Entocort: Targeted Relief for Crohn's and Ulcerative Colitis
| Product dosage: 100mcg | |||
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| Product dosage: 200mcg | |||
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Synonyms | |||
Entocort (budesonide) is a locally acting corticosteroid designed specifically for the treatment of mild to moderate Crohn’s disease affecting the ileum and/or ascending colon, and for the induction of remission in mild to moderate ulcerative colitis. Its advanced delivery system targets inflammation directly at the site of disease activity in the bowel, maximizing therapeutic effect while minimizing systemic exposure and the side effects commonly associated with traditional steroids. This makes it a cornerstone in the gastroenterological management of inflammatory bowel disease, offering a favorable risk-benefit profile for appropriate patients.
Features
- Active Ingredient: Budesonide
- Formulation: Controlled-release capsules (Entocort EC 3 mg) or rectal foam (Uceris)
- Mechanism: Topical anti-inflammatory action with high first-pass metabolism
- Release System: pH-dependent, ileal-targeted release
- Bioavailability: Approximately 9% systemic absorption
Benefits
- Provides potent anti-inflammatory effects directly at the site of intestinal inflammation
- Significantly reduces systemic steroid exposure compared to conventional corticosteroids like prednisone
- Lowers the risk of adrenal suppression and other systemic corticosteroid side effects
- Promotes mucosal healing in Crohn’s disease and ulcerative colitis
- Induces clinical remission in a substantial proportion of patients with active disease
- Offers convenient once-daily dosing for maintenance of remission
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 induction of remission in patients with active, mild to moderate ulcerative colitis. Gastroenterologists often prescribe it as a first-line therapy for these conditions due to its targeted action and reduced systemic side effects compared to conventional steroids. The medication is typically used for 8-16 weeks for induction of remission, with some patients continuing on maintenance therapy under specialist supervision.
Dosage and direction
For Crohn’s disease: The recommended adult dosage is 9 mg once daily in the morning for up to 8 weeks. For maintaining remission, the dosage may be reduced to 6 mg daily. For ulcerative colitis: The recommended dosage is 9 mg once daily for up to 8 weeks. Capsules should be swallowed whole with water and not chewed or crushed. Administration should occur at the same time each day, preferably in the morning. The medication may be taken with or without food, though consistent administration with respect to meals is recommended.
Precautions
Patients should be monitored for signs of hypercorticism and adrenal suppression, particularly when transferring from systemic corticosteroids. Caution is advised in patients with liver impairment, as budesonide metabolism may be reduced. Patients should avoid recent exposure to chickenpox or measles and notify their physician if exposure occurs. Those with osteoporosis or at risk for osteoporosis should be monitored appropriately. The medication may mask signs of infection, and new infections may appear during therapy. Patients should not discontinue therapy abruptly without medical supervision.
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, quiescent, or suspected tuberculosis; untreated fungal, bacterial, or viral systemic infections; or ocular herpes simplex. The medication is contraindicated in patients with severe liver impairment (Child-Pugh Class C). It should not be administered to patients receiving potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and clarithromycin.
Possible side effects
Common side effects (≥1%) include headache, nausea, dyspepsia, abdominal pain, flatulence, vomiting, fatigue, acne, muscle cramps, arthralgia, and respiratory infection. Less frequent adverse reactions may include mood changes, insomnia, increased appetite, fluid retention, hypertension, hyperglycemia, easy bruising, and adrenal suppression. Although less common than with systemic corticosteroids, long-term use may lead to glucocorticosteroid-related side effects including osteoporosis, cataracts, glaucoma, and growth suppression in children.
Drug interaction
Budesonide is primarily metabolized by CYP3A4. Concomitant administration with strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, indinavir, clarithromycin) may significantly increase budesonide plasma concentrations and should be avoided. Moderate CYP3A4 inhibitors (erythromycin, verapamil, diltiazem) may require dose adjustment. Inducers of CYP3A4 (rifampin, carbamazepine, phenytoin, phenobarbital) may decrease budesonide plasma concentrations. Budesonide may decrease the efficacy of vaccines and should not be administered with live vaccines.
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 effect, particularly during the induction phase of treatment.
Overdose
Acute overdose with Entocort is unlikely to cause serious problems due to its low systemic bioavailability. Single doses up to 32 mg have been administered without significant adverse effects. However, chronic overdose may lead to systemic corticosteroid effects including hypercorticism and adrenal suppression. There is no specific antidote for budesonide overdose. Treatment should be supportive and symptomatic. In cases of significant overdose, gastric lavage may be considered if performed soon after ingestion.
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 medication in its original container with the lid tightly closed. Protect from moisture and light. Do not store in bathroom areas. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Entocort is a prescription medication that should be used only under the supervision of a qualified healthcare professional. Individual response to treatment may vary. Patients should consult their physician for proper diagnosis and treatment recommendations. The full prescribing information should be reviewed before initiating therapy.
Reviews
Clinical studies demonstrate that Entocort induces remission in approximately 50-60% of patients with active Crohn’s disease within 8 weeks of treatment. Maintenance therapy with 6 mg daily has shown efficacy in prolonging time to relapse. For ulcerative colitis, clinical trials have shown significant improvement in symptoms and endoscopic findings compared to placebo. Many gastroenterologists report favorable patient experiences with reduced steroid-related side effects compared to traditional corticosteroids. Patient satisfaction surveys indicate improved quality of life measures during treatment with Entocort.