Budesonide, Oral byoo-DES-oh-nide

What are other names for this medicine?

Type of medicine: corticosteroid

Generic and brand names: budesonide, oral; Entocort EC

What is this medicine used for?

This medicine is taken by mouth to treat Crohn's disease in the last part of the small intestine and the first part of the large intestine.

This medicine may be used for other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• blood clots
• cataracts, glaucoma, or other eye problems or eye infection
• depression or other mental illness
• diabetes
• heart disease or a heart attack
• high blood pressure
• liver disease or kidney disease
• myasthenia gravis
• osteoporosis
• seizures
• thyroid disease
• tuberculosis
• ulcers, diverticulitis, or other intestinal problems

Tell your provider if you currently have any kind of infection.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant while taking this medicine. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

This medicine comes in the form of tablets, capsules, or liquid. Swallow the tablets or capsules whole. Do not open, chew, or crush the capsules. If you are taking the liquid medicine, use the measuring device that comes with the medicine to measure the doses carefully.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval. If you have taken it for over 2 weeks, you may have to gradually reduce your dosage to prevent serious side effects.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach.

What if I miss a dose?

If you miss a dose of this medicine and you are taking just one dose daily, take the missed dose as soon as you remember that same day. If you do not remember until the next day, skip the missed dose. Do not take double doses. If you are not sure of what to do if you miss a dose or you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

Contact your healthcare provider if your condition does not improve in a few days or if it gets worse.

This medicine may make you dizzy or confused. It may also affect your vision. Do not drive or operate machinery until you are fully alert and can see clearly. Talk to your healthcare provider about this.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first. Vaccines or skin tests may need to be postponed until after you have stopped taking this medicine. Talk with your healthcare provider about this.

If you have not had chickenpox, the measles, or tuberculosis (TB), and are exposed to them while taking this medicine, contact your healthcare provider right away.

If you use this medicine for a long time, you will need to have checkups regularly to see how this medicine affects you. Keep all appointments.

Diabetics: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (report these to your healthcare provider right away): Signs of an infection (fever, sore throat, pain while urinating, muscle pain); unusual bruising, bleeding or pinpoint red spots on the skin; warm, painful, or swollen ankles or calves, or any unexplained swelling; muscle weakness; depression; unexplained mood changes; confusion; chest pain; irregular heartbeat; vision changes; severe headache; bloody or black bowel movements; seizures.

Other: Nausea, vomiting, dizziness, headache, back pain, gas, changes in menstrual period, nervousness, shaking, trouble sleeping, increased appetite, gradual weight gain, round face, acne, increased sweating, increased hair growth.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• aminoglutethimide (Cytadren)
• antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (Erythrocin, E-Mycin, Ery-Tab), isoniazid, levofloxacin (Levaquin), rifampin (Rifadin, Rimactane), rifabutin (Mycobutin), and rifapentine (Priftin)
• antifungal medicines such as amphotericin B (Abelcet, AmBisome, Amphotec; Fungizone), itraconazole (Sporanox), ketoconazole (Nizoral), and metronidazole (Flagyl)
• antiseizure medicines such as carbamazepine (Tegretol), fosphenytoin (Cerebyx), and phenytoin (Dilantin)
• any other steroid medicines taken by mouth or inhaled
• aprepitant (Emend)
• aspirin and other salicylates
• barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, primidone (Mysoline), and secobarbital (Seconal)
• birth control pills, rings, patches, and implants and hormones such as conjugated estrogens (Premarin), estradiol (Estrace), and estrogens such as Estrace, Estraderm, FemPatch, Vivelle, Premarin, Estinyl, Estratab, and Cenestin
• bupropion (Wellbutrin, Zyban)
• cholesterol-lowering medicines such as cholestyramine (Questran) and colestipol (Colestid)
• cyclosporine (Gengraf, Sandimmune, Neoral)
• diabetes medicines such as glipizide (Glucotrol, Glucotrol XL), glyburide (DiaBeta, Glynase PresTab), insulin, metformin (Glucophage, Glucovance), pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia)
• digoxin (Lanoxin)
• diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• ephedrine
• growth hormones such as somatrem (Protropin) and somatropin (Genotropin, Serostim, Humatrope, Nutropin)
• heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Tiazac), and verapamil (Isoptin, Calan)
• heartburn medicine such as cimetidine (Tagamet)
• medicines to treat Alzheimer’s such as donepezil (Aricept), galantamine (Razadyne), rivastigmine (Exelon), and tacrine (Cognex)
• medicines to treat myasthenia gravis such as guanidine, neostigmine (Prostigmin), and pyridostigmine (Regonol, Mestinon)
• medicines to treat HIV such as indinavir (Crixivan), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• nonsteroidal anti-inflammatory drugs (NSAIDs) such as diclofenac (Voltaren, Cataflam), ibuprofen (Motrin, Motrin IB, Advil), indomethacin (Indocin), ketoprofen, nabumetone (Relafen), naproxen (Naprosyn, Anaprox, Aleve, Naprelan), oxaprozin (Daypro), ketorolac (Toradol), piroxicam (Feldene), and sulindac (Clinoril)
• quetiapine (Seroquel)
• warfarin (Coumadin)

Do not drink grapefruit juice while taking this medicine. Grapefruit affects the way this medicine works and may increase the risk of side effects.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.