Generic Name: indacaterol (IN-da-KA-ter-ol)
Brand Name: Arcapta Neohaler
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
This may not be a complete list of all interactions that may occur. Ask your health care provider if Arcapta Neohaler may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Arcapta Neohaler:
Use Arcapta Neohaler as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Arcapta Neohaler comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Arcapta Neohaler refilled.
- Arcapta Neohaler is for inhalation only. Do NOT swallow the capsule.
- Store Arcapta Neohaler in the original blister in a dry place. Do not remove the capsule from the blister or the foil until right before use. Be sure your hands are completely dry before you handle the capsules.
- If a second capsule is exposed to the air when you are removing a capsule for use, it must be discarded. Do not save the capsule for later.
- Use the new inhaler device that comes with each refill. Do not reuse an old inhaler. Do not use Arcapta Neohaler with a different kind of inhaler. Do not use a different medicine with Arcapta Neohaler's inhaler. Do not try to use a spacer device with Arcapta Neohaler.
- To prepare the device for use, remove the inhaler cover and tilt the mouthpiece to open the inhaler. Place a capsule in the capsule chamber in the base of the inhaler. Do NOT place a capsule in the mouthpiece of the inhaler. Close the mouthpiece fully; you should hear a click as it fully closes.
- 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.
Important safety information:
- Do not stop using Arcapta Neohaler or other medicines used to control or treat your COPD without checking with your doctor.
- Arcapta Neohaler will not relieve sudden, severe onset or worsening COPD symptoms or other breathing problems once they have already occurred. Be sure to carry a short-acting bronchodilator inhaler (eg, albuterol) with you at all times to treat any breathing problems that may occur between doses of Arcapta Neohaler (eg, severe or sudden onset of wheezing or shortness of breath). If you have any questions about which medicines relieve these breathing problems, check with your doctor or pharmacist.
- If you have been regularly using a short-acting bronchodilator inhaler, talk with your doctor about how to use it with Arcapta Neohaler. Short-acting bronchodilators are normally used with Arcapta Neohaler to treat breathing problems that may occur between doses.
- The risk of serious heart problems (eg, irregular heartbeat) may be greater if you use Arcapta Neohaler in high doses. Do NOT use more than recommended dose or use more often than prescribed.
- If your symptoms do not get better or if they get worse, contact your doctor right away.
- Tell your doctor at once if you notice that your short-acting bronchodilator inhaler does not work as well, if you need to use it often, or if you have a decrease in your peak flow meter results.
- Contact your doctor or seek medical care right away if you have breathing problems that worsen quickly, or if you use your short-acting bronchodilator and do not get relief.
- Talk with your doctor or pharmacist about all of your COPD medicines and how to use them. Your doctor may make changes to your COPD control medicines once your COPD is well controlled. Do not start, stop, or change the dose of any asthma medicine unless your doctor tells you to.
- The medicine may cause severe breathing problems right after you use a dose. If this happens, use your short-acting bronchodilator. Contact your doctor or seek other medical care at once.
- Arcapta Neohaler may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
- Lab tests, including lung function and blood potassium levels, may be performed while you use Arcapta Neohaler. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Arcapta Neohaler should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Arcapta Neohaler while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use Arcapta Neohaler, check with your doctor. Discuss any possible risks to your baby.
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.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fast or irregular heartbeat; muscle pain, weakness, or cramps; new or worsening COPD symptoms (eg, increased chest tightness, coughing, shortness of breath, wheezing) or other breathing problems; severe or persistent headache or dizziness; swelling of the hands, ankles, or feet; tremor.
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.
This information should not be used to decide whether or not to take Arcapta Neohaler or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Arcapta Neohaler. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Arcapta Neohaler. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Arcapta Neohaler.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.