Entocort


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

Budesonide belongs to the class of medications called corticosteroids. It is used to treat Crohn’s disease, an inflammatory disease of the bowel. Budesonide is useful in mild-to-moderate cases of Crohn’s disease. It works by decreasing inflammation in the intestine and colon.

Your doctor may have suggested this medication for conditions other than the ones 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.

How should I use Entocort Capsules?

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

To maintain control over the disease and prevent further flare-ups, the recommended adult maintenance dose is 6 mg taken once daily in the morning before breakfast. This may be reduced to the lowest dose where control is still maintained.

The capsules should be swallowed whole with water, and not chewed, broken, or crushed before being swallowed.

To end treatment with Budesonide, it is recommended that the dose be reduced gradually over two to four weeks before stopping the medication.

Many things can affect the dose of a 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 that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible 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.

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.

What form(s) does Entocort Capsules come in?

Each controlled ileal 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.

Some medications may have other generic brands available. Always ask your doctor or pharmacist about the safety of switching between brands of the same medication.

Who should NOT take Entocort Capsules?

Budesonide should not be taken by anyone who has:

  • an internal or local bacterial, fungal, or viral infection
  • an allergy to Budesonide or any of the ingredients of the medication
  • 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.

More common:

  • increased appetite
  • indigestion
  • nervousness or restlessness

Less common or rare:

  • darkening or lightening of skin color
  • dizziness or lightheadedness
  • flushing of face or cheeks
  • hiccups
  • increased sweating
  • sensation of spinning

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

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

Less common:

  • decreased or blurred vision
  • frequent urination
  • increased thirst

Rare:

  • confusion
  • depression
  • excitement
  • false sense of well-being
  • hallucinations
  • mistaken feelings of self-importance or of being mistreated
  • mood swings (sudden and wide)
  • palpitations
  • restlessness
  • skin rash or hives

Additional side effects may occur if this medication is used for long periods of time. Check with the doctor if any of the following side effects occur:

  • abdominal or stomach pain or burning (continuing)
  • acne
  • bloody or black, tarry stools
  • changes in vision
  • eye pain
  • filling or rounding out of the face
  • headache
  • irregular heartbeat
  • menstrual problems
  • muscle cramps or pain
  • muscle weakness
  • nausea
  • pain in arms, back, hips, legs, ribs, or shoulders
  • reddish-purple lines on arms, face, groin, legs, or trunk
  • redness of eyes
  • sensitivity of eyes to light
  • stunting of growth (in children)
  • swelling of feet or lower legs
  • tearing of eyes
  • thin, shiny skin
  • trouble sleeping
  • unusual bruising
  • unusual increase in hair growth
  • unusual tiredness or weakness
  • vomiting
  • weight gain (rapid)
  • wounds that will not heal

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.

Diabetes: When taken by mouth, Budesonide may lead to poor blood glucose control for people with diabetes. High blood sugar may occur, glucose tolerance may be altered, and diabetes may worsen. If you have diabetes, monitor your blood glucose closely while taking Budesonide (by mouth) and report any abnormalities to your doctor.

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

Gastrointestinal: 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).

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 take Budesonide. Children and adults who have not had these diseases should take particular care to avoid exposure.

Medical conditions: As this medication may affect other co-existing medical conditions, inform your doctor if you have the following conditions:

  • active stomach ulcer
  • acute heart disease
  • blood circulation diseases
  • cataracts
  • diabetes
  • diverticulitis
  • glaucoma
  • high blood pressure
  • kidney problems
  • myasthenia gravis
  • osteoporosis
  • overactive thyroid
  • psychiatric disturbances

Osteoporosis: When taken by mouth, long-term use of Budesonide may result in weakening of the bones, causing them to have an increased risk for fracture. If you have been taking this medication on a continuous basis, talk with your doctor about your particular risk for osteoporosis.

Stress: People who take this medication by mouth and who are subjected to any unusual stress should increase the dosage of rapidly-acting corticosteroids before, during, and after the stressful situation as prescribed by their doctor.

Pregnancy: The safety of Budesonide use by pregnant women is not established. Its use by pregnant women is not recommended unless benefits outweigh the risks.

Breast-feeding: Budesonide is not recommended for use by nursing mothers.

Children: The safety and effectiveness of Budesonide for use by children have not been established. Its use by this age group is not recommended.

What other drugs could interact with Entocort Capsules?

There may be an interaction between Budesonide and any of the following:

  • cyclosporine
  • erythromycin
  • fluconazole
  • grapefruit juice
  • itraconazole
  • ketoconazole
  • miconazole

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. In many cases, interactions are intended or are managed by close monitoring. 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 that 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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