ENTOCORT

Entocort contains the active ingredient budesonide. It belongs to a class of medications known as corticosteroid.

It is used to reduce inflammation in the digestive tract to help treat certain types of Crohn's disease affecting the ileum and the beginning of the large intestine.

Entocort may be prescribed for:

Treating mild to moderate active Crohn's disease involving the ileum and/or ascending colon

Helping bring Crohn's disease symptoms under control during active flare-ups

Maintaining symptom control for up to 3 months in some adults after symptoms improve

Use this medication only as directed by a licensed healthcare professional.

Important: ENTOCORT (BUDESONIDE) CAN WEAKEN YOUR IMMUNE SYSTEM AND MAY REDUCE YOUR BODY'S NATURAL STEROID HORMONE PRODUCTION (ADRENAL SUPPRESSION), ESPECIALLY IF USED FOR A LONG TIME OR WHEN SWITCHING FROM ANOTHER CORTICOSTEROID.

Contact a healthcare professional immediately if you experience symptoms of a serious reaction.

Do not stop, start, or change the dose of this medication without consulting your healthcare provider unless instructed otherwise.

Entocort can weaken your immune system, making it harder for your body to fight infections. It may also reduce your body's natural steroid hormone production (adrenal suppression), especially after long-term use or when switching from another corticosteroid. Long-term use may increase the risk of osteoporosis, glaucoma, cataracts, and other steroid-related side effects.

Take Entocort exactly as prescribed by your healthcare provider.

General administration information:

Route: Oral

With food: Either

Typical administration: Take once daily in the morning, unless your healthcare provider gives different instructions. Take once daily in the morning, unless your healthcare provider gives different instructions. The recommended adult dose is 9 mg (three 3 mg capsules) once daily for up to 8 weeks to treat active disease. After symptoms improve, your healthcare provider may prescribe 6 mg (two 3 mg capsules) once daily for up to 3 months to help maintain remission.

Special instructions: Swallow the capsules whole with a glass of water when possible. Do not crush or chew the capsules or their contents. If you are unable to swallow a capsule whole, ask your healthcare provider about opening the capsule and sprinkling the granules on a tablespoon of applesauce, which is an FDA-approved alternate method of administration; the mixture should be swallowed right away without chewing and followed with a glass of water.

Your individual dose may depend on your medical condition, age, kidney or liver function, other medications, and your healthcare provider’s instructions.

Do not use Entocort if:

You are allergic to budesonide or any of the ingredients in Entocort.

You have had a serious allergic reaction to budesonide or any ingredient in the product.

Consult your healthcare provider before taking this medication if you are unsure whether any of these conditions apply to you.

Before taking Entocort, tell your healthcare provider if you:

Have tuberculosis or another untreated infection, or have been exposed to chickenpox or measles

Have high blood pressure, diabetes, osteoporosis, glaucoma, or cataracts

Have kidney problems

Have liver problems

Are scheduled for surgery or a medical procedure

Are pregnant or planning to become pregnant

Are breastfeeding

Take other prescription or nonprescription medications

Common side effects

Common side effects may include:

Headache

Nausea

Abdominal pain

Tiredness

Serious side effects — seek immediate medical attention if these occur.

Seek immediate medical attention if you experience:

Signs of a serious infection, such as fever, chills, or persistent sore throat

Symptoms of adrenal insufficiency, such as severe tiredness, dizziness, fainting, or vomiting

Vision changes, severe eye pain, or other symptoms of glaucoma or cataracts

Signs of a severe allergic reaction, such as swelling of the face, lips, tongue, or throat or difficulty breathing

This is not a complete list of possible side effects.

Entocort may interact with certain prescription medications, over-the-counter medicines, vitamins, supplements, or herbal products.

Important interactions may include:

Strong CYP3A4 inhibitors, such as ketoconazole, itraconazole, ritonavir, or clarithromycin, which can increase budesonide levels in your body.

CYP3A4 inducers, such as rifampin, carbamazepine, or phenytoin, which may reduce how well Entocort works.

Other corticosteroids or immunosuppressant medicines, which may increase the risk of steroid-related side effects or infections.

Grapefruit or grapefruit juice, which can increase the amount of budesonide in your bloodstream and should be avoided during treatment.

Tell your healthcare provider and pharmacist about all medications and supplements you take.

Available information has not identified a drug-associated risk of major birth defects, miscarriage, or other adverse pregnancy outcomes with budesonide use during pregnancy. However, corticosteroid use during pregnancy may carry potential risks, so Entocort should be used only if clearly needed.

Tell your healthcare provider if you are pregnant, think you may be pregnant, or plan to become pregnant.

Budesonide passes into breast milk in small amounts. Available information suggests that the amount reaching a breastfed infant is expected to be low, but you and your healthcare provider should discuss the benefits of breastfeeding and your need for treatment.

Discuss the potential risks and benefits with your healthcare provider before breastfeeding while taking this medication.

The safety and effectiveness of Entocort have been established in children 8 to 17 years of age who weigh more than 25 kg for the treatment of mild to moderate active Crohn's disease involving the ileum and/or ascending colon. Safety and effectiveness have not been established in children younger than 8 years of age or in children weighing 25 kg or less.

Clinical studies did not include enough adults aged 65 years and older to determine whether they respond differently from younger adults. Because older adults may be more sensitive to corticosteroid-related side effects, they may require closer monitoring during treatment.

Older adults may require additional monitoring depending on kidney function, other medical conditions, and other medications being taken.

Kidney impairment

No specific dose adjustment is recommended for people with kidney impairment. Although budesonide has not been specifically studied in patients with reduced kidney function, an increased risk of side effects is not expected because the active drug is not eliminated unchanged by the kidneys.

Liver impairment

Liver problems can increase the amount of budesonide in your body. If you have moderate to severe liver disease, your healthcare provider may monitor you more closely for steroid-related side effects and may consider reducing your dose.

If you miss a dose of Entocort, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and take your next dose at the usual time.

Do not take extra medication to make up for a missed dose unless specifically instructed by your healthcare provider.

If you believe you have taken too much Entocort, contact a healthcare professional or Poison Control promptly.

Store Entocort:

At 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F to 86°F).

Protect from light

Protect from moisture

Keep in original container

Away from children and pets

Do not use medication that is expired, damaged, or stored improperly.