Uceris (Oral)

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

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

Budesonide delayed-release capsules are used to lower protein levels in the urine (proteinuria) in patients who have a kidney disease called primary immunoglobulin A nephropathy (IgAN) and are at risk of worsening.

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

It is very important that your doctor checks your or your child's progress at regular visits to ensure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

If your condition does not improve or if it becomes worse, contact 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 the 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 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, Ortikos™, Tarpeyo™, or Uceris™, check first with your doctor. This may increase your chance of having steroid withdrawal side effects, including 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.

In deciding to use a medicine, you and your doctor will weigh the risks against the benefits. The following points should be considered for this medicine:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medications. Also, let your healthcare provider know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Current studies have not shown any specific problems that would limit the use of budesonide extended-release capsules in children aged 8 to 17 years who weigh more than 25 kilograms (kg). However, safety and effectiveness have not been established for children younger than 8 years or for children aged 8 to 17 years who weigh 25 kg or less. Safety and effectiveness for preventing Crohn's disease symptoms from returning have not been established in children. Since budesonide may slow growth in children, those using it for a long time should have their weight and growth monitored by a doctor regularly.

No studies have been conducted on how age affects the use of budesonide extended-release tablets in children. Safety and effectiveness have not been established. Because budesonide may slow growth in children, those using it for a long time should have their weight and growth checked by a doctor regularly.

No studies have been conducted on how age affects the use of budesonide delayed-release capsules in children. Safety and effectiveness have not been established.

Geriatric

Current studies have not indicated any age-related problems that would limit the use of budesonide in older adults. However, elderly patients are more likely to have liver, kidney, or heart problems related to aging, which may require careful monitoring and possible dose adjustments for patients taking budesonide.

Breast Feeding

There are no adequate studies in women to determine if there is a risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with caution. In these cases, your doctor may adjust the dose or take other precautions. When taking this medicine, it is important for your healthcare provider to know if you are taking any of the medicines listed below. The following interactions have been selected based on 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 prescribe this medication or may change some of your other medications.

• Desmopressin
• Levoketoconazole
• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or the frequency of use for one or both medicines.

• Aceclofenac
• Acemetacin
• Adagrasib
• Amtolmetin Guacil
• Aspirin
• Atazanavir
• Balofloxacin
• Belzutifan
• Bemiparin
• Besifloxacin
• Boceprevir
• Bromfenac
• Bufexamac
• Bupropion
• Celecoxib
• Ceritinib
• Choline Salicylate
• Ciprofloxacin
• Clarithromycin
• Clonixin
• Cobicistat
• Conivaptan
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Duvelisib
• Enoxacin
• Etodolac
• Etofenamate
• Etoricoxib
• Fedratinib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Fexinidazole
• Fleroxacin
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Flumequine
• Flurbiprofen
• Fosnetupitant
• Gatifloxacin
• Gemifloxacin
• Ibuprofen
• Idelalisib
• Indinavir
• Indomethacin
• Itraconazole
• Ivosidenib
• Ketoconazole
• Ketoprofen
• Ketorolac
• Larotrectinib
• Lefamulin
• Lenacapavir
• Levofloxacin
• Lomefloxacin
• Lopinavir
• Lorlatinib
• Lornoxicam
• Loxoprofen
• Lumacaftor
• Lumiracoxib
• Lutetium Lu 177 Dotatate
• Macimorelin
• Mavacamten
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Moxifloxacin
• Nabumetone
• Nadifloxacin
• Nadroparin
• Naproxen
• Nefazodone
• Nelfinavir
• Nepafenac
• Netupitant
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nirmatrelvir
• Norfloxacin
• Ofloxacin
• Olutasidenib
• Omaveloxolone
• Oxaprozin
• Oxyphenbutazone
• Pacritinib
• Parecoxib
• Pazufloxacin
• Pefloxacin
• Phenobarbital
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pirtobrutinib
• Posaconazole
• Pranoprofen
• Primidone
• Proglumetacin
• Propyphenazone
• Proquazone
• Prulifloxacin
• Ritlecitinib
• Ritonavir
• Rofecoxib
• Rufloxacin
• Salicylic Acid
• Salsalate
• Saquinavir
• Sargramostim
• Sodium Salicylate
• Somatrogon-ghla
• Sparfloxacin
• Sulindac
• Telaprevir
• Telithromycin
• Tenoxicam
• Tiaprofenic Acid
• Tocilizumab
• Tolfenamic Acid
• Tolmetin
• Tosufloxacin
• Trofinetide
• Valdecoxib
• Voriconazole

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be necessary for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both medicines.

