Rarely, serious (sometimes fatal) breathing problems have happened to people with asthma using a long-acting inhaled beta agonist (salmeterol). Since indacaterol is similar to salmeterol, it might cause these serious breathing problems. Indacaterol has not been shown to be safe or effective to treat asthma and is not approved for this use. Talk with your doctor about the risks and benefits of treatment with this medication.Who should not take Arcapta Neohaler inhalation?
Indacaterol is used to treat trouble breathing and wheezing due to a certain ongoing lung disease (chronic obstructive pulmonary disease-COPD, including chronic bronchitis and/or emphysema). It is used if your breathing problems are not controlled with other medication (such as a quick-relief inhaler). It works in the airways by relaxing muscles and opening air passages to improve breathing.
This medication should not be used for severe/sudden breathing problems. Other medications, such as a quick-relief inhaler should be used instead of indacaterol for sudden breathing problems. This medication is not a substitute for corticosteroids (such as beclomethasone, fluticasone, prednisone).
Read the Medication Guide and the Instructions for Use provided by your pharmacist before you start using indacaterol and each time you get a refill. Learn and follow the directions for proper use and care of the inhaler device and this medication. If you have any questions, ask your healthcare provider or pharmacist.
Indacaterol comes in a capsule. Do not swallow these capsules. Inhale the contents of the capsule by mouth using the inhaler device as directed by your doctor, usually one capsule once daily. Indacaterol must always be used with its own special inhaler device. Always discard your old inhaler device and use the new inhaler device that you get each time you refill your indacaterol prescription. Do not use a "spacer" device with the inhaler.
Leave the capsule sealed in the blister card until just before use. Wash and completely dry hands before touching the capsules. Inhale the capsule contents as directed to make sure you inhale all of the drug. Be sure to inhale rapidly and deeply through the mouthpiece when using this drug. Do not exhale into the inhaler.
If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication.
Using too much indacaterol or using it too often may make the drug work less well and increase the risk of serious side effects. Do not use more than the recommended dose or use this drug more often than prescribed. If you are using a quick-relief inhaler on a regular schedule (such as 4 times a day), you should stop the regular schedule and continue using your quick-relief inhaler only as needed for severe/sudden breathing problems. Do not stop or decrease the dose of your other prescribed medications (including inhaled corticosteroids such as beclomethasone) without your doctor's approval.
Learn which of your inhalers you should use every day and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, waking up at night with trouble breathing, if you use your quick-relief inhaler more often, or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.
Tell your doctor right away if your symptoms do not improve or if they worsen.
Shakiness (tremor), nausea, headache, or cough may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.
Tell your doctor right away if you have any serious side effects, including: muscle weakness/cramping, increased thirst/urination.
Get medical help right away if you have any very serious side effects, including: fast/pounding/irregular heartbeat, severe dizziness, fainting.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
Rarely, indacaterol can cause a worsening of breathing problems (paradoxical bronchospasm) that may be life-threatening. If this occurs, get medical help right away.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before using indacaterol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, heart disease (such as irregular heartbeat, angina), high blood pressure, overactive thyroid (hyperthyroidism), seizures.
Indacaterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using indacaterol, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using indacaterol safely.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if indacaterol passes into breast milk. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
This medication will not work and may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fast/irregular heartbeat, severe nervousness, severe muscle cramps.
Do not share this medication with others.
Avoid substances that can worsen breathing problems by causing irritation or allergic reaction, such as smoke, pollen, pet dander, dust, and mold.
Talk with your doctor about getting a yearly flu shot.
Laboratory and/or medical tests (such as blood pressure, heart rate, lung function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised May 2015. Copyright(c) 2015 First Databank, Inc.
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