Entocort (budesonide) is a modern glucocorticosteroid engineered for the topical treatment of mild to moderate active Crohn’s disease affecting the ileum and/or ascending colon. Its unique formulation utilizes a multi-matrix (MMX) release system and pH-dependent coating to ensure the active ingredient, budesonide, is delivered precisely to the site of intestinal inflammation. This localized action provides potent anti-inflammatory effects directly where they are needed most, while its high first-pass metabolism in the liver significantly minimizes systemic exposure and the classic steroid-related side effects. It represents a cornerstone in the therapeutic strategy for inducing remission, offering a favorable efficacy-to-safety profile for appropriate patients.

Features

• Active Ingredient: Budesonide (3 mg per capsule)
• Pharmacologic Class: Locally-acting glucocorticosteroid
• Delivery System: pH-dependent, extended-release capsules
• Mechanism: Potent local anti-inflammatory and immunosuppressive effects
• Administration: Oral capsule, taken whole; not to be chewed or crushed

Benefits

• Achieves high local concentrations of corticosteroid directly at the site of intestinal inflammation for effective symptom control.
• Significantly reduces the risk of systemic steroid side effects, such as moon face, buffalo hump, and hyperglycemia, due to its high first-pass liver metabolism.
• Provides a clinically meaningful induction of clinical remission in patients with active mild to moderate Crohn’s disease.
• Offers a convenient, once-daily oral dosing regimen, improving patient adherence compared to traditional corticosteroids.
• Serves as a key therapeutic option for patients who may be intolerant or have contraindications to amino salicylates or for whom aminosalicylates have been ineffective.

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 used to induce clinical remission, which is characterized by a reduction in symptoms such as abdominal pain, diarrhea, and rectal bleeding, and by endoscopic improvement of mucosal inflammation. Its use is generally limited to a course of therapy for induction (typically 8 weeks), and it is not intended for long-term maintenance of remission.

Dosage and direction

The recommended adult dosage for the induction of remission in active Crohn’s disease is 9 mg (three 3 mg capsules) taken once daily in the morning before breakfast. The capsules must be swallowed whole with a glass of water; they should not be chewed or crushed. Treatment should not be continued beyond 8 weeks for a single episode. If symptom control is not achieved within this period, alternative therapeutic strategies should be considered. Dosage tapering is not typically required due to the drug’s low systemic bioavailability, but a clinician may recommend it based on individual patient response and treatment duration.

Precautions

Patients should be monitored for signs of hypercorticism (Cushing’s syndrome) and adrenal suppression, especially if transferred from a systemically active corticosteroid, as the switch may unmask pre-existing adrenal insufficiency. Caution is advised in patients with liver impairment, as budesonide exposure may be increased. Entocort should be used with caution in patients with osteoporosis, hypertension, diabetes mellitus, peptic ulcer disease, glaucoma, or cataracts. As with all corticosteroids, patients may experience an impaired ability to fight infections. Live vaccines should not be given to patients on immunosuppressive doses of corticosteroids.

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 the treatment of patients with severe liver impairment (Child-Pugh Class C), as significantly increased systemic exposure is expected.

Possible side effect

While designed for local action, systemic side effects can still occur. The most common side effects (>1/10) include headache. Common side effects (≥1/100 to <1/10) include nausea, dyspepsia, abdominal pain, flatulence, acne, eczema, muscle cramps, arthralgia, dizziness, fatigue, anxiety, and sleep disturbance. Uncommon side effects (≥1/1,000 to <1/100) include fluid retention, peripheral edema, mood swings, depression, palpitations, increased appetite, bruising, skin thinning, and signs of hypercorticism. As with any drug, serious allergic reactions are possible but rare.

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 CYP3A4 inhibitors like ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and clarithromycin can significantly increase plasma concentrations of budesonide, increasing the risk of systemic side effects. Concomitant administration should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid effects.

Missed dose

If a dose is missed, it should be taken as soon as remembered on the same day. If it is not remembered until the next day, the patient should skip the missed dose and take the next dose at the regular time. Do not take a double dose to make up for the missed one.

Overdose

Acute overdose with Entocort is unlikely to produce acute, life-threatening symptoms due to its limited systemic bioavailability. Single doses of up to 32 mg have been administered without significant adverse events. However, repeated overdose could lead to systemic glucocorticosteroid effects such as hypercorticism and adrenal suppression. There is no specific antidote. Treatment should be symptomatic and supportive. If discovered early, gastric lavage or administration of activated charcoal may be considered.

Storage

Store Entocort capsules at room temperature (15°C to 30°C or 59°F to 86°F). Keep the bottle tightly closed in the original packaging to protect from moisture. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging.

Disclaimer

This information is for educational purposes only and 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 before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here.

Reviews

• “As a gastroenterologist, Entocort has become a first-line tool in my arsenal for appropriate Crohn’s patients. Its targeted action allows me to achieve remission with far fewer concerns about the long-term metabolic consequences of traditional steroids. Patient acceptance and adherence are notably higher.” – Dr. A. Sharma, MD, Gastroenterologist
• “After struggling with systemic prednisone side effects for years, switching to a course of Entocort was transformative. I achieved remission with minimal side effects—no more intense mood swings or significant weight gain. It gave me my quality of life back during a flare.” – Patient M., 34
• “The clinical trial data robustly supports the use of budesonide for inducing remission in ileocecal Crohn’s. Its superior safety profile over conventional steroids makes it an evidence-based choice, though clinicians must remain vigilant for the possibility of adrenal axis suppression with longer use.” – Clinical Pharmacologist Review
• “While effective for induction, it’s crucial to have a long-term management plan in place, as budesonide is not effective for maintenance. It serves its purpose excellently as a bridge to more sustainable therapies like immunomodulators or biologics.” – IBD Specialist Nurse