Entocort (budesonide) is a locally acting corticosteroid designed to treat inflammatory bowel diseases with a targeted mechanism of action. It delivers potent anti-inflammatory effects directly to the intestinal mucosa while minimizing systemic exposure. This results in effective control of symptoms like abdominal pain, diarrhea, and rectal bleeding, with a reduced risk of typical steroid-related side effects. Ideal for managing mild to moderate Crohn’s disease affecting the ileum and/or ascending colon, as well as for maintaining remission in ulcerative colitis, Entocort offers a favorable risk-benefit profile for appropriate patient populations.

Features

• Active ingredient: Budesonide 3 mg
• Formulation: pH-dependent, extended-release capsules
• Mechanism: Topical anti-inflammatory action with high glucocorticoid receptor affinity
• Release: Designed for targeted delivery in the terminal ileum and colon
• Bioavailability: Approximately 9% systemic absorption
• Half-life: 2-3 hours after hepatic first-pass metabolism

Benefits

• Provides targeted anti-inflammatory action directly at the site of intestinal inflammation
• Reduces systemic steroid exposure compared to conventional corticosteroids
• Effectively induces remission in mild to moderate Crohn’s disease affecting the ileum and ascending colon
• Helps maintain clinical remission in ulcerative colitis patients
• Minimizes typical corticosteroid side effects such as moon face, buffalo hump, and glucose intolerance
• Offers convenient once-daily dosing for improved patient compliance

Common use

Entocort is primarily indicated for the treatment of mild to moderate active Crohn’s disease involving the ileum and/or ascending colon. It is also approved for the maintenance of clinical remission in patients with ulcerative colitis for up to 3 months. Gastroenterologists often prescribe Entocort as a first-line therapy for appropriate candidates due to its targeted action and reduced systemic side effect profile compared to traditional corticosteroids like prednisone.

The medication works by binding to glucocorticoid receptors in the intestinal mucosa, inhibiting the production of inflammatory mediators and reducing mucosal inflammation. This localized action makes it particularly effective for managing the symptoms of inflammatory bowel disease while preserving systemic physiological function.

Dosage and direction

For active Crohn’s disease: The recommended adult dosage is 9 mg (three 3 mg capsules) taken once daily in the morning for up to 8 weeks. For maintenance of remission in ulcerative colitis: 6 mg (two 3 mg capsules) taken once daily for up to 3 months.

Capsules should be swallowed whole with water and not chewed or crushed. Administration with food may help improve tolerance. The medication should be taken at the same time each day to maintain consistent drug levels. Dosage adjustments may be necessary for patients with hepatic impairment, as budesonide undergoes extensive first-pass metabolism in the liver.

Treatment duration should not exceed 3 months for ulcerative colitis maintenance therapy. For Crohn’s disease, if symptoms persist after 8 weeks of treatment, alternative therapies should be considered. Tapering is generally not required when discontinuing Entocort due to its low systemic bioavailability.

Precautions

Patients should be monitored for signs of hypercorticism, especially with prolonged use. Caution is advised in patients with diabetes, hypertension, osteoporosis, peptic ulcer disease, or glaucoma. Liver function should be monitored periodically during treatment, as impaired hepatic function can increase systemic exposure to budesonide.

Due to its immunosuppressive effects, patients should be advised to avoid exposure to chickenpox or measles and to seek immediate medical attention if exposed. The medication may mask signs of infection, so patients should report any signs of infection promptly. Special caution is required when transferring patients from systemic corticosteroids to Entocort due to the risk of adrenal insufficiency.

Patients should be advised that the full therapeutic effect may not be apparent for 2-4 weeks. Regular follow-up with a gastroenterologist is essential to monitor treatment response and adjust therapy as needed.

Contraindications

Entocort is contraindicated in patients with known hypersensitivity to budesonide or any components of the formulation. It should not be used in patients with active, untreated infections including fungal, bacterial, viral, or parasitic infections. The medication is contraindicated in patients with severe hepatic impairment (Child-Pugh Class C).

Concomitant administration with strong CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and clarithromycin is contraindicated due to significantly increased systemic exposure to budesonide. The medication is also contraindicated in patients with intestinal obstruction, perforation, or recent intestinal anastomosis.

