What is the most important information I should know about indacaterol?
Indacaterol inhalation is for use only in people with chronic obstructive pulmonary disease (COPD) and should not be used to treat asthma.
Indacaterol inhalation is not a rescue medicine. It will not work fast enough to treat a bronchospasm attack.
Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.
What is indacaterol?
Indacaterol inhalation is used to control the symptoms of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Indacaterol inhalation may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before using indacaterol?
You should not use indacaterol if you are allergic to it. Indacaterol is for use only in people with COPD and should not be used to treat asthma.
Tell your doctor if you have ever had:
- heart disease, high blood pressure;
- diabetes;
- a seizure;
- a thyroid disorder; or
- galactose intolerance, or severe problems with lactose (milk sugar).
Tell your doctor if you are pregnant or breastfeeding.
Indacaterol is not approved for use by anyone younger than 18 years old.
How should I use indacaterol?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Using too much of this medicine can cause life-threatening side effects.
Indacaterol is not a rescue medicine for bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.
Do not take an indacaterol capsule by mouth. It is for use only in the Neohaler device.
Arcapta Neohaler is a powder 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 use the medicine. Pushing the buttons on the side of the Neohaler device will pierce the capsule and release the medicine into the inhaler chamber.
You may have a mild cough for about 15 seconds after using the inhaler.
Store at room temperature away from moisture, heat, and light. Keep each capsule in the blister pack until you ready to load your inhaler device.
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 capsules run out. Always use the inhaler device that comes with each new prescription.
You should not stop using indacaterol suddenly. Stopping suddenly may make your condition worse.
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.
Do not use this medicine more than 1 time in a 24-hour period.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of indacaterol can be fatal.
Overdose symptoms may include muscle cramps, tremors, chest pain, fast heartbeats, weak pulse, fainting, or slow breathing (breathing may stop).
What should I avoid while using indacaterol?
Do not use a second inhaled bronchodilator that contains indacaterol or a similar medicine (such as arformoterol, formoterol, olodaterol, salmeterol, or vilanterol).
What are the possible side effects of indacaterol?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- tremors, nervousness, chest pain, fast or pounding heartbeats;
- wheezing, choking, or other breathing problems after using this medicine;
- worsening breathing problems;
-
high blood sugar --increased thirst, increased urination, dry mouth, fruity breath odor; or
-
low potassium level --leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling.
Common side effects may include:
- runny nose;
- cough, sore throat;
- nausea; or
- headache.
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 indacaterol?
If you also use a short-acting bronchodilator, do not use it daily while you are using indacaterol. Use the short-acting bronchodilator only for a sudden bronchospasm attack.
Other drugs may affect indacaterol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about indacaterol.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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