Use Arcapta regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure Arcapta is helping your condition and not causing harmful effects, your lung function will need to be tested often. You may also need blood tests at your doctor's office. Visit your doctor regularly.

Call your doctor right away if your symptoms do not improve, or if they get worse while using Arcapta. Tell your doctor if any of your medications do not seem to work as well in preventing attacks.

Store Arcapta at room temperature away from moisture, heat, and light.

Do not try to wash or take apart the Neohaler device. You may use a tissue to wipe the mouthpiece after each use. Throw away the device when your capusles run out. Always use the inhaler device that comes with each new prescription.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Arcapta can be fatal.

Overdose symptoms may include some of the serious side effects listed in this medication guide, as well as weak pulse, fainting, or slow breathing (breathing may stop).

What should I avoid while taking Arcapta?

Do not take an Arcapta capsule by mouth. It is for use only in the Neohaler device.

Avoid using medicines that contain formoterol (Foradil, Perforomist, Dulera, Symbicort) or salmeterol (Advair, Serevent). Using these medicines together with Arcapta can cause a dangerous drug interaction, leading to serious side effects.

Arcapta side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Arcapta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Arcapta and call your doctor at once if you have any of these serious side effects:

• chest pain, tremors, fast heart rate, pounding heartbeats or fluttering in your chest;
• new or worsening cough, fever, trouble breathing;
• swelling of your ankles or feet;
• bronchospasm (wheezing, chest tightness, trouble breathing);
• feeling suddenly short of breath;
• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);
• high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss); or
• worsening of your condition.

Less serious Arcapta side effects may include:

• throat pain;
• nausea;
• headache;
• muscle pain or spasm; or
• cold symptoms such as stuffy nose, sinus pain, sneezing, cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Arcapta?

Tell your doctor about all other medications you use, especially:

• ketoconazole (Nizoral);
• ritonavir (Norvir, Kaletra);
• a decongestant (cold medicine), stimulant, or ADHD medication such as Ritalin or Concerta;
• a diuretic (water pill) or blood pressure medication;
• verapamil (Calan, Covera, Isoptin, Verelan), and others;
• aminophylline (Truphylline), theophylline (Elixophyllin, Theo-24, Uniphyl), and others;
• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), levofloxacin (Levaquin), moxifloxacin (Avelox), or pentamidine (NebuPent, Pentam);
• an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), nortriptyline (Pamelor), and others;
• anti-malaria medications such as chloroquine (Aralen) or mefloquine (Lariam);
• a beta blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;
• heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), dronedarone (Multaq), ibutilide (Corvert), procainamide (Procan, Pronestyl), propafenone (Rythmol), quinidine (Quin-G), or sotalol (Betapace);
• an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate);
• medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (FazaClo, Clozaril), haloperidol (Haldol), pimozide (Orap), thioridazine (Mellaril), or ziprasidone (Geodon);
• medicine to prevent or treat nausea and vomiting such as dolasetron (Anzemet), droperidol (Inapsine), or ondansetron (Zofran);
• migraine headache medicine such as sumatriptan (Imitrex, Treximet) or zolmitriptan (Zomig);
• narcotic medication such as methadone (Methadose, Diskets, Dolophine);
• steroid medicine (prednisone and others); or
• other medications for COPD or other breathing disorders, such as albuterol (Proventil, Ventolin, Combivent), formoterol (Foradil, Perforomist, Dulera, Symbicort), isoproterenol (Isuprel), pirbuterol (Maxair), salmeterol (Advair, Serevent), terbutaline (Brethaire, Brethine, Bricanyl), and others.