Entocort: Targeted Relief for Moderate Crohn's Disease
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| Product dosage: 200mcg | |||
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Synonyms | |||
Entocort (budesonide) is a locally acting glucocorticoid designed specifically for the treatment of mild to moderate Crohn’s disease involving the ileum and/or ascending colon. Unlike systemic corticosteroids, it offers targeted anti-inflammatory action directly at the site of intestinal inflammation, aiming to induce and maintain clinical remission. Its unique formulation utilizes a pH-dependent release mechanism, ensuring the active ingredient is delivered precisely where it is needed most, thereby maximizing efficacy while striving to minimize systemic exposure and the associated side effects common with traditional steroid therapies.
Features
- Active Ingredient: Budesonide (3 mg per capsule)
- Mechanism: Locally acting glucocorticoid with high topical anti-inflammatory activity
- Formulation: pH-modified release capsules designed for targeted ileo-colonic delivery
- Release System: Eudragit L100-55 coating dissolves at pH >5.5, ensuring release primarily in the terminal ileum and ascending colon
- Bioavailability: Approximately 9% systemic absorption due to extensive first-pass metabolism in the liver
- Half-life: Plasma elimination half-life is approximately 2-4 hours post-administration
Benefits
- Provides potent, localized anti-inflammatory action directly at the site of intestinal lesions in Crohn’s disease.
- Designed to minimize systemic steroid exposure, thereby reducing the risk of classic corticosteroid side effects like moon face, buffalo hump, and adrenal suppression.
- Effectively induces remission in patients with active, mild to moderate Crohn’s disease affecting the ileum and/or ascending colon.
- Offers a favorable safety profile compared to systemically absorbed corticosteroids like prednisone.
- The targeted release system helps maximize drug concentration at the intended site of action while limiting unwanted effects elsewhere.
- Can contribute to improved quality of life by reducing symptoms such as abdominal pain and diarrhea.
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 used to induce clinical remission in adult patients. It may also be used off-label in certain cases of microscopic colitis (lymphocytic or collagenous colitis) after specialist evaluation, though this is not an FDA-approved indication. Its use is generally reserved for cases where aminosalicylates have been insufficient and where the risks of systemic corticosteroids are deemed undesirable.
Dosage and direction
The recommended adult dosage for active Crohn’s disease is 9 mg once daily in the morning, taken before a meal, for up to 8 weeks. For recurring episodes of active disease, a repeat 8-week course may be considered. Capsules should be swallowed whole with water and must not be chewed or crushed, as this would disrupt the pH-dependent release mechanism. Dosage tapering is not typically required when discontinuing treatment after a standard course, due to the low systemic bioavailability. Treatment duration beyond 8 weeks for active disease or for maintenance of remission is not generally recommended and should be guided by a gastroenterologist based on individual patient response and risk assessment.
Precautions
Patients should be monitored for signs of hypercorticism (Cushing’s syndrome), especially with prolonged use, despite the low systemic exposure. Caution is advised in patients with liver impairment, as budesonide is metabolized extensively in the liver; reduced elimination may lead to increased systemic effects. Use with care in patients with osteoporosis, diabetes mellitus, hypertension, peptic ulcer disease, or glaucoma. Due to its immunosuppressive effects, patients may have an increased susceptibility to infections; special caution is warranted in those with latent tuberculosis, fungal or viral infections (e.g., herpes simplex). Avoid live vaccines during treatment. Adrenal function may be suppressed; consider testing in patients presenting with symptoms of adrenal insufficiency, especially under stress (e.g., surgery, trauma, severe illness). Long-term use is associated with an increased risk of cataracts and glaucoma; regular ophthalmological examinations are recommended.
Contraindications
Entocort is contraindicated in patients with known hypersensitivity to budesonide or any of the excipients in the formulation. It should not be used in patients with severe hepatic impairment (Child-Pugh Class C), as significantly reduced metabolism can lead to pronounced systemic corticosteroid effects. Its use is contraindicated in systemic fungal infections and untreated active bacterial or viral infections unless the potential benefit outweighs the risk and appropriate anti-infective therapy is instituted. Concomitant administration with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) is contraindicated due to the potential for significantly increased systemic budesonide exposure and toxicity.
