Entocort EC

ENTOCORT® EC
(budesonide)

Entocort EC

DRUG DESCRIPTION

Budesonide, the active ingredient of ENTOCORT EC capsules, is a synthetic corticosteroid. Budesonide is designated chemically as (RS)-11β, 16α, 17,21tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is:

ENTOCORT® EC (budesonide) Structural Formula Illustration

Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water and heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 5 is 1.6 x 103 ionic strength 0.01.

Each capsule for oral administration contains 3 mg of micronized budesonide with the following inactive ingredients: ethylcellulose, acetyltributyl citrate, methacrylic acid copolymer type C, triethyl citrate, antifoam M, polysorbate 80, talc, and sugar spheres. The capsule shells have the following inactive ingredients: gelatin, iron oxide, and titanium dioxide.

What are the possible side effects of budesonide (Entocort EC)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist);
  • increased blood pressure (severe headache, fast or uneven heart rate, blurred vision); or
  • general ill feeling with headache, tiredness, nausea, and vomiting.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Entocort EC »

What are the precautions when taking budesonide (Entocort EC)?

Before taking budesonide, tell your doctor if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye disease (such as cataracts, glaucoma), high blood pressure, liver disease, thyroid problems, diabetes, stomach/intestinal problems (such as diverticulitis, ulcer), brittle bones (osteoporosis), current/past infections (such as tuberculosis, positive tuberculosis test, herpes, fungal), bleeding problems, mental/mood conditions (such as psychosis, anxiety, depression).

Using corticosteroid medications for a long time can make it...

Read All Potential Precautions of Entocort EC »

Last reviewed on RxList: 1/10/2012
This monograph has been modified to include the generic and brand name in many instances.

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Entocort EC - User Reviews

Entocort EC User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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