budesonide 2 mg/actuation rectal foam

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Medication name

Generic name:
Budesonide foam - rectal

Pronunciation
(bue-DES-oh-nide)

Brand name(s)
Uceris

Uses

This medication is used to treat symptoms of a certain bowel disease (ulcerative colitis). It works by reducing swelling (inflammation). Budesonide belongs to a class of drugs known as corticosteroids. Budesonide does not cure ulcerative colitis, but it may help relieve symptoms such as abdominal pain, diarrhea, and bloody stools. Using this medication as a foam allows it to work directly on the bowel and rectum.

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. Follow the illustrated directions for the proper use of this medication. If you have any questions, ask your doctor or pharmacist.

Use this medication as a foam in the rectum as directed by your doctor, usually in the morning and evening for the first 2 weeks, then once a day in the evening for the next 4 weeks. It is best to use this medication just before bedtime in the evening.

This medication is flammable. Avoid smoking when applying this medication and immediately afterward. Do not use or store it near heat or open flame.

It is best to use this medication after a bowel movement. You may apply this medication while standing, lying down, or sitting. Do not insert any part of the canister into the anus. Use the enclosed applicator to apply this drug. Follow the instructions for attaching the applicator to the canister. Warm the canister in your hands and shake the canister well for 10 to 15 seconds before use. Hold the canister upside down and gently insert the applicator tip into the anus. Push down on the pump and hold it in that position for 2 seconds to apply the foam. Afterward, release your finger from the pump and continue to hold the applicator in place for 10 to 15 seconds. Then, remove the applicator and throw it away. Wash your hands after use. Keep the medication in your rectum for as long as possible, for example overnight.

If you are regularly taking a different corticosteroid by mouth (such as prednisone), you should not stop taking it unless directed by your doctor. Some conditions (such as asthma, allergies) may become worse when the drug is suddenly stopped. You may also have withdrawal symptoms if the drug is suddenly stopped. To prevent withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness), your doctor may direct you to slowly lower the dose of your old medication when you are using budesonide. Ask your doctor or pharmacist for more details, and report any withdrawal reactions right away. See also Precautions section.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) 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 this drug is suddenly stopped. Your dose may need to be gradually decreased.

Tell your doctor if your condition persists or worsens.

Side effects

Nausea may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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.

Rarely, it is possible this medication will be absorbed into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time. Tell your doctor right away if any of the following side effects occur:

  • unusual/extreme tiredness
  • weight loss
  • headache
  • swelling ankles/feet
  • increased thirst/urination
  • vision problems

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 fever, chills, persistent sore throat, 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 or pharmacist 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:

  • liver disease
  • high blood pressure
  • personal or family history of diabetes
  • bone loss (osteoporosis)
  • stomach/intestinal ulcer
  • a certain bowel disease (diverticulitis)
  • mental/mood disorders (such as depression, psychosis)
  • personal or family history of high pressure in the eye (glaucoma)
  • cataracts
  • current/past infections (such as tuberculosis, ocular herpes simplex, fungal)
  • thyroid problems

Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, 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 few months.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Budesonide may mask signs of infection. It can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. 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.

Budesonide may cause vaccines not to work as well. Therefore, do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Though it is unlikely, this medication may slow down a child's growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child's height 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 persistent nausea/vomiting, 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
Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. 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

This medication is flammable. Store at room temperature away from heat and open flame. 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.

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised June 2018.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.