Pronunciation:

bue-DES-oh-nide

Brand Names:

• Uceris

Dosage Forms:

• Foam

Classifications:

Therapeutic—

Gastrointestinal Agent

Pharmacologic—

Adrenal Glucocorticoid

Uses of This Medicine:

Budesonide rectal foam is used to help get mild to moderate active ulcerative colitis that extends from the rectum to the sigmoid colon under control (induce remission). Budesonide is a steroid (cortisone-like) medicine.

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

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of budesonide rectal foam 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.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of budesonide rectal foam 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 rectal foam.

Breast-feeding—

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.

Other medicines—

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
• Levoketoconazole
• Rotavirus Vaccine, Live

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
• 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 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

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 is usually not recommended, 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 of This Medicine:

Use this medicine exactly as directed by your doctor. Do not use it more often, and do not use it for a longer time than your doctor ordered.

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

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.

To use:

• Before using this medicine, it is best to empty your bowels.
• This medicine is to be applied on the anus. Do not take this medicine by mouth.
• Attach the applicator (provided in the package) to the can. Each applicator is coated with a lubricant. If additional lubrication is needed, you may use petrolatum or petroleum jelly.
• Warm the canister foam by shaking it in your hands for 10 to 15 seconds.
• You may use the rectal foam in a standing, lying, or sitting position (eg, while using the toilet).
• Apply the foam in the morning and evening for the first 2 weeks. When applied in the evening, use it before bedtime. Try not to empty bowels until the next morning.

Do 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 rectal dosage form (foam):
  • For induction of remission mild to moderate distal ulcerative colitis
    • Adults—One metered dose (containing 2 milligrams [mg]) two times a day (in the morning and evening) for the first 2 weeks. After 2 weeks, apply it once a day in the evening (before bedtime) for 4 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.

Store the foam can at room temperature, away from heat and direct light. Do not keep this medicine inside a car where it could be exposed to extreme heat. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Precautions While Using This Medicine:

It is very important that your doctor check your 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.

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 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 of This Medicine:

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:

Less common

Darkening of the skin

diarrhea

dizziness

fainting

loss of appetite

mental depression

nausea

skin rash

unusual tiredness or weakness

vomiting

Incidence not known

Blistering, burning, crusting, dryness, or flaking of the skin

blurred vision

cough or hoarseness

difficulty swallowing

fever or chills

headache

hives or itching

itching, scaling, severe redness, soreness, or swelling of the skin

lower back or side pain

painful or difficult urination

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

slow or fast heartbeat

tightness in the chest

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:

Rare

Blemishes on the skin

pimples

trouble sleeping

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.