Entocort: Targeted Relief for Inflammatory Bowel Disease
| Product dosage: 100mcg | |||
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| Product dosage: 200mcg | |||
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Synonyms | |||
Entocort (budesonide) is a locally acting glucocorticosteroid specifically engineered for the treatment of mild to moderate Crohn’s disease affecting the ileum and/or ascending colon, and for the induction of remission in microscopic colitis. Unlike systemic corticosteroids, its advanced multi-matrix release technology and high first-pass metabolism in the liver allow for potent anti-inflammatory action directly at the site of intestinal inflammation, while significantly minimizing systemic exposure and the associated steroid-related side effects. It represents a cornerstone of modern gastroenterological therapy, offering a superior risk-benefit profile for managing chronic bowel inflammation.
Features
- Active Ingredient: Budesonide 3 mg
- Formulation: pH-dependent, extended-release capsules
- Mechanism: Topical anti-inflammatory action with high glucocorticoid receptor affinity
- Release System: Multi-matrix system (MMX) for targeted delivery to the terminal ileum and colon
- Bioavailability: Approximately 9-21% due to extensive first-pass metabolism
- Half-life: 2-3.6 hours
Benefits
- Targeted Action: Delivers the potent anti-inflammatory effects of a corticosteroid directly to the inflamed intestinal mucosa, maximizing local efficacy.
- Reduced Systemic Side Effects: Its high first-pass metabolism minimizes circulation of active drug, leading to a significantly lower incidence of steroid-related adverse events like moon face, buffalo hump, and adrenal suppression compared to conventional systemic steroids like prednisone.
- Effective Induction of Remission: Clinically proven to induce remission in patients with active, mild to moderate Crohn’s disease localized to the ileum and/or ascending colon, as well as in lymphocytic and collagenous colitis.
- Favorable Safety Profile: Offers a treatment option with a well-documented and generally manageable side effect profile, making it suitable for medium-term therapy.
- Convenient Dosing: Typically administered as a once-daily oral regimen, improving patient compliance and quality of life during treatment.
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. Its targeted release mechanism makes it particularly effective for inflammation in these specific regions of the bowel. Furthermore, it is a first-line therapy for inducing remission in microscopic colitis, including both lymphocytic and collagenous subtypes. It is not indicated for the maintenance of remission in Crohn’s disease beyond several months, nor is it used for ulcerative colitis affecting other parts of the colon or for severe, extensive disease requiring systemic intervention.
Dosage and direction
For the treatment of active Crohn’s disease, the recommended adult dosage is 9 mg (three 3 mg capsules) taken orally once daily in the morning, with or without food, for a duration of up to 8 weeks. Recurring episodes may be treated with a repeat 8-week course. For the induction of remission in microscopic colitis, the recommended dosage is also 9 mg once daily for 6-8 weeks. The capsules must be swallowed whole with a glass of water; they should not be chewed or crushed, as this will damage the controlled-release properties. Dosage tapering is not typically required for the standard 8-week course due to the low systemic exposure, but clinical judgment should be exercised for longer durations. The safety and efficacy in pediatric patients have not been established.
Precautions
- Hepatic Impairment: Patients with moderate to severe liver disease (e.g., cirrhosis) may experience reduced first-pass metabolism and increased systemic exposure to budesonide. Dose adjustment should be considered.
- Adrenal Function: Although the risk is lower than with systemic steroids, Entocort can suppress the hypothalamic-pituitary-adrenal (HPA) axis. Patients should be monitored for signs of adrenal insufficiency, especially when switching from systemic steroids, during times of stress (surgery, trauma, severe infection), or after withdrawal.
- Osteoporosis: Long-term use of corticosteroids is a risk factor for decreased bone mineral density. Consider calcium and vitamin D supplementation and monitor bone health in patients on prolonged or repeated courses.
- Ophthalmic Effects: Prolonged use may increase the risk of cataracts and glaucoma. Regular ophthalmologic examinations are advisable.
- Infections: Corticosteroids can mask symptoms of infection and impair the immune response. Use with caution in patients with latent tuberculosis, fungal infections, or other opportunistic infections.
- Pregnancy and Lactation: Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Budesonide is excreted in human milk; a decision should be made to discontinue nursing or discontinue the drug.
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, active, or systemic infections unless adequate anti-infective therapy is instituted.
Possible side effect
The majority of side effects are mild to moderate and often related to its local glucocorticoid action.
- Very Common (>1/10): Headache.
- Common (1/10 to 1/100): Nausea, dyspepsia, abdominal pain, flatulence, vomiting, fatigue, acne, muscle cramps, arthralgia, respiratory tract infection, dizziness, anxiety, skin reactions (rash, eczema).
- Uncommon (1/100 to 1/1000): Edema, sleep disturbance, increased sweating, changes in appetite, dyspnea, palpitations, bruising, facial edema, mood swings, menstrual disorders.
- Rare (<1/1000): Symptoms of hypercorticism (e.g., moon face, buffalo hump), anaphylactic reactions, glaucoma, increased intraocular pressure, cataracts.
Drug interaction
- Strong CYP3A4 Inhibitors: Drugs like ketoconazole, itraconazole, ritonavir, indinavir, and clarithromycin can significantly inhibit the metabolism of budesonide, leading to increased systemic exposure and an elevated risk of systemic steroid side effects and HPA axis suppression. Concomitant use should be avoided unless the benefit outweighs the increased risk, in which case dose reduction should be considered.
- Estrogens: Oral contraceptives and hormone replacement therapy containing estrogens can potentially increase budesonide plasma levels.
- Warfarin: Budesonide has been reported to both increase and decrease the International Normalized Ratio (INR) in patients on warfarin, requiring close monitoring of coagulation parameters.
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 a missed one.
Overdose
Acute overdose with Entocort is unlikely to lead to acute toxic effects due to its limited systemic availability. Single doses of up to 32 mg have been administered without significant clinical consequences. However, chronic overdose or exposure in the context of drug interactions with strong CYP3A4 inhibitors could lead to systemic glucocorticosteroid effects such as hypercorticism and adrenal suppression. There is no specific antidote. Treatment should be symptomatic and supportive. In cases of chronic overdose, the dose should be reduced gradually.
Storage
Store at room temperature between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). Keep the bottle tightly closed to protect from moisture. Keep out of reach of children. 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
- Clinical Consensus: “Entocort has revolutionized our approach to distal Crohn’s disease and microscopic colitis. It provides the efficacy we need with a side effect profile that patients can tolerate much better than prednisone. It’s a vital tool in our therapeutic arsenal.” – Gastroenterologist, 15 years experience.
- Patient Experience (Compiled): Many patients report significant improvement in abdominal cramping and diarrhea within the first few weeks of treatment. A common sentiment is appreciation for the lack of the severe side effects typically associated with “steroids,” allowing them to continue daily activities. Some note mild, transient headaches or nausea at the start of therapy.
- Meta-Analysis Findings: Systematic reviews consistently affirm that budesonide is superior to placebo and mesalamine and equivalent to conventional prednisolone for inducing remission in active Crohn’s disease, with a significantly more favorable safety profile concerning steroid-specific adverse events.