Budicort ER Tablet (Extended Release)

Budicort ER tablet is a glucocorticoid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.

Budesonide is a synthetic corticosteroid having potent glucocorticoid activity and weak mineralocorticoid activity. It has approximately 200-fold higher affinity for the glucocorticoid receptor than cortisol and 15-fold than prednisolone. Budesonide is effective against inflammatory bowel diseases. It reduces inflammation of colon and also helps heal the lining of the colon.

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.

Avoid Cytochrome P450 3A4 inhibitors (e.g. ketoconazole, grapefruit juice). It may cause increased systemic corticosteroid effects. Budicort ER does not affect the plasma levels of oral contraceptives.

Common side effects are headache, nausea, upper abdominal pain, fatigue, acne, flatulence, joint pain, urinary tract infection, abdominal distension, constipation.

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Budesonide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Budesonide is secreted in human milk. So, a decision should be made whether to discontinue nursing or budesonide taking into account the clinical importance of the drug to the mother.

• Since Budicort ER is a glucocorticoid, general warnings concerning glucocorticoids should be followed.
• Risk of impaired adrenal function when transferring from glucocorticoid treatment with higher systemic effects to glucocorticoid treatment with lower systemic effects, such as Budicort ER. Taper patients slowly from systemic corticosteroids if transferring to Budicort ER.
• Potential worsening of infections (e.g., chickenpox, measles, existing tuberculosis, fungal, bacterial, viral, or parasitic infection). Use with caution in patients with these infections.
• Reduced liver function affects the elimination of glucocorticoid, and increases systemic availability of oral Budicort ER.

If glucocorticoids are used at excessive doses for prolonged periods, systemic glucocorticoid effects such as hypercorticism and adrenal suppression may occur.

Ulcerative Colitis

Budicort ER extended-release tablets should be stored below 30°C. Store in a cool and dry place protected from light and moisture.