1. Introduction
Budesonide, marketed under brand names such as Entocort, Uceris, and Ortikos, is a corticosteroid used for the treatment of inflammatory bowel diseases (IBD) such as Crohn’s disease and ulcerative colitis. Its formulations are designed for localised action in the gastrointestinal tract, minimising systemic side effects.
2. Indications
- Approved Indications:
- Induction of remission in mild-to-moderate Crohn’s disease affecting the ileum and/or ascending colon.
- Maintenance of remission in Crohn’s disease (capsules).
- Treatment of mild-to-moderate ulcerative colitis.
- Treatment of microscopic colitis (lymphocytic or collagenous colitis).
- Off-Label Uses:
- Eosinophilic gastroenteritis.
3. Dosage
- Crohn’s Disease (Induction of Remission):
- Adults: 9 mg orally once daily in the morning for up to 8 weeks.
- Crohn’s Disease (Maintenance of Remission):
- Adults: 6 mg orally once daily for up to 3 months, then taper as directed.
- Ulcerative Colitis (Induction of Remission):
- Adults: 9 mg orally once daily in the morning for up to 8 weeks.
- Microscopic Colitis:
- Adults: 9 mg orally once daily for 6–8 weeks, then taper.
4. Administration
- Swallow tablets or capsules whole; do not crush, chew, or break them.
- Granules should be mixed with a small amount of soft food (e.g., applesauce) and consumed immediately without chewing.
- Take in the morning before or with food.
5. Forms Available
- Capsules: 3 mg, 6 mg, 9 mg (controlled-release).
- Tablets: 9 mg (extended-release).
- Granules: 2 mg per sachet.
6. Side Effects
6.1. Common Side Effects
- Headache.
- Nausea.
- Abdominal pain.
- Fatigue.
6.2. Less Common Side Effects
- Flatulence.
- Acne.
- Muscle cramps.
6.3. Rare but Serious Side Effects
- Adrenal suppression.
- Hyperglycaemia.
- Osteoporosis.
7. Warnings
- Not for use in acute, severe exacerbations of IBD requiring systemic therapy.
- Use caution in patients with active infections, as corticosteroids suppress immune function.
8. Precautions
- Use the lowest effective dose to minimise systemic corticosteroid effects.
- Avoid abrupt discontinuation; taper doses gradually when discontinuing.
- Monitor for signs of adrenal insufficiency, especially in prolonged use.
9. Interactions
- Drug-Drug Interactions:
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole) can increase systemic exposure to budesonide.
- Immunosuppressants (e.g., cyclosporine) may enhance the risk of infections.
- Drug-Food Interactions:
- Avoid grapefruit juice, as it can increase budesonide bioavailability.
10. Monitoring Parameters
- Symptom improvement within 2–4 weeks of initiation.
- Adrenal function in long-term use or after discontinuation.
- Bone density for patients on prolonged therapy.
11. Use in Children
- Approved for paediatric use in Crohn’s disease for children aged 8 years and older and weighing ≥25 kg.
- Dose: 9 mg daily for up to 8 weeks, taper as needed.
12. Use in Pregnancy
- Category C: Limited data in pregnancy.
- Use only if the benefits outweigh potential risks to the foetus.
- Maternal IBD control is crucial for a healthy pregnancy outcome.
13. Use in Elderly
- No specific dosage adjustments required, but monitor for systemic corticosteroid side effects such as osteoporosis and adrenal suppression.
14. Use in Kidney Disease
- No specific dosage adjustments required due to minimal systemic absorption.
15. Use in Liver Disease
- Use with caution in severe hepatic impairment as systemic corticosteroid exposure may increase.
16. Patient Counselling Points
- Take budesonide in the morning as directed.
- Do not chew or crush capsules, tablets, or granules.
- Avoid grapefruit juice during treatment.
- Inform patients about potential side effects such as headache or nausea and the importance of reporting signs of adrenal insufficiency (e.g., fatigue, dizziness).
- Emphasise adherence to prescribed doses and the importance of not stopping therapy abruptly.
17. Table of Brand Names, Manufacturers, and Prices
| Brand Name | Manufacturer | Price (USD) |
|---|---|---|
| Entocort EC | AstraZeneca | $200–250 (90 capsules, 3 mg) |
| Uceris | Bausch Health | $300–350 (30 tablets, 9 mg) |
| Ortikos | Ferring Pharmaceuticals | $400–450 (30 capsules, 9 mg) |
| Generic Options | Various | $50–100 (90 capsules, 3 mg) |
18. FAQs (15 Questions)
- What is budesonide used for?
Budesonide is used to treat inflammatory bowel diseases like Crohn’s disease, ulcerative colitis, and microscopic colitis. - How does budesonide work?
It reduces inflammation in the gastrointestinal tract by suppressing the immune response. - How long does budesonide take to work?
Improvement is usually seen within 2–4 weeks of starting treatment. - Can budesonide be used in children?
Yes, it is approved for children aged 8 years and older for Crohn’s disease. - Is budesonide safe during pregnancy?
It can be used if necessary, with benefits outweighing potential risks. - How should I take budesonide capsules or tablets?
Swallow them whole, preferably in the morning, and avoid crushing or chewing. - Can I drink grapefruit juice while taking budesonide?
No, grapefruit juice can increase the drug’s absorption and potential side effects. - What are the common side effects of budesonide?
Headache, nausea, and abdominal pain. - Can budesonide cause weight gain?
Systemic side effects like weight gain are less likely due to its localised action, but they may occur with prolonged use. - Does budesonide interact with other medications?
Yes, CYP3A4 inhibitors like ketoconazole may increase its systemic effects. - Can I stop budesonide suddenly?
No, it should be tapered gradually to avoid adrenal insufficiency. - How long can I take budesonide?
Typically, it is used for up to 8 weeks for induction of remission, but longer use should be guided by a healthcare provider. - Does budesonide treat all types of Crohn’s disease?
It is effective for mild-to-moderate disease involving the ileum and/or ascending colon. - How should budesonide be stored?
Store at room temperature, away from moisture and heat. - What should I do if I miss a dose?
Take the missed dose as soon as you remember, unless it’s close to the next dose. Do not double the dose.