What You Need to Know About Entocort EC (Budesonide)

Entocort EC (budesonide) is approved for use in treating mild to moderate Crohn's disease involving the ileum and/or the ascending colon. Entocort EC is a non-systemic glucocorticosteroid that is released into the intestine and works to reduce inflammation. Because 90% of the drug is released in the intestine and not into the bloodstream, it causes fewer side effects than other corticosteroids (such as prednisone).

Entocort EC is manufactured by AstraZeneca in the United States.

Entocort EC is normally taken in capsule form in the morning with or without food. Entocort EC should be swallowed whole and should never be crushed, chewed or broken in half. This is because Entocort EC has a coating on it that allows the drug to pass through part of the digestive system until it gets to the area of inflammation in the small intestine. If the pills are crushed or broken, the outer coating will be disturbed, and the medication won't work in the way it was intended.

According to the Entocort prescribing information, it is normally taken in a 9 mg dose every morning to treat mild to moderately active Crohn’s disease for up to 8 weeks. If the Crohn's disease doesn't respond in those 8 weeks, another 8-week course might be recommended.

For Crohn's disease that is in clinical remission, Entocort EC may be prescribed as a maintenance drug. In this case, 6 mg is taken once a day for up to 3 months. After 3 months, it has not been proven to have any more benefit on Crohn's disease.

Even though Entocort EC belongs to the class of drugs known as corticosteroids, it may be more effective and have fewer side effects than other medications in this category.

If you miss a dose, take it as soon as you remember. If your next dose should be taken soon, just take that dose. Don't double up, or take more than one dose at a time.

Tell your doctor if you have ever had any of the following conditions:

• Any condition that suppresses the immune system
• Cataracts
• Diabetes (or a family history of the disease)
• Glaucoma (or a family history of the disease)
• High blood pressure
• Liver disease
• Osteoporosis
• Tuberculosis
• Ulcers

The biggest difference between Entocort EC and other formulations of steroids is that Entocort passes through the upper gastrointestinal tract without the medication being released. The medication isn't released until it gets to the small intestine, which means it can act on the inflammation there. Because it's not put right into the bloodstream, it causes fewer side effects than other formulations of steroid drugs that don't have that time-release factor. Common side effects of Entocort EC, which occurred in more than 5% of people taking it during clinical trials, include headache, respiratory infection, nausea, back pain, dyspepsia, dizziness, abdominal pain, flatulence, vomiting, fatigue, pain.

Sexual Side Effects

Entocort EC is not known to cause any sexual side effects in either men or women.

Interactions

Ketoconazole can intefere with the way the liver processes Entocort EC.

Grapefruit or grapefruit juice can interact with Entocort EC and cause more of it to be released into the bloodstream.

The FDA has classified Entocort EC as a type C drug. The effect that Entocort EC has on an unborn child has not been studied extensively. Entocort EC should only be used during pregnancy if clearly needed. Notify the prescribing doctor if you become pregnant while taking Entocort EC. Entocort EC does pass into breast milk and can affect a nursing infant.

People taking Entocort EC should avoid exposure to anyone who has chickenpox or the measles or who has been vaccinated with a live virus. Entocort may also suppress the response of the hypothalamus-pituitary-adrenal (HPA), and therapy may be necessary before surgery (including dental surgery) or other stressful events.