Budesonide tablet is a glucocorticoid used for inducing remission in patients with active, mild to moderate ulcerative colitis.

Budesonide is a synthetic corticosteroid with strong glucocorticoid activity and minimal mineralocorticoid effects. It has a significantly higher affinity for glucocorticoid receptors compared to cortisol and prednisolone. Budesonide is effective in treating inflammatory bowel diseases by reducing inflammation in the colon and promoting healing of the intestinal lining.

Adult: One 9 mg Budesonide extend release tablet should be taken once daily in the morning with or without food for up to 8 weeks or as prescribed by the doctor.

Use in children: Safety and effectiveness of budesonide in pediatric patients have not been established.

Use in Hepatic Impaired patients: Monitor patients for signs and/or symptoms of hypercorticism.

Concomitant use of strong CYP3A4 inhibitors (such as ketoconazole or grapefruit juice) should be avoided, as they may increase systemic corticosteroid exposure. Budesonide does not significantly affect the plasma concentrations of oral contraceptives.

Common adverse effects include headache, nausea, upper abdominal pain, fatigue, acne, flatulence, joint pain, urinary tract infection, abdominal bloating, and constipation.

Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Budesonide should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus. Budesonide is excreted into breast milk. A decision should be made whether to discontinue breastfeeding or discontinue the drug, considering the importance of the therapy to the mother.

• As budesonide is a glucocorticoid, general precautions associated with this class should be followed.
• There is a risk of adrenal insufficiency when switching from systemic corticosteroids to budesonide; therefore, tapering should be gradual.
• Infections (such as chickenpox, measles, tuberculosis, fungal, bacterial, viral, or parasitic infections) may worsen; use cautiously in such patients.
• Impaired liver function may reduce clearance and increase systemic exposure to budesonide.

Prolonged use of excessive doses of glucocorticoids may lead to systemic effects such as hypercorticism and adrenal suppression.

Ulcerative Colitis

Store extended-release budesonide tablets below 30°C in a cool, dry place, protected from light and moisture.