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Budesonide

Perennial Allergic Rhinitis, Inflammatory Bowel Diseases ... show more

DRUG STATUS

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Government Approvals

US(FDA), UK(BNF)

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WHO Essential Medicine

YES

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Known Teratogen

Unlisted

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Pharmaceutical Class

Corticosteroid

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Controlled Drug Substance

No

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Drug Ingredient

Budesonide

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Summary

  • Budesonide is used to treat mild to moderate ulcerative colitis and Crohn's disease. It helps induce remission in active cases of these conditions and maintain remission.

  • Budesonide is a corticosteroid that reduces inflammation and suppresses the immune response in the body. This helps decrease symptoms associated with inflammatory bowel diseases like ulcerative colitis and Crohn's disease.

  • For adults with mild to moderate ulcerative colitis, the recommended dose is 9 mg taken orally once daily in the morning. The safety and effectiveness of Budesonide for children have not been established.

  • Common side effects of Budesonide include headache, nausea, and decreased blood cortisol. Serious adverse effects can include hypercorticism, adrenal suppression, and increased risk of infections.

  • Budesonide is contraindicated in patients with hypersensitivity to the drug or its ingredients. It should be used cautiously in elderly patients and those with severe liver impairment. Important warnings include the risk of hypercorticism, adrenal suppression, immunosuppression and increased risk of infections.

Indications and Purpose

What is Budesonide used for?

Budesonide is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. It is also used for treating mild to moderate active Crohn's disease involving the ileum and/or ascending colon, and for the maintenance of clinical remission in Crohn's disease.

How does Budesonide work?

Budesonide is a corticosteroid that reduces inflammation by inhibiting multiple inflammatory cells and mediators. It has a high glucocorticoid effect and a weak mineralocorticoid effect, providing targeted relief with minimal systemic exposure due to its first-pass metabolism.

Is Budesonide effective?

Budesonide has been shown to be effective in inducing remission in patients with active, mild to moderate ulcerative colitis. Clinical trials demonstrated that Budesonide extended-release tablets 9 mg were superior to placebo in inducing remission, with significant improvements in clinical symptoms and endoscopic findings.

How does one know if Budesonide is working?

The benefit of Budesonide is evaluated through clinical assessments, including symptom relief and endoscopic findings. Patients are monitored for improvements in their condition, such as reduced inflammation and symptom remission, to determine the effectiveness of the treatment.

Directions for Use

What is the usual dose of Budesonide?

For adults with mild to moderate ulcerative colitis, the recommended dose is 9 mg taken orally once daily in the morning for up to 8 weeks. For children, the dosage and administration depend on the specific condition being treated and should be determined by a healthcare provider.

How do I take Budesonide?

Budesonide extended-release tablets should be taken orally once daily in the morning, with or without food. The tablets should be swallowed whole and not chewed, crushed, or broken. Patients should avoid grapefruit juice, as it can increase Budesonide levels in the blood.

For how long do I take Budesonide?

Budesonide is typically used for up to 8 weeks for the induction of remission in patients with active, mild to moderate ulcerative colitis. The duration may vary based on the condition being treated and the patient's response to the medication.

How long does it take for Budesonide to start working?

Budesonide may start to show effects within a few days to a week, but it can take up to 8 weeks to achieve full remission in conditions like ulcerative colitis. The exact time frame can vary based on the individual's response to the medication.

How should I store Budesonide?

Budesonide should be stored at room temperature, between 68°F to 77°F (20°C to 25°C). Keep the container tightly closed to protect from light and moisture. Always store medications out of the reach of children.

Warnings and Precautions

Who should avoid taking Budesonide?

Budesonide is contraindicated in patients with hypersensitivity to the drug or its ingredients. Important warnings include the risk of hypercorticism, adrenal suppression, immunosuppression, and increased infection risk. Patients with liver disease should be monitored closely, and the drug should be used cautiously in those with conditions like hypertension, diabetes, and osteoporosis.

Can I take Budesonide with other prescription drugs?

Budesonide interacts with CYP3A4 inhibitors like ketoconazole, which can increase its systemic exposure. Grapefruit juice should be avoided as it can also increase Budesonide levels. Patients should inform their healthcare provider of all medications they are taking to avoid potential interactions.

Can I take Budesonide with vitamins or supplements?

From all available and reliable information, there is no confirmed data on this. Please consult a doctor for personalized advice.

Can Budesonide be taken safely while pregnant?

Budesonide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown potential risks, but there is limited data from human studies. Pregnant women should consult their healthcare provider to weigh the risks and benefits.

Can Budesonide be taken safely while breastfeeding?

Budesonide is present in human milk following maternal inhalation, but the effects on the breastfed infant are not well-studied. Nursing mothers should consider the benefits of breastfeeding along with the mother's need for Budesonide and any potential adverse effects on the infant.

Is Budesonide safe for the elderly?

Budesonide should be used cautiously in elderly patients due to the potential for decreased hepatic, renal, or cardiac function, and the presence of other diseases or drug therapies. It's important for elderly patients to be closely monitored by their healthcare provider while using Budesonide.

Is it safe to exercise while taking Budesonide?

From all available and reliable information, there is no confirmed data on this. Please consult a doctor for personalized advice.

Is it safe to drink alcohol while taking Budesonide?

From all available and reliable information, there is no confirmed data on this. Please consult a doctor for personalized advice.