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 BRAND NAMES
 MECHANISM OF ACTION
The anti-inflammatory effects of budesonide, such as inhibition of the release of inflammatory mediators and suppression of the cellular immunological response, is the main mechanism of action. The intrinsic potency of budesonide, measured by its affinity to the glucocorticoid receptor, is about 15 times higher than the potency of prednisolone.
- Crohn’s disease:
- Treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon.
- Maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months.
- Ulcerative colitis:
- Extended release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.
- Mild to moderate active Crohn’s disease: 9 mg once daily in the morning for up to 8 weeks. Repeated 8 week courses of Budesonide (Oral) can be given for recurring episodes of active disease.
- Maintenance of clinical remission of mild to moderate Crohn’s disease: 6 mg once daily for up to 3 months. Continued treatment with Budesonide (Oral) 6 mg for more than 3 months has not been shown to provide substantial clinical benefit.
- The recommended dosage for the induction of remission in adult patients with active, mild to moderate ulcerative colitis is one 9 mg extended release tablet to be taken once daily in the morning with or without food for up to 8 weeks.
 DOSAGE FORMS AND STRENGTHS
- Capsules: 3 mg
- Extended release tablets: 9 mg
- hypersensitivity to budesonide or any of the ingredients
- hepatic cirrhosis
 WARNINGS AND PRECAUTIONS
- Hypercorticism and adrenal suppression: Since Budesonide (Oral) is a glucocorticosteroid, general warnings concerning glucocorticoids should be followed.
- Transferring patients from systemic glucocorticosteroid therapy: Care is needed in patients who are transferred from glucocorticosteroid treatment with high systemic effects to corticosteroids with lower systemic availability, such as Budesonide (Oral).
- Immunosuppression: Potential worsening of infections (e.g., existing tuberculosis, fungal, bacterial, viral, or parasitic infection). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
- CYP3A4 inhibitors: The main route of metabolism of budesonide, is via CYP3A4. Inhibitors of CYP3A4 (e.g. ketoconazole, itraconazole, clarithromycin, erythromycin etc.) may increase plasma concentration of orally administered budesonide.
 PREGNANCY AND LACTATION
- Pregnancy Category C (US). Budesonide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- Nursing Mothers: a decision should be made whether to discontinue nursing or to discontinue Budesonide (Oral), taking into account the clinical importance of Budesonide (Oral) to the mother.
 SIDE EFFECTS
Most common adverse reactions (≥ 5%) are headache, respiratory infection, nausea, back pain, dyspepsia, dizziness, abdominal pain, flatulence, vomiting, fatigue, pain.