Budesonide Sustained-Release Capsules (Entocort) is an oral corticosteroid medication, primarily indicated for the treatment of mild to moderately active Crohn's disease (involving the ileum and/or ascending colon) and for maintaining clinical remission in adult patients. To ensure the efficacy of the medication, patients must strictly follow the doctor’s instructions during the course of treatment and pay close attention to relevant monitoring matters.

What are the Precautions for Taking Budesonide Sustained-Release Capsules (Entocort)?

Absolute Contraindications

Contraindicated in patients with hypersensitivity to budesonide or any component of this product.

Conditions Requiring Caution or Avoidance of Use

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

Contraindicated in patients with active ocular herpes simplex, cerebral malaria, or known or suspected strongyloidiasis (nematode infection).

Caution and thorough assessment are required for patients with systemic fungal infections or latent amebiasis.

Pregnant and lactating women should use this medication under the guidance of a physician after weighing the potential benefits against risks.

Dosage Adjustments for Special Populations

Patients with Hepatic Impairment: For adult patients with moderate hepatic impairment (Child-Pugh Class B), the dose is recommended to be reduced to 3 mg once daily. Generally, no dosage adjustment is needed for patients with mild hepatic impairment.

Pediatric Patients: Suitable for children aged 8 years and older with a body weight over 25 kg for the treatment of active Crohn's disease, but the efficacy and safety of maintenance therapy have not been established.

Elderly Patients: Medication should be administered with caution, usually starting from the lower limit of the dosage range.

Diet and Drug Interactions

Grapefruit juice should be avoided during treatment, as it can inhibit the CYP3A4 enzyme and significantly increase the plasma concentration of budesonide.

Avoid concomitant use with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, certain antiviral drugs) to prevent an increased risk of adverse reactions.

Medication Monitoring for Budesonide Sustained-Release Capsules (Entocort)

Cushing’s Syndrome and Adrenal Axis Suppression

Signs of Cushing’s syndrome: Acne, easy bruising, hirsutism, moon face, buffalo hump, skin striae, etc.

Manifestations of adrenal insufficiency: Fatigue, weakness, hypotension, nausea, vomiting, etc., especially during long-term medication use or stressful conditions.

Monitoring of Infection Risk

During treatment, closely monitor for the occurrence of new infections or exacerbation of existing infections, with particular attention to tuberculosis, varicella, measles, and hepatitis B virus reactivation.

If a patient is exposed to varicella or measles, prompt medical attention should be sought to assess the need for prophylactic treatment.

Before initiating long-term treatment, screening for hepatitis B, tuberculosis, and latent parasitic infections is recommended.

Other Hormone-Related Effects Monitoring

Monitor changes in blood pressure, blood glucose, and bone mineral density, especially in patients with pre-existing conditions such as hypertension, diabetes mellitus, and osteoporosis.

Be alert to the development of ocular symptoms such as glaucoma and cataracts, particularly in patients on long-term therapy.