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| Product dosage: 200mcg | |||
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Synonyms | |||
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Entocort: Targeted Relief for Inflammatory Bowel Disease
Entocort (budesonide) is a locally acting corticosteroid specifically designed for the treatment of mild to moderate Crohn’s disease involving the ileum and/or ascending colon, and for the induction of remission in microscopic colitis. Unlike systemic corticosteroids, Entocort utilizes advanced pH-dependent release technology to deliver its anti-inflammatory action primarily at the site of intestinal inflammation, thereby minimizing systemic exposure and reducing the risk of widespread side effects. It represents a significant advancement in the management of inflammatory bowel conditions, offering effective symptom control with a more favorable safety profile for appropriate patients.
Features
- Contains budesonide as the active pharmaceutical ingredient
- Utilizes a multi-matrix system (MMX) or pH-dependent release mechanism for targeted delivery
- Available in 3 mg gastro-resistant capsules
- Designed for once-daily dosing convenience
- Manufactured under strict pharmaceutical quality control standards
- Prescription-only medication requiring medical supervision
Benefits
- Provides potent anti-inflammatory effects directly at the site of intestinal inflammation
- Reduces systemic steroid exposure compared to conventional corticosteroids
- Minimizes the risk of adrenal suppression and other systemic corticosteroid side effects
- Offers convenient once-daily dosing that supports treatment adherence
- Effectively induces remission in appropriate Crohn’s disease and microscopic colitis patients
- Maintains local therapeutic efficacy while limiting overall body burden
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 microscopic colitis, including both lymphocytic and collagenous subtypes. The medication works by reducing inflammation in the intestinal mucosa, thereby alleviating symptoms such as diarrhea, abdominal pain, and cramping. Healthcare providers may prescribe Entocort when targeted anti-inflammatory action is desired with reduced systemic effects compared to traditional corticosteroids.
Dosage and direction
For active Crohn’s disease: The recommended adult dosage is 9 mg once daily in the morning for up to 8 weeks. For recurring episodes of active disease, repeated 8-week courses may be used. For microscopic colitis: The recommended dosage is 9 mg once daily in the morning for 8 weeks. The capsules should be swallowed whole with water and not chewed or crushed. Administration should occur at approximately the same time each day to maintain consistent drug levels. Dosage adjustments may be necessary for patients with hepatic impairment.
Precautions
Patients should be monitored for signs of hypercorticism and adrenal suppression, particularly when transferring from systemic corticosteroids. Caution is advised in patients with tuberculosis, untreated fungal, bacterial, or viral infections, or ocular herpes simplex. Regular monitoring of blood pressure, body weight, and blood glucose is recommended during treatment. Patients should avoid exposure to chickenpox or measles and seek immediate medical advice if exposed. Gradual withdrawal is recommended after long-term therapy to prevent adrenal insufficiency.
Contraindications
Entocort is contraindicated in patients with hypersensitivity to budesonide or any components of the formulation. It should not be used in patients with systemic fungal infections or those who have demonstrated hypersensitivity to any corticosteroid. The medication is contraindicated in patients with severe hepatic impairment (Child-Pugh class C). Concomitant administration with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and cyclosporine is contraindicated due to increased systemic exposure to budesonide.
Possible side effects
Common side effects may include headache, nausea, dyspepsia, abdominal pain, flatulence, fatigue, acne, muscle cramps, and arthralgia. Less frequently reported effects include mood changes, insomnia, increased sweating, dermatitis, peripheral edema, and menstrual disorders. Although less common than with systemic corticosteroids, potential serious side effects include adrenal suppression, ocular effects (cataracts, glaucoma), decreased bone mineral density, and increased susceptibility to infections. Most adverse reactions are dose-dependent and generally reversible upon discontinuation of therapy.
Drug interaction
Budesonide is primarily metabolized by CYP3A4; concomitant use with strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, indinavir, clarithromycin) may significantly increase budesonide plasma concentrations and systemic effects. Inducers of CYP3A4 (rifampicin, carbamazepine, phenytoin, phenobarbital, St. John’s wort) may decrease budesonide plasma concentrations, potentially reducing efficacy. The combination with other corticosteroids may result in enhanced steroid effects. Concurrent use with non-potassium-sparing diuretics may exacerbate potassium depletion. Budesonide may decrease the efficacy of hypoglycemic agents and hypertension medications.
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. Maintaining a consistent dosing schedule is important for optimal therapeutic effect, and patients may benefit from setting daily reminders or using pill organizers to improve adherence.
Overdose
Acute overdose with Entocort is unlikely to produce life-threatening symptoms due to its limited systemic bioavailability. Single doses up to 32 mg have been administered without significant adverse effects. However, chronic overdose may 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 overdose, gastric lavage may be considered if performed soon after ingestion. Medical supervision is recommended for assessment of adrenal function if concerning symptoms develop.
Storage
Store at room temperature between 15-30Β°C (59-86Β°F) in the original container to protect from moisture. Keep the container tightly closed and out of reach of children. Do not store in bathroom areas where moisture levels may fluctuate. Do not use beyond the expiration date printed on the packaging. Protect from light and excessive heat. Proper storage ensures maintenance of the enteric coating integrity, which is essential for targeted drug delivery.
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 patient needs may vary, and treatment decisions should be made in consultation with a physician. The complete prescribing information should be consulted before initiating therapy. Patients should not adjust dosage or discontinue medication without medical guidance.
Reviews
Clinical studies have demonstrated that Entocort provides effective induction of remission in 60-70% of patients with mild to moderate Crohn’s disease affecting the ileum and/or ascending colon. In microscopic colitis, clinical trials show symptomatic improvement in approximately 80% of patients after 8 weeks of treatment. Gastroenterologists appreciate its targeted action and reduced systemic side effects compared to conventional corticosteroids. Patients report satisfaction with the convenience of once-daily dosing and the generally favorable side effect profile. Long-term follow-up studies indicate maintained efficacy with repeated courses when medically indicated.
