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budesonide

Pronunciation

Generic Name: budesonide (oral) (bue DES oh nide)
Brand Name: Entocort EC, Uceris

What is budesonide?

Budesonide is a steroid that reduces inflammation in the body.

Budesonide is used to treat mild to moderate Crohn's disease.

Budesonide may also be used for purposes not listed in this medication guide.

What is the most important information I should know about budesonide?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What should I discuss with my healthcare provider before taking budesonide?

You should not use budesonide if you are allergic to it.

To make sure budesonide is safe for you, tell your doctor if you have:

  • tuberculosis (now or in the past);

  • a serious bacterial, viral, or fungal infection;

  • a weak immune system (caused by disease or by using certain medicines);

  • high blood pressure;

  • cirrhosis or other liver disease;

  • stomach ulcer;

  • osteoporosis or low bone mineral density;

  • eczema;

  • any allergies; or

  • a personal or family history of diabetes, cataracts, or glaucoma.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Budesonide can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Budesonide is not approved for use by anyone younger than 18 years old.

How should I take budesonide?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine in the morning with a full glass of water.

Do not crush, chew, or break a budesonide capsule or tablet. Swallow it whole.

Your dosage needs may change if you have surgery, are ill, or are under stress. Do not change your doses or medication schedule without advice from your doctor.

Call your doctor if your symptoms do not improve, or if they get worse while using budesonide.

Budesonide can weaken your immune system. Tell your doctor if you have signs of infection such as fever, chills, body aches, vomiting, or feeling tired.

If you use this medicine long-term, you may need frequent medical tests.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking budesonide?

Grapefruit and grapefruit juice may interact with budesonide and lead to potentially dangerous effects. Avoid the use of grapefruit products while taking budesonide.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using budesonide.

Budesonide side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • thinning skin, easy bruising, increased acne or facial hair;

  • swelling in your ankles;

  • weakness, tiredness, or a light-headed feeling, like you might pass out;

  • nausea, vomiting, rectal bleeding;

  • pain or burning when you urinate;

  • menstrual problems (in women), impotence or loss of interest in sex (in men); or

  • stretch marks, changes in the shape or location of body fat (especially in your face, neck, back, and waist).

Common side effects may include:

  • headache;

  • nausea, stomach pain, gas, bloating, constipation;

  • feeling tired;

  • joint pain;

  • acne; or

  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Budesonide dosing information

Usual Adult Dose for Asthma -- Maintenance:

FLEXHALER(R)
Initial dose: 360 mcg via oral inhalation twice a day: in some patients an initial dose of 180 mcg twice a day may be adequate
Maintenance dose: May increase dose in 1 to 2 weeks if response is not adequate; after asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects
Maximum dose: 720 mcg twice a day

TURBUHALER(R)
Initial dose: 400 to 2400 mcg via oral inhalation daily in divided doses
Maintenance dose: 200 to 400 mcg via oral inhalation twice a day; higher doses may be necessary for longer or shorter periods of time in some patients; after asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects
-Once daily dosing may be considered in patients requiring 400 mcg per day; dose should be given in the evening

Comments:
-Improvement in asthma control can occur as early as 24 hours; maximum benefit is usually achieved within 1 to 2 weeks; individual patients may experience a variable onset and degree of symptom relief.
-If asthma symptoms arise, a fast acting inhaled bronchodilator should be used for immediate relief; this drug should not be used for the relief of acute bronchospasm.

Use: For the maintenance treatment of asthma as prophylactic therapy.

Usual Adult Dose for Crohn's Disease -- Acute:

Enteric coated capsules
Initial dose: 9 mg orally once a day in the morning for up to 8 weeks
-May repeat course for recurring episodes of active disease

Comments:
-Patients with mild to moderate active Crohn's disease involving the ileum and/or ascending colon have been switched from oral prednisolone to this drug with no reported episodes of adrenal insufficiency; prednisolone should be tapered while initiating therapy with this drug.
-Capsules should be swallowed whole; avoid grapefruit juice for the duration of therapy.
-Once patients symptoms are controlled (Crohn's Disease Activity Index [CDAI] less than 150); maintenance dosing should be started.

Use: Treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon.