Possible side effect
The most common side effects are headache, nausea, dyspepsia, abdominal pain, flatulence, and fatigue. Although designed for local action, corticosteroid-related side effects can still occur due to some systemic absorption. These may include symptoms of hypercorticism such as moon face, buffalo hump, acne, ecchymosis, and hirsutism with longer use. Psychiatric disturbances such as mood swings, insomnia, depression, or euphoria are possible. Other potential effects include increased blood pressure, glucose intolerance, fluid retention, and weight gain. Less commonly, skin reactions like rash or urticaria may occur. As with any corticosteroid, long-term use carries a risk of adrenal suppression, osteoporosis, and increased intraocular pressure.
Drug interaction
Concomitant use with strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, clarithromycin) is contraindicated, as they can markedly increase budesonide plasma levels and the risk of systemic side effects. Inducers of CYP3A4 (e.g., rifampicin, carbamazepine, phenobarbital, phenytoin, St. John’s Wort) may decrease budesonide plasma concentrations, potentially reducing its efficacy. Caution is advised when co-administering with other corticosteroids, as additive systemic effects may occur. Budesonide may decrease the efficacy of drugs metabolized by CYP3A4 due to potential enzyme induction with chronic use. Its effects may be potentiated in patients taking estrogens or other drugs that inhibit CYP3A4 moderately.
Missed dose
If a dose is missed, it should be taken as soon as remembered on the same day. However, if it is nearly time for the next scheduled dose, the missed dose should be skipped. Patients should not take a double dose to make up for a missed one. Maintaining a consistent daily schedule is recommended to ensure optimal therapeutic effect.
Overdose
Acute overdose with Entocort is unlikely to produce serious acute toxicity due to its low systemic bioavailability, but repeated excessive dosing could lead to systemic corticosteroid effects such as hypercorticism and adrenal suppression. There is no specific antidote for budesonide overdose. Treatment should be supportive and symptomatic. In cases of significant recent ingestion, gastric lavage or administration of activated charcoal may be considered if presented early. Monitoring for signs of corticosteroid excess and adrenal insufficiency is recommended. Hemodialysis is not expected to be effective due to high protein binding and extensive metabolism.
Storage
Store at room temperature between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). Keep the bottle tightly closed to protect from moisture. Do not store in the bathroom or other damp places. Keep out of reach of children and pets. Do not use beyond 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. The content has been compiled from various medical resources but may not encompass all possible uses, directions, precautions, or interactions. The manufacturer’s official prescribing information should be consulted for complete details.
Reviews
“As a gastroenterologist with over 20 years of experience, Entocort has become a valuable tool in my arsenal for managing ileal and right-sided colonic Crohn’s disease. Its targeted action allows me to induce remission with significantly fewer systemic steroid side effects compared to prednisone. I find it particularly useful for patients who are steroid-responsive but intolerant of the adverse effects. The once-daily dosing also aids in patient compliance.” – Dr. A. Reynolds, MD, Gastroenterologist
“After struggling with frequent flares of Crohn’s affecting my terminal ileum, my doctor switched me to Entocort. The difference was noticeable within a couple of weeks—my abdominal pain and diarrhea reduced significantly. Most importantly, I didn’t experience the weight gain, mood swings, or moon face I had with prednisone in the past. It has given me a much better quality of life during active phases.” – Patient M, 34
“From a clinical pharmacology perspective, the design of Entocort is impressive. The pH-dependent release mechanism is a clever way to maximize local efficacy while leveraging first-pass metabolism to limit systemic exposure. It represents a significant advancement in topical steroid therapy for IBD, though it is important to remember that some systemic absorption still occurs and monitoring is prudent, especially with longer or repeated courses.” – Clinical Pharmacologist, Academic Medical Center