Anoro Ellipta powder

Generic Name: umeclidinium/vilanterol (ue-me-kli-DIN-ee-um/vye-LAN-ter-ol)
Brand Name: Anoro Ellipta

Long-acting beta-agonists such as one of the active ingredients in Anoro Ellipta powder (vilanterol) have been rarely associated with an increased risk of asthma-related death. Anoro Ellipta powder is not approved to treat asthma; safety and effectiveness in patients with asthma have not been confirmed.


Anoro Ellipta powder is used for:

Treating chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It may also be used for other conditions as determined by your doctor.

Anoro Ellipta powder is an anticholinergic and long-acting bronchodilator combination. It works by relaxing and widening the airways in the lungs, making it easier to breathe.

Do NOT use Anoro Ellipta powder if:

  • you are allergic to any ingredient in Anoro Ellipta powder or to milk proteins
  • you are having severe breathing problems (eg, sudden, severe onset or worsening of COPD symptoms [eg, chest tightness, cough, shortness of breath, wheezing])
  • you are using another medicine that has a long-acting inhaled bronchodilator (eg, formoterol, salmeterol) in it

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Anoro Ellipta powder:

Some medical conditions may interact with Anoro Ellipta powder. 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 a history of other lung or breathing problems (eg, asthma), diabetes, heart problems (eg, fast or irregular heartbeat, heart blood vessel problems), high blood pressure, nervous system problems, liver problems, low blood potassium levels, high blood acid levels (eg, ketoacidosis), seizures, or thyroid problems
  • if you have eye problems (eg, glaucoma), prostate problems (eg, enlargement of the prostate), bladder problems, or urinary blockage or trouble urinating
  • if you are having a COPD flare-up
  • 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 or have taken linezolid, a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or a tricyclic antidepressant (eg, amitriptyline) within the last 14 days

Some MEDICINES MAY INTERACT with Anoro Ellipta powder. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Diuretics (eg, hydrochlorothiazide, furosemide) because the risk of low blood potassium levels may be increased
  • Anticholinergic medicines (eg, aclidinium, ipratropium, tiotropium), atropine, azole antifungals (eg, itraconazole, ketoconazole), clarithromycin, cobicistat, conivaptan, linezolid, other long-acting inhaled bronchodilators (eg, salmeterol, formoterol), MAOIs (eg, phenelzine), mifepristone, nefazodone, protease inhibitors (eg, boceprevir, ritonavir), telithromycin, or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Anoro Ellipta powder's side effects
  • Beta-blockers (eg, propranolol) because they may decrease Anoro Ellipta powder's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Anoro Ellipta powder 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 Anoro Ellipta powder:

Use Anoro Ellipta powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Anoro Ellipta powder comes with an extra patient information sheet called a Medication Guide. It also comes with detailed instructions for use. Read them carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about Anoro Ellipta powder.
  • A health care provider will teach you how to use Anoro Ellipta powder at home. Be sure you understand how to use Anoro Ellipta powder. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • To prepare a dose of Anoro Ellipta powder, remove the inhaler from the foil tray. Open the cover of the inhaler until you hear a click. The counter will count down by 1 number. Your inhaler is now ready to use.
  • Do not open the cover of the inhaler until you are ready to use it. To avoid wasting doses after the inhaler is ready, do not close the cover until after you have inhaled the medicine.
  • To use a dose of Anoro Ellipta powder, hold the inhaler away from your mouth and breathe out fully. Do not breathe out into the mouthpiece. Place the mouthpiece between your lips, and close your lips firmly around it. Take a long, deep breath through your mouth. Do not block the air vents of the inhaler with your fingers. Remove the inhaler from your mouth and hold your breath for about 3 to 4 seconds, or as long as comfortable for you. Breathe out slowly.
  • Before you close the cover, you may clean the mouthpiece with a dry tissue if needed. Slide the cover up and over the mouthpiece when you are done.
  • You may not taste or feel the medicine, even when you are using the inhaler correctly. Do NOT use another dose if you do not taste or feel the medicine. If you are not sure if you are receiving your dose, contact your doctor or pharmacist.
  • If you are using other inhaled medicines, wait a few minutes between using Anoro Ellipta powder and other inhalers, unless directed otherwise by your doctor.
  • Never wash the mouthpiece or any other part of the inhaler. Keep it dry. Store Anoro Ellipta powder in a dry place.
  • Store Anoro Ellipta powder in the unopened foil tray until right before the first use. Throw Anoro Ellipta powder away 6 weeks after you opening the foil tray or after the dose counter reads "0," whichever comes first.
  • Use Anoro Ellipta powder on a regular schedule to get the most benefit from it. Using Anoro Ellipta powder at the same time each day will help you remember to use it. Do not stop using Anoro Ellipta powder even if you feel better unless your doctor tells you to.
  • If you miss a dose of Anoro Ellipta powder, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once. Do not use Anoro Ellipta powder more often than 1 time every 24 hours.

