Entocort (Budesonide)

Entocort EC (budesonide) is a prescription steroid medicine used to treat mild to moderate Crohn’s disease in the lower small intestine and the first part of the colon. It works by reducing inflammation and irritation in the gut. Entocort EC comes as a delayed-release capsule that releases the medicine where it is needed, which means fewer side effects than regular steroid medicines. Entocort EC can be used by adults and children ages 8 and older. In adults, it may also help keep Crohn’s disease under control for up to 3 months.

Directions

Entocort EC is taken by mouth once each morning. For active Crohn’s disease in adults, the usual dose is 9 mg once daily for up to 8 weeks, although flares may be treated again if needed. After symptoms are controlled, a 6 mg daily dose may be used for up to 3 months, then slowly stopped as directed.

Swallow the capsules whole; do not chew or crush them. If you cannot swallow capsules, open one and sprinkle the granules on 1 tablespoon of applesauce, swallow the mixture within 30 minutes without chewing, then drink 8 ounces of cool water.

Avoid grapefruit juice during treatment because it can increase budesonide levels in the body. Only take Entocort EC as prescribed by a healthcare provider.

Ingredients

The active ingredient in Entocort EC is budesonide. Inactive ingredients include ethylcellulose, acetyltributyl citrate, methacrylic acid copolymer type C, triethyl citrate, antifoam M, polysorbate 80, talc, and sugar spheres. The capsule shell contains gelatin, iron oxide, and titanium dioxide.

Cautions

Before using this medication, you may want to consult a healthcare provider about the following:

• Any existing health conditions
• Any allergies
• A list of all medications currently being taken

Use caution when switching from another systemic steroid such as prednisone to Entocort EC. Some allergy symptoms that prednisone was keeping under control may come back, such as a runny or stuffy nose, sneezing, or eczema.

Long-term use can lead to symptoms of too much steroid in the body, known as hypercorticism, and adrenal axis suppression. Children and people with liver problems may be at higher risk.

Entocort EC may suppress the immune system and increase the risk of viral, bacterial, fungal, parasitic, or worm infections, including potentially fatal cases of chickenpox, also called varicella, or measles. Tell a healthcare provider about any current infection or recent exposure to chickenpox or measles. Avoid use in people with fungal infections, Strongyloides infestation, cerebral malaria, or ocular herpes simplex, and screen for hepatitis B before starting therapy.

Kaposi’s sarcoma has been reported in patients receiving corticosteroid therapy, most often for chronic conditions.

Avoid drinking grapefruit juice while taking Entocort EC, since it can increase the amount of the drug in the body.

Avoid using this drug with strong CYP3A4 inhibitors such as ketoconazole, which can increase budesonide levels and potentially lead to increased side effects.

People with moderate liver impairment may need a reduced dose. Entocort EC should be avoided in those with severe liver impairment.

Use with caution during pregnancy, since animal studies suggest possible harm to an unborn baby; budesonide is also passed into breast milk.

Patients should also let their provider know about diabetes, glaucoma, cataracts, high blood pressure, osteoporosis, peptic ulcers, or any condition that suppresses the immune system, as these may be worsened by corticosteroid use.

Contraindications

Avoid taking or using this medication if you have a known allergy or hypersensitivity to budesonide or any of the ingredients in Entocort EC.

Side Effects

Common side effects of Entocort EC include:

• Headache
• Respiratory infection, such as cold-like symptoms
• Nausea
• Back pain
• Indigestion
• Dizziness
• Abdominal pain
• Gas, also called flatulence
• Vomiting
• Fatigue
• General body pain

Stop taking Entocort EC and get medical help if signs of a serious allergic reaction develop, such as itching, skin rash, swelling of the face or throat, or trouble breathing.

Long-term use may lead to symptoms of too much steroid in the body, including rounding of the face, acne, easy bruising, weight gain, and mood changes. It may also increase the risk of infection, including more severe chickenpox or measles, high blood pressure, glaucoma, cataracts, bone thinning, also called osteoporosis, and high blood sugar.

Stopping treatment too quickly after long-term use can cause steroid withdrawal symptoms, so the dose should be tapered down with guidance from a healthcare provider.

References

• Entocort EC Highlights of Prescribing Information. Minneapolis, MN: Padagis US LLC; 2024.
• Entocort EC Drug Label Information. Södertälje, Sweden: AstraZeneca AB; 2012.