Indacaterol maleate Inhalation powder, capsule
What is this medicine?
INDACATEROL (IN da CA ter ol) is a slow-acting bronchodilator. It helps to open up the airways of your lungs. This medicine is used to treat COPD. It should not be used alone for asthma. Do NOT use for an acute asthma attack. Do NOT use for a COPD attack.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
have asthma and are not taking any other asthma medicine
heart disease or irregular heartbeat
high blood pressure
low levels of potassium in the blood
an unusual or allergic reaction to indacaterol, milk, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
This medicine is used in a special inhaler. Do NOT swallow the capsules. Do NOT use a spacer device. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice. Make sure that you are using your inhaler correctly. Ask your doctor or health care provider if you have any questions. Small pieces of the capsule may get in your mouth or throat when you breathe in your medicine. This is normal and should not hurt you.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
other medicines that contain a long-acting beta2-agonist (LABA), such as formoterol or salmeterol
This medicine may also interact with the following medications:
certain medicines for depression, anxiety, or psychotic disturbances
certain medicines for blood pressure, heart disease, irregular heart beat
medicines for colds
some antibiotics like clarithromycin, erythromycin, levofloxacin, and linezolid
steroid medicines like prednisone or cortisone
stimulant medicines for attention disorders, weight loss, or to stay awake
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor for regular check ups. Tell your doctor or health care professional if your symptoms do not get better. If your symptoms get worse or if you need your short-acting inhalers more often, call your doctor right away. Do not use this medicine more than every 24 hours.
If you have asthma, be aware that using this medicine may increase your risk of dying from asthma-related problems. Talk to your doctor about the risks and benefits of taking this medicine. NEVER use this medicine for an acute asthma attack.
If you are going to have surgery tell your doctor or health care professional that you are using this medicine.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
difficulty breathing or wheezing that increases or does not go away
dizziness or fainting
fast, irregular heartbeat
high blood pressure
unusually weak or tired
Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
March 21, 2017
U.S. FDA-approved Package Insert