Budesonide Sustained-Release Capsules (Entocort) is an oral corticosteroid specifically designed to release the drug in the ileum and/or ascending colon. It is primarily indicated for the treatment of mild to moderately active Crohn's disease and for maintaining clinical remission in adults.

Dosage and Administration of Budesonide Sustained-Release Capsules (Entocort)

Administration Method

Dosing Frequency and Time: Once daily, to be taken in the morning.

Mode of Administration: Swallow the capsule whole. Do not chew or crush it.

Special Administration Instructions: For patients unable to swallow the capsule whole, the capsule may be opened, and the contents (microspheres) mixed with one tablespoon of applesauce and taken immediately. The entire mixture must be consumed within 30 minutes, followed by an immediate drink of approximately 240 mL of cool water to aid swallowing. Do not chew or crush the microspheres.

Dietary Precautions: Grapefruit juice should be avoided throughout the course of treatment, as it can significantly increase the plasma concentration of the drug.

Treatment of Mild to Moderately Active Crohn's Disease

Adults: The recommended dose is 9 mg once daily for a maximum treatment duration of 8 weeks. For recurrent active episodes of the disease, 8-week treatment courses may be repeated.

Pediatric Patients Aged 8–17 Years and Over 25 kg: The recommended dose is 9 mg once daily for a maximum of 8 weeks, followed by a maintenance dose of 6 mg once daily for 2 weeks.

Dosage Adjustment of Budesonide Sustained-Release Capsules (Entocort)

Dosage Adjustment in Patients with Hepatic Impairment

Adult Patients with Moderate Hepatic Impairment (Child-Pugh Class B): A dose reduction to 3 mg once daily should be considered.

Patients with Severe Hepatic Impairment (Child-Pugh Class C): Use of this product is contraindicated.

Patients with Mild Hepatic Impairment (Child-Pugh Class A): No dosage adjustment is required.

Use of Budesonide Sustained-Release Capsules (Entocort) in Special Populations

Pregnancy

Based on animal data, budesonide may cause fetal harm.

Pregnant women should be informed of the potential risks and advised to notify their physician if pregnancy is known or suspected.

Patients at Risk of Specific Infections

Tuberculosis: Reactivation of latent tuberculosis may occur in affected patients. Close monitoring is required during treatment, and chemoprophylaxis should be considered.

Varicella and Measles: Exposure to these viruses in non-immune or non- vaccinated patients may lead to severe, even fatal, infections; such exposure should be avoided. Immediate medical attention is needed if exposure occurs.

Hepatitis B Virus Carriers: Immunosuppressive therapy may result in reactivation of hepatitis B virus. Screening for hepatitis B should be performed before initiating long-term treatment.

Other Infections: This product should not be used in patients with systemic fungal infections, strongyloidiasis, cerebral malaria, or active ocular herpes simplex.

Patients with Concomitant Diseases

Corticosteroid use may adversely affect patients with hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, as well as those with a family history of these conditions.

Close monitoring of the progression of these conditions is necessary during treatment.