Entocort

Entocort (budesonide) is a topically acting corticosteroid specifically engineered for the treatment of mild to moderate Crohn’s disease affecting the ileum and/or ascending colon, and for the induction of remission in microscopic colitis. Unlike systemic corticosteroids, its advanced delivery mechanism ensures high topical anti-inflammatory efficacy within the intestinal lumen with a significantly reduced risk of systemic steroid-related side effects. It represents a cornerstone in the gastroenterological management of these conditions, offering a favorable risk-benefit profile for appropriate patient populations.

Features

• Active Pharmaceutical Ingredient: Budesonide
• Formulation: pH-dependent, extended-release capsules or granules for oral administration
• Mechanism of Action: Locally acting glucocorticoid with high affinity for glucocorticoid receptors, exerting potent anti-inflammatory and immunosuppressive effects directly on the intestinal mucosa
• Release Profile: Designed for targeted release in the terminal ileum and colon
• Bioavailability: Approximately 9-21% due to extensive first-pass metabolism in the liver

Benefits

• Achieves rapid and effective induction of clinical remission in active Crohn’s disease of the ileum and/or ascending colon.
• Provides highly targeted anti-inflammatory action directly at the site of bowel inflammation, minimizing systemic exposure.
• Demonstrates a significantly lower incidence of steroid-related adverse effects (e.g., moon face, buffalo hump, hyperglycemia, adrenal suppression) compared to conventional systemic corticosteroids like prednisone.
• Offers a convenient, oral dosing regimen that supports patient adherence to treatment.
• Serves as a first-line pharmacological option for inducing remission in lymphocytic and collagenous colitis (microscopic colitis).

Common use

Entocort is primarily indicated for the treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon. It is also approved for the induction of remission in patients with microscopic colitis (lymphocytic colitis and collagenous colitis). Its use is focused on the induction of clinical remission; the role of budesonide in maintenance therapy is more limited and must be evaluated on a case-by-case basis by a gastroenterologist.

Dosage and direction

For the treatment of active Crohn’s disease, the recommended adult dosage is 9 mg (three 3 mg capsules) taken orally once daily in the morning before breakfast for up to 8 weeks. Following the initial 8-week treatment period, dosing may be tapered to 6 mg once daily for a 2-week weaning period before complete cessation. For maintenance of remission, dosing is not routinely recommended, but if used, should not exceed 6 mg daily. For microscopic colitis, the typical dose is 9 mg once daily for 8 weeks. The capsules must be swallowed whole with a glass of water and must not be chewed or crushed.

Precautions

Patients should be monitored for signs of hypercorticism and adrenal suppression, especially after withdrawal from treatment. Caution is advised in patients with liver impairment, as budesonide is extensively metabolized in the liver; dosage adjustment may be necessary. The drug may mask symptoms of a latent infection; special care is required in patients with tuberculosis, fungal, viral, or parasitic infections. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Patients should inform their surgeon or other physicians of their current or recent corticosteroid treatment. Vaccination with live or live-attenuated vaccines is not recommended.

Contraindications

Entocort is contraindicated in patients with known hypersensitivity to budesonide or any of the excipients in the formulation. Its use is also contraindicated in patients with active, severe infections not controlled by anti-infective agents (e.g., untreated tuberculosis).

Possible side effect

The most common side effects are related to its corticosteroid class and local action, and include headache, nausea, dyspepsia, flatulence, abdominal pain, and fatigue. As with any corticosteroid, more serious potential side effects include adrenal insufficiency (particularly upon withdrawal), symptoms of hypercorticism (e.g., rounding of the face, weight gain), increased intraocular pressure, glaucoma, cataracts, and psychiatric reactions including mood swings, insomnia, and depression. Due to its first-pass metabolism, these systemic effects are less frequent than with conventional steroids.

Drug interaction

The efficacy of Entocort may be reduced by potent CYP3A4 inducers such as rifampicin, rifabutin, phenobarbital, phenytoin, carbamazepine, and St. John’s Wort; concomitant use should be avoided. Conversely, potent inhibitors of the CYP3A4 enzyme system (e.g., ketoconazole, itraconazole, ritonavir, indinavir, clarithromycin) can significantly increase systemic plasma concentrations of budesonide, increasing the risk of systemic steroid side effects and adrenal suppression. Concomitant administration is not recommended. The interaction with oral contraceptives is considered minimal.

Missed dose

If a dose is missed, it should be taken as soon as remembered on the same day. If a patient remembers a missed dose on the day following the missed dose, the missed dose should be skipped. The patient should not take a double dose to make up for the forgotten dose. It is crucial to maintain the prescribed schedule and inform the treating physician of any significant pattern of missed doses.

Overdose

Acute overdose with Entocort is unlikely to produce acute, life-threatening symptoms due to its low systemic bioavailability. Single doses of up to 32 mg have been administered without significant adverse consequences. However, chronic overdosage would be expected to produce symptoms of hypercorticism, such as moon face, central obesity, glucose intolerance, and hypertension. There is no specific antidote. Treatment should be symptomatic and supportive. In the case of recent ingestion, gastric lavage may be considered.

Storage

Store Entocort capsules at room temperature, between 20°C to 25°C (68°F to 77°F), in a dry place. Excursions are permitted between 15°C and 30°C (59°F and 86°F). Keep the medication in its original blister packaging to protect it from moisture and light. Keep all medications out of the reach of children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so.

Disclaimer

This information is for educational and informational purposes only and does not constitute medical advice. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication. Never disregard professional medical advice or delay in seeking it because of something you have read here. The content has been compiled from various sources believed to be accurate and reliable, however, no warranty is made to its accuracy. The manufacturer’s official prescribing information should be consulted for complete details.

Reviews

“After struggling with systemic steroid side effects for years while managing my Crohn’s flares, switching to Entocort was a game-changer. I achieved remission with minimal side effects. The targeted action is precisely what I needed.” – Patient M.C.

“As a gastroenterologist, Entocort is my first-line go-to for appropriate patients with ileal/right-sided Crohn’s and microscopic colitis. It provides excellent efficacy where it’s needed with a safety profile that is far superior to prednisone, greatly improving the treatment experience for my patients.” – Dr. A. Sharma, MD

“The reduction in systemic side effects is notable. While I experienced some minor initial nausea, it subsided, and the relief from my Crohn’s symptoms was rapid and effective without the weight gain and mood swings I had with previous treatments.” – Patient R.L.