ENTOCORT (BUDESONIDE) ENEMA

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

Budesonide belongs to the class of medications called glucocorticosteroids. Budesonide enemas are used to treat diseases caused by inflammation of the colon and rectum, such as certain types of ulcerative colitis that involve the rectum, sigmoid, and descending colon. It works within the colon and rectum to decrease inflammation.

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 budesonide enema 0.02 mg/mL consists of 2 components: a dispersible tablet and an applicator bottle of vehicle solution.

Each dispersible tablet contains 2.3 mg of micronized budesonide. Nonmedicinal ingredients: colloidal silicon dioxide, lactose, lactose anhydrous, magnesium stearate, cross-linked polyvidone, and riboflavin-5-phosphate sodium.

The vehicle is a solution containing methylparaben, propylparaben, sodium chloride, and purified water.

How should I use this medication?

The usual adult dose of budesonide enema is the contents of one 115 mL enema nightly, at bedtime, for 4 weeks. If necessary, the treatment period may be lengthened to 8 weeks.

To prepare the medication:

• Unscrew the cap from the bottle.
• Remove a tablet from the aluminum foil pack and put it into the bottle.
• Put the cap back on the bottle. Make sure it is on tightly.
• Shake the bottle vigorously for at least 15 seconds, or until the tablet has dissolved. The liquid will be slightly yellow in colour.
• Remove the cap from the bottle and replace with a nozzle from the pouch labelled “Applicator Enema”. Screw the nozzle on the bottle tightly.
• After preparation, the budesonide enema should be used immediately.

To use the medication:

• Lie on whichever side is most comfortable, shake the bottle well, and grasp the bottle at the neck where it is most rigid.
• Carefully insert the nozzle into the rectum.
• Slowly squeeze the container until it is almost empty. You will not be able to empty the whole bottle.
• Remove the tip from the rectum.
• Roll over on your stomach and stay in this position for at least 5 minutes, to allow enough time for the medication to coat the colon.
• Retain the enema as long as possible, preferably the whole night.

Many things can affect the dose of a 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 using the medication without consulting your doctor.

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

If you miss a 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 use this medication if you:

• are allergic to budesonide or any ingredients of the medication
• have complications in the area of the digestive tract where this medication is effective (e.g., bowel perforation, possibility of bowel obstruction, abscess or fistulae)
• have any active bacterial, fungal, or viral infections
• have active tuberculosis 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.

• diarrhea
• feelings of unease
• gas in the stomach or bowels
• itching
• nausea
• skin rash
• sleepiness
• 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:

• behavioural changes (e.g., agitation, anxiety, mood swings, restlessness)
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• vision changes or blurred vision

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

• 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.

Eye problems: The use of corticosteroids has been associated with the development of glaucoma and cataracts. Report any change in vision, blurring of vision, eye pain, eye irritation, redness, or discharge to your doctor as soon as possible.

General precautions: Advise all doctors involved in your care that you have been using this medication. If you have been taking “cortisone” tablets, your doctor may want you to discontinue the tablet form of the medication. Much less corticosteroid is absorbed from budesonide enemas, so stopping the tablets should be done gradually to reduce the likelihood of withdrawal symptoms such as tiredness, headache, nausea, or vomiting.

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.

Medical conditions: People with diabetes, glaucoma, liver disease, osteoporosis, or stomach ulcers 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.

Severe bowel disease: People with severe ulcerative disease of the bowel should use this medication with caution, as they are susceptible to perforation of the bowel wall. If you have severe ulcerative disease, 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.

Stopping medication: Stopping this medication suddenly may cause symptoms of the illness to return. Do not stop using this medication abruptly without checking with your doctor first.

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

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

Children: The safety and effectiveness of budesonide enemas have not been established for children.

What other drugs could interact with this medication?

There may be an interaction between budesonide and any of the following:

• aldesleukin
• aprepitant
• “azole” antifungals (e.g., itraconazole, ketoconazole, voriconazole)
• birth control pills
• cobicistat
• calcium channel blockers (e.g., amlodipine, diltiazem, verapamil)
• conivaptan
• cyclosporine
• dronedarone
• grapefruit juice
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• mifepristone
• protein kinase inhibitors (e.g., crizotinib, idelalisib, nilotinib)
• stiripentol

If you are taking any of these 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.

Medications other than those listed above may interact with this medication. 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.