AI Summary
Generated by AI for informational purposes only
This tablet works by reducing swelling in the gut. It is used to treat conditions like Crohn's disease and ulcerative colitis. Use during pregnancy should be avoided unless necessary and it should be used with caution while breastfeeding.
Indications
Budesonide tablet is a glucocorticoid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.
Pharmacology
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.
Dosage & Administration
Important: Do not take any medication without a doctor's prescription. Self-medication can be dangerous.
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.
Interaction
Avoid Cytochrome P450 3A4 inhibitors (e.g. ketoconazole, grapefruit juice). It may cause increased systemic corticosteroid effects. Budesonide does not affect the plasma levels of oral contraceptives.
Side Effects
Common side effects are headache, nausea, upper abdominal pain, fatigue, acne, flatulence, joint pain, urinary tract infection, abdominal distension, constipation.
Pregnancy & Lactation
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.
Precautions & Warnings
Since budesonide 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 budesonide. Taper patients slowly from systemic corticosteroids if transferring to budesonide.
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 budesonide.
Overdose Effects
If glucocorticoids are used at excessive doses for prolonged periods, systemic glucocorticoid effects such as hypercorticism and adrenal suppression may occur.
Storage Conditions
Budesonide extended-release tablets should be stored below 30°C. Store in a cool and dry place protected from light and moisture.
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