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Entocort Capsules

Common Name:

budesonide (capsules)


How does Entocort Capsules work? What will it do for me?

Budesonide capsules belong to the class of medications called corticosteroids. It is used to treat mild-to-moderate Crohn’s disease, an inflammatory disease of the bowel. It works by decreasing inflammation in the intestine and colon. The full effect of this medication is usually seen within 2 to 4 weeks.

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 Entocort Capsules come in?

Each controlled release, 2-piece hard gelatin capsule, with an opaque light-grey body and an opaque pink cap, printed "CIR" over "3mg" in black radial ink, contains micronized budesonide 3 mg. Nonmedicinal ingredients: acetyltributyl citrate, dimethicone, ethylcellulose, gelatin, iron oxide, methacrylic acid copolymer, polysorbate 80, sodium lauryl sulfate, sugar spheres (sucrose and maize starch), talc, titanium dioxide, and triethylcitrate.

How should I use Entocort Capsules?

The recommended adult dose to treat a flare-up of Crohn’s disease is 9 mg taken once daily in the morning before breakfast for up to 8 weeks.

After the initial 8 weeks of treatment and when symptoms are controlled, the recommended adult maintenance dose is 6 mg taken once daily in the morning before breakfast for up to 3 months.

The capsules should be swallowed whole with water and not chewed, broken, or crushed before being swallowed. People who are taking this medication should avoid drinking grapefruit juice or eating grapefruit on a regular basis as this may increase the amount of budesonide that gets into the body and increase the risk of side effects.

If your symptoms are controlled after 3 months, your doctor may suggest that you gradually stop taking this medication by reducing the dose gradually over 2 to 4 weeks. Follow your doctor’s instructions closely.

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

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular schedule. If it is almost time for your next 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 in its original container in a dry place, 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 Entocort Capsules?

Budesonide should not be taken by anyone who:

  • is allergic to budesonide or to any of the ingredients of the medication
  • has a bacterial, fungal, or viral infection
  • has active tuberculosis

What side effects are possible with Entocort Capsules?

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.

  • indigestion

Although most of these side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • acne
  • blurred vision
  • depression
  • filling or rounding out of the face
  • frequent urination
  • headache
  • increased thirst
  • menstrual problems
  • mood swings
  • muscle cramps
  • muscle weakness
  • nervousness
  • palpitations (fast or pounding heartbeat)
  • reddish-purple lines on arms, face, groin, legs, or trunk
  • skin rash or hives
  • stunting of growth (in children)
  • swelling of feet or lower legs
  • symptoms of low potassium (e.g., muscle cramps)
  • thin skin
  • tremor or shaking
  • trouble sleeping
  • unusual increase in hair growth
  • weight gain (rapid)
  • wounds that will not heal

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

  • symptoms of a severe allergic reaction (e.g., hives; difficulty breathing; or swelling of the face, tongue, or 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 Entocort Capsules?

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.

Corticosteroids: Inform all of your doctors if you have recently taken or are taking corticosteroids.

Diabetes: Corticosteroids such as budesonide may cause an increase in blood sugar levels. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication. If you have diabetes or are at risk for developing diabetes, 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.

Illness and surgery: People who take this medication, or have taken other corticosteroids (e.g., prednisone) in the last several months, may need additional corticosteroids (e.g., prednisone) during times of any unusual stress, such as trauma, surgery, or infection.

Infections: When taken by mouth, this medication may mask some signs of infection and put people at increased risk for new infections. Viral infections such as chickenpox, measles, or herpes can be more serious for people who are taking budesonide. Children and adults who have not had these diseases should take particular care to avoid exposure.

Liver problems: If you have cirrhosis, your doctor may monitor you more closely for side effects. People with reduced liver function 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.

Medical conditions: People with the following medical conditions 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.

  • acute heart disease
  • cataracts (or a family history of cataracts)
  • chickenpox
  • diverticulitis
  • glaucoma (or a family history of glaucoma)
  • high blood pressure
  • kidney problems
  • measles
  • mental health issues
  • myasthenia gravis
  • overactive thyroid
  • rubella
  • stomach ulcer
  • thrombophlebitis (blood clot in a vein)

Osteoporosis: Long-term use of corticosteroids may increase the risk of bone loss and osteoporosis. If your doctor recommends that you use this medication for a long period of time, talk to your doctor about supplements and strategies to slow down and reduce bone loss.

Steroid medication use: If you have taken or are still taking an oral steroid medication (e.g., prednisone) during the last several months, consult your doctor before using this medication. If you experience symptoms such as tiredness, headache, nausea, or vomiting while taking this medication, contact your doctor.

Stomach and intestinal problems: When taken by mouth, budesonide may cause heartburn or even stomach ulcers. Tell your doctor if you have had any stomach discomfort or signs of bleeding in the stomach (black, tarry stools). People with certain stomach and intestinal problems (e.g., blockage, infection) 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.

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

Breast-feeding: Budesonide passes into breast milk. If you are a breast-feeding mother and are taking budesonide, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with Entocort Capsules?

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

  • abiraterone acetate
  • aldesleukin
  • antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
  • amiodarone
  • aprepitant
  • “azole” antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • bicalutamide
  • boceprevir
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • colesevelam
  • conivaptan
  • crizotinib
  • cyclosporine
  • deferasirox
  • denosumab
  • desipramine
  • dronedarone
  • echinacea
  • grapefruit juice
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delaviridine, efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • hyaluronidase
  • imatinib
  • leflunomide
  • lomitapide
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • metronidazole
  • nefazodone
  • norfloxacin
  • pimecrolimus
  • simeprevir
  • tacrolimus
  • telaprevir
  • tetracycline
  • vaccines

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.

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