Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Entocort EC
  2. Uceris

Canadian Brand Name

  1. Pulmicort
  2. Pulmicort Spacer

Descriptions


Budesonide is used to treat mild to moderate active Crohn's disease, an inflammatory bowel disease. This medicine works inside the intestines (bowels) to reduce inflammation and symptoms of the disease. It also helps keep the symptoms of Crohn's disease from coming back. Budesonide is a steroid (cortisone-like) medicine.

Budesonide extended-release tablets are used to help get active mild to moderate ulcerative colitis under control (induce remission).

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Capsule, Extended Release
  • Capsule, Delayed Release
  • Tablet, Extended Release

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of budesonide extended-release capsules in children 8 to 17 years of age and weighing more than 25 kilograms (kg). However, safety and efficacy have not been established in children younger than 8 years of age, or in children 8 to 17 years of age and weighs 25 kg or less.

Appropriate studies have not been performed on the relationship of age to the effects of budesonide extended-release tablets in the pediatric population. Safety and efficacy have not been established. Because budesonide may cause slowed growth in children, those who will be using it for a long time should have their weight and growth measured by the doctor regularly.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of budesonide in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving budesonide.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Desmopressin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aceclofenac
  • Acemetacin
  • Amtolmetin Guacil
  • Balofloxacin
  • Bemiparin
  • Besifloxacin
  • Boceprevir
  • Bromfenac
  • Bufexamac
  • Bupropion
  • Celecoxib
  • Ceritinib
  • Choline Salicylate
  • Ciprofloxacin
  • Clonixin
  • Cobicistat
  • Conivaptan
  • Darunavir
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Dipyrone
  • Droxicam
  • Duvelisib
  • Enoxacin
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Fleroxacin
  • Floctafenine
  • Flufenamic Acid
  • Flumequine
  • Flurbiprofen
  • Fosnetupitant
  • Gatifloxacin
  • Gemifloxacin
  • Ibuprofen
  • Idelalisib
  • Indomethacin
  • Ivosidenib
  • Ketoprofen
  • Ketorolac
  • Larotrectinib
  • Lefamulin
  • Levofloxacin
  • Lomefloxacin
  • Lorlatinib
  • Lornoxicam
  • Loxoprofen
  • Lumacaftor
  • Lumiracoxib
  • Lutetium Lu 177 Dotatate
  • Macimorelin
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Morniflumate
  • Moxifloxacin
  • Nabumetone
  • Nadifloxacin
  • Nadroparin
  • Naproxen
  • Nepafenac
  • Netupitant
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Norfloxacin
  • Ofloxacin
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Pazufloxacin
  • Pefloxacin
  • Phenylbutazone
  • Piketoprofen
  • Piroxicam
  • Pranoprofen
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Prulifloxacin
  • Ritonavir
  • Rofecoxib
  • Rufloxacin
  • Salicylic Acid
  • Salsalate
  • Sargramostim
  • Sodium Salicylate
  • Sparfloxacin
  • Sulindac
  • Telaprevir
  • Tenoxicam
  • Tiaprofenic Acid
  • Tolfenamic Acid
  • Tolmetin
  • Tosufloxacin
  • Valdecoxib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Auranofin
  • Erythromycin
  • Ketoconazole

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Cataracts (eye disease), or a family history of or
  • Diabetes, or a family history of or
  • Eczema (skin disease) or
  • Glaucoma, or a family history of or
  • Hypertension (high blood pressure) or
  • Infection (eg, bacteria, virus, fungus) or
  • Osteoporosis (thin bones) or
  • Rhinitis (inflammation inside your nose) or
  • Stomach ulcer, active or history of or
  • Tuberculosis, active or history of or
  • Weakened immune system—Use with caution. May make these conditions worse.
  • Liver disease (including cirrhosis), moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop using this medicine without first checking with your doctor.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the extended-release capsule and extended-release tablet whole. Do not break, crush, chew, or open it.

If you cannot swallow the extended-release capsule, you may open it and mix the granules into a tablespoonful of applesauce (not hot). Swallow the mixture whole. Do not chew or crush the granules. Take the mixture within 30 minutes. Drink a glass (8 ounces) of water right after.

Keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.

