Entocort EC

Generic Name: budesonide

What is budesonide (oral)?

Budesonide is in a class of drugs called corticosteroids. Budesonide works in the intestines to reduce inflammation, tissue damage, and diarrhea.

Budesonide is used to treat mild to moderate Crohn’s disease.

Budesonide may also be used for purposes other than those listed in this medication guide.

Uses Side Effects Precautions Interactions Overdose
What should I discuss with my healthcare provider before taking budesonide (oral)?

Do not take budesonide if you have a serious bacterial, viral, or fungal infection. Budesonide weakens the body’s immune response and thus its ability to fight infection.

Before taking this medication, tell your doctor if you have

  • liver disease,

  • tuberculosis,

  • stomach ulcers,

  • high blood pressure,

  • osteoporosis,

  • glaucoma or cataracts,

  • diabetes mellitus, or

  • a family history of diabetes or glaucoma.

You may not be able to take budesonide, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Budesonide is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not take budesonide without first talking to your doctor if you are pregnant or could become pregnant during treatment.

Budesonide passes into breast milk. Do not take budesonide without first talking to your doctor if you are breast-feeding a baby.

How should I take budesonide (oral)?

Take budesonide exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse or doctor to explain them to you.

Take each dose with a full glass of water.

Budesonide can be taken with or without food or milk.

Do not crush, break, or chew the capsules. Swallow them whole. They are specially formulated to release the medication after they have passed through the stomach.

Do not drink grapefruit juice or eat grapefruit during treatment with budesonide.

Store budesonide at room temperature away from moisture and heat.

What happens if I miss a dose of budesonide (oral)?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of this medication.

Where can I get more information about budesonide (oral)?
Your pharmacist has information about budesonide (oral) written for health professionals that you may read.
What are the possible side effects of budesonide (oral)?

If you experience any of the following serious side effects, stop taking budesonide and seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

  • increased blood pressure (severe headache or blurred vision); or

  • sudden weight gain (more than 2 pounds in one day or 5 pounds in a week).

Other, less serious side effects may be more likely to occur. Continue to take budesonide and talk to your doctor if you experience

  • insomnia;

  • nausea, vomiting, or stomach upset;

  • fatigue or dizziness;

  • respiratory infection;

  • hyperglycemia (increased blood sugar);

  • flatulence; or

  • headache.

Other side effects may occur rarely, usually with high doses or long-term use of steroids. Talk to your doctor if you experience any of the following side effects:

  • acne;

  • obesity (especially around the stomach);

  • increased hair growth (especially around the face);

  • thinning of the skin and easy bruising;

  • cataracts;

  • glaucoma;

  • swollen hands, feet, or ankles (fluid retention);

  • sore or weak muscles;

  • osteoporosis;

  • roundness of the face; and

  • changes in behavior.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What is the most important information I should know about budesonide (oral)?

Do not drink grapefruit juice or eat grapefruit during treatment with budesonide.

Do not crush, break, or chew the capsules. Swallow them whole. They are specially formulated to release the medication after they have passed through the stomach.

What should I avoid while taking budesonide (oral)?

Do not drink grapefruit juice or eat grapefruit during treatment with budesonide.

Budesonide can lower the activity of the immune system making you more susceptible to infection. Avoid contact with people who have colds, the flu, or other contagious illnesses. In addition, do not receive vaccines that contain a live strain of the virus (e.g., live oral polio vaccine) and avoid contact with individuals who have recently been vaccinated with a live virus.

What other drugs will affect budesonide (oral)?

Before taking budesonide, tell your doctor if you are taking any of the following medicines:

  • the stomach medicine cimetidine (Tagamet, Tagamet HB);

  • an antifungal medicine such as ketoconazole (Nizoral) or itraconazole (Sporanox);

  • an AIDS or HIV medicine such as amprenavir (Agenerase), ritonavir (Norvir), indinavir (Crixivan), nelfinavir (Viracept), or saquinavir (Fortovase, Invirase); or

  • the antibiotic erythromycin (ESS Granules, ESS-200, ESS-400, E-Mycin, Eryc, Ery-Tab, Ilosone, MY-E, Robimycin, others).

You may not be able to take budesonide, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with budesonide. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

What happens if I have an overdose of budesonide (oral)?

Seek emergency medical attention. A single large dose of this medication is unlikely to cause symptoms or death. An overdose is more likely to be caused by a chronic overdose—large doses taken over a period of time.

Symptoms of a chronic overdose include obesity (especially around the stomach); a round face; increased hair growth (especially around the face); acne; bruising; increased blood pressure; swollen hands, feet, or ankles (fluid retention); and sore or weak muscles.

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. Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Content provided by Multum - Last Updated 2/11/2008