Fluticasone and Vilanterol

Pediatric Medication
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This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.

Brand Names: US

Breo Ellipta

Brand Names: Canada

Breo Ellipta

What is this drug used for?

  • It is used to treat asthma.
  • Do not use this drug to treat intense flare-ups of shortness of breath. Use a rescue inhaler. If you have questions, talk with the doctor.

What do I need to tell the doctor BEFORE my child takes this drug?

  • If your child is allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.
  • If your child has a milk allergy.
  • If your child is using another drug like this one. If you are not sure, ask your child’s doctor or pharmacist.

This is not a list of all drugs or health problems that interact with this drug.

Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe to give this drug with all of your child’s other drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while my child takes this drug?

  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • If your child has high blood sugar (diabetes), this drug may sometimes raise blood sugar. Talk with your child’s doctor about how to keep your child’s blood sugar under control.
  • Call the doctor right away if your child has breathing problems that get worse, if the rescue inhaler does not work as well, or if your child needs to use the rescue inhaler more often.
  • Do not give more of this drug or have your child use it more often than you were told. Deaths have happened when too much of this type of drug has been taken. Talk with your child’s doctor.
  • When changing from an oral steroid to another form of steroid, there may be severe and sometimes deadly side effects. Signs like weakness, feeling tired, dizziness, upset stomach, throwing up, confusion, or low blood sugar may happen. Call the doctor right away if your child has any of these signs. If your child has a bad injury, has surgery, or any type of infection, they may need extra doses of oral steroids. These extra steroids will help your child’s body deal with these stresses. Have your child wear medical alert ID (identification).
  • Long-term use may raise the chance of cataracts or glaucoma. Talk with the doctor.
  • Get your child an eye exam as you have been told by the doctor.
  • This drug may cause weak bones (osteoporosis) with long-term use. Talk with the doctor to see if your child has a higher chance of weak bones, or if you have any questions.
  • Have your child get a bone density test as you have been told by your child’s doctor.
  • Your child may have more chance of getting infections. Have your child wash hands often. Avoid crowds and people with infections, colds, or flu.
  • Chickenpox and measles can be very bad or even deadly in some people taking steroid drugs like this drug. Avoid having your child near anyone with chickenpox or measles if your child has not had these health problems before. If your child has been exposed to chickenpox or measles, talk with the doctor.
  • This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.

If your child is pregnant or breast-feeding a baby:

  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.

What are some side effects that I need to call my child’s doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of high blood sugar like confusion, feeling sleepy, unusual thirst or hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
  • Signs of a weak adrenal gland like a severe upset stomach or throwing up, severe dizziness or passing out, muscle weakness, feeling very tired, mood changes, decreased appetite, or weight loss.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Chest pain or pressure or a fast heartbeat.
  • Shakiness.
  • Feeling nervous and excitable.
  • Bone pain.
  • Change in eyesight, eye pain, or severe eye irritation.
  • Mouth irritation or mouth sores.
  • Redness or white patches in mouth or throat.
  • Feeling very tired or weak.
  • This drug can cause very bad breathing problems right after your child takes a dose. Sometimes, this may be life-threatening. If your child has trouble breathing, breathing that is worse, wheezing, or coughing after using this drug, have your child use a rescue inhaler and get medical help right away.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:

  • Headache.
  • Runny nose.
  • Nose or throat irritation.
  • Signs of a common cold.
  • Flu-like signs.
  • Change in voice.
  • Back pain.
  • Joint pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.

You may report side effects to your national health agency.

How is this drug best given?

Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.

  • For breathing in only.
  • Give this drug at the same time of day.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • Do not take out the inhaler from the foil tray until right before first use.
  • Close the device after each dose. Do not open the device unless a dose is being used.
  • Do not take the device apart or wash it. Do not use it with a spacer. Be sure your child does not breathe out into the device.
  • Have your child rinse out the mouth after each use. Do not let your child swallow the rinse water. Have your child spit it out.
  • If your child is using more than 1 inhaled drug, ask your child’s doctor which inhaled drug to give first.

What do I do if my child misses a dose?

  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.

How do I store and/or throw out this drug?

  • Store at room temperature in a dry place. Do not store in a bathroom.
  • Protect from heat and sunlight.
  • This inhaler has a dose counter to keep track of how many doses are left. Throw away the inhaler when the dose counter reaches “0”, 6 weeks after opening the foil container, or after the expiration date, whichever comes first.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

General drug facts

  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This generalized information is a limited summary of diagnosis, treatment, and/or medication information. It is not meant to be comprehensive and should be used as a tool to help the user understand and/or assess potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a specific patient. It is not intended to be medical advice or a substitute for the medical advice, diagnosis, or treatment of a health care provider based on the health care provider’s examination and assessment of a patient’s specific and unique circumstances. Patients must speak with a health care provider for complete information about their health, medical questions, and treatment options, including any risks or benefits regarding use of medications. This information does not endorse any treatments or medications as safe, effective, or approved for treating a specific patient. UpToDate, Inc. and its affiliates disclaim any warranty or liability relating to this information or the use thereof. The use of this information is governed by the Terms of Use, available at https://www.wolterskluwer.com/en/know/clinical-effectiveness-terms.

Last Reviewed Date

2023-05-30

Copyright

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Last Updated

Friday, June 2, 2023