Budesonide (By mouth)

Introduction

Budesonide (bue-DES-oh-nide)

Treats active Crohn disease. Also helps prevents symptoms of the disease. This medicine is a steroid.

Brand Name(s)

Entocort EC

When This Medicine Should Not Be Used

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding or if you have liver disease (including cirrhosis), osteoporosis, diabetes, high blood pressure, stomach ulcers, tuberculosis, or a family history of cataracts, diabetes, or glaucoma.
• Your risk of adrenal gland problems is increased if you use this medicine for a long time or use too much. Talk to your doctor if you have more than one of these symptoms: darkening of the skin; diarrhea; dizziness or fainting; loss of appetite; depression; nausea or vomiting; skin rash; unusual tiredness or weakness.
• You may get infections more easily while you use this medicine. Avoid people who are sick or have infections. Tell your doctor right away if you have been exposed to someone who has chickenpox or measles.
• Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
• If your symptoms do not improve or if they get worse, call your doctor.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.

How to Use This Medicine

Capsule

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to. This medicine is usually taken in the morning.
• Swallow the capsule whole. Do not break, crush, chew, or open it.
• Keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you also use erythromycin (Ery-tab®), medicine to treat a fungal infection (such as itraconazole, ketoconazole, Nizoral®, or Sporanox®), or medicine to treat HIV or AIDS (such as indinavir, ritonavir, saquinavir, Crixivan®, Invirase®, or Norvir®).
• Tell your doctor if you use a medicine that weakens your immune system, such as other steroids or cancer medicines.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Diarrhea, nausea, vomiting, or loss of appetite
• Darkening of the skin, round or full face, or skin rash
• Fever, chills, cough, sore throat, and body aches
• Lightheadedness, dizziness, or fainting
• Unusual tiredness or weakness

If you notice these less serious side effects, talk with your doctor:

• Headache or upset stomach
• Runny nose, sneezing, or congestion

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088