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this means that Arcapta Neohaler (Inhalation) Generic Name: indacaterol (Inhalation route) in-da-KAT-er-ol Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings Breastfeeding Warnings User Reviews Support Group Q & A Pricing & Coupons Inhalation route(Capsule) Indacaterol maleate is not indicated for the treatment of asthma. Long-acting beta-2-adrenergic agonists (LABAs), such as indacaterol, increase the risk of asthma-related death . Commonly used brand name(s) In the U.S. Arcapta Neohaler Available Dosage Forms: Capsule Therapeutic Class: Bronchodilator Pharmacologic Class: Beta-2 Adrenergic Agonist Slideshow COPD: Could You Be At Risk? Uses For Arcapta Neohaler Indacaterol is used to treat air flow blockage and prevent worsening of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. COPD is a long-term lung disease that causes bronchospasm (wheezing or difficulty with breathing). Indacaterol is a long-acting bronchodilator. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes. This medicine is available only with your doctor's prescription. Before Using Arcapta Neohaler In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Allergies Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Pediatric Indacaterol is not indicated for use in the pediatric population. Safety and efficacy have not been established. Geriatric Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of indacaterol in the elderly. Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. Breast Feeding There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Interactions with Medicines Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Carteolol Carvedilol Labetalol Levobunolol Metipranolol Nadolol Oxprenolol Penbutolol Pindolol Practolol Propranolol Sotalol Timolol Interactions with Food/Tobacco/Alcohol Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. Other Medical Problems The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: Allergy to milk proteins Use with caution. This medicine contains lactose (milk sugar) and milk proteins. Asthma Do not use this medicine if you have this condition. Some people with asthma have had more severe asthma attacks when they used this medicine. COPD attack, severe Should not be used if you are having a severe COPD attack, or if symptoms of COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. Diabetes or Heart or blood vessel disease or Heart rhythm problems (e.g., QT prolongation) or Hypertension (high blood pressure) or Hyperthyroidism (overactive thyroid) or Hypokalemia (low potassium in the blood) or Ketoacidosis (high ketones in the blood) or Seizures, history of Use with caution. May make these conditions worse. Proper Use of Arcapta Neohaler Use this medicine only as directed by your doctor . Do not use more of it and do not use it more often than recommended on the label, unless otherwise directed by your doctor. Using the medicine more often may increase the chance of serious unwanted effects. In order for this medicine to help prevent COPD attacks, it must be used once a day at the same time each day as ordered by your doctor . Indacaterol inhalation powder is used with a special inhaler (Neohaler ) and usually comes with a Medication Guide and patient directions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your doctor to show you what to do. Also, ask your doctor to check how you use the inhaler to make sure you are using it properly. To use indacaterol inhalation powder with the Neohaler : Dry your hands before handling this medicine. Open a blister card of capsules. Do not remove a capsule until you are ready for a dose. Open the base of inhaler firmly and tilt the mouthpiece to open the inhaler. Place the capsule only in the capsule-chamber in the base of the inhaler. Do not swallow the capsule and do not place a capsule directly into the mouthpiece. Hold the mouthpiece of the inhaler upright and press both buttons at the same time. Press the buttons only once. You should hear a click as the capsule is being pierced. Breathe out fully. Do not exhale into the mouthpiece. Place the mouthpiece in your mouth then close your lips around the mouthpiece. Breathe in quickly and deeply. Remove the inhaler from your mouth. Hold your breath as long as you can and then exhale. Open the inhaler after using it, and remove and discard the empty capsule. Do not leave the used capsule inside the chamber. Close the mouthpiece and then replace the cover. Do not wash the inhaler. Keep it dry. You may reuse your inhaler. But use a new inhaler with each refill of your medicine. Do not use the inhaler for this medicine with any other medicine. Dosing The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. For inhalation powder dosage form (used with Neohaler ): For maintenance treatment of COPD: Adults 75 micrograms (mcg) (1 capsule) by oral inhalation once a day. Children Use is not recommended. Missed