How does this medication work? What will it do for me?

Budesonide rectal foam belongs to the class of medications called corticosteroids. It is used to treat mild to moderate ulcerative colitis in the lower part of the digestive tract. Ulcerative colitis is caused by inflammation of the colon and rectum, which causes symptoms such as abdominal pain and cramping, weight loss, fatigue, as well as rectal pain and bleeding.  Budesonide rectal foam works within the last 40 cm of the colon and rectum to decrease inflammation and symptoms.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each metered dose of rectal foam provided by actuating the canister, contains 2 mg of budesonide. Nonmedicinal ingredients: cetyl alcohol, citric acid monohydrate, edetate disodium, emulsifying wax, polyoxyl (10) stearyl ether, propylene glycol, and purified water; propellant: isobutane, N-butane, and propane.

How should I use this medication?

The usual adult dose of this medication is the application of 1 metered dose of foam into the rectum twice daily, using the single-use disposable applicators that come with the medication.  After 2 weeks of using the medication in the morning and evening, the use of the medication should be reduced to once daily in the evening for 4 weeks. Try to not have a bowel movement until the following morning.

  1. Before using the medication, use the bathroom to empty your bowels.
  2. Remove an applicator from the special tray included in the package. Push the applicator firmly onto the nozzle of the canister.
  3. Unlock the canister by twisting the dome on the top of the canister until the notch underneath the dome is in line with the nozzle.
  4. Warm the canister by holding it in your hand.
  5. Shake the canister vigorously for 10 to 15 seconds.
  6. Place your index finger on top of the pump dome and turn the canister upside down. The canister will only work properly with the dome pointing down.
  7. Insert the applicator into the rectum as far as it is comfortable.
  8. Fully push down on the pump dome and hold it for 2 seconds in that position.
  9. Release finger pressure on the dome and hold the applicator in place for 10 to 15 seconds.
  10. Remove the applicator from the rectum.
  11. Remove the applicator from the canister and safely discard.
  12. Twist the notch on the dome away from the nozzle to close the canister.
  13. Wash your hands with soap and water.

Review the information provided in the package with the medication and applicators. If you have questions about preparing a dose, talk to your doctor or pharmacist before using the foam for the first time.

The propellant in this medication is flammable. Avoid fire, flame, and smoking while using this medication and immediately after administering a dose.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to budesonide or any ingredients of the medication
  • have or have had tuberculosis
  • have herpes simplex of the eye
  • have an untreated fungal, bacterial, systemic viral, or parasitic infection

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • constipation
  • headache
  • trouble sleeping

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • anxiety
  • aggressiveness
  • signs of infections or increased frequency of infections (e.g., symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • symptoms of decreased adrenal gland function (e.g., round face, weight gain, high blood sugar, swollen legs, irregular menstrual periods, unwanted body hair, acne, stretch marks)
  • symptoms of glaucoma (e.g., blurred vision, seeing halos of bright colours around lights, red eyes, increased pressure in your eyes, eye pain or discomfort)
  • symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
  • symptoms of severely increased blood pressure: (e.g., chest pain, blurred vision, dizziness, excessive tiredness, headache, stronger or faster heartbeat)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Adrenal gland problems: Adrenal glands produce chemical messengers that are responsible for the normal function of the body’s organs, including how your body responds to injury or stress. Although budesonide rectal foam is not absorbed into the body to the same degree that oral corticosteroids are, the use of this medication may cause your adrenal gland to function improperly. Your doctor may monitor your adrenal gland condition especially if you have experienced stress such as surgery, injury, or severe infection.

Blood pressure: This medication can increase blood pressure, especially when high doses are used. Your doctor will monitor your blood pressure closely while you are taking this medication. Your doctor may suggest diet changes or other measures to keep your blood pressure under control. People with high blood pressure should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Diabetes: Budesonide may cause a loss of control of blood glucose levels, resulting in increased blood sugar and changed glucose tolerance. If you have diabetes, it may be necessary to test your blood sugar levels more often while you are using this medication.

General precautions: Advise all doctors involved in your care that you have been using this medication.

Infections: This medication may mask some signs of infection, and new infections may occur. Contact your doctor if you notice any symptoms of an infection (e.g., fever, chills, cough, sore throat), or if you are in contact with someone who has measles or chickenpox.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Osteoporosis: This medication can increase the risk of osteoporosis (brittle bones). Talk to your doctor about ways to help prevent osteoporosis. Your doctor will monitor your bone density if you take this medication for a long period of time.

Vision problems: Budesonide may cause changes in vision as a result of increased pressure in the eye (glaucoma) or clouding of the lens of the eye (cataracts). If you have glaucoma or cataracts, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Report any vision changes, blurring vision, eye pain, eye irritation, redness, or discharge to your doctor as soon as possible, while you are using this medication.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are breast-feeding and using budesonide rectal foam, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: Seniors may be at an increased risk of experiencing the side effects of this medication as a result of decreased liver, kidney or heart function. Lower doses may be needed.

What other drugs could interact with this medication?

For a full list of interactions, use the Drug Interaction Checker available on the website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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