Generic Name: budesonide (Oral route)
Commonly used brand name(s)
In the U.S.
- Entocort EC
- Pulmicort Spacer
Available Dosage Forms:
- Capsule, Delayed Release
- Tablet, Extended Release
- Capsule, Extended Release
Therapeutic Class: Endocrine-Metabolic Agent
Pharmacologic Class: Adrenal Glucocorticoid
Uses For Entocort EC
Budesonide is used to treat an inflammatory bowel disease called Crohn's disease. This medicine works inside the intestine (bowel) to reduce inflammation and symptoms of the disease. It also helps keep the symptoms of Crohn's disease from coming back. Budesonide is a steroid (cortisone-like) medicine.
Budesonide extended-release tablets are used to help get active mild to moderate ulcerative colitis under control (induce remission).
This medicine is available only with your doctor's prescription.
Before Using Entocort EC
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of budesonide capsules in children 8 years to 17 years of age and weighing more than 25 kilograms (kg). However, safety and efficacy have not been established in children younger than 8 years of age, or in children 8 to 17 years of age and weighs 25 kg or less.
Appropriate studies have not been performed on the relationship of age to the effects of budesonide extended release tablets in the pediatric population. Safety and efficacy have not been established. Because budesonide may cause slowed growth in children, those who will be taking it for a long time should have their weight and growth measured by the doctor regularly.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of budesonide in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving budesonide.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amtolmetin Guacil
- Choline Salicylate
- Flufenamic Acid
- Mefenamic Acid
- Niflumic Acid
- Nimesulide Beta Cyclodextrin
- Salicylic Acid
- Sodium Salicylate
- Tiaprofenic Acid
- Tolfenamic Acid
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Cataracts (eye disease), or a family history of or
- Diabetes, or a family history of or
- Eczema (skin disease) or
- Glaucoma, or a family history of or
- Hypertension (high blood pressure) or
- Infection (eg, bacteria, virus, fungus) or
- Osteoporosis (thin bones) or
- Rhinitis (inflammation inside your nose) or
- Stomach ulcer, active or history of or
- Tuberculosis, active or history of or
- Weakened immune system—Use with caution. May make these conditions worse.
- Liver disease (including cirrhosis), moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of budesonide
This section provides information on the proper use of a number of products that contain budesonide. It may not be specific to Entocort EC. Please read with care.
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without first checking with your doctor.
This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor or pharmacist if you have any questions.
Swallow the capsule and extended-release tablet whole. Do not break, crush, chew, or open it.
Keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.
Grapefruits and grapefruit juice may increase the effects of budesonide by increasing the amount of this medicine in your body. You should not eat grapefruit or drink grapefruit juice while you are taking this medicine.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (capsules):
- For mild to moderate Crohn's disease:
- Adults—9 milligrams (mg) once a day in the morning for up to 8 weeks. Your doctor may adjust your dose as needed.
- Children 8 to 17 years of age and weighing more than 25 kilograms (kg)—At first, 9 mg once a day in the morning for up to 8 weeks, followed by 6 mg once a day in the morning for 2 weeks.
- Children 8 to 17 years of age and weighing 25 kg or less—Use and dose must be determined by your doctor.
- Children younger than 8 years of age—Use and dose must be determined by your doctor.
- For prevention of symptoms of Crohn's disease from coming back:
- Adults—6 milligrams (mg) once a day in the morning for up to 3 months. Your doctor may adjust your dose as needed.
- Children—Use and dose must be determined by your doctor.
- For mild to moderate Crohn's disease:
- For oral dosage form (extended-release tablets):
- For mild to moderate ulcerative colitis:
- Adults—9 milligrams (mg) once a day in the morning for up to 8 weeks.
- Children—Use and dose must be determined by your doctor.
- For mild to moderate ulcerative colitis:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using Entocort EC
It is very important that your doctor check your progress at regular visits for any problems or unwanted effects that may be caused by this medicine.
If your condition does not improve or if it become worse, check with your doctor.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these side effects occur, get emergency help at once.
Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you have more than one of these symptoms while you are using this medicine: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
If you are taking another steroid medicine and will switch to Uceris™, check first with your doctor. This may increase your chance of having steroid withdrawal side effects, such as headache, loss of appetite, blurred vision, change in the ability to see colors (especially blue or yellow), or vomiting.
You may get infections more easily while using this medicine. Avoid people who are sick or have infections. Tell your doctor right away if you have been exposed to someone with chickenpox or measles.
Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Entocort EC Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:More common
- Bruising easily
- cough or hoarseness
- flu-like symptoms
- sore throat
- Abdominal or stomach pain
- bladder pain
- bleeding after defecation
- bloody or cloudy urine
- blurred vision
- burning while urinating
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain
- cough producing mucus
- decreased urine
- difficult or labored breathing
- difficult or painful urination
- dry mouth
- eye pain
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling of warmth
- general feeling of discomfort or illness
- increase in body movements
- increased thirst
- increased urge to urinate during the night
- irregular heartbeat
- joint pain
- loss of appetite
- lower back or side pain
- mood changes
- muscle aches and pains
- nausea or vomiting
- numbness or tingling in the hands, feet, or lips
- pain or discomfort in the chest, upper stomach, or throat
- pounding in the ears
- rectal bleeding
- redness of the face, neck, arms, and occasionally, upper chest
- runny nose
- severe constipation
- shakiness in the legs, arms, hands, or feet
- slow or fast heartbeat
- stomach cramps
- swelling of the legs and feet
- swelling or puffiness of the face
- tightness in the chest
- trouble sleeping
- uncomfortable swelling around the anus
- unusual tiredness or weakness
- upper abdominal or stomach pain
- waking to urinate at night
- weight gain
- weight loss
- Bulging soft spot on the head of an infant
- change in the ability to see colors, especially blue or yellow
- difficulty with swallowing
- hives, itching, or skin rash
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Acid or sour stomach
- blemishes on the skin
- pain or tenderness around the eyes and cheekbones
- rounded or moon face
- stomach discomfort, upset, or pain
- stuffy nose
- Accumulation of pus
- blistering, crusting, irritation, itching, or reddening of the skin
- bloated or full feeling
- change in hearing
- changes in vision
- cracked, dry, or scaly skin
- cracks in the skin at the corners of mouth
- difficulty having a bowel movement (stool)
- difficulty with moving
- dizziness or lightheadedness
- ear drainage
- earache or pain in the ear
- excess air or gas in the stomach or intestines
- feeling of constant movement of self or surroundings
- hair loss or thinning of the hair
- increased appetite
- increased hair growth, especially on the face
- lack or loss of strength
- loss of memory
- muscle pains or stiffness
- pain, swelling, or redness in the joints
- passing gas
- pinpoint red or purple spots on the skin
- pressure in the stomach
- problems with memory
- redness, swelling, or soreness of the tongue
- sensation of spinning
- skin rash
- skin rash, encrusted, scaly, and oozing
- sleepiness or unusual drowsiness
- soreness or redness around the fingernails and toenails
- swelling of the abdominal or stomach area
- swollen joints
- uterine bleeding between menstrual periods
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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