Usual Adult Dose for Crohn's Disease -- Maintenance:

Enteric coated capsules:
6 mg orally once a day in the morning for up to 3 months
-If symptom control is maintained at 3 months, attempt to taper to complete cessation

Comments:
-Maintenance therapy should be started once symptoms are controlled (Crohn's Disease Activity Index [CDAI] less than 150).
-Swallow capsules whole; avoid grapefruit juice for the duration of therapy.
-Continued maintenance treatment beyond 3 months has not been shown to provide substantial benefit.

Use: Maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum and/or the ascending colon for up to 3 months.

Usual Adult Dose for Ulcerative Colitis:

Extended-release tablets:
Initial dose: 9 mg orally once a day in the morning
Duration of therapy: Up to 8 weeks

Rectal Foam:
For Active Mild to Moderate Distal Ulcerative Colitis Extending up to 40 cm from the Anal Verge:
1 metered dose administered rectally twice a day for 2 weeks, then 1 metered dose administered rectally once a day for 4 weeks

Comments:
-Avoid grapefruit juice for the duration of therapy.

Use: For the induction of remission in patients with active, mild to moderate ulcerative colitis.

Usual Pediatric Dose for Asthma -- Maintenance:

Inhalation Suspension (administer via jet nebulizer):
Age: 1 to 8 years: Initial and maximum dose are based on prior asthma therapy:
-Previously treated with bronchodilators alone: 0.5 mg via oral inhalation once a day or 0.25 mg via oral inhalation twice a day; Maximum daily dose: 0.5 mg
-Previously treated with inhaled corticosteroids: 0.5 mg once a day or 0.25 mg twice a day; may increase up to 0.5 mg twice a day; Maximum daily dose: 1 mg
-Previously treated with oral corticosteroids: 1 mg once a day or 0.5 mg twice a day; Maximum daily dose: 1 mg

Comment: For symptomatic patients who do not respond to non-steroid therapy, an initial inhalation suspension dose of 0.25 mg once a day may be considered.

FLEXHALER(R) Inhalation Powder (oral inhaler):
Age: 6 to 12 years:
-Initial dose: 180 mcg via oral inhalation twice a day; some patients may require an initial dose of 360 mcg twice a day
-Maintenance dose: May increase dose after 1 to 2 weeks if response is not adequate; once asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects
-Maximum dose: 360 mcg twice a day

TURBUHALER(R) Inhalation Powder (oral inhaler):
Age 6 to 12 years:
-Initial dose: 100 to 200 mcg via oral inhalation twice a day
Maintenance dose: Lowest dose that keeps patient symptom-free

TURBUHALER(R) Inhalation Powder (oral inhaler):
Age: Over 12 years:
Initial dose: 400 to 2400 mcg via oral inhalation daily in divided doses
Maintenance dose: 200 to 400 mcg via oral inhalation twice a day; higher doses may be necessary for longer or shorter periods of time in some patients; after asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects
-Once daily dosing may be considered in patients requiring 400 mcg per day; dose should be given in the evening

Comments:
-Improvement in asthma control can occur as early as 24 hours; maximum benefit is usually achieved within 1 to 2 weeks; individual patients may experience a variable onset and degree of symptom relief.
-If asthma symptoms arise between doses, a fast acting inhaled bronchodilator should be used for immediate relief; this drug should not be used for the relief of acute bronchospasm.
-Once daily dosing may be used unless it does not provide adequate control, then dosing should be administered as a divided dose, adjusting dose as needed.
-Once asthma stability has been achieved, titrate to the lowest effective dose to reduce the possibility of side effects.

Use: For the maintenance treatment of asthma as prophylactic therapy.

Usual Pediatric Dose for Crohn's Disease -- Acute:

Age 8 years or older; weight greater than 25 kg

Enteric coated capsules:
9 mg orally once a day in the morning for up to 8 weeks; then 6 mg orally once a day for 2 weeks

Comments:
-Swallow capsules whole; avoid grapefruit juice for the duration of therapy.

Use: Treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon.

What other drugs will affect budesonide?

Many other drugs may interact with budesonide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

See also: Side effects (in more detail)

Where can I get more information?

  • Your pharmacist can provide more information about budesonide.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.01.

Date modified: September 05, 2017
Last reviewed: December 19, 2016

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