Information on Entocort Ec

24 Hour Capsule 

Chemical Name: BUDESONIDE (byoo-DESS-oh-nide)

Common uses
Entocort Ec 3mg is a glucocorticosteroid used to treat Crohn's disease. 

Before using
Some medicines or medical conditions may interact with Entocort Ec 3mg. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE ENTOCORT EC 3mg if you are also taking mifepristone. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITIONS may be needed if you are taking ketoconazole Erectosil, itraconazole, ritonavir, indinavir, saquinavir, rifampin, or macrolides (e.g., erythromycin, clarithromycin). Inform your doctor of any other medical conditions, including liver disease, high blood pressure, osteoporosis, stomach ulcers, cataracts, glaucoma, allergies, pregnancy, or breast-feeding. Contact your doctor or pharmacist if you have any questions or concerns about taking Entocort Ec 3mg. 

Directions
Follow the directions for using Entocort Ec 3mg provided by your doctor. ENTOCORT EC 3mg COMES WITH A PATIENT INFORMATION LEAFLET. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about Entocort Ec 3mg. TAKE ENTOCORT EC 3mg in the morning at the same time every day. SWALLOW WHOLE. Do not break, crush, or chew before swallowing. AVOID EATING GRAPEFRUIT OR GRAPEFRUIT JUICE while you are taking Entocort Ec 3mg. STORE ENTOCORT EC 3mg at room temperature at 77 degrees F (25 degrees C) in a tightly-closed container away from heat and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. IF YOU MISS A DOSE OF ENTOCORT EC 3mg and you are taking 1 dose daily, take the missed dose if you remember the same day. Skip the missed dose if you do not remember until the next day. DO NOT TAKE 2 doses at once. 

Cautions
DO NOT TAKE ENTOCORT EC 3mg if you have had an allergic reaction to it or if you are allergic to any ingredient in this product. DO NOT EXCEED THE RECOMMENDED DOSE or take Entocort Ec 3mg for longer than prescribed without checking with your doctor. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are taking Entocort Ec 3mg. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to Entocort Ec 3mg. Using Entocort Ec 3mg alone, with other medicines, or with alcohol, may lessen your ability to drive or to perform other potentially dangerous tasks. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using Entocort Ec 3mg or have used it in the past. IF YOUR SYMPTOMS DO NOT IMPROVE or if they become worse, contact your doctor. CORTICOSTEROIDS MAY LOWER YOUR ABILITY TO FIGHT INFECTION or may cause infections to be more severe. The risk may be greater if you take them for a long time. Avoid contact with people who have infections such as colds, chickenpox, measles, or tuberculosis (TB). Tell your doctor right away if you have contact with anyone who has these infections. Tell your doctor if you develop symptoms such as fever, sore throat, rash, or chills. Check with your doctor if you have questions about your risk of infection. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of taking Entocort Ec 3mg during pregnancy. ENTOCORT EC 3mg IS EXCRETED IN BREAST MILK. DO NOT BREAST-FEED while taking Entocort Ec 3mg. IF YOU HAVE DIABETES, Entocort Ec 3mg may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine. 

Possible side effects
SIDE EFFECTS that may occur while taking Entocort Ec 3mg include headache, nausea, vomiting, dizziness, back pain, upset stomach or gas, changes in menstrual cycle, nervousness, tremor, and trouble sleeping. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience a sudden increase in weight, acne, unusual bruising, swollen ankles or face, change in mood or behavior, confusion, chest pain, vision changes, or severe headache. AN ALLERGIC REACTION to Entocort Ec 3mg is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, or trouble breathing. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 

Drug interactions
Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other. Check drug interactions 

If you take too much
IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. 

Additional information
Carry an identification card at all times that says you are taking Entocort Ec 3mg. DO NOT SHARE ENTOCORT EC 3mg with others for whom it was not prescribed. DO NOT USE ENTOCORT EC 3mg for other health conditions. KEEP ENTOCORT EC 3mg out of the reach of children. IF YOU WILL BE USING ENTOCORT EC 3mg FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out. 

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Selected data included with permission and copyrighted by Medi-Span, 2011. This copyrighted material has been downloaded from a Licensed data provider and is not for distribution in professional healthcare settings.
The name and strength of the drug discussed above has been provided for clarity by drugstore.com, inc. and without the express permission of Medi-Span, and Medi-Span makes no representation as to the accuracy of such additional information.

Entocort EC Drug Description

Budesonide, the active ingredient of ENTOCORT® EC (budesonide) capsules, is a synthetic corticosteroid. It is designated chemically as (RS)-11β, 16α, 17,21-tetrahydroxypregna-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 Vigora molecular weight is 430.5. Its structural formula is:

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 inchloroform. Its partition coefficient between octanol and water at pH 5 is 1.6 x 10³ ionic strength 0.01.

Each capsule 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.

SIDE EFFECTS:Budesonide capsules usually have fewer side effects than other corticosteroids because budesonide works in the gut and only small amounts are absorbed into the body. Nausea, heartburn, and headache, may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Because this drug works by weakening the immune system, it may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor immediately if you have any signs of infection (such as cough, sore throat, fever, chills). Use of this medication for prolonged or repeated periods may result in oral thrush or a yeast infection. Contact your doctor if you notice white patches in your mouth or a change in vaginal discharge.

Tell your doctor immediately if any of these rare but serious side effects occur: unusual tiredness, vision problems, easy bruising/bleeding, puffy face, unusual hair growth, mental/mood changes (such as depression, mood swings, agitation), muscle weakness/pain, thinning skin, slow wound healing.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: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 more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past 12 months. Tell your doctor immediately if you develop unusual/extreme tiredness or weight loss. If you will be using this medication for a long time, carry a warning card or medical ID bracelet that identifies your use of this medication.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit alcoholic beverages. Consult your doctor or pharmacist for more information.

This medication may mask signs of infection. It can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Budesonide may cause vaccines not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

This medication may slow down a child's growth if used for a long time. Consult the doctor or pharmacist for more details. See the doctor regularly so your child's height and growth can be checked.

During pregnancy, budesonide should be used only when clearly needed. Discuss the risks and benefits with your doctor. Infants born to mothers who have used corticosteroids for a long time may have hormone problems. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness.

This drug passes into breast milk and may have undesirable effects in a nursing infant. Consult your doctor before breast-feeding.