Entocort: Targeted Relief for Inflammatory Bowel Disease

Entocort

Entocort

Entocort inhalation is used to prevent asthma attacks.
Product dosage: 100mcg
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Product dosage: 200mcg
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Synonyms

Similar products

Entocort (budesonide) is a locally acting glucocorticosteroid specifically engineered for the treatment of mild to moderate active Crohn’s disease involving the ileum and/or ascending colon, and for the maintenance of clinical remission. Unlike systemic corticosteroids, its advanced delivery technology ensures high topical anti-inflammatory activity within the intestinal lumen with significantly reduced systemic exposure. This results in effective control of inflammation at the disease site while minimizing the burden of class-wide steroid side effects, making it a cornerstone of modern gastroenterological therapy for appropriate patients.

Features

  • Active Ingredient: Budesonide
  • Formulation: pH-dependent, extended-release capsules
  • Mechanism: Locally acting glucocorticoid with high affinity for glucocorticoid receptors
  • Release Profile: Designed for targeted release in the terminal ileum and ascending colon
  • Bioavailability: Approximately 9% systemic absorption due to extensive first-pass metabolism
  • Dosage Strengths: Available in 3 mg capsules

Benefits

  • Targeted Action: Delivers potent anti-inflammatory effects directly to the site of intestinal inflammation
  • Reduced Systemic Effects: Minimizes typical steroid-related adverse events through low oral bioavailability
  • Effective Induction Therapy: Demonstrated efficacy in achieving clinical remission in active Crohn’s disease
  • Maintenance Capability: Helps sustain clinical remission in appropriate patient populations
  • Favorable Safety Profile: Lower incidence of corticosteroid-associated complications compared to systemic steroids
  • Improved Quality of Life: Reduces disease symptoms while limiting treatment-related morbidity

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 used for the maintenance of clinical remission for up to 3 months in adults. Gastroenterologists may prescribe it for off-label uses in certain cases of microscopic colitis or other inflammatory bowel conditions where localized corticosteroid action is desired. The medication is particularly valuable for patients who require corticosteroid therapy but are at risk for, or wish to avoid, the systemic effects of traditional steroids like prednisone.

Dosage and direction

For the treatment of active Crohn’s disease: The recommended adult dosage is 9 mg once daily in the morning for up to 8 weeks. For maintenance of remission: Following successful treatment of active disease, 6 mg once daily may be used for maintenance of clinical remission for up to 3 months. Capsules should be swallowed whole with water and not chewed or crushed. Administration should occur at approximately the same time each day. For patients with hepatic impairment, dosage adjustment may be necessary. The medication may be taken with or without food, though consistency in administration relative 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 diabetes, hypertension, osteoporosis, peptic ulcer disease, or those with recent intestinal anastomoses. Hepatic function should be monitored during treatment. Patients should avoid exposure to chickenpox or measles and report any exposures immediately. The medication may mask signs of infection, and new infections may appear during therapy. Ophthalmologic examinations are recommended with prolonged use. Gradual tapering is recommended when discontinuing treatment after prolonged therapy to avoid adrenal insufficiency.

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 untreated infections, systemic fungal infections, or tuberculosis. The medication is contraindicated in patients with severe hepatic 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 due to significantly increased systemic exposure to budesonide.

Possible side effect

Common side effects (≥1%) include headache, nausea, dyspepsia, abdominal pain, flatulence, fatigue, acne, muscle cramps, and arthralgia. Respiratory tract infections may occur more frequently. Less common but potentially serious side effects include adrenal suppression, hypercorticism, ocular effects (cataracts, glaucoma), decreased bone mineral density, and psychiatric reactions including mood changes, insomnia, and depression. Gastrointestinal perforation has been reported rarely. Allergic reactions including rash and angioedema may occur. Most side effects are dose-dependent and often resolve with dosage reduction or discontinuation.

Drug interaction

Budesonide is primarily metabolized by CYP3A4. Concomitant administration with strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, indinavir, clarithromycin) significantly increases budesonide exposure and is contraindicated. Moderate inhibitors (erythromycin, verapamil, diltiazem) may also increase budesonide levels and require caution. Inducers of CYP3A4 (rifampin, carbamazepine, phenytoin, St. John’s wort) may decrease budesonide efficacy. Budesonide may decrease the efficacy of salicylates. Concomitant use with other corticosteroids may result in additive effects. The medication may potentiate hypokalemia effects of diuretics and amphotericin B.

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. Consistency in daily administration is important for maintaining therapeutic effects, particularly for maintenance therapy. Patients should be educated on the importance of adherence and strategies to incorporate medication administration into their daily routine.

Overdose

Acute overdose with Entocort is unlikely to produce serious consequences 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 symptoms of hypercorticism including moon face, central obesity, glucose intolerance, hypertension, and adrenal suppression. Treatment should be supportive and symptomatic. There is no specific antidote. In cases of significant overdose, gastric lavage may be considered if administered soon after ingestion. Medical supervision is recommended to monitor for potential adrenal insufficiency following discontinuation.

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 in the original container to protect from moisture and light. Keep tightly closed and out of reach of children. Do not use after the expiration date printed on the packaging. Do not store in bathroom areas where moisture levels may be higher. Proper storage ensures maintenance of the enteric coating and controlled-release properties.

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 not make any changes to their medication regimen without consulting their physician. The complete prescribing information should be consulted before initiating therapy. This summary does not include all possible information about this medication and cannot replace professional medical advice.

Reviews

Clinical studies demonstrate that Entocort provides effective induction of remission in 48-51% of patients with active Crohn’s disease at 8 weeks, compared to 20-25% with placebo. Maintenance therapy shows 32-42% remission rates at 3 months compared to 25-30% with placebo. Gastroenterologists report satisfaction with its targeted action and reduced steroid side effects compared to conventional corticosteroids. Patients appreciate the improved quality of life with better symptom control and fewer treatment-related complications. The medication receives particular praise for its role in steroid-sparing strategies and management of patients who cannot tolerate systemic steroid effects.