Grapefruit and grapefruit juice may increase the effects of budesonide by increasing the amount of this medicine in your body. You should not eat grapefruit or drink grapefruit juice while you are using this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For mild to moderate active Crohn's disease:
      • Adults—9 milligrams (mg) once a day in the morning for up to 8 weeks. Your doctor may adjust your dose as needed.
      • Children 8 to 17 years of age and weighing more than 25 kilograms (kg)—At first, 9 mg once a day in the morning for up to 8 weeks, followed by 6 mg once a day in the morning for 2 weeks.
      • Children 8 to 17 years of age and weighing 25 kg or less—Use and dose must be determined by your doctor.
      • Children younger than 8 years of age—Use and dose must be determined by your doctor.
    • For prevention of symptoms of Crohn's disease from coming back:
      • Adults—6 milligrams (mg) once a day in the morning for up to 3 months. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (extended-release tablets):
    • For mild to moderate ulcerative colitis:
      • Adults—9 milligrams (mg) once a day in the morning for up to 8 weeks.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Throw away any unused applesauce mixture after 30 minutes.

Precautions

It is very important that your doctor check your or your child's progress at regular visits for any problems or unwanted effects that may be caused by this medicine.

If your condition does not improve or if it become worse, check with your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these side effects occur, get emergency help at once.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you have more than one of these symptoms while you are using this medicine: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

If you are taking another steroid medicine and will switch to Entocort® EC or Uceris™, check first with your doctor. This may increase your chance of having steroid withdrawal side effects, such as headache, loss of appetite, blurred vision, change in the ability to see colors (especially blue or yellow), or vomiting.

You may get infections more easily while using this medicine. Avoid people who are sick or have infections. Tell your doctor right away if you have been exposed to someone with chickenpox or measles.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Bruising easily
  2. chills
  3. colds
  4. cough
  5. diarrhea
  6. fever
  7. general feeling of discomfort or illness
  8. headache
  9. hoarseness
  10. joint pain
  11. loss of appetite
  12. muscle aches and pains
  13. nausea
  14. runny nose
  15. shivering
  16. sneezing
  17. sore throat
  18. sweating
  19. trouble sleeping
  20. unusual tiredness or weakness
  21. vomiting

Less common

  1. Bladder pain
  2. bleeding after defecation
  3. blistering, crusting, irritation, itching, or reddening of the skin
  4. bloody or cloudy urine
  5. blurred vision
  6. burning feeling while urinating
  7. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  8. changes in vision
  9. chest pain
  10. cough producing mucus
  11. decreased urine
  12. diarrhea
  13. difficult or labored breathing
  14. difficult or painful urination
  15. dizziness
  16. dry mouth
  17. eye pain
  18. fast, irregular, pounding, or racing heartbeat or pulse
  19. feeling of warmth
  20. heartburn
  21. increase in body movements
  22. increased thirst
  23. increased urge to urinate during the night
  24. irregular heartbeat
  25. lower back or side pain
  26. mood changes
  27. nervousness
  28. pain or discomfort in the chest, upper stomach, or throat
  29. pinpoint red or purple spots on the skin
  30. pounding in the ears
  31. rectal bleeding
  32. redness of the face, neck, arms, and occasionally, upper chest
  33. seizures
  34. severe constipation
  35. shakiness in the legs, arms, hands, or feet
  36. shivering
  37. skin rash, encrusted, scaly, and oozing
  38. slow or fast heartbeat
  39. stomach cramps or pain
  40. sweating
  41. swelling of the legs and feet
  42. swelling or puffiness of the face
  43. tightness in the chest
  44. trouble sleeping
  45. uncomfortable swelling around the anus
  46. upper abdominal or stomach pain
  47. waking to urinate at night
  48. weight gain or loss

Incidence not known

  1. Bulging soft spot on the head of an infant
  2. change in the ability to see colors, especially blue or yellow
  3. difficulty with swallowing
  4. hives, itching, or skin rash
  5. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  1. Belching
  2. blemishes on the skin
  3. heartburn
  4. indigestion
  5. pain or tenderness around the eyes and cheekbones
  6. pimples
  7. rounded or moon face
  8. stomach discomfort or upset
  9. stuffy nose

Less common

  1. Accumulation of pus
  2. agitation
  3. bloated or full feeling
  4. change in hearing
  5. cracked, dry, or scaly skin
  6. cracks in the skin at the corners of mouth
  7. difficulty having a bowel movement
  8. difficulty with moving
  9. dizziness or lightheadedness
  10. ear drainage
  11. earache or pain in the ear
  12. excess air or gas in the stomach or bowels
  13. feeling of constant movement of self or surroundings
  14. hair loss or thinning of the hair
  15. increased appetite
  16. increased hair growth, especially on the face
  17. lack or loss of strength
  18. loss of memory
  19. muscle stiffness
  20. nervousness
  21. pain, swelling, or redness in the joints
  22. passing gas
  23. pressure in the stomach
  24. problems with memory
  25. redness, swelling, or soreness of the tongue
  26. sensation of spinning
  27. sleepiness or unusual drowsiness
  28. soreness or redness around the fingernails and toenails
  29. swelling of the abdominal or stomach area
  30. swollen joints
  31. uterine bleeding between menstrual periods

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.