Entocort: Targeted Relief for Active Crohn's Disease

Product dosage: 100mcg
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Product dosage: 200mcg
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Synonyms

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Entocort (budesonide) is a locally acting corticosteroid specifically formulated for the treatment of mild to moderate active Crohn’s disease involving the ileum and/or ascending colon. Its advanced delivery system targets inflammation directly at the source within the intestinal tract, offering effective symptom control with a reduced risk of systemic steroid-related side effects compared to conventional corticosteroids. This makes it a cornerstone therapy for managing flare-ups and inducing remission in appropriate patient populations.

Features

  • Active Pharmaceutical Ingredient: Budesonide 3 mg per capsule.
  • Pharmacological Class: Glucocorticoid, corticosteroid.
  • Mechanism of Action: Exerts a high local anti-inflammatory effect directly on the intestinal mucosa.
  • Delivery System: pH-dependent, extended-release capsules designed to release the active substance in the terminal ileum and ascending colon.
  • Form: Hard gelatin capsules containing enteric-coated granules.
  • Prescription Status: Available by prescription only.

Benefits

  • Targeted Action: Delivers the anti-inflammatory medication precisely to the site of intestinal inflammation, maximizing local efficacy.
  • Reduced Systemic Exposure: The high first-pass metabolism in the liver significantly minimizes the amount of active drug entering the systemic circulation.
  • Lower Incidence of Steroid-Specific Side Effects: Compared to systemic corticosteroids like prednisone, Entocort is associated with a markedly lower risk of side effects such as moon face, buffalo hump, hyperglycemia, and adrenal suppression when used at recommended doses.
  • Effective Induction of Remission: Clinically proven to reduce the symptoms of active Crohn’s disease, including abdominal pain, diarrhea, and overall disease activity scores.
  • Favorable Safety Profile: Well-tolerated by most patients for short-term treatment of active disease.

Common use

Entocort is indicated for the treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon. It is used to induce clinical remission. Its use is typically reserved for acute flare-ups and is not generally indicated for long-term maintenance therapy.

Dosage and direction

The recommended adult dosage for the treatment of active Crohn’s disease is 9 mg (three 3 mg capsules) taken once daily in the morning before breakfast. The capsules should be swallowed whole with water and must not be chewed or crushed. Treatment duration should not exceed 8 weeks for an active episode. If symptom improvement is insufficient after 2-4 weeks of treatment, alternative therapeutic options should be considered. Dosage for pediatric patients has not been established. Always follow the specific dosage instructions provided by the prescribing physician.

Precautions

  • Patients transferring from a systemic corticosteroid to Entocort require careful medical supervision due to the risk of adrenal insufficiency.
  • Use with caution in patients with liver impairment, as budesonide metabolism may be reduced, increasing systemic exposure and the risk of side effects.
  • Close monitoring is advised for patients with osteoporosis, hypertension, diabetes mellitus, or a history of glaucoma.
  • As with all corticosteroids, caution is warranted in patients with peptic ulcer disease, active or latent tuberculosis, or systemic fungal infections.
  • Long-term use, even with a locally acting steroid, can potentially lead to adrenal suppression and related complications.
  • The use of corticosteroids may impair the immune response; therefore, Entocort should be used with caution in patients with existing or recent infections (e.g., chickenpox, measles, herpes simplex).

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 severe liver impairment (Child-Pugh Class C).

Possible side effect

Like all medicines, Entocort can cause side effects, although not everybody gets them. The most commonly reported side effects are related to its local action and corticosteroid class:

  • Very common (≥1/10): Headache.
  • Common (≥1/100 to <1/10): Nausea, dyspepsia, abdominal pain, flatulence, acne, muscle cramps, arthralgia (joint pain), respiratory tract infection, agitation, dizziness, fatigue, skin reactions (e.g., eczema, purpura).
  • Uncommon (≥1/1,000 to <1/100): Fluid retention, peripheral edema, sleep disorder, dysphonia (voice disorder), glaucoma, increased intraocular pressure, cataract, ecchymosis (bruising), weight gain.
  • Signs of systemic corticosteroid effects (e.g., moon face, buffalo hump, hirsutism) may occur but are less frequent than with conventional systemic steroids.

Drug interaction

Concomitant use of Entocort with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) is not recommended, as these drugs can significantly increase the plasma concentrations of budesonide by inhibiting its metabolism, thereby increasing the risk of systemic side effects. The efficacy of oral contraceptives may be reduced. Caution is advised when co-administering with other corticosteroids due to additive effects.

Missed dose

If a dose is missed, it should be taken as soon as remembered on the same day. If it is almost time for the next dose, the missed dose should be skipped, and the regular dosing schedule resumed. Do not take a double dose to make up for a forgotten one.

Overdose

Acute overdose with Entocort is unlikely to produce acute toxic effects due to its limited systemic availability. Single doses of up to 40 mg have been administered without significant clinical consequences. However, chronic overdose or misuse could lead to the development of systemic glucocorticosteroid side effects such as hypercortisolism and adrenal suppression. There is no specific antidote. Treatment should be symptomatic and supportive.

Storage

Store below 25°C (77°F). Keep the blister strips in the outer carton to protect from light and moisture. Keep out of the sight and reach of children. Do not use after the expiration date printed on the packaging.

Disclaimer

This information is for educational 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 medication. Never disregard professional medical advice or delay in seeking it because of something you have read here. The full official prescribing information should be consulted before initiating treatment.

Reviews

“Entocort has been a game-changer for managing my Crohn’s flares. I experienced significant relief from abdominal pain and diarrhea within the first week, without the severe side effects I had with prednisone.” – Patient M.C.

“As a gastroenterologist, Entocort is a valuable tool in my arsenal for inducing remission in appropriate Crohn’s patients. Its targeted action provides effective local control of inflammation while minimizing the systemic burden, leading to better patient tolerance and adherence to therapy.” – Dr. A. Sharma, MD.

“While effective for my acute symptoms, I did notice some mild bloating and facial flushing during the 8-week course. However, these were minor compared to the benefit of achieving remission.” – Patient J.L.