Generic Name: indacaterol (IN-da-KA-ter-ol)
Long-acting beta-agonists such as Arcapta Neohaler have been rarely associated with an increased risk of asthma-related death. Arcapta Neohaler is not approved for the treatment of asthma; safety and effectiveness in patients with asthma have not been confirmed.
Arcapta Neohaler is used for:
Long-term control of chronic obstructive pulmonary disease (COPD) symptoms. It may also be used for other conditions as determined by your doctor.
Arcapta Neohaler is a long-acting beta-agonist bronchodilator. It works by widening the airways in the lungs, which helps you breathe more easily.
Do NOT use Arcapta Neohaler if:
- you are allergic to any ingredient in Arcapta Neohaler
- you are using another medicine that has a long-acting beta-agonist (eg, salmeterol) in it
- you are having sudden, severe onset or worsening of COPD symptoms (eg, chest tightness, cough, shortness of breath, or wheezing)
- you have asthma
Contact your doctor or health care provider right away if any of these apply to you.
Before using Arcapta Neohaler:
Some medical conditions may interact with Arcapta Neohaler. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have had a severe allergic reaction to milk protein or are lactose intolerant
- if you have a history of diabetes, heart problems (eg, fast or irregular heartbeat, heart blood vessel problems), high blood pressure, low blood potassium levels, seizures, or an overactive thyroid
- if you have had an unusual reaction to a sympathomimetic medicine (eg, albuterol, pseudoephedrine), such as fast or irregular heartbeat, overexcitement, or severe trouble sleeping
- if you are taking linezolid, a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or a tricyclic antidepressant (eg, amitriptyline) or you have taken any of these medicines within the last 14 days
- if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat
Some MEDICINES MAY INTERACT with Arcapta Neohaler. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Corticosteroids (eg, prednisone), diuretics (eg, furosemide, hydrochlorothiazide), or xanthines (eg, theophylline) because the risk of low blood potassium or irregular heartbeat may be increased
- Linezolid, other long-acting beta-agonists (eg, salmeterol), MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Arcapta Neohaler's side effects
- Beta-blockers (eg, propranolol) because they may decrease Arcapta Neohaler's effectiveness or worsen your condition
- Hold the inhaler upright and press both buttons at the same time. You should hear a click as the capsule is pierced. Do NOT press the buttons more than once. Release the buttons.
- Before placing the inhaler in your mouth, breathe out fully. Do NOT exhale into the device for any reason. Keep the inhaler level, with the buttons to the left and the right (not up and down). Place the mouthpiece in your mouth and close your lips around it. Breathe in quickly, steadily, and as deeply as you can. Do not press the piercing buttons.
- As you breathe in through the inhaler, you should hear a whirring noise as the capsule spins around inside the inhaler. If you do not hear a whirring noise, the capsule may be stuck. If this occurs, open the inhaler and loosen the capsule by tapping the base of the device. Do NOT push the buttons again. Then, repeat the inhalation process. If you are not sure if you are receiving your dose correctly, contact your doctor or pharmacist.
- After breathing in your dose, remove the inhaler from your mouth. Continue to hold your breath for as long as possible. Then, breathe out slowly.
- After you use Arcapta Neohaler, open the inhaler to see if any powder is still in the capsule. If any powder remains in the capsule, close the inhaler. Repeat the inhalation process. Most people are able to empty the capsule in 1 or 2 inhalations.
- After you have taken your dose, open the inhaler, remove the capsule, and throw it away. Do not leave a used capsule in the inhaler. Close the mouthpiece and replace the cover.
- Rarely, very small pieces of the gelatin capsule may get past the screen and enter your mouth. It is not harmful if these pieces are swallowed or inhaled. To avoid this, store Arcapta Neohaler properly, remove the capsules from the blister right before use, and pierce each capsule only once.
- Never wash the mouthpiece or any part of the inhaler. Keep it dry and always store it in a dry place. Do NOT try to take the inhaler apart.
- Use Arcapta Neohaler on a regular schedule to get the most benefit from it.
- If you miss a dose of Arcapta Neohaler, use it as soon as possible. Do not use more often than 1 time every 24 hours.
Ask your health care provider any questions you may have about how to use Arcapta Neohaler.
Possible side effects of Arcapta Neohaler:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Cough; headache; nausea; nervousness; runny nose; sore throat.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest pain; fainting; fast or irregular heartbeat; seizures; severe or persistent dizziness, dry mouth, headache, muscle pain, weakness, cramps, nausea, nervousness, tiredness, trouble sleeping, tremors, or weakness; severe or persistent symptoms of high blood sugar (eg, increased thirst, hunger, or urination; drowsiness; flushing of the skin; confusion; fruit-like breath odor).Proper storage of Arcapta Neohaler:
Store Arcapta Neohaler at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in the sealed blister, away from heat, moisture, and light. Do not store capsules in the inhaler device. Keep Arcapta Neohaler out of the reach of children and away from pets.
- If you have any questions about Arcapta Neohaler, please talk with your doctor, pharmacist, or other health care provider.
- Arcapta Neohaler is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.