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budesonide (Rectal route)

Pronunciation

bue-DES-oh-nide

Commonly used brand name(s)

In the U.S.

  • Uceris

Available Dosage Forms:

  • Kit
  • Foam

Therapeutic Class: Gastrointestinal Agent

Pharmacologic Class: Adrenal Glucocorticoid

Uses For budesonide

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.

budesonide is available only with your doctor's prescription.

Before Using budesonide

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 budesonide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to budesonide 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 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.

Geriatric

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.

Interactions with 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 budesonide, 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 budesonide 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
  • Bemiparin
  • Boceprevir
  • Bromfenac
  • Bufexamac
  • Bupropion
  • Celecoxib
  • Ceritinib
  • Choline Salicylate
  • Clonixin
  • Cobicistat
  • Darunavir
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Dipyrone
  • Droxicam
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Flufenamic Acid
  • Flurbiprofen
  • Ibuprofen
  • Idelalisib
  • Indomethacin
  • Ketoprofen
  • Ketorolac
  • Lornoxicam
  • Loxoprofen
  • Lumacaftor
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Morniflumate
  • Nabumetone
  • Nadroparin
  • Naproxen
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Phenylbutazone
  • Piketoprofen
  • Piroxicam
  • Pixantrone
  • Pranoprofen
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Ritonavir
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sodium Salicylate
  • Sulindac
  • Telaprevir
  • Tenoxicam
  • Tiaprofenic Acid
  • Tolfenamic Acid
  • Tolmetin
  • Valdecoxib

Using budesonide 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.

  • Balofloxacin
  • Besifloxacin
  • Ciprofloxacin
  • Enoxacin
  • Erythromycin
  • Fleroxacin
  • Flumequine
  • Gatifloxacin
  • Gemifloxacin
  • Ketoconazole
  • Levofloxacin
  • Lomefloxacin
  • Moxifloxacin
  • Nadifloxacin
  • Norfloxacin
  • Ofloxacin
  • Pazufloxacin
  • Pefloxacin
  • Prulifloxacin
  • Rufloxacin
  • Sparfloxacin
  • Tosufloxacin

Interactions with Food/Tobacco/Alcohol

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of budesonide. 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 budesonide

Use budesonide 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.

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

Keep using budesonide 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 budesonide, it is best to empty your bowels.
  • budesonide is to be applied on the anus. Do not take budesonide 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 budesonide.

Dosing

The dose of budesonide 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 budesonide. 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 budesonide, 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 budesonide 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 budesonide

It is very important that your doctor check your progress at regular visits for any problems or unwanted effects that may be caused by budesonide.

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

Using too much of budesonide 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 budesonide: 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 budesonide. 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 budesonide. You may need to stop using budesonide 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.

budesonide 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:

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.

See also: Side effects (in more detail)

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