Dose If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Do not use this medicine more than one time every 24 hours. Storage Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. Precautions While Using Arcapta Neohaler If you will be using this medicine for a long time, it is very important that your doctor check you at regular visits . This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects. Tell your doctor if you are also using other medicines for your COPD. Your doctor may want you to stop using the other medicine and use it only during a severe COPD attack. Follow your doctor's instructions on how you should take your medicine. This medicine should not be used if you are having a severe COPD attack, or if symptoms of COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. If the other medicine does not work as well, tell your doctor right away. Talk to your doctor or get medical care right away: Your symptoms do not improve after using this medicine within a few days or if they become worse. Your short-acting inhaler does not seem to be working as well as usual and you need to use it more often. This medicine should not be used together with similar inhaled medicines such as arformoterol (Brovana ), budesonide/formoterol (Symbicort ), formoterol (Foradil , Perforomist ), salmeterol (Serevent ), or salmeterol/fluticasone (Advair ). This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Stop using this medicine and check with your doctor right away if you are having a cough, difficulty with breathing, shortness of breath, or wheezing after using this medicine . Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have more than one of the following symptoms: decreased urine; dry mouth; increased thirst; loss of appetite; mood changes; muscle pain or cramps; nausea or vomiting; numbness or tingling in the hands, feet, or lips; seizures; shortness of breath; uneven heartbeat; or unusual tiredness or weakness. This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Arcapta Neohaler Side Effects Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: More common Arm, back, or jaw pain chest pain or discomfort chest tightness or heaviness cough dizziness fainting fast or irregular heartbeat fever or chills nausea shortness of breath sneezing sore throat sweating tightness in the chest troubled breathing wheezing Less common Abdominal or stomach pain bloating or swelling of the face, arms, hands, lower legs, or feet blurred vision body aches or pain dry mouth ear congestion fainting flushed, dry skin fruit-like breath odor headache increased hunger increased thirst increased urination loss of consciousness loss of voice rapid weight gain runny or stuffy nose stomachache sweating tingling of the hands or feet unexplained weight loss unusual tiredness or weakness unusual weight gain or loss vomiting Incidence not known Fast, irregular, pounding, or racing heartbeat or pulse Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Less common Muscle or bone pain muscle spasm pain or tenderness around the eyes and cheekbones Incidence not known Itching skin rash Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Side Effects (complete list) The information contained in the Truven Health Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you. The use of the Truven Health products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Truven Health and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, TRUVEN HEALTH MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Truven Health does not assume any responsibility or risk for your use of the Truven Health products. Copyright 2017 Truven Health Analytics, Inc. All Rights Reserved. Next Side Effects Print this page Add to My Med List More about Arcapta (indacaterol) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: adrenergic bronchodilators Consumer resources Arcapta Arcapta Neohaler inhalation Arcapta Neohaler Professional resources Arcapta Neohaler (AHFS Monograph) Arcapta Neohaler (FDA) Related treatment guides COPD, Maintenance} Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug 6 years Approval History FDA approved 2011 WADA Class Anti-Doping Classification Manufacturer Sunovion Pharmaceuticals Inc. Drug Class Adrenergic bronchodilators Related Drugs COPD, Maintenance Symbicort , Spiriva , albuterol , ProAir HFA , Advair Diskus , ipratropium , Breo Ellipta , Ventolin , Ventolin HFA , tiotropium , Combivent , DuoNeb , albuterol / ipratropium , Proventil , Anoro Ellipta , Xopenex , Atrovent , Combivent Respimat , fluticasone / salmeterol , Proventil HFA , budesonide / formoterol , levalbuterol , Stiolto Respimat , Spiriva Respimat , Advair HFA , More... Arcapta Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Help and Support Looking for answers? Ask a question or go join the Arcapta support group to connect with others who have similar interests.} } great


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