budesonide (Oral route)

bue-DES-oh-nide

Commonly used brand name(s):

In the U.S.

• Entocort EC

In Canada

• Pulmicort
• Pulmicort Spacer

Available Dosage Forms:

• Capsule, Delayed Release
• Capsule, Extended Release

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Adrenal Glucocorticoid

Uses For budesonide

Budesonide is used to treat an inflammatory bowel disease called Crohn's disease. budesonide works inside the intestine (bowel) to reduce inflammation and symptoms of the disease. Budesonide is a steroid (cortisone-like medicine).

budesonide is available only with your doctor's prescription.

Before Using budesonide

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 budesonide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to budesonide 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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of budesonide in the pediatric population. Safety and efficacy have not been established.

Geriatric

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.

Pregnancy

Breast Feeding

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

Using budesonide 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.

• Bupropion

Using budesonide 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.

• Erythromycin
• Itraconazole
• Ketoconazole

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Using budesonide 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 budesonide, 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 budesonide. Make sure you tell your doctor if you have any other medical problems, especially:

• Cataracts (eye disease) or
• Diabetes, or a family history of or
• Glaucoma, or a family history of or
• Hypertension (high blood pressure) or
• Immune system problems or
• Osteoporosis (thin bones) or
• Stomach ulcer, active or history of or
• Tuberculosis, active or history of—Use with caution. May make these conditions worse.

• Liver disease (including cirrhosis)—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Proper Use of budesonide

Take budesonide 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 budesonide without first checking with your doctor.

budesonide comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Swallow the capsule whole. Do not chew, crush, or open it.

Keep using budesonide for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.

Dosing

The dose of budesonide 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 budesonide. 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 Crohn's disease:
    • Adults—9 milligrams (mg) once a day in the morning. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of budesonide, 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.

Storage

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 budesonide

It is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by budesonide.

If your condition does not improve or if it become worse, check with your doctor.

You may get infections more easily while using budesonide. 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 budesonide. You may need to stop using budesonide several days before having surgery or medical tests.

Grapefruits and grapefruit juice may increase the effects of budesonide by increasing the amount of budesonide in your body. You should not eat grapefruit or drink grapefruit juice while you are taking budesonide.

budesonide 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:

• Bruising easily
• chills
• colds
• cough or hoarseness
• fever
• flu-like symptoms
• sneezing
• sore throat

• Abdominal or stomach pain
• bleeding after defecation
• blurred vision
• burning while urinating
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain
• convulsions
• cough producing mucus
• decreased urine
• diarrhea
• difficult or labored breathing
• difficult or painful urination
• dizziness
• dry mouth
• eye pain
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling of warmth
• general feeling of discomfort or illness
• headache
• heartburn
• increase in body movements
• increased thirst
• increased urge to urinate during the night
• irregular heartbeat
• joint pain
• loss of appetite
• mood changes
• muscle aches and pains
• nausea or vomiting
• nervousness
• 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
• shivering
• shortness of breath
• slow or fast heartbeat
• stomach cramps
• sweating
• 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
• waking to urinate at night
• weight gain
• weight loss
• wheezing

• 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
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• skin rash

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:

• Acid or sour stomach
• belching
• blemishes on the skin
• heartburn
• indigestion
• pain or tenderness around the eyes and cheekbones
• pimples
• rounded or moon face
• stomach discomfort, upset, or pain
• stuffy nose

• Accumulation of pus
• agitation
• blistering, crusting, irritation, itching, or reddening of the skin
• change in hearing
• changes in vision
• cracked, dry, or scaly skin
• difficulty with moving
• dizziness or lightheadedness
• ear drainage
• earache or pain in the ear
• 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
• nervousness
• pain, swelling, or redness in the joints
• pinpoint red or purple spots on the skin
• problems with memory
• redness, swelling, or soreness of the tongue
• sensation of spinning
• skin rash cracks in the skin at the corners of mouth soreness or redness around the fingernails and toenails
• skin rash, encrusted, scaly, and oozing
• sleepiness or unusual drowsiness
• sleeplessness
• swollen joints
• unable to sleep
• 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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