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Amuity Ellipta powder

Pronunciation

Generic Name: fluticasone (floo-TIK-a-SONE)
Brand Name: Examples include Amuity Ellipta and Flovent Diskus

Amuity Ellipta powder is used for:

Preventing and controlling symptoms of asthma. Amuity Ellipta powder will not stop an asthma attack once one has started. It may also be used to treat other conditions as determined by your doctor.

Amuity Ellipta powder is a corticosteroid. It works by decreasing the irritation and swelling of the breathing tubes (bronchial tubes) of the lung to control or prevent asthma symptoms.

Do NOT use Amuity Ellipta powder if:

  • you are allergic to any ingredient in Amuity Ellipta powder or to milk proteins
  • you are having an asthma attack

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

Before using Amuity Ellipta powder:

Some medical conditions may interact with Amuity 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 weak bones (osteoporosis) or have risk factors of osteoporosis (eg, a family history of osteoporosis, tobacco use, long-term alcohol use, long-term use of corticosteroids or certain seizure medicines, limited physical exercise, poor nutrition)
  • if you have liver problems; have eye problems (eg, glaucoma, cataracts); have a bacterial, fungal, or parasitic infection; have a viral infection (eg, measles, chickenpox, shingles); have tuberculosis (TB); have a history of a positive TB skin test; have a herpes infection in the eye; or have an immune system problem or are taking a medicine to suppress the immune system (eg, tacrolimus); or if you have had a recent vaccination

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

  • Azole antifungals (eg, ketoconazole), clarithromycin, conivaptan, nefazodone, protease inhibitors (eg, ritonavir), telithromycin, or troleandomycin because they may increase the risk of Amuity Ellipta powders side effects

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

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

  • An extra patient leaflet is available with Amuity Ellipta powder. Talk to your pharmacist if you have questions about this information.
  • Amuity Ellipta powder is for oral inhalation only.
  • Do not use Amuity Ellipta powder with a spacer device.
  • Rinse your mouth out with water after using Amuity Ellipta powder to prevent mouth sores or a bad aftertaste. Do NOT swallow the rinse solution. Spit the rinse water out.
  • Use Amuity Ellipta powder on a regular schedule to get the most benefit from it.
  • If you miss a dose of Amuity Ellipta powder, skip the missed dose and go back to your regular dosing schedule. Do NOT use 2 doses at once.

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

Important safety information:

  • Tell your doctor or dentist that you take Amuity Ellipta powder before you receive any medical or dental care, emergency care, or surgery.
  • Amuity Ellipta powder will not stop an asthma attack once one has started. Always have a rescue inhaler (eg, albuterol) with you to use during an asthma attack. If you do not have a rescue inhaler or you have any questions about which medicines should be used during an asthma attack, 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 Amuity Ellipta powder. Rescue inhalers are normally only used with Amuity Ellipta powder to treat breathing problems that may occur between doses.
  • Amuity 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.
  • Tell your doctor at once if you notice that your rescue inhaler does not work as well, if you need to use it more often than normal, or if you have a decrease in your peak meter flow results.
  • After you begin using Amuity Ellipta powder, a few weeks may pass before the full benefit is obtained. Continue to use it as directed during this time.
  • Use caution if you switch from an oral steroid (eg, prednisone) to Amuity Ellipta powder. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, a sudden asthma attack or severe fluid or electrolyte loss. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid (eg, prednisone) again. Carry a card at all times that says you may need an oral steroid (eg, prednisone) if any of these events occur.
  • If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does. Tell your doctor right away if you are exposed to anyone who has these infections.
  • Check with your doctor before you receive any vaccine while you are using Amuity Ellipta powder.
  • Do not stop using Amuity Ellipta powder without checking with your doctor.
  • Amuity Ellipta powder may cause weak bones (osteoporosis) with long-term use. Talk with your doctor to see if you have a higher chance of weak bones or if you have any questions.
  • Long-term use of Amuity Ellipta powder may increase the risk of glaucoma or cataracts. Talk with your doctor.
  • Tell your doctor if you feel very tired, weak, or touchy; are trembling; or have a fast heartbeat, confusion, sweating, or dizziness if you missed a dose or recently stopped Amuity Ellipta powder.
  • Lab tests, including lung function, bone density, and eye exams, may be performed while you use Amuity 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.
  • Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Amuity Ellipta powder.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Amuity Ellipta powder 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 Amuity Ellipta powder, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Amuity 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:

Flu-like symptoms; headache; nose or throat irritation; runny nose; sore throat.

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); flushing; symptoms of infection (eg, fever, chills, cough, persistent sore throat, increased mucus production, change in mucus color); vision changes (eg, blurred vision); white patches or sores in the mouth or throat; worsening of asthma 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 Amuity Ellipta powder:

Store Amuity Ellipta powder at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from direct sunlight, heat, and moisture. Do not store in the bathroom. Store in the foil over-wrap until you are ready to use. The inhalation device is not reusable. Do not try to take the inhaler apart. Different brands of Amuity Ellipta powder can be used for different amounts of time after the foil over-wrap is opened. Be sure you know how long you can use your brand after opening it. Throw away Amuity Ellipta powder after the amount of time you are told or when the counter reads "0," whichever comes first. Do not puncture any of the blisters until you are ready to take a dose. Keep Amuity Ellipta powder out of the reach of children and away from pets.

General information:

  • If you have any questions about Amuity Ellipta powder, please talk with your doctor, pharmacist, or other health care provider.
  • Amuity 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 Amuity 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 Amuity Ellipta powder. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Amuity 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 healthcare provider for complete information about the risks and benefits of using Amuity Ellipta powder.

Review Date: November 3, 2016

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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