Entocort EC
Generic name: budesonide (oral) [ bue-DES-oh-nide ]
Brand names: Eohilia, Ortikos, Tarpeyo, Uceris, Entocort EC
Drug class: Glucocorticoids
What is Entocort EC?
Entocort EC capsules can be used to treat mild to moderate Crohn's disease in adults and children at least 8 years old who weigh 55 pounds (25 kg) or more. These medicines are also used in adults for up to 3 months to keep symptoms from returning.
Entocort EC capsules can also be used to reduce the loss of kidney function in adults with a kidney disease called primary immunoglobulin A nephropathy, who are at risk of their disease worsening.
Entocort EC suspension is used to treat eosinophilic esophagitis in adults and children at least 11 years old for up to 12 weeks.
Entocort EC extended release tablet is used to treat mild to moderate ulcerative colitis (UC) in adults.
Entocort EC may also be used for purposes not listed in this medication guide.
Entocort EC side effects
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:
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fever, chills, sore throat;
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mouth sores, red or swollen gums;
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pale skin, easy bruising, unusual bleeding; or
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chest discomfort, wheezing, dry cough or hack, diarrhea or rapid weight loss.
Also call your doctor at once if you have:
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heartburn, chest pain, trouble swallowing, any skin lesion or rash, no matter how mild;
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signs of inflammation inside your nose (rhinitis)--sneezing, stuffy or runny nose;
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increased adrenal gland hormones--hunger, weight gain, swelling, skin discoloration, slow wound healing, sweating, acne, increased body hair, tiredness, mood changes, muscle weakness, missed menstrual periods, sexual changes; or
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signs of thrush (a fungal infection)--sores or white patches in your mouth or throat, trouble swallowing.
High doses or long-term use of budesonide can cause certain side effects such as symptoms of decreased adrenal gland hormones such as: nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods.
Entocort EC can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using Entocort EC.
Common side effects of Entocort EC may include:
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headache, dizziness, high blood pressure, feeling tired;
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upset stomach, nausea, vomiting, diarrhea, stomach pain, bloating, gas, constipation;
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weight gain, back pain, muscle cramps, joint pain;
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thicker or increased hair on your body and face, swelling of the face, lower legs, ankles, and feet;
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pain and burning when you urinate, irritation or inflammation of the skin, acne;
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cold symptoms such as stuffy nose, sneezing, sore throat, increased white blood cell (WBC) counts;
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decreased adrenal gland hormones; or
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fungal infection of the mouth, throat, and esophagus (thrush).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Warnings
You may get infections more easily, even serious or fatal infections. Call your doctor if you have flu symptoms, cough, night sweats, neck stiffness, diarrhea, confusion, or vision problems.
Before taking this medicine
You should not use Entocort EC if you are allergic to it.
Tell your doctor if you have or have ever had:
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herpes infection of the eyes;
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high blood pressure;
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a weak immune system (caused by disease or by using certain medicines);
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osteoporosis or low bone mineral density;
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a planned surgery;
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cerebral malaria;
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any allergies;
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diabetes, cataracts, or glaucoma (in you or a family member);
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unexplained diarrhea or if you recently traveled;
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chickenpox or measles (or have been exposed to it); or
Steroids can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have. Tell your doctor about any recent, active, or chronic illness, especially any type of infection caused by bacteria, virus, fungus, or parasites, including threadworm.
Entocort EC may harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Ask a doctor if it is safe to breastfeed while using Entocort EC.
How should I take Entocort EC?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using exactly as directed on the label, or as prescribed by your doctor.
Entocort EC suspension is taken by mouth twice per day, 1 time in the morning and 1 time in the evening. Do not mix with liquid or food.
Shake the oral suspension (liquid) for at least 10 seconds before taking it. Wait at least 30 minutes after taking Entocort EC oral suspension before you drink or eat.
Entocort EC tablet or capsule is usually taken once per day in the morning with a full glass of water.
Certain brand forms of budesonide should be taken at least 1 hour before a meal. Other brands may be taken with or without food. Follow your doctor's dosing instructions very carefully.
Swallow the tablet or capsule whole and do not crush, dissolve, chew, break, or open it.
Do not change your dose or stop using Entocort EC suddenly without your doctor's advice. Follow your doctor's instructions about tapering your dose.
Read and carefully follow the Instructions for Use provided with this medicine on how to prepare, store, throw away, and take if unable to swallow Entocort EC. Ask your doctor or pharmacist if you do not understand these instructions.
Your dosage needs may change if you have surgery, are ill, or are under stress. Tell your doctor if your medicine seems to stop working.
Call your doctor if your symptoms do not improve, or if they get worse.
If you've had hepatitis B, tuberculosis or any other infection, it may come back or get worse. Before you use Entocort EC, your doctor may test you for hepatitis B or other infections. You may also need frequent medical tests during treatment with this medicine.
Store the medicine tightly closed at room temperature, away from moisture, heat, and light.
You may also store the oral suspension in the refrigerator, do not freeze.
Related/similar drugs
Entyvio, Cimzia, prednisone, dexamethasone, hydrocortisone, budesonide, Humira, mesalamine, azathioprine, Stelara
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
If you take Entocort EC for primary immunoglobulin A nephropathy, skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Entocort EC?
Grapefruit may interact with Entocort EC and cause side effects. Avoid consuming grapefruit products.
Avoid receiving a "live" vaccine and being near people who are sick or have infections. The vaccine may not work as well while you are using Entocort EC. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles). Also call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using this medicine.
What other drugs will affect Entocort EC?
Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.
Tell your doctor about all your other medicines, especially if you use stomach acid reducers.
This list is not complete. Other drugs may affect Entocort EC, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
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Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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