• Auranofin
• Erythromycin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may adjust the dose or frequency of this medicine, or provide special instructions regarding food, alcohol, or tobacco use.

• Grapefruit Juice

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to inform your doctor about any other medical problems, especially:

• Cataracts (eye disease), or a family history of
• Diabetes, or a family history of
• Eczema (skin disease)
• Glaucoma, or a family history of
• Hypertension (high blood pressure)
• Infection (e.g., bacteria, virus, fungus)
• Osteoporosis (thin bones)
• Rhinitis (inflammation inside your nose)
• Stomach ulcer, whether active or in your history
• Tuberculosis, whether active or in your history
• 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 stronger due to slower removal of the medicine from the body.

• Liver disease, severe—Using delayed-release capsules is not recommended in patients with this condition.

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

• Bruising easily
• chills
• colds
• cough
• diarrhea
• fever
• general feeling of discomfort or illness
• headache
• hoarseness
• joint pain
• loss of appetite
• muscle aches and pains
• nausea
• runny nose
• shivering
• sneezing
• sore throat
• sweating
• trouble sleeping
• unusual tiredness or weakness
• vomiting

Less common

• Bladder pain
• bleeding after defecation
• blistering, crusting, irritation, itching, or reddening of the skin
• bloody or cloudy urine
• blurred vision
• burning feeling while urinating
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• changes in vision
• chest pain or tightness
• cough producing mucus
• decreased urine
• diarrhea
• difficult or labored breathing
• difficult or painful urination
• dizziness
• dry mouth
• eye pain
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling of warmth
• heartburn
• increase in body movements
• increased thirst
• increased urge to urinate during the night
• irregular heartbeat
• lower back or side pain
• mood changes
• nervousness
• pain or discomfort in the chest, upper stomach, or throat
• pinpoint red or purple spots on the skin
• pounding in the ears
• rectal bleeding
• redness of the face, neck, arms, and occasionally, upper chest
• seizures
• severe constipation
• shakiness in the legs, arms, hands, or feet
• shivering
• skin rash, encrusted, scaly, and oozing
• slow or fast heartbeat
• stomach cramps or pain
• sweating
• swelling of the legs and feet
• swelling or puffiness of the face
• trouble sleeping
• uncomfortable swelling around the anus
• upper abdominal or stomach pain
• waking to urinate at night
• weight gain or loss

Incidence not known

• Bulging soft spot on the head of an infant
• change in the ability to see colors, especially blue or yellow
• difficulty with swallowing
• hives, itching, or skin rash
• 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

• Back pain
• belching
• blemishes on the skin
• heartburn
• indigestion
• pain or tenderness around the eyes and cheekbones
• pimples
• rounded or moon face
• stomach discomfort or upset
• stuffy nose

Less common

• Accumulation of pus
• agitation
• bloated or full feeling
• change in hearing
• cracked, dry, or scaly skin
• cracks in the skin at the corners of mouth
• difficulty having a bowel movement
• difficulty with moving
• dizziness or lightheadedness
• ear drainage
• earache or pain in the ear
• excess air or gas in the stomach or bowels
• fatty hump between the shoulders
• feeling of constant movement of self or surroundings
• increased appetite
• increased hair growth, especially on the face
• lack or loss of strength
• loss of memory
• loss or thinning of the hair
• muscle stiffness
• nervousness
• pain, swelling, or redness in the joints
• passing gas
• pressure in the stomach
• problems with memory
• redness, swelling, or soreness of the tongue
• sensation of spinning
• sleepiness or unusual drowsiness
• soreness or redness around the fingernails and toenails
• swelling of the abdominal or stomach area
• swollen joints
• 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.

In the U.S.

• Entocort EC
• Ortikos
• Uceris

In Canada

• Pulmicort
• Pulmicort Spacer

Available Dosage Forms:

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

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Adrenal Glucocorticoid

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 Entocort® EC 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.

Swallow the delayed-release capsule whole. Do not open, crush, or chew it. Take this medicine in the morning, at least 1 hour before a meal.

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 (delayed-release capsules):For proteinuria: Adults—16 milligrams (mg) once a day in the morning for up to 9 months. Before stopping treatment, reduce your dose to 8 mg once a day in the morning for the last 2 weeks of treatment. Children—Use and dose must be determined by your doctor.
• For oral dosage form (extended-release 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 younger than 8 years of age or weighing 25 kg or less—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.

If you miss a dose of the delayed-release capsule, 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.

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