"The US Food and Drug Administration (FDA) has approved ustekinumab (Stelara, Janssen Biotech, Inc) for the treatment of moderately to severely active Crohn's disease in patients aged 18 years or older.
Specifically, the interle"...
(EN-toe-cort EE CEE)
Read this Patient Information before you start taking ENTOCORT EC and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is ENTOCORT EC?
ENTOCORT EC is a prescription corticosteroid medicine used to treat mild to moderate Crohn’s disease that affects part of the small intestine (ileum) and part of the large intestine (ascending colon):
- in people 8 years of age and older with active Crohn’s disease
- in adults to help keep symptoms from coming back for up to 3 months
It is not known if ENTOCORT EC is safe and effective in children under 8 years of age, or in children 8 to 17 years of age who weigh 55 pounds (25 kg) or less, for the treatment of mild to moderate active Crohn’s disease that affects part of the small intestine (ileum) and part of the large intestine (ascending colon).
It is not known if ENTOCORT EC is safe and effective in children to help keep symptoms of mild to moderate Crohn’s disease that affects part of the small intestine (ileum) and part of the large intestine (ascending colon) from coming back.
Who should not take ENTOCORT EC?
Do not take ENTOCORT EC if:
- you are allergic to budesonide or any of the ingredients in ENTOCORT EC. See the end of this leaflet for a complete list of ingredients in ENTOCORT EC.
What should I tell my healthcare provider before taking ENTOCORT EC?
Before you take ENTOCORT EC tell your healthcare provider if you:
- have liver problems
- are planning to have surgery
- have chicken pox or measles or have recently been near anyone with chicken pox or measles
- have an infection
- have diabetes or glaucoma or have a family history of diabetes or glaucoma
- have cataracts
- have or had tuberculosis
- have high blood pressure (hypertension)
- have decreased bone mineral density (osteoporosis)
- have stomach ulcers
- have any other medical condition
- are pregnant or plan to become pregnant. ENTOCORT EC may harm your unborn baby. Talk to your healthcare provider about the possible risk to your unborn baby if you take ENTOCORT EC when you are pregnant. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during your treatment with ENTOCORT EC.
- are breastfeeding or plan to breastfeed. It is not known if ENTOCORT EC passes into your breast milk or if it will affect your baby. Talk to your healthcare provider about the best way to feed your baby if you take ENTOCORT EC.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ENTOCORT EC and other medicines may affect each other causing side effects.
How should I take ENTOCORT EC?
- Take ENTOCORT EC exactly as your healthcare provider tells you.
- Your healthcare provider will tell you how many ENTOCORT EC capsules to take. Your healthcare provider may change your dose if needed.
- Take ENTOCORT EC 1 time each day in the morning.
- Take ENTOCORT EC capsules whole. Do not chew or crush ENTOCORT EC capsules before swallowing.
- If you take too much ENTOCORT EC call your healthcare provider right away or go to the nearest hospital emergency room.
What should I avoid while taking ENTOCORT EC?
- Do not drink grapefruit juice during your treatment with ENTOCORT EC. Drinking grapefruit juice can increase the level of ENTOCORT EC in your blood.
What are the possible side effects of ENTOCORT EC?
ENTOCORT EC may cause serious side effects, including:
- Effects of having too much corticosteroid medicine in your blood (hypercorticism). Long-time use of ENTOCORT EC can cause you to have too much corticosteroid medicine in your blood. Tell your healthcare provider if you have any of the following signs and symptoms of hypercorticism:
- Adrenal suppression. When ENTOCORT EC is taken for a long period of time (chronic use), adrenal suppression can happen. This is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal suppression include: tiredness, weakness, nausea and vomiting and low blood pressure. Tell your healthcare provider if you are under stress or have any symptoms of adrenal suppression during treatment with ENTOCORT EC.
- Worsening of allergies. If you take certain other corticosteroid medicines to treat allergies, switching to ENTOCORT EC may cause your allergies to come back. These allergies may include a skin condition called eczema or inflammation inside your nose (rhinitis). Tell your healthcare provider if any of your allergies become worse while taking ENTOCORT EC.
- Increased risk of infection. ENTOCORT EC weakens your immune system. Taking medicines that weaken your immune system makes you more likely to get infections. Avoid contact with people who have contagious diseases, such as chicken pox or measles, while taking ENTOCORT EC. Tell your healthcare provider right away if you come in contact with anyone who has chicken pox or measles.
Tell your healthcare provider about any signs or symptoms of infection during treatment with ENTOCORT EC, including:
- feeling tired
- nausea and vomiting
T he most common side effects of ENTOCORT EC in adults include:
- infection in your air passages (respiratory infection)
- back pain
- stomach area (abdominal) pain
The most common side effects of ENTOCORT EC in children 8 to 17 years of age, who weigh more than 55 pounds (25 kg), are similar to the most common side effects in adults.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of ENTOCORT EC. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Perrigo at 1-866-634-9120.
How should I store ENTOCORT EC?
- Store ENTOCORT EC at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep ENTOCORT EC in a tightly closed container.
Keep ENTOCORT EC and all medicines out of the reach of children.
General information about the safe and effective use of ENTOCORT EC
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ENTOCORT EC for a condition for which it was not prescribed. Do not give ENTOCORT EC to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about ENTOCORT EC that is written for health professionals.
What are the ingredients in ENTOCORT EC?
Active ingredient: budesonide
Inactive ingredients: 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.
Last reviewed on RxList: 8/1/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Entocort EC Information
Entocort EC - User Reviews
Entocort EC User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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