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Budesonide Oral tablet, extended release

It is used in the treatment of Crohn's disease and ulcerative colitis which are types of inflammator... more

Generic Name: budesonide

Brand Names: Entocort EC

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 02/18/2010] FDA notified healthcare professionals and consumers that, due to safety concerns, FDA is requiring a risk management strategy (REMS) and class-labeling changes for all Long-Acting Beta-Agonists (LABAs). The REMS will require a revised Medication Guide written specifically for patients, and a plan to educate healthcare professionals about the appropriate use of LABAs. These changes are based on FDA's analyses of studies showing an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations in pediatric and adult patients as well as death in some patients using LABAs for the treatment of asthma.

Healthcare professionals are reminded that to ensure the safe use of these products:

  • Single-ingredient LABAs should only be used in combination with an asthma controller medication; they should not be used alone.
  • LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications.
  • LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.
  • Pediatric and adolescent patients who require the addition of a LABA to an inhaled corticosteroid should use a combination product containing both an inhaled corticosteroid and a LABA, to ensure compliance with both medications.

FDA has determined that the benefits of LABAs in improving asthma symptoms outweigh the potential risks when used appropriately with an asthma controller medication in patients who need the addition of LABAs. FDA believes the safety measures recommended will improve the safe use of these drugs. For more information visit the FDA website at: [Web] and [Web].

REMS:

FDA approved a REMS for budesonide to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of budesonide and consists of the following: communication plan. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

What is this medicine?

BUDESONIDE (bue DES oh nide) is a corticosteroid. It is used in the treatment of Crohn's disease and ulcerative colitis which are types of inflammatory bowel disease.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • any active infection
  • cataracts
  • diabetes
  • immune system problems
  • glaucoma
  • high blood pressure
  • history of stomach bleeding or stomach ulcers
  • liver disease
  • osteopetrosis
  • an unusual or allergic reaction to budesonide, other corticosteroids, medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, chew, crush, or break open this medicine. Take your dose in the morning. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine except on the advice of your doctor or health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • mifepristone

This medicine may also interact with the following medications:

  • anastrozole
  • antacids
  • cimetidine
  • grapefruit juice
  • ketoconazole

What should I watch for while using this medicine?

This medicine may increase your risk of getting an infection. Stay away from people who are sick. Tell your doctor or health care professional if you are around anyone with measles or chickenpox.

You may need to avoid receiving certain vaccines or may need to have changes in the vaccination schedules to ensure adequate protection from certain diseases. Make sure to tell your doctor or health care professional that you are taking this medicine before receiving any vaccine.

If you are going to have surgery, tell your doctor or health care professional that you are taking this medicine.

This medicine can affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.

Alcohol, grapefruit, and grapefruit juice can increase the risk of getting serious side effects while you are taking this medicine. Avoid grapefruit, grapefruit juice, and alcoholic drinks while taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • changes in vision
  • fever, sore throat, sneezing, cough, or other signs of infection, wounds that will not heal
  • frequent passing of urine
  • increased thirst
  • mental depression, mood swings, mistaken feelings of self-importance or of being mistreated
  • pain in hips, back, ribs, arms, shoulders, or legs
  • severe stomach pain
  • swelling of feet or lower legs
  • unusually weak or tired
  • vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • headache
  • increased appetite
  • nausea
  • skin problems, acne, thin and shiny skin


Last Updated: January 17, 2013
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