Uses

This medication is used to treat symptoms of inflammatory bowel disease (ulcerative colitis). Budesonide does not cure this condition, but it may help relieve symptoms such as abdominal pain, diarrhea, and bloody stools. Using this medication as an enema allows it to work directly on the bowel and rectum. Budesonide is a corticosteroid that works by decreasing swelling (inflammation).

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start using budesonide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Use this medication as an enema in the rectum as directed by your doctor, usually once daily in the evening at bedtime. Dissolve the tablet in the enema solution provided, shaking well for at least 10 seconds. The mixed solution should be pale yellow. After mixing, use the solution right away. Do not prepare the solution in advance. Do not swallow the tablet.

For best results, use after a bowel movement. Lie on your left side with the left knee bent toward the chest. Gently insert the nozzle into the rectum. Gently but firmly squeeze the bottle so that all of the drug flows into the rectum. Straighten your leg, roll over on your stomach, and stay in that position for at least 5 minutes. Keep the medicine in your rectum overnight or for as long as possible.

The dosage and length of treatment are based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Do not stop using this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Also, you may experience symptoms such as extreme tiredness, muscle/joint pain, headache, weakness, or nausea. To prevent these symptoms while you are stopping treatment with this drug, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details. Report any new or worsening symptoms right away.

Tell your doctor if your condition lasts or gets worse.

Side Effects

See also Precautions section.

Gas, nausea, diarrhea, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Because this medication is used as an enema, serious side effects are less likely than with corticosteroids taken by mouth. Tell your doctor right away if any of these rare but very serious side effects occur:

• headache that is severe or doesn't go away
• mental/mood changes (such as depression, mood swings, agitation, confusion)
• unusual/extreme tiredness
• weight loss
• swelling ankles/feet
• bone pain
• vision problems
• increased thirst/urination
• symptoms of stomach/intestinal bleeding (such as stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds)

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using budesonide, tell your doctor if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• stomach/intestinal problems (such as blockage, perforation, recent intestinal surgeries, ulcer, diverticulitis, infections including abscesses and peritonitis)
• current/past infections (such as tuberculosis, ocular herpes simplex, fungal)
• mental/mood disorders (such as depression, psychosis)
• diabetes
• certain eye problems (cataracts, glaucoma)
• high blood pressure
• liver disease
• bone loss (osteoporosis)
• thyroid problems

Using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. If you will be using this medication for a long time, carry a warning card or medical ID bracelet that identifies your use of this medication.

Budesonide may mask signs of infection. It can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using budesonide before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Older adults may be more sensitive to the side effects of this drug, especially bone loss/pain, stomach/intestinal bleeding, and mental/mood changes (such as confusion).

This medication may slow down a child's growth if used for a long time. Consult the doctor or pharmacist for more details. See the doctor regularly so your child's height and growth can be checked.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Babies born to mothers who have used corticosteroids for a long time may develop hormone problems. Tell your doctor right away if you notice symptoms such as nausea/vomiting that doesn't stop, severe diarrhea, or weakness in your newborn.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• aldesleukin
• mifepristone
• drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as dabigatran/warfarin, NSAIDs such as aspirin/celecoxib/ibuprofen)

If your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lifestyle changes that may help reduce the risk of bone loss (osteoporosis) during long-term corticosteroid treatment include weight-bearing exercise, getting enough calcium and vitamin D, stopping smoking, and limiting alcohol. Ask your doctor about lifestyle changes that may benefit you.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Storage

Store the tablet and unmixed solution at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details.