Ask your health care provider any questions you may have about how to use Anoro Ellipta powder.

Important safety information:

  • Anoro Ellipta powder will not stop sudden breathing problems once they have already started. Be sure to always carry a rescue inhaler (eg, albuterol) with you to use during sudden breathing problems. If you do not have a rescue inhaler or you have any questions about which medicines should be used during sudden breathing problems, check with your doctor or pharmacist.
  • If you have been regularly using a rescue inhaler, talk with your doctor about how to use it with Anoro Ellipta powder. Rescue inhalers are normally only used with Anoro Ellipta powder to treat breathing problems that may occur between doses.
  • Tell your doctor or dentist that you take Anoro Ellipta powder before you receive any medical or dental care, emergency care, or surgery.
  • If your symptoms become worse, you need to use your rescue inhaler medicine more often than normal, or your rescue inhaler medicine does not work well to treat sudden breathing problems, get medical help right away.
  • The risk of serious heart problems (eg, irregular heartbeat) and sometimes death may be greater if you use too much of Anoro Ellipta powder. Do NOT use more than the recommended dose or use more often than prescribed without checking with your doctor.
  • Do not stop using Anoro Ellipta powder without checking with your doctor.
  • Anoro Ellipta powder may sometimes cause severe breathing problems right after you use a dose. If this happens, use your rescue inhaler. Contact your doctor or seek other medical care at once.
  • Diabetes patients - Anoro Ellipta powder may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Lab tests, including lung function, blood sugar, potassium levels, and eye exams, may be performed while you use Anoro Ellipta powder. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Anoro Ellipta powder should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Anoro Ellipta powder while you are pregnant. It is not known if Anoro Ellipta powder is found in breast milk. If you are or will be breast-feeding while you use Anoro Ellipta powder, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Anoro Ellipta powder:

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:

Constipation; diarrhea; mild sore throat; runny or stuffy nose; sneezing.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest, jaw, arm, or neck pain; difficult, frequent, or painful urination; eye pain or discomfort; fast or irregular heartbeat; fever, chills, or persistent cough or sore throat; muscle pain, spasms, weakness, or cramps; nervousness; red eyes; severe or persistent dizziness or headache; severe or persistent nausea or vomiting; symptoms of high blood sugar (eg, increased thirst, urination, or hunger; unusual weakness or drowsiness; confusion); tremor; unusual tiredness or weakness; vision changes (eg, blurred vision, seeing halos or bright colors around lights); weak urine stream or drips; worsening of COPD symptoms (eg, increased wheezing, coughing, chest tightness, shortness of breath).

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.

Proper storage of Anoro Ellipta powder:

Store Anoro Ellipta powder between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Anoro Ellipta powder out of the reach of children and away from pets.

General information:

  • If you have any questions about Anoro Ellipta powder, please talk with your doctor, pharmacist, or other health care provider.
  • Anoro Ellipta powder 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 Anoro Ellipta powder 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 Anoro Ellipta powder. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Anoro Ellipta powder. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Anoro Ellipta powder.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

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.

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