Possible side effect

Common side effects (occurring in >1% of patients) include headache, nausea, dyspepsia, abdominal pain, flatulence, fatigue, and acne. Respiratory infections such as pharyngitis and sinusitis may occur due to mild immunosuppressive effects.

Less frequent side effects include mood changes, anxiety, insomnia, dizziness, palpitations, increased sweating, muscle cramps, and skin reactions. Although rare, more serious side effects may include adrenal suppression, ocular changes including glaucoma and cataracts, decreased bone mineral density, and hypersensitivity reactions.

Patients should be monitored for signs of Cushing’s syndrome with prolonged use, though this occurs less frequently than with systemic corticosteroids. Most side effects are mild to moderate in severity and often resolve with continued treatment or dose adjustment.

Drug interaction

Entocort interacts significantly with strong CYP3A4 inhibitors including ketoconazole, itraconazole, clarithromycin, ritonavir, and indinavir, which can increase budesonide plasma concentrations by up to 8-fold. Concomitant use should be avoided.

Moderate CYP3A4 inhibitors such as erythromycin, fluconazole, and diltiazem may increase budesonide exposure and require dose adjustment. Inducers of CYP3A4 including rifampicin, carbamazepine, phenytoin, and St. John’s wort may decrease budesonide efficacy.

Concomitant use with other corticosteroids may increase the risk of systemic corticosteroid effects. The medication may decrease the efficacy of vaccines and should not be administered with live vaccines. Antacids and proton pump inhibitors do not significantly affect the absorption of Entocort due to its pH-dependent release mechanism.

Missed dose

If a dose is missed, it should be taken as soon as remembered on the same day. If remembered the next day, the missed dose should be skipped and the regular dosing schedule resumed. Patients should not take a double dose to make up for a missed dose.

Consistent daily administration is important for maintaining therapeutic effects. Patients should be educated about the importance of adherence and provided with strategies such as pill organizers or reminder systems to minimize missed doses. If multiple doses are missed, patients should contact their healthcare provider for guidance.

Overdose

Acute overdose with Entocort is unlikely to cause serious toxicity due to its low systemic bioavailability. Single doses up to 32 mg have been administered without serious adverse effects. However, chronic overdose may lead to systemic corticosteroid effects including hypercorticism and adrenal suppression.

In case of suspected overdose, symptomatic and supportive treatment should be initiated. There is no specific antidote for budesonide overdose. Gastric lavage may be considered if ingestion occurred within a short time frame. Patients should be monitored for signs of adrenal insufficiency if overdose occurs after prolonged use.

Medical attention should be sought immediately for any suspected overdose, particularly in children or patients with pre-existing medical conditions. Healthcare providers should have information available about the timing and amount of ingestion when seeking medical advice.

Storage

Entocort capsules should be stored at room temperature between 15-30°C (59-86°F) in their original container. The medication should be protected from light and moisture and kept in a tightly closed container. Capsules should not be stored in bathroom cabinets or other humid environments.

Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging. Proper disposal of unused medication should follow local regulations, typically through medication take-back programs rather than flushing down toilets or throwing in household trash.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Individual patient needs may vary, and healthcare providers should make treatment decisions based on their clinical judgment and individual patient circumstances. Always consult with a qualified healthcare professional before starting or changing any medication regimen.

The prescribing information provided here is not exhaustive. Please refer to the official prescribing information for complete details. Patients should not discontinue or change their medication without consulting their healthcare provider.

Reviews

Clinical studies demonstrate that Entocort effectively induces remission in approximately 50-60% of patients with mild to moderate Crohn’s disease within 8 weeks of treatment. Patient-reported outcomes show significant improvement in quality of life measures, particularly reduction in abdominal pain and normalization of bowel habits.

Many gastroenterologists report favorable experiences with Entocort, noting its efficacy in maintaining remission in ulcerative colitis patients with reduced steroid-related side effects compared to conventional corticosteroids. Patients often appreciate the once-daily dosing and generally good tolerability profile.

Long-term follow-up studies indicate that Entocort maintains its safety profile with extended use, though monitoring for adrenal function and bone density is recommended with prolonged therapy. The targeted delivery system continues to receive praise for its innovative approach to managing inflammatory bowel disease while minimizing systemic exposure.