Budesonide

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Update Date 11/05/2020 . 1 min read
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Uses

What is Budesonide used for?

Budesonide is commonly used to treat certain bowel conditions (such as Crohn’s disease, ulcerative colitis). While budesonide does not cure these conditions, it may decrease symptoms such as pain and diarrhea. Budesonide is an anti-inflammatory drug (corticosteroid hormone). It works by decreasing the body’s natural defense response (immune response).

How should I take Budesonide?

Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. Take this medication by mouth with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Swallow this medication whole. Do not crush or chew. Doing so can release all of the drug at once, increasing the risk of side effects. If you are using the extended-release tablets, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

The dosage and length of treatment are based on your medical condition, response to treatment, and age.

Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise. Grapefruit may increase the amount of certain medications in your body. Consult your doctor or pharmacist for more details.

If you are regularly taking a different corticosteroid by mouth (such as prednisone), you should not stop taking it unless directed by your doctor. Some conditions (such as asthma, allergies) may become worse when the drug is suddenly stopped. You may have withdrawal symptoms if the drug is suddenly stopped. To prevent withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness), your doctor may direct you to slowly lower the dose of your old medication when you are taking budesonide. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

Use this medication regularly and exactly as prescribed in order to get the most benefit from it. To help you remember, use it at the same time each day. Do not increase your dose, take it more frequently, or use it for a longer time than prescribed because this may increase your risk of serious side effects.

Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

Inform your doctor if your condition persists or worsens.

How do I store Budesonide?

Budesonide is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Budesonide in the bathroom or the freezer. There may be different brands of Budesonide that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Budesonide down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Budesonide?

Before taking budesonide, tell your doctor if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye disease (such as cataracts, glaucoma), high blood pressure, liver disease, thyroid problems, diabetes, stomach/intestinal problems (such as diverticulitis, ulcer), brittle bones (osteoporosis), current/past infections (such as tuberculosis, positive tuberculosis test, herpes, fungal), bleeding problems, mental/mood conditions (such as psychosis, anxiety, depression).

Using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. If you will be using this medication for a long time, carry a warning card or medical ID bracelet that identifies your use of this medication.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit alcoholic beverages. Consult your doctor or pharmacist for more information.

This medication may mask signs of infection. It can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Budesonide may cause vaccines not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

This medication may slow down a child’s growth if used for a long time. Consult the doctor or pharmacist for more details. See the doctor regularly so your child’s height and growth can be checked.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Babies born to mothers who have used corticosteroids for a long time may develop hormone problems. Tell your doctor right away if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Budesonide during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking this Budesonide. This Budesonide is pregnancy risk category ___ according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Budesonide?

Because this drug works by weakening the immune system, it may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as cough, sore throat, fever, chills). Use of this medication for prolonged or repeated periods may result in oral thrush or a yeast infection. Contact your doctor if you notice white patches in your mouth or a change in vaginal discharge.

Tell your doctor right away if any of these rare but seriousunusual tiredness, vision problems, easy bruising/bleeding, puffy face, unusual hair growth, mental/mood changes (such as depression, mood swings, agitation), muscle weakness/pain, thinning skin, slow wound healing.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Budesonide?

Some products that may interact with this drug include: aldesleukin, mifepristone, drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, “blood thinners” such as dabigatran/warfarin, NSAIDs such as aspirin/celecoxib/ibuprofen).

If your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

This product may interfere with certain lab tests (such as skin tests). Make sure laboratory personnel and all your doctors know you use this drug.

Budesonide may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Budesonide?

Budesonide may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Budesonide?

Budesonide may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Budesonide.

What is the dose of Budesonide for an adult?

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.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Moderate to severe hepatic impairment: Due to increasing systemic exposure with increasing degree of hepatic impairment, patients with moderate to severe hepatic impairment should be monitored for increased signs and/or symptoms of hypercorticism; discontinuation should be considered if signs and/or symptoms of hypercorticism develop.

Enteric Coated Capsules:

Severe hepatic impairment (Child-Pugh Class C): Avoid use

Moderate hepatic impairment (Child-Pugh Class B): Adults: Consider reducing the dose to 3 mg orally once a day

-Pediatric: Dose adjustments may be required; however, no specific guidelines have been suggested; caution is recommended.

Dose Adjustments

Elderly patients: Dose selection should be cautious, generally starting at the low end of the dose range.

What is the dose of Budesonide for a child?

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.

Precautions

Safety and efficacy of enteric coated capsules have not been established in patients younger than 8 years

Safety and efficacy of extended-release tablets have not been established in patients younger than 18 years.

Safety and efficacy of inhaled powder (oral inhaler) have not been established in patients younger than 6 years.

Safety and efficacy of inhaled suspension (oral nebulizer) has been established in patients 12 months to 8 years.

How is Budesonide available?

Budesonide is available in the following dosage forms and strengths:

  • Capsule
  • Inhalation Suspension
  • Nasal Spray

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Budesonide, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

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