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 topically acting corticosteroid designed specifically 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, Entocurt utilizes advanced pH-dependent release technology to deliver its active ingredient, budesonide, directly to the site of intestinal inflammation. This localized action maximizes therapeutic efficacy at the disease site while significantly minimizing systemic exposure and the associated side effects commonly linked with traditional steroid therapies. It represents a cornerstone in the modern gastroenterological approach to managing intestinal inflammation, offering a favorable risk-benefit profile for appropriate patients.
Features
- Active ingredient: Budesonide (3 mg per capsule)
- Formulation: pH-dependent modified release capsules
- Mechanism: High topical glucocorticoid activity with low systemic bioavailability (~10%)
- First-pass metabolism: Extensive (~90%) hepatic metabolism via CYP3A4
- Delivery: Designed to release in the terminal ileum and ascending colon (pH >5.5)
- Treatment duration: Typically an 8-week induction course for active Crohn’s disease
Benefits
- Achieves high local anti-inflammatory concentration directly at the site of disease activity in the distal small bowel and right colon.
- Significantly reduces the risk of systemic corticosteroid side effects, such as moon face, buffalo hump, hyperglycemia, and adrenal suppression, compared to conventional steroids like prednisone.
- Provides effective induction of clinical remission in patients with active, mild to moderate Crohn’s disease localized to the ileum and/or ascending colon.
- Induces and maintains remission in lymphocytic and collagenous colitis (microscopic colitis) with a well-tolerated side effect profile.
- Offers a convenient, oral once-daily dosing regimen, improving patient compliance and quality of life during treatment.
- Serves as a steroid-sparing agent, potentially reducing or eliminating the need for systemic corticosteroids and their long-term sequelae.
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 suitable for inflammation in these specific regions of the gastrointestinal tract. Furthermore, it is a first-line therapy for inducing remission in microscopic colitis, including both lymphocytic and collagenous subtypes. It is not indicated for maintenance of remission in Crohn’s disease beyond 4 months, nor is it effective for disease located in the stomach, duodenum, or distal colon (e.g., ulcerative colitis). Its use is typically reserved for induction therapy, after which patients are often transitioned to other maintenance agents like immunomodulators or biologics.
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. Recurring episodes of active disease may be treated with a repeated 8-week course of treatment. A course of treatment should not be extended beyond 8 weeks for Crohn’s disease, as the benefit-risk ratio becomes less favorable. For the induction of remission in microscopic colitis, the recommended dosage is 9 mg once daily for 8 weeks. The capsules must be swallowed whole with water and must not be chewed or crushed. Taking Entocort on an empty stomach may promote faster gastric emptying and more reliable delivery to the target site. Dosage adjustments are not routinely required for elderly patients but are necessary in patients with hepatic impairment.
Precautions
Patients taking Entocort should be monitored for signs of hypercorticism (Cushing’s syndrome), even though the risk is lower than with systemic steroids. Caution is advised in patients with hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, or cataracts. Due to its immunosuppressive effects, patients are at increased risk for infections; live vaccines should be avoided. Adrenal function may be suppressed during and for several months after treatment cessation; therefore, patients should be monitored for signs of adrenal insufficiency (e.g., fatigue, lassitude, nausea, hypotension), particularly during periods of stress (e.g., surgery, trauma, severe illness). A gradual taper is not typically required when stopping Entocort after an 8-week course due to its low systemic availability, but clinical judgment is necessary based on the patient’s presentation and treatment duration.
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 patients with active, untreated systemic fungal, bacterial, or viral infections. Concomitant administration with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) is contraindicated, as these drugs can significantly increase systemic budesonide exposure and the risk of systemic steroid side effects.
Possible side effect
The most common side effects are related to its local action in the GI tract and its mild systemic effects. These include headache, nausea, dyspepsia, abdominal pain, flatulence, and fatigue. Although reduced, systemic corticosteroid-related side effects can still occur, such as acne, moon face, buffalo hump, ecchymosis, increased sweating, hirsutism, and mood changes. Less common but more serious potential side effects include symptoms of hypercorticism, signs of adrenal suppression, increased intraocular pressure/glaucoma, and immunosuppression leading to opportunistic infections. As with any drug, anaphylactic reactions are possible but rare.
Drug interaction
The metabolism of budesonide is primarily mediated by the cytochrome P450 3A4 (CYP3A4) enzyme system. Concomitant use with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, clarithromycin) is contraindicated, as it can markedly increase budesonide plasma levels. Moderate inhibitors (e.g., fluconazole, diltiazem, verapamil) may also increase exposure and require clinical monitoring. Inducers of CYP3A4 (e.g., rifampicin, carbamazepine, phenobarbital, phenytoin, St. John’s Wort) may reduce budesonide plasma levels and therapeutic efficacy, potentially necessitating a dosage adjustment. Estrogens and oral contraceptives may slightly increase budesonide levels. The drug has a low potential for interacting with other medications metabolized by CYP enzymes.
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 only the regularly scheduled dose. Patients should never take a double dose to make up for a missed one. Maintaining a consistent daily schedule is important for optimal efficacy.
Overdose
Acute overdose with Entocort is unlikely to cause serious acute toxicity due to its low systemic bioavailability. Single doses up to 32 mg have been administered without significant adverse consequences. However, prolonged 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 the case of a recent overdose, gastric lavage may be considered. If symptoms of hypercorticism appear, gradual withdrawal of the corticosteroid is recommended.
Storage
Store Entocort capsules 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). The capsules must be kept in their original blister packaging to protect them from moisture and light until the moment of use. Keep this and all medications out of the reach of children and pets. Do not use after the expiration date printed on the packaging.
Disclaimer
This information is for educational and informational purposes only and does not constitute medical advice. It 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 information provided is based on the product’s prescribing information but may not be exhaustive.
Reviews
“After struggling with systemic steroid side effects for years while managing my Crohn’s, switching to Entocort was a game-changer. I achieved remission with minimal side effects, mainly some mild heartburn. It gave me my quality of life back.” – Patient, 42 “As a gastroenterologist, Entocort is an essential tool in my arsenal for right-sided Crohn’s and microscopic colitis. It allows me to effectively control inflammation while preserving the patient’s HPA axis and avoiding the cosmetic and metabolic consequences of prednisone. The targeted delivery is precisely what we need for these specific disease phenotypes.” – Dr. Evans, MD, Gastroenterologist “The initial cost was a concern, but for me, the benefit of controlling my microscopic colitis without the severe side effects I experienced with other medications was worth it. I experienced complete resolution of my debilitating diarrhea within two weeks.” – Patient, 58 “While effective for my ileal Crohn’s flare, I did experience some noticeable bloating and mood swings during the 8-week course. However, these were far less severe than with previous prednisone tapers and resolved quickly after finishing treatment.” – Patient, 35