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Budesonide (Systemic, Oral Inhalation) (byoo DES oh nide)

Pediatric Medication

Brand Names: U.S.

Entocort EC; Pulmicort; Pulmicort Flexhaler; Uceris

Brand Names: Canada

Entocort; Pulmicort Turbuhaler

What is this drug used for?

  • It is used to treat asthma.
  • It is used to treat Crohn’s disease.
  • It is used to treat ulcerative colitis.
  • It may be given to your child for other reasons. Talk with the doctor.

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

All products:

  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

All products for breathing in:

  • If your child is having a breathing attack.
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 for your child to take this drug with all of their 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?

All products:

  • Tell dentists, surgeons, and other doctors that your child is using this drug.
  • Have your child’s blood work checked often. Talk with your child’s doctor.
  • Talk with the doctor before your child gets any vaccines. Use with this drug may either raise the chance of very bad infection or make the vaccine not work as well.
  • If your child has been taking this drug for many weeks, talk with your child’s doctor before stopping. You may want to slowly stop this drug.
  • Your child may have more chance of getting infections. 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.
  • Long-term use may raise the chance of cataracts, glaucoma, or weak bones (osteoporosis). Talk with your child’s doctor.
  • Your child may need to have a bone density test. Talk with the doctor.
  • Have your child’s eye pressure checked if your child is on this drug for a long time. Talk with the doctor.
  • If your child has high blood sugar (diabetes), talk with the doctor. This drug can raise blood sugar.
  • Have your child’s blood sugar checked as you have been told by your child’s 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 of using this drug.

Tablets and capsules:

  • This drug may lower how much natural steroid is in your child’s body. If your child has a fever, an infection, surgery, or is hurt, talk with the doctor. Your child may need extra doses of oral steroids. These extra steroids will help your child’s body deal with these stresses. Carry a warning card saying that there may be times when your child needs extra steroids.
  • Avoid giving your child grapefruit and grapefruit juice.
  • You may need to lower how much salt is in your child’s diet and give your child extra potassium. Talk with your child’s doctor.
  • Alcohol may interact with this drug. Be sure your child does not drink beer, wine, or mixed drinks.

All products for breathing in:

  • When changing from an oral steroid to a breathed in one, there may be very bad and sometimes deadly side effects. Signs like weakness, feeling tired, dizziness, upset stomach, throwing up, not thinking clearly, 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, he/she 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).
  • 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.
  • This drug is not helpful during an asthma attack.
  • Do not give this drug to treat an asthma attack. Use a rescue inhaler. Talk with the doctor.

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:

All products:

  • 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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • Signs of infection. These include a fever of 100.5°F (38°C) or higher, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, wound that will not heal, or anal itching or pain.
  • Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
  • If your child is feeling very tired, weak, or touchy; is trembling; has a fast heartbeat, confusion, sweating, or dizziness if a dose was missed or the drug was recently stopped.
  • Shortness of breath, a big weight gain, swelling in the arms or legs.
  • Very bad headache.
  • A fast heartbeat.
  • A heartbeat that does not feel normal.
  • Chest pain or pressure.
  • Redness or white patches in mouth or throat.
  • Feeling very tired or weak.
  • Bone or joint pain.
  • Change in eyesight.
  • Mood changes.
  • Change in how you act.
  • Low mood (depression).
  • Seizures.
  • A burning, numbness, or tingling feeling that is not normal.
  • Very bad belly pain.
  • Any bruising or bleeding.
  • Black, tarry, or bloody stools.
  • Throwing up blood or throw up that looks like coffee grounds.

All products for breathing in:

  • 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:

Tablets and capsules:

  • Headache.
  • Upset stomach.
  • Change in body fat.
  • Skin changes (pimples, stretch marks, slow healing, hair growth).
  • Not able to sleep.
  • Restlessness.
  • Sweating a lot.
  • Belly pain.
  • Feeling tired or weak.
  • Gas.
  • Hard stools (constipation).
  • Bloating.
  • Back pain.
  • Dizziness.

Liquid for breathing in:

  • Cough.
  • Nosebleed.

All products for breathing in:

  • Stuffy nose.
  • Runny nose.
  • Nose and throat irritation.
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 and follow the dosing on the label closely.

All products:

  • To gain the most benefit, do not miss giving your child doses.
  • Give as you have been told, even if your child feels well.

Tablets and capsules:

  • Give in the morning if giving once a day.
  • Give this drug with or without food. Give with food if it causes an upset stomach.
  • Have your child swallow whole. Do not let your child chew, break, or crush.

Puffer (inhaler):

  • For breathing in only.
  • Prime puffer (inhaler) before first use by twisting brown grip as far as it will go both ways. Then repeat twisting.
  • Check your child’s puffer (inhaler) use with the doctor at each visit. Read and follow facts on how to use the puffer. Make sure your child’s uses the puffer the right way.
  • Do not use a spacer with the puffer (inhaler).
  • If your child is using more than 1 puffer (inhaler), ask the doctor which puffer to use first.

Liquid for breathing in:

  • For breathing in only as a liquid (solution) by a special machine (nebulizer) into the lungs.
  • Follow how to give this drug as you have been told by your child’s doctor or read the package insert.
  • Do not mix other drugs in nebulizer.
  • Shake well before use.
  • Wash face if using a face mask.
  • If your child is using a puffer (inhaler), wait 10 minutes before giving this drug.

All products for breathing in:

  • Have your child rinse out mouth after each use.

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?

Tablets and capsules:

  • Store at room temperature.

Puffer (inhaler):

  • Store at room temperature. Throw away after date shown on the puffer (inhaler).

Liquid for breathing in:

  • Store upright at room temperature. Throw away any part not used after 2 weeks.
  • Protect from light.

All products:

  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

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.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, 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 information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

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