Budesonide Sustained-Release Capsules (Entocort) is an oral corticosteroid medication specifically designed to provide targeted treatment for inflammatory bowel disease (IBD) affecting specific regions. With budesonide as its active ingredient, the medication achieves effective release at specific sites in the intestinal tract through a unique sustained-release technology.

Indications for Budesonide Sustained-Release Capsules (Entocort)

Adult Treatment Scope

Treatment of active Crohn's disease: Indicated for mild to moderate active Crohn's disease in patients aged 8 years and older, where the lesions involve the ileum and/or ascending colon.

The recommended dosage is 9 mg per day, taken once in the morning, with a maximum treatment course of 8 weeks. For recurrent active lesions, an 8-week treatment course may be repeated.

Maintenance treatment for clinical remission: Used for maintaining clinical remission of mild to moderate Crohn's disease in adults, with a maximum treatment duration of 3 months.

The recommended dosage is 6 mg per day. After 3 months, a gradual dose reduction to complete discontinuation is advised.

Pediatric Use

Indicated for pediatric patients aged 8-17 years with a body weight exceeding 25 kg.

Limited to the treatment of active Crohn's disease; not indicated for maintenance treatment during the remission phase.

Specifications and Properties of Budesonide Sustained-Release Capsules (Entocort)

Formulation Composition

Active ingredient: Each capsule contains 3 mg of budesonide.

Capsule characteristics: Hard gelatin sustained-release capsules, composed of an opaque light gray body and an opaque pink cap, marked with "ENTOCORT EC 3mg".

Physical properties: White to off-white odorless powder, almost insoluble in water, and freely soluble in chloroform.

Excipients: Including ethyl cellulose, tributyl acetylcitrate, methacrylic acid copolymer Type C, etc.

Standard Administration Method

Standard administration: Take once daily in the morning, swallow the capsule whole; do not chew or crush.

Alternative method (for patients unable to swallow the capsule whole):

Place one tablespoon of applesauce into a clean container.

Open the capsule.

Pour all the granules into the applesauce.

Mix thoroughly and consume within 30 minutes.

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

Storage Conditions for Budesonide Sustained-Release Capsules (Entocort)

Environmental Control

Temperature range: Store at 25°C (77°F); brief deviations to 15-30°C (59-86°F) are permitted.

Container management: Keep the container tightly closed.

Safety warning: Store out of the reach of children.

Drug Interactions

CYP3A4 inhibitors: Avoid concurrent use with potent CYP3A4 inhibitors such as ketoconazole.

Grapefruit juice: Avoid drinking grapefruit juice during treatment, as it may increase the systemic exposure of budesonide.