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Budesonide ER

Budesonide Extended-Release (ER) is a corticosteroid medication specifically designed to treat inflammatory bowel diseases, such as Crohn's disease and ulcerative colitis. The extended-release formulation allows the medication to be released slowly in the gastrointestinal tract, targeting the inflamed areas more effectively. Budesonide ER works by reducing inflammation in the intestines and suppressing the immune response, helping to induce and maintain remission in patients with mild to moderate disease.

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Frequently Asked Questions

How long does it take for Budesonide ER to start working?
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Budesonide ER typically begins to reduce inflammation within a few days to a week of starting treatment, but it may take several weeks to achieve the full therapeutic effect, especially for chronic conditions like Crohn’s disease or ulcerative colitis.

Can I stop taking Budesonide ER if my symptoms improve?
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No, you should not stop taking Budesonide ER without consulting your healthcare provider. Abrupt discontinuation can lead to a flare-up of symptoms or adrenal insufficiency. Your healthcare provider may gradually reduce your dose if discontinuation is necessary.

Is Budesonide ER safe to use during pregnancy?
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The safety of Budesonide ER during pregnancy depends on the condition being treated. It is generally considered safer than systemic corticosteroids because it has lower systemic absorption. However, pregnant women or those planning to become pregnant should consult their healthcare provider to discuss the potential risks and benefits.

What should I do if I miss a dose of Budesonide ER?
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If you miss a dose, take it as soon as you remember. If it is close to the time of your next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses at once.

Can Budesonide ER cause weight gain?
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Weight gain is a potential side effect of corticosteroids, including Budesonide ER, particularly when used in high doses or for prolonged periods. However, the risk is generally lower with Budesonide ER compared to systemic corticosteroids. If you notice significant weight changes, discuss them with your healthcare provider.

Comprehensive Drug Guide

How Does Budesonide ER Work?

Budesonide ER works by binding to glucocorticoid receptors in the gastrointestinal tract, leading to the inhibition of inflammatory cytokines and mediators. The extended-release formulation allows Budesonide to be released gradually as it passes through the intestines, targeting the areas most affected by inflammation. This localized action reduces systemic exposure and minimizes potential side effects compared to systemic corticosteroids.

What is Budesonide ER Used For?

Induction of Remission in Mild to Moderate Ulcerative Colitis: To reduce inflammation and induce remission in patients with active disease.

Maintenance of Remission in Crohn’s Disease: Specifically for patients with mild to moderate Crohn’s disease involving the ileum and/or ascending colon.

Common Dosages

Budesonide ER is available by prescription only and is not classified as a controlled substance. It is available in oral capsule form, often marketed under brand names such as Uceris for ulcerative colitis and Entocort EC for Crohn's disease.

Administration: Budesonide ER capsules should be taken once daily in the morning. The capsules should be swallowed whole, not crushed, chewed, or broken, to maintain the extended-release properties. It can be taken with or without food, but it is important to take it consistently at the same time each day.

Tapering: When discontinuing therapy, particularly after long-term use, the dose should be tapered gradually under medical supervision to avoid potential withdrawal symptoms or adrenal insufficiency.

Typical Dosing

FDA Approved Indications

The typical dosage of Budesonide ER depends on the condition being treated:

For Ulcerative Colitis (Uceris):

  • Adults: 9 mg taken orally once daily in the morning for up to 8 weeks.

For Crohn’s Disease (Entocort EC):

  • Adults: 9 mg taken orally once daily in the morning for up to 8 weeks, followed by a maintenance dose of 6 mg once daily for up to 3 months or longer if needed.

Who Shouldn't Take Budesonide ER?

Budesonide ER is contraindicated in patients with:

  • Known hypersensitivity to Budesonide or any component of the formulation.
  • Severe untreated infections, particularly fungal infections, due to the immunosuppressive effects of corticosteroids.


Advice From The Pharmacist

Patients using Budesonide ER should be advised to:

  • Take the medication exactly as prescribed and at the same time each day to maintain consistent blood levels.
  • Do not stop taking Budesonide ER abruptly, especially after long-term use, as this can lead to adrenal insufficiency. Always follow the healthcare provider's instructions for tapering off the medication.
  • Inform their healthcare provider if they experience any signs of infection, as Budesonide can suppress the immune system.
  • Be aware of potential side effects, especially if using high doses or long-term therapy, and report any unusual symptoms, such as vision changes, persistent sore throat, or fatigue, to their healthcare provider.
  • Avoid exposure to chickenpox or measles if they have not been vaccinated, as Budesonide can increase the risk of severe infection.


Side Effects of Budesonide ER

Common Side Effects

  • Headache
  • Nausea
  • Abdominal pain
  • Fatigue
  • Joint pain


Uncommon/Severe Side Effects

  • Adrenal Suppression: Long-term use of corticosteroids like Budesonide can lead to adrenal insufficiency, particularly when transitioning from systemic corticosteroids.
  • Increased Risk of Infections: Due to the immunosuppressive effects, patients may be more susceptible to infections.
  • Osteoporosis: Long-term use of corticosteroids can lead to bone loss, increasing the risk of fractures.
  • Cataracts and Glaucoma: Long-term use, particularly of systemic corticosteroids, can increase the risk of cataracts or glaucoma.

Patients should seek immediate medical attention if they experience severe or persistent side effects.



Risks and Warnings of Budesonide ER

Adrenal Insufficiency: Sudden discontinuation of Budesonide ER after prolonged use can lead to adrenal insufficiency. Patients should be tapered off the medication gradually under medical supervision.

Growth Suppression in Children: Long-term use of corticosteroids can slow growth in children. Growth should be monitored regularly in pediatric patients.

Immunosuppression: Budesonide ER can suppress the immune system, increasing the risk of infections. Patients should be monitored for signs of infection, and live vaccines should be avoided during treatment.

Interactions with Budesonide ER

Common Drug Interactions

Budesonide ER may interact with other medications, including:

  • CYP3A4 Inhibitors: Such as ketoconazole or ritonavir, which can increase the levels of Budesonide in the blood, potentially leading to increased side effects.
  • Live Vaccines: Due to immunosuppression, live vaccines should be avoided during treatment with Budesonide.
  • Other Corticosteroids: Concurrent use of multiple corticosteroids can increase the risk of systemic side effects.

Patients should inform their healthcare provider of all medications and supplements they are taking to avoid potential interactions.



Alternatives to Budesonide ER

Alternative treatments for the conditions treated by Budesonide ER include:

  • Other Corticosteroids: Such as prednisone or hydrocortisone, which can be used for more severe cases of inflammatory bowel disease.
  • Aminosalicylates: Such as mesalamine, used to reduce inflammation in the colon in cases of ulcerative colitis.
  • Biologics: Such as infliximab or adalimumab, which target specific components of the immune system and are used in more severe cases of inflammatory bowel disease.
  • Immunomodulators: Such as azathioprine or methotrexate, which help reduce inflammation by suppressing the immune system.

The choice of treatment depends on the specific condition, the patient’s response to previous treatments, and any underlying medical conditions.