Budesonide Sustained-Release Capsules (Entocort) contain budesonide as the active ingredient and are a type of synthetic corticosteroid medication. This drug is mainly used to treat mild to moderate active Crohn's disease involving the ileum and/or ascending colon, and to maintain clinical remission of mild to moderate Crohn's disease in adults.

How to Use Budesonide Sustained-Release Capsules (Entocort)

Standard Dosing Regimen

Budesonide Sustained-Release Capsules should be taken once daily in the morning. The capsules must be swallowed whole; do not chew or crush them.

Special Administration Method

Place one tablespoon of applesauce into a clean container.

Open the capsule.

Carefully pour all the granular contents onto the applesauce.

Mix the granules with the applesauce.

Consume the entire mixture within 30 minutes after mixing.

Immediately drink 8 ounces of cold water to ensure complete swallowing of the granules.

Do not store the applesauce and granule mixture for future use.

Dietary Precautions

Grapefruit juice should be avoided throughout the treatment period with Budesonide Sustained-Release Capsules.

Dosage Adjustment of Budesonide Sustained-Release Capsules (Entocort)

Treatment of Active Crohn's Disease in Adults

The recommended dosage is 9 mg, taken orally once daily, for a maximum of 8 weeks.

For recurrent active disease, an 8-week treatment course may be repeated.

Treatment in Pediatric Patients

Pediatric patients aged 8 to 17 years with a body weight greater than 25 kg: 9 mg taken orally once daily for a maximum of 8 weeks, followed by 6 mg taken orally once daily in the morning for 2 weeks.

Maintenance Treatment Regimen

For adult patients whose symptoms are controlled after 8 weeks of treatment for active disease, the recommended dosage of Budesonide Sustained-Release Capsules is 6 mg taken orally once daily to maintain clinical remission for a maximum of 3 months.

If symptom control is still maintained at 3 months, a gradual dose reduction to complete discontinuation is recommended.

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

Patients with Hepatic Impairment

For adult patients with moderate hepatic impairment (Child-Pugh Class B), consideration should be given to reducing the dosage to 3 mg once daily.

Use in patients with severe hepatic impairment (Child-Pugh Class C) should be avoided.

Pediatric Patients

The efficacy of this medication has been established in pediatric patients aged 8 to 17 years.

The average systemic exposure and cortisol suppression in pediatric Crohn's disease patients are 17% higher than those in adult patients.

Geriatric Patients

Clinical studies did not include a sufficient number of patients aged 65 years and older to determine whether they respond differently from younger patients.

Dosage selection for geriatric patients should be cautious, usually starting from the lower end of the dosage range.

Pregnant Women

Based on animal data, Budesonide Sustained-Release Capsules may cause harm to the fetus.

Pregnant women are advised to inform their healthcare providers of any known or suspected